Aesthetics april 2014

VOLUME 1/ISSUE 5 - APRIL 2014

ELEGANT • FULFILLED • MY TIME

Prescribing Information can be found on the inside front cover Date of preparation March 2014 1137/BOC/NOV/2013/LD

Cosmeceutical ingredients - CPD Dr Sandeep Cliff and Dr Carolina Fernandez explore commonly used skincare ingredients. CPD accredited article

Treating pigmentation

Periorbital rejuvenation

Imaging in aesthetics

A roundtable discussion on the treatment of pigmentation with lasers and lights

Mr Taimur Shoaib and Dr Raj Acquilla explain a new treatment protocol for total eye area revitalisation

Nicolas MiedzianowskiSinclair on the importance of taking good patient photographs

When it comes to evidence you’re safe with Radiesse…

FDA approved for aesthetic & therapeutic indications1 The most studied safety profile of any dermal filler2 Biocompatible, safe & versatile1

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1. Sadick N, et al A Multicentre, 47 month Study of Safety & Efficacy of Calcium Hydroxylapatite for Soft-Tissue Augmentation of Nasolabial Folds and Other Areas of the Face. Dermatol Surg 2007; 33 (Supp 2): s112-s127.

2. DoF-1-001_01

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Date of preparation: December 2013 RAD074/0813/LD

Bocouture® 50 Abbreviated Prescribing Information Please refer to the Summary of Product Characteristics (SmPC). Presentation 50 LD50 units of Botulinum toxin type A (150 kD), free from complexing proteins as a powder for solution for injection. Indications Temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at frown (glabellar frown lines) in adults under 65 years of age when the severity of these lines has an important psychological impact for the patient. Dosage and administration Unit doses recommended for Bocouture are not interchangeable with those for other preparations of Botulinum toxin. Reconstitute with 0.9% sodium chloride. Intramuscular injection (50 units/1.25 ml). Standard dosing is 20 units; 0.1 ml (4 units): 2 injections in each corrugator muscle and 1x procerus muscle. May be increased to up to 30 units. Not recommended for use in patients over 65 years or under 18 years. Injections near the levator palpebrae superioris and into the cranial portion of the orbicularis oculi should be avoided. Contraindications Hypersensitivity to Botulinum neurotoxin type A or to any of the excipients. Generalised disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome). Presence of infection or inflammation at the proposed injection site.

Special warnings and precautions. Should not be injected into a blood vessel. Not recommended for patients with a history of dysphagia and aspiration. Adrenaline and other medical aids for treating anaphylaxis should be available. Caution in patients receiving anticoagulant therapy or taking other substances in anticoagulant doses. Caution in patients suffering from amyotrophic lateral sclerosis or other diseases which result in peripheral neuromuscular dysfunction. Too frequent or too high dosing of Botulinum toxin type A may increase the risk of antibodies forming. Should not be used during pregnancy unless clearly necessary. Interactions Concomitant use with aminoglycosides or spectinomycin requires special care. Peripheral muscle relaxants should be used with caution. 4-aminoquinolines may reduce the effect. Undesirable effects Usually observed within the first week after treatment. Localised muscle weakness, blepharoptosis, localised pain, tenderness, itching, swelling and/or haematoma can occur in conjunction with the injection. Temporary vasovagal reactions associated with pre-injection anxiety, such as syncope, circulatory problems, nausea or tinnitus, may occur. Frequency defined as follows: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10,000, < 1/1000); very rare (< 1/10,000). Infections and infestations; Uncommon: bronchitis, nasopharyngitis, influenza infection. Psychiatric disorders; Uncommon: depression, insomnia Nervous system disorders; Common: headache. Uncommon: facial paresis (brow ptosis), vasovagal syncope, paraesthesia, dizziness. Eye disorders; Uncommon: eyelid oedema, eyelid ptosis, blurred vision, eye

disorder, blepharitis, eye pain. Ear and Labyrinth disorders; Uncommon: tinnitus. Gastrointestinal disorders; Uncommon: nausea, dry mouth. Skin and subcutaneous tissue disorders; Uncommon: pruritus, skin nodule, photosensitivity, dry skin. Musculoskeletal and connective tissue disorders; Common: muscle disorders (elevation of eyebrow), sensation of heaviness; Uncommon: muscle twitching, muscle cramps. General disorders and administration site conditions Uncommon: injection site reactions (bruising, pruritis), tenderness, Influenza like illness, fatigue (tiredness). General; In rare cases, localised allergic reactions; such as swelling, oedema, erythema, pruritus or rash, have been reported after treating vertical lines between the eyebrows (glabellar frown lines) and other indications. Overdose May result in pronounced neuromuscular paralysis distant from the injection site. Symptoms are not immediately apparent post-injection Bocouture® may only be used by physicians with suitable qualifications and proven experience in the application of Botulinum toxin Legal Category: POM. List Price 50 U/vial £72.00 Product Licence Number: PL 29978/0002 Marketing Authorisation Holder: Merz Pharmaceuticals GmbH, Eckenheimer Landstraße 100, 60318 Frankfurt/Main, Germany. Date of revision of text: November 2013.

Full prescribing information and further information is available from Merz Pharma UK Ltd., 260 Centennial Park, Elstree Hill South, Elstree, Hertfordshire WD6 3SR.Tel: +44 (0) 333 200 4143 Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Merz Pharma UK Ltd at the address above or by email to medical.information@merz.com or on +44 (0) 333 200 4143.

1. Bocouture 50U Summary of Product Characteristics. Bocouture SPC 2012 September Available from: URL: http://www.medicines.org.uk/emc/medicine/23251. 2. Prager, W et al. Onset, longevity, and patient satisfaction with incobotulinumtoxinA for the treatment of glabellar frown lines: a single-arm prospective clinical study. Clin. Interventions in Aging 2013; 8: 449-456. 3. Sattler, G et al.

Noninferiority of IncobotulinumtoxinA, free from complexing proteins, compared with another botulinum toxin type A in the treatment of glabelllar frown lines. Dermatol Surg 2010; 36: 2146-2154.

4. Prager W, et al. Botulinum toxin type A treatment to the upper face: retrospective analysis of daily practice. Clin. Cosmetic Invest Dermatol 2012; 4: 53-58. 5. Data on File: BOC-DOF-11-001_01 Bocouture® is a registered trademark of Merz Pharma GmbH & Co, KGaA. Date of preparation: March 2014 1137/BOC/NOV/2013/LD

Contents • April 2014 INSIDER 06 News The latest product and industry news 14 On the Scene Out and about in the industry this month 17 On the Scene: HEE Workshop We report on the Health Education England stakeholder workshop 18 Aesthetics Conference and Exhibition Report The highlights from ACE 2014

CLINICAL PRACTICE Cosmeceutical ingredients Page 28

CLINICAL PRACTICE 22 Special Feature: Treating Pigmentation We ask a panel of practitioners to discuss the benefits of using lasers and lights to treat pigmentation 28 CPD Clinical Article Dr Sandeep Cliff and Dr Carolina Fernandez explore common effective skincare ingredients 34 Treatment Focus Dr Ahmed Al-Qahtani discusses the use of growth factors to prevent skin ageing

IN PRACTICE Imaging in aesthetics Page 52

38 Techniques Mr Taimur Shoaib and Dr Raj Acquilla explain a new treatment protocol for periorbital rejuvenation 42 Clinical Focus Dr Askari Townshend on patient safety in injectables 44 Spotlight On We discuss the Silhouette Soft thread lift with surgeon Angelica Kavouni

Clinical contributors Dr Sandeep Cliff is a consultant dermatologist and dermatological surgeon based in London and Surrey. He has lectured extensively both nationally and internationally on facial rejuvenation.

46 Clinical Focus Dr Mervyn Patterson offers advice on understanding clinical studies 50 Abstracts The latest clinical studies

Dr Carolina Fernandez is a clinical teaching fellow in dermatology based at St. Helier Hospital. She graduated in Medicine from Imperial College London in 2009 and obtained a BSc in Neuroscience.

IN PRACTICE

Dr Al-Qahtani is a National Institutes of Health (NIH) scientist and is accredited with numerous scientific.

He is also an assistant professor with the faculty of medicine at United Arab Emirates University.

52 Consultation Protocols Nicolas Miedzianowski-Sinclair on the importance of taking good patient photographs

Mr Taimur Shoaib is a specialist consultant plastic surgeon with over 20 years of medical experience. He runs a cosmetic practice at his clinic in Glasgow, and is a Faculty Member of the Allergan Medical Institute.

56 Documentation Dr Natalie Blakely and lawyer Mandy Luckman discuss the legal and ethical issues surrounding consent

Dr Raj Acquilla is a cosmetic dermatologist with over 11 years experience in facial aesthetic medicine. He is a UK ambassador and masterclass trainer in botulinum toxin and dermal fillers.

60 Revalidation Taruna Chauhan explains how to meet the four domains of good medical practice

Dr Askari Townshend is an international Sculptra trainer as well as lead UK Sculptra trainer and medical consultant for Sinclair Pharma. His interests include injectables, lasers and peels.

62 In Profile We speak to Dr Tracy Mountford about building a successful clinic

Dr Mervyn Patterson is a co-owner of Woodford Medical and has worked in aesthetic medicine for the past 15 years. He specialises in the latest injectable anti-ageing treatments.

64 The Last Word Simon McMillan argues that greater data transparency would aid patients and practitioners

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Editor’s letter This issue of Aesthetics is, sadly, my last as I complete my temporary role as launch Editor of the revamped journal and move on to focus on my increasing consumer-facing writing. I have very much enjoyed the role, working with fantastic Leah Hardy contributors from the aesthetics community and Editor helping to build an outstanding editorial team.

Together we have completed the first stage of the journal, making the transition from its previous identity as Cosmetic News to Aesthetics.

From May, the journal will be led by a new Editor who will continue to move Aesthetics in a more clinical and educational direction, focussed on delivering the skills and knowledge required by today’s medical aesthetic practitioners.

This month saw the hugely successful Aesthetics Conference and Exhibition (ACE) held in London on March 8 and 9. Over 1,600 visitors attended the event over the two days, which featured more than 90 exhibitors along with opportunities to hear from over 60 speakers on a huge range of topics plus live expert clinical demonstrations. The new Question Time was a hugely popular session on the Saturday evening, one that provided a useful and engaging forum for discussion of some of the foremost issues in our industry today. We were also delighted to be in attendance at the Health Education England Non-surgical Cosmetic Interventions workshop in February, where stakeholders discussed issues surrounding training and qualifications. We are

hopeful that this type of discourse between key individuals, groups and associations will help to promote high standards in aesthetic medicine and are positive steps on the road to ensuring patient safety.

This month the journal has a focus on dermatology and we spoke with a distinguished panel to discuss treatments and techniques when treating pigmentation, in this case, focusing on the use of lasers and lights. Dr Sandeep Cliff and Dr Carolina Fernandez have produced an informative CPD accredited article on commonly used cosmeceutical ingredients. You can also find out about Allergan’s new periorbital treatment protocol from Dr Raj Acquilla and Mr Taimur Shoaib. In our business section, Nick Miedzianowski-Sinclair discusses the vital importance of imaging in aesthetics, both to protect the clinician and to help the patient. Dr Natalie Blakely and specialist lawyer Mandy Luckman also answer key questions on obtaining and storing consent from patients. Discussion, awareness and understanding of these ethical issues is vital in this new era of aesthetics where in the absence of effective government regulation, practitioners themselves must take responsibility for patient education and the highest professional standards. I know Aesthetics will continue to press for, and support, an even better, safer and more successful cosmetic medicine profession in the UK. Finally, we are the first to acknowledge when we get something wrong and I would like to apologise for an error in the March issue of Aesthetics for which a retraction has been issued on page six of this month’s journal.

Editorial advisory board We are honoured that a number of leading figures from the medical aesthetic community have joined Aesthetics journal’s editorial advisory board to help steer the direction of educational, clinical and business content Dr Mike Comins is president and Fellow of the British College

Amanda Cameron is a sales and marketing professional,

of Aesthetic Medicine. He is part of the cosmetic interventions working group, and is on the faculty for the European College of Aesthetic Medicine. Dr Comins is also an accredited trainer for advanced Vaser liposuction, having performed over 3000 Vaser liposuction treatments.

and was one of the first nurse injector trainers in the UK for dermal fillers. With over 20 years experience in the industry in both the UK and Europe, Amanda has extensive knowledge of medical aesthetics and business development.

Mr Adrian Richards is a plastic and cosmetic surgeon with

Dr Sarah Tonks is an aesthetic doctor and previous

12 years of specialism in plastic surgery at both NHS and private clinics. He is a member of the British Association of Plastic and Reconstructive Surgeons (BAPRAS) and the British Association of Aesthetic Plastic Surgeons (BAAPS). He has won numerous awards and has written a best-selling textbook.

maxillofacial surgery trainee with dual qualifications in both medicine and dentistry, who fell in love with the results possible through minimally invasive methods. Now based at Beyond Medispa in Harvey Nichols, she practises cosmetic injectables and hormonal based therapies.

Sharon Bennett is currently vice chair of the British

Dr Nick Lowe is president of the BCDG and a consultant

Association of Cosmetic Nurses (BACN) and also the UK lead on the BSI committee for aesthetic non-surgical medical standard.

Sharon has been developing her practice in aesthetics for 25 years and has recently taken up a board position with the UK Academy of Aesthetic Practitioners (UKAAP).

dermatologist with over 30 years of experience who practises in London and California. Dr Lowe is Clinical Professor of Dermatology at the UCLA School of Medicine in Los Angeles, as well as director of a clinical research company specialising in skin ageing.

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Insider News

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Retraction We wish to retract a statement made in our News Special IMCAS 2014 article, published in the March 2014 issue of Aesthetics journal. The statement, which alluded to a tissue regenerator causing multiple cases of spontaneous permanent blindness when injected into the temple region with a needle, was unfounded. We are not aware of any medical practitioner or evidence in support of this claim.

There have been over 20 clinical studies conducted in over 4000 patients in the use of poly-L-lactic acid, with excellent safety and efficacy data. We deeply regret the effect that the publication of this unfounded statement may have had on Sinclair IS Pharma and its product Sculptra, and urge all readers to disregard the remark made.

Talk Aesthetics

The venue for the prestigious Aesthetics Awards 2014 has been revealed as the luxurious Park Plaza Westminster Bridge Hotel in Central London. The event, to be held in the evening of Saturday, December 6, follows the success of the 2013 Awards, where 23 winners were honoured during a glamorous ceremony attended by 500 guests. Entry for the 2014 Awards will be open in May, when guests will also be able to book tickets to the event, with the finalists to be announced in September.

Skincare

Dermagenica launch Advanced Molecular Mask

#ACE2014 Special Regency Aesthetics /@Regency_Clinic This weekend Dr Parekh attended the @AestheticsGroup Conference. A great event focusing solely on the medical aesthetics industry

Dermagenica has launched its Advanced Molecular Mask, intended to target the visible signs of premature ageing. The mask is paraben free, silk protein based and impregnated with Botanical Stem Cells. By supporting long lasting hydration, strengthening skin carrier, restoring optimal cutaneous pH and stimulating cellular regeneration, the product is designed to provide significant improvements in skin suppleness, skin tone, fine lines and irritation.

Dr Tapan Patel/@drtapanp Exhausted after a full on day at #ACE2014 with @RajAcquilla but delighted to have such an enthusiastic delegation!

Sue Ibrahim/@SkinSpecialist @LornaBowes I thought your peel masterclass was excellent yesterday. #ACE2014

Radiofrequency

Elite Aesthetics/@Elite_Aesthetic @DrSarahTonks fab lecture on lower face treatment and great seeing you again #ACE2014 sharonbennettskin/@sharonbennettuk @aestheticsgroup Question Time with Peter Sissons great. Result=no one should be injecting without a medical and prescribing qualification.

Dr Leah/@DrLeahTotton Honoured to have been on the expert panel for question time at ‘Aesthetics Conference 2014’ this evening #ace2014

Adare Aesthetics launch Scarlet RF at the ACE 2014 Adare Aesthetics has launched the Scarlet fractional radio frequency device after being appointed sole distributor for the UK and Ireland

by South Korean manufacturer Viol. Scarlet RF delivers concentrated radio waves together with 25 needles to both the epidermal and deep layers of the dermis. Needle depths are between 0.5mm and 3mm, which allows treatment of both the face and body. Indications include lines and wrinkles, scars, stretch marks, pigmentation and body tightening.

Peels

Mesoestetic launches new chemical peel range

Juan Lopez/@Dermatops @aestheticsgroup #ACE2014 Congratulations for an excellent organisation. Great weekend.

Looking forward to next year’s conference. #ACE2015

If you would like to get in touch, email us at editorial@aestheticsjournal.com, or follow us at Twitter @aestheticsgroup and include #talkaesthetics in your comments.

6

Aesthetics Awards 2014 venue is announced

The Aesthetics Conference and Exhibition played host to the launch of mesopeel from mesoestetic on the weekend of March 8 2014. The new range consists of two families of peel; single acid peels which are available in various concentrations and combined acid peels, which are formulated with an exclusive combination of chemoexfoliation agents.

Mesopeel products can be combined, producing a bespoke treatment for patients.

Aesthetics | April 2014

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Sculptra celebrates 15th birthday Last month marked collagen stimulator Sculptra’s 15th year in the aesthetics market.

Sculptra obtained its CE mark in 1999, and went on to receive CE Mark and FDA approval for treatment of HIV lipoatrophy in 2004. It received FDA approval for use in aesthetics in 2009.

The product, distributed by Sinclair IS Pharma, is composed of poly L lactic acid, and is a resorbable agent that acts as a collagen stimulator by gradually restoring volume through deep tissue regeneration.

It is suitable for treating skin ageing and for increasing the volume of depressed areas, such as in skin creases, wrinkles, folds and scars. It can

also be used for large volume corrections of the signs of lipoatrophy.

When injected, the product immediately fills out the wrinkles and volume defects, before stimulating patients’ own facial collagen production. This results in a natural, soft, gradual buildup of the connective tissue, smoothing out wrinkles and contour defects.

The product provides a long-lasting effect of up to 25 months and has performed well in clinical studies; following a randomised, evaluator-blinded, multicentre study of 233 patients (116 treated with Sculptra and 117 with collagen), 80% of patients rated their results as ‘good to

Technology

excellent’ at 25 months after their first injection with Sculptra, and only 0.9% of patients reported pain at the injection site.

Dr Ayham Al-Ayoubi, facial, plastic and laser surgeon at London Medical and Aesthetic Clinic, who has performed over 4000 Sculptra procedures, said, “Sculptra provides gradual and natural facial volumisation with a subtle result, and makes the skin glow, as it stimulates fibroblasts to make collagen.

“Poly L-lactic acid has been used in medicine for 40 years; patients want safe treatments with longlasting results that are discrete, and the ultimate answer for that is Sculptra,” he said.

Dr Tracy Mountford, medical

director at The Cosmetic Skin Clinic, said, “I have used Sculptra successfully for 15 years now.

My patients love the results it delivers, as do I; it provides natural, soft volume replacement and support, which is naturally rejuvenating. Patients are also reassured by the fact that it has a long-standing safety record and that it is FDA approved.”

On the pharmaceutical company, Dr Al-Ayoubi said, “Sinclair IS Pharma have an ethical and honest approach, present the facts and put minimal pressure on doctors to purchase products.

They have a good training strategy for educating doctors, therapists and nurses, which is always improving.”

Research

Dr Leah Totton introduces practice management technology Qinec to clinic Dr Leah Totton has introduced patient management system QinecEnterprise to her new range of UK aesthetic practices.

The cloud-based platform aims to facilitate efficient and confidential diagnosis, care planning and patient monitoring by collating patient data. Dr Totton said, “I want to advance the industry through better use of technology, move away from archaic practices and offer innovative tools that make the journey more interactive.”

Qinec has recently also developed a new version of its iPad app for Dr Leah clinics that will enable Dr Totton and her team of practitioners to upload images of patients during consultation.

“The iPad app has great booking and data-keeping software, which means that we don’t double book appointments, and an interactive face that can be annotated for the purposes of before and after photos,” said Dr Totton. “This makes documentation paperless, which is the future for patient confidentiality. It’s stored in a very secure iCloud, ideal for high-profile patients.”

Qinec is currently serving nearly 1,000 clinics across the UK and abroad. “Qinec work with BUPA and have a great reputation that I could trust,” Dr Totton said. “They are forward thinking and integrate the latest software to help patients.”

Robbie Hughes, CEO of Qinec, said, “Leah’s forward thinking approach about how technology can change patient interaction and outcomes is setting a new standard and raising the bar for other clinics.”

Fat dissolving injection trials show positive results The US phase 3 trials of new fat dissolving injectable ATX-101 developed by biopharmaceutical company Kythera have and shown statistically significant reductions in submental fat (double chin). The results of the trials were presented by Dr Jean Curruthers at the annual meeting of the American Society for Dermatologic Surgery. Two identical multicenter, double-blind, randomised, placebo-controlled trials of more than 1,000 patients with moderate to severe submental fat were conducted, with 70.3% and 66.9% showing a clinically meaningful improvement in the first and second trials respectively. In the first study, MRI measurements showed a reduction in submental fat in 46.6% of patients compared to just 5.4% in the placebo group. In the second trial, 40% of those treated with ATX-101 had a measurable MRI result compared to 5.1% of those in the placebo group. Subjects also reported a visual and psychological improvement using the Patient-Reported Submental Fat Impact Scale. Common side effects reported included swelling, pain, bruising and numbness, but were temporary and only mildto-moderate in severity. ATX-101 is a proprietary formulation of a synthetic version of deoxycholic acid, a naturally occurring molecule in the body that aids in the breakdown of dietary fat. Further analysis of the data from the trial will be conducted in order to determine how many monthly treatments patients will need to receive to achieve this level of improvement. On March 10 Kythera announced the acquisition of rights to ATX-101 outside of the US and Canada from Bayer Consumer Care and are currently planning to file a New Drug Application for ATX-101 with the US. Food and Drug Administration in the second quarter of 2014.

Aesthetics | April 2014

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Business

Medik8 launches Ultimate Recovery Advanced Skin Repair cream

Ambicare Health and Healthxchange Pharmacy announce new partnership

British skin research company Medik8 has launched its Ultimate Recovery cream, which speeds up skin healing by promoting tissue renewal. The highly absorbent cream is designed to be used post-treatment to minimise downtime for those undergoing aesthetic procedures such as lasers, peels, skin needling and dermabrasion.

With ingredients such as Silk Serica, beta Glucan, Perfluorodecalin and Arnica, the product helps to restore the skin barrier function and improve the appearance of compromised skin.

Industry

WhatClinic.com announces winners of customer service awards Global clinic comparison site WhatClinic.com have announced the 2013 winners of their customer service awards. This year less than 1% of over 100,000 clinics listed on the site qualified for the award, which is based on feedback from customers over a twelve month period. Clinics were rated on how well customers were treated, how quickly they were contacted and seen, and patient satisfaction with the treatment.

DermalClinic in Edinburgh, was one of those honoured as having an excellent record of service and superior satisfaction record. DermalClinic’s Clinical Director, Jackie Partridge said “We are absolutely delighted to receive this award for the second year in a row. We are dedicated to ensuring excellent customer focus with everything we do.” Commenting on the importance of high standards of patient care, Jackie said, “Our methodology is simply to treat every patient as we would wish to be treated and the results speak for themselves as patients become friends and keep returning.”

Ambicare Health and Healthxchange Pharmacy have announced an exclusive UK Sales and Marketing Agreement for the distribution of Lustre Pro. Lustre Pure Light was launched two years ago with the faster Lustre Professional device replacing the Classic device in July 2013.

The blue light technology device for treatment of mild to moderate acne was highly commended for Best New Product or Treatment at the Aesthetics Awards 2013.

The device is only available through clinics but is intended for home use. Paul James Donnelly, CEO of Ambicare

Health Ltd, said, “We are delighted to announce this new and exciting partnership with Healthxchange Pharmacy who will provide full national coverage to our UK clinic customers.” Karen Hill, managing director for Healthxchange Pharmacy said, “We are always on the look out for truly effective technology. Lustre Pro has shown itself to deliver results for the acne sufferer.

The psychological impact on someone with acne is often hugely underrated and we are pleased to be able to offer a solution that avoids antibiotic and oral treatments.”

Practitioners & their patients feel the difference...

“The favourable safety profile has lead to high patient satisfaction and subsequent recommendations from one patient to another, increasing our practice1” n

Not palpable2 ®

No Tyndall Effect1 ®

Comfortable on injection2 ®

BEL065/0813/LD Date of Preparation: December 2013

1. Kuhne, U et al. Five-year retrospective review of safety, injected volumes, and longevity of the hyaluronic acid Belotero Basic for facial treatments in 317 patients. J Drugs Dermatol. 2012 Sep; 11(9):1032-5 2. Data on File: BEL-DOF2_001 Belotero Juvederm Study MRZ 90028_4007

Injectable Product of the Year 2013

®

Tel: +44(0) 333 200 4140 Fax: +44(0) 208 236 3526 Email: customerservices@merz.com

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Research

High-intensity ultrasound investigated as treatment for women’s back fat A dermatologist in the US is testing HIFU for ‘bra strap fat’, an area often complained about by patients. Dr Cheryl Karcher, assistant clinical professor of dermatology at the New York University Medical Centre, has been testing the treatment on the fibrous, dense subcutaneous fat on the back in patients with a BMI of less than 30, and good skin tightness. Dr Karcher has studied two different frequencies, a lower energy that takes an hour to treat, and a higher energy that takes 45 minutes. The average circumference of fat lost by her 12 patients has been 1.08 inches, with no significant safety concerns. Some patients experienced mild bruising and best results were seen after eight to 12 weeks. Dr Karcher says, “Our early results using HIFU to treat back and bra fat have been positive and well received by our patients, especially as this noninvasive technique doesn’t pose the risks associated with surgery.”

Clinogen Laboratories launch Aesthetic Vision Clinogen Laboratories has launched Aesthetic Vision professional magnifying glasses at the Aesthetics Conference and Exhibition 2014. The professional magnifying glasses for use during cosmetic procedures are super-lightweight and have twin LED lights and five magnification lenses.

The Cosmetic Skin Clinic awarded The UK’s Sculptra Clinic Of Excellence Dr Tracy Mountford, founder and medical director of The Cosmetic Skin Clinic, has been awarded the UK’s Sculptra Clinic of Excellence. Katrina Ellison, brand manager for Sculptra, presented the award and said of Dr Mountford, “Her skill and technique combined with the durability of results have ensured a loyal and growing clientele who love the gradual and natural results that Sculptra provides.”

Marketing

Transform Group win marketing award Transform Cosmetic Surgery Group has been announced as the winner of the Marketing Excellence Awards in the Healthcare category for its Transform Clear campaign. The campaign was found to have led to positive media perception, an increase in patient satisfaction levels, an increase in surgical consultations and a strengthening of position amongst 25-34 year olds.

The awards, run by the Chartered Institute of Marketing, champion outstanding work from across the marketing profession.

Acne

JLA holds acne treatment Priority Setting Partnership workshop The James Lind Alliance recently held a workshop for the JLA Acne Priority Setting Partnership. There, 24 patients and health care professionals debated what they felt were the most important unanswered questions about acne treatments, finally reaching agreement about the top ten priority areas for research to address. The key questions agreed on included: What management strategy should be adopted for the treatment of acne in order to optimise short and long-term outcomes? What is the best treatment for acne scars? What is the best way of preventing acne? Dr Alison Layton, consultant dermatologist and clinical lead of the Acne PSP said, “As a specialist who has been looking after patients suffering from acne for many years, it has been fascinating to understand what matters most to all those people with acne who I never see in my hospital-based clinic. It has also been revealing to see what my fellow healthcare professionals and those who treat acne outside the NHS regard as priorities for acne treatment research.”

JLA are a non-profit making initiative established to bring patients, carers and clinicians together to identify and prioritise the unanswered questions about treatments that they agree are most important.

Aesthetics | April 2014

Lumenis launches distribution operation in the UK Medical laser company Lumenis has launched a new customer service, sales and distribution operation in the United Kingdom. “We are delighted to be ramping up our customer service operation in the UK with direct sales and distribution capabilities,” said Remco Schmitz, regional sales director. The new specialist expert service team will cover the entire UK and has a service centre based near London in Elstree, Hertfordshire.

Nestlé creates Nestle Skin Health S.A. Nestlé has announced it will extend its activities to include the field of specialised medical skin treatments through the creation of Nestlé Skin Health S.A. The foundation will be the transfer of L’Oréal’s 50% stake in Galderma as part of a transaction in which Nestlé sells part of its shareholding in L’Oréal.

Sinclair IS Pharma acquires Atlean Pharmaceuticals company Sinclair IS Pharma has acquired GSK Stiefel’s dermal filler Atlean. Atlean combines a collagen stimulator and hyaluronic acid filler for the treatment of the lower face. Atlean will undergo European CE Mark registration before the product becomes available. The company will launch Atlean in 2015.

Nerve-stimulation device Ezzilift launched in the UK Electronic nerve-stimulation device The Ezzilift System has launched in the UK. It uses a gentle micro-current to stimulate nerve paths, prompting the brain to produce neuropeptides, therefore increasing production of collagen and elastins. This promotes facial rejuvenation, lifting and toning. Patients undergo a course of six to eight sessions, with top-ups recommended.

9

Insider News

Events diary 3rd - 5th April 2014 Anti-Ageing Medicine World Congress AMWC 2014, Monaco www.euromedicom.com/amwc-2014

aestheticsjournal.com Stem cell

Sinclair IS Pharma launches Perfectha at ACE 2014

20th September 2014 British College of Aesthetic MedicineBCAM Conference 2014, London www.bcam.ac.uk 25th - 26th September 2014 The British Association of Aesthetic Plastic Surgeons - BAAPS Meeting 2014, London www.baaps.meetings.org.uk 3rd October 2014 British Association of Cosmetic Nurses BACN Meeting 2014, London www.cosmeticnurses.org Rosacea

Mirvaso acquires European approval Galderma has announced that the European Commission has given marketing authorisation for its breakthrough brimonidine topical gel, Mirvaso.

The gel is used for treating facial erythema of adult rosacea and was FDA-approved for treatment of facial erythema of adults with rosacea in 2013. “Up until now, there has been no clinically approved treatment targeting the facial erythema of rosacea and Mirvaso can play a key role in the treatment of facial redness,” said Dr Alison Layton, consultant dermatologist at Harrogate and District NHS Foundation Trust. The authorisation was based on data from two phase 3, one-month clinical trials of 553 patients. Patients who used Mirvaso displayed significantly greater reduction in facial rosacea erythema compared with those who only applied vehicle gel. 449 participants used Mirvaso for up to one year in a long-term study showing the product to be effective and well-tolerated. The marketing authorisation includes 28 member states of the European Union, plus Iceland, Lichtenstein and Norway. Mirvaso is currently awaiting an NHS price and while it will be available privately from April, individual health trusts will set their own criteria for NHS prescribing. Mirvaso is expected to cost less than £35 for a 30g tube. In studies patients used on average 0.53g per day, meaning the drug could cost patients less than 50p a day. Mirvaso has been shown to be effective on around 70% of patients, with between 1-4% experiencing side effects such as increased redness and skin irritation.

10

Sinclair IS Pharma have added hyaluronic acid-based dermal filler Perfectha to their product portfolio, after launching it last month at the Aesthetics Conference and Exhibition (ACE) 2014.

The launch, which took place on March 8, follows Sinclair IS Pharma acquiring the global rights to the Perfectha brand in January.

The Perfectha range, made in France, includes Perfectha Finelines, Derm, Deep, SubSkin and Complement, offering products for application in superficial, middle and deep dermis.

The five fillers are distinguishable by their particle size, dependent on filler capacity and area of injection.

They can be used to treat fine lines and superficial wrinkles, the face and lip contour, deep wrinkles and nasolabial folds, the jaw, chin, cheeks and hands. Perfectha Deep can also augment lip volume, and Perfectha Complement is used to re-touch after a botulinum toxin injection or dermal peel. Dr Ayham Al-Ayoubi, facial, plastic and laser surgeon at London Medical and Aesthetic Clinic, said, “The advantage of Perfectha is that it is very smooth to inject, so is far less traumatic to the tissue, causing less bruising and pain for the patient.“Because it is a natural hyaluronic acid product, a Aesthetics | April 2014

substance already produced in the body, injecting it into the tissue does not give a foreign body reaction.

There is also little risk of medicine encapsulation from injecting.

“Perfectha is a safe and effective addition to the market of hyaluronic acids. Knowing Sinclair IS Pharma as a well-established pharmaceutical company, I fully trust the product from a clinical point of view.”

Sinclair IS Pharma is a medicinal and aesthetic dermatology company, established in 1971, which aims to improve the health, appearance and confidence of their patients through creating value for healthcare providers and shareholders. By the end of 2014, aesthetic dermatology, including Perfectha, is expected to make up more than one third of Sinclair IS Pharma’s total sales. The company is also planning a new branding and marketing campaign for 2014, alongside a pan European physician training programme. Andrew Morris, country operations director at Sinclair IS Pharma, said, “‘Facial aesthetics is a key part of Sinclair’s growth strategy for the future. Our heritage in dermatology alongside our growing portfolio of strong effective brands and a dynamic UK team means we are well equipped to expand in the aesthetic market.”

Insider News

aestheticsjournal.com Stem cell

Consultation

Study converts adult human cells to hair follicle generating stem cells Researchers from the Perelman School of Medicine at the University of Pennsylvania have published results of a study describing how they were able to convert adult stem cells into epithelial stem cells (EpSCs). When implanted into immunocompromised mice, the EpSCs regenerated the different cell types of human skin and hair follicles, and produced structurally recognisable hair shafts, raising the possibility that they may eventually enable hair regeneration in humans. Xiaowei Xu, associate professor of Pathology and Laboratory Medicine and Dermatology and his team, started with human dermal fibroblasts. By adding three genes, they converted those cells into induced pluripotent stem cells (iPSCs), which have the capability to differentiate into any cell types in the body). They then converted the iPSCs into EpSCs, usually found at the bulge of hair follicles. The team succeeded in turning over 25% of iPSCs into epithelial stem cells in 18 days.

Those cells were then purified using the proteins they expressed on their surfaces. When these cells were mixed with mouse follicular inductive dermal cells and grafted onto the skin of immunodeficient mice, they produced functional human epidermis and follicles structurally similar to human hair follicles.

“This is the first time anyone has made scalable amounts of epithelial stem cells that are capable of generating the epithelial component of hair follicles,” Dr Xu said, explaining that these cells have many potential applications, including wound healing, cosmetics, and hair regeneration. The technique is not yet ready to use in humans. Hair follicles contain both epithelial cells and a certain kind of adult stem cell called dermal papillae and scientists are yet to discover how to make new dermal papillae cells.

Dr Ravi Jain and Galderma launch Harmony Programme Dr Ravi Jain and Galderma have teamed up to launch new consultation process, the Harmony Programme. The new consultation method is designed to involve the patient to a much greater degree in the process of choosing their treatment plan, also with the aim of minimising their spend. The bespoke treatment plan draws on the latest techniques and products to restore and enhance facial balance. After a two year development period and successful trials at Riverbanks Clinic, the programme has now been launched with Dr Jain acting as a global spokesperson and reference. “The key to The Harmony Programme is that its for people who don’t want to look different, they just want to look how they feel,” Dr Jain said. “It’s about natural looking tweaks and adjustments that restore facial balance and enhance the appearance rather than altering it. The programme has been developed with other aesthetic experts from all over the globe over the last two years in conjunction with Galderma. ”I truly believe this is the way forward when it comes to optimising the patient/practitioner relationship whilst also helping patients to keep costs to a minimum and achieving the best results possible,” said Dr Jain.

Business

Marketing consultancy 5 Squirrels launches at ACE 2014

New company 5 Squirrels Ltd launched at the Aesthetics Conference and Exhibition. The company is a service-based marketing consultancy for the UK medical aesthetics industry offering products and services with emphasis on market entry, learning, marketing and branding. Co-founders Gary Conroy and Amanda Cameron have between them over 35 years experience in the medical aesthetics industry. 5 Squirrels’ first product introduction will be a range of clinically-proven private label cosmeceuticals that can be tailored to individual requirements.

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Business

Syneron Medical acquires New Star Lasers Syneron Medical has entered into an agreement to acquire New Star Lasers Inc, developer, manufacturer and marketer of the CoolTouch family of aesthetic devices. The aim of the acquisition is to diversify Syneron’s product portfolio, and provide entry into new markets. Shimon Eckhouse, chief executive officer of Syneron, said, “We believe CoolTouch will add value to Syneron’s product offerings by expanding our reach into new markets such as minimally-invasive laser assisted lipolysis. In addition, the CoolTouch business model also supports our strategy to increase sales of products with recurring revenue streams. We are very pleased to welcome the CoolTouch team to Syneron and look forward to expanding adoption of their products and technology through our global commercial infrastructure.”

One gram of botulinum toxin type A is all that is required to make the global supply of Botox for a year Transform Cosmetic Surgery Group

PIGMENTATION UNEVEN SKIN COLOUR

&

16% of women surveyed cited pigmentation and uneven skin colour as their top skin dislike Syneron-Candela, Censuswide survey

Research

Research suggests glycemic index of food can influence acne severity Research published in the Journal of the Academy of Nutrition and Dietetics suggests that young adults with moderate to severe acne consume food with a higher glycemic index, than those with minimal acne. The study included 248 volunteers aged 18 to 25 years old. Participants reporting moderate to severe acne ate foods with an average glycemic index of 51.8 compared to 49.6 for those with mild acne and 48.9 for those with no acne.

Those with acne consumed on average 199g/day of sugar, compared to 56.4g/ day for those without. Those with acne also drank more milk, and ate more trans and saturated fats. Findings are yet to be confirmed by controlled trials.

62% of consumers

surveyed use online reviews as a first step for finding a new doctor

ZocDoc

Nurses provide 54% of dermal filler treatments British Association of Cosmetic Nurses

19.2% of women surveyed said they were open to facial aesthetic procedures

Devices

Michelson Diagnostics launches VivoSight OCT scanner upgrade Medical device company Michelson Diagnostics have launched an upgrade of their VivoSight Optical Coherence Tomography (OCT) scanner, arming dermatologists with more features to investigate skin lesions. The Vivosight OCT scanner provides high definition vertical cross-sectional images of sub-surface skin tissue of depths of 1-1.5mm. This provides clinicians with information about the type, depth and lateral spread of the skin lesion, which is not possible from just looking at the surface appearance. It can now also display horizontal ‘en-face’ images at any desired depth in the imaged area, showing a ‘field of view’ of 6mm x 6mm. This aims to help map the lateral spread of skin lesions, improve accuracy of diagnosis aided by OCT and aid differential diagnosis between malignant and benign skin features. It could also be developed to help clinicians diagnose other skin conditions, such as pigmented lesions.

“The capability of VivoSight to provide en-face section as well as vertical section OCT images is very welcome,” said Professor Dr Julia Welzel. “We will have more detailed insight into anatomical features like shape of the dermoepidermal junction and three-dimensional distribution of tumour nests.”

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Aesthetics | April 2014

Galderma’s IMPACT study

20%

of women surveyed said that bad skin made them depressed Syneron–Candela, Censuswide survey

Male skin is denser and contains more collagen Transform Cosmetic Surgery Group

Ideally, skin should be prepared for at least six weeks prior to a chemical peel British College of Aesthetic Medicine

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BACN Business Workshop, London The British Association of Cosmetic Nurses held a business workshop at the Royal College of Obstetricians and Gynaecologists on March 10, which aimed to enhance nurses’ understanding of business themes. The ‘Super Secrets to Business School’ workshop programme included a welcome address by BACN vice chair Sharon Bennett, followed by a talk by Nina McMurray, practice development manager at Galderma, who spoke on Galderma’s IMPACT (The Identify Motivation of Patients and Access to Aesthetic Treatments)

study. This provided information on what drives the motivations of the aesthetics market; notable statistics discussed included 19.2% of women surveyed were open to facial aesthetics, 87% of customers think follow-up appointments are important, and that it is five times more expensive to acquire new customers than retain existing ones. Nina McMurray said, “If you focus on the customers you have and grow them, then you will be growing your business.” Scott Baker of Blow Media then spoke on creating effective brand logos and straplines, followed by a discussion by Lorna Bowes on how incorporating skincare into your clinic can enhance your business.

The afternoon saw Ron Myers, director of the Consulting Room, talk on building business models, Aesthetic Response director Gilly Dickons discuss enhancing your patients’ first enquiry experiences, and Allergan’s senior business development manager Marcus Haycock speak on building a successful mobile responsive website.

“For those of us in the medical field, it’s sometimes hard to ethically combine medical practice and making a profit,” said Sharon Bennett.

“As nurses we concentrate heavily on the delivery of great clinical outcomes, but we also need to be business savvy. This workshop is about joining medicine and business together to achieve a balance in our clinics, whilst using our instinct as medical professionals to remember that we have patients, not clients.”

Interventional Cosmetics Conference, Royal Society of Medicine Dr Sarah Tonks reports on the RSM ICG-6 Interventional Cosmetics conference, which took place on February 28 The interventional cosmetics conference took place at the Royal Society of Medicine this March. This two-day conference was geared specifically towards medical practitioners interested in aesthetic medicine, and heavy emphasis was placed on the science behind the procedures, rather than looking at the beauty-orientated side of the industry. The conference comprised of two full days of lectures and a one-day concurrent workshop, mostly pitched to beginner level, and also several posters exhibited by delegates. The winner of these poster presentations was Dr Livia Soriano for her poster on intralesional laser treatment of filler deformity using the Marangoni procedure (use of laser to treat filler complications such as granuloma).

Highlights from the programme on Friday included a lecture on the complications of cosmetic procedures by Ms Vickie Lee, ophthalmic and oculoplastic surgeon, who spoke about the risks associated with dermal fillers, demonstrated by some very good clinical cases. Also of interest to everyone at the conference was a lecture by dermatologist Dr Tamara Griffiths, concerning the future of cosmetic practice, in which Dr Griffiths discussed the Keogh regulatory framework and how this could impact on clinical practice.

Dermatologist Dr Marina Landau then discussed the phenol peel, which she claimed is an underused treatment at present, though it gives excellent results. Dr Landau also gave a lecture on filler complications and their treatments later in the day, which was pitched at a more basic level.

Saturday highlights included Dr Mark Palmer providing an update on injection lipolysis, as well as a live demonstration on this technique on the face – to be used for facial sculpting – and the abdomen. Other highlights included a live interactive advanced anatomy video demonstration of the face by plastic surgeon Dr Thierry Lemaire.

For those of us used to other industry conferences, this conference felt more geared towards doctors not already practising in aesthetic medicine who may be looking towards the market to expand their current practice.

Mesotherapy training, Wotton House in Surrey Wotton House was host to a two-day mesotherapy training workshop led by Dr Britta Knoll on March 10 and 11. An intimate group of seven participants attended training for areas of the face and body, organised by Vida Health and Beauty. A pioneer in the field, Dr Knoll trained with the originator of mesotherapy, Dr Michel Pistor. Following an introduction to mesotherapy and areas of treatment, participants then carried out treatments on models, and then by request, on themselves.

Dr Berlinde Drucker, who attended the two-day event, said, “Dr Britta took us through in-depth theory and clinical protocols based on her immense experience, leading us then to the practical hands-on training using our critical eye, knowledge and clinical skills.

Treatments for face, neck, and whole body were explored and applied using simply fingers and hands or the famous Pistor Eliance mesogun, known for its precision and versatility.”

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Aesthetics | April 2014

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Health Education England stakeholder workshop Health Education England (HEE) held its first cosmetic interventions stakeholder workshop at Prospero House on February 24. The first of two workshops conducted last month, the aim of the session was to continue developing research into establishing a minimum standard for education and training within the field of non-surgical medical aesthetics. HEE’s cosmetic non-surgical interventions project was established in September 2013, following Sir Bruce Keogh’s ‘Review of the Regulation of Cosmetic Interventions’ report. In it, Sir Keogh recommended that, “The government’s mandate for Health Education England should include the development of appropriate accredited qualifications for providers of non-surgical interventions and it should determine accreditation requirements for the various professional groups.”

Since its formation, the project has issued a call for evidence and has continued to garner information from regulators, royal colleges and other stakeholders in order to gain sufficient industry insight.

The stakeholder workshop was comprised of over 70 participants representing regulatory bodies, royal colleges, the Department of Health, professional associations, manufacturers, insurers, training providers, consumers and practitioners. HEE managing director Charles Bruce introduced the session, stating clearly in his introductory note that this was phase one of many forecasted to carry out research on non-surgical cosmetic interventions. Stakeholders were given examples of feedback gathered from the call for evidence, which included letters, documentation, training materials and suggestions about accreditation. The audience were then asked a series of questions that were debated at length in randomised groups, such as “What elements of training should be common to all treatments and could be included in a foundation training programme?”

Topics stemming from these discussion points included statutory regulation versus self-regulation, supervision, qualifications and the levels of expertise required for treatments. In a discussion regarding the prospect of supervision for professionals undertaking procedures, Emma Davies, chair of the BACN, said, “We will need to explore what kind of supervision is appropriate for the treatment and the practitioner. For some it may be in the same building and for others it may be in the same company; it may be that supervision can be for hire, but supervisors should have clear responsibilities and direct accountability to the patient.” Discussion was also raised surrounding levels of training, Tiffany Tarrant, development manager at Hair and Beauty Industry Authority (Habia), said, “In terms of non-surgical procedures, fillers and injectables seemed to be the key focus of the

meeting. There was a lot of discussion around levels of training and where these would sit in a framework. Lasers and peels may fall under different levels depending on the nature of the services; the level of expertise required to perform peels will vary depending on whether it is superficial or deep. The same applies for lasers and IPL; CO2 lasers might fall under a higher level. I imagine there will be different levels for injectables, such as foundation, intermediate and advanced.”

The final throes of the groupwork session were dedicated to discussing the proposition of a revised term for a future ‘qualified’ practitioner. Attendee Sharron Brown, nurse and BACN board member, said, “The term aesthetic practitioner is too generic: it gives the general public no clue as to the background of the individual carrying out the procedure. In nursing, the term nurse practitioner is a professional qualification, which usually means the individual has studied a specific course that will enable them to prescribe, perform physical examinations, interpret diagnostic tests, diagnose and treat the cohort of patients that they manage within their scope of practice appropriately. This is a post-graduate degree or masters with fairly strict entry criteria. I think any course designed to cover aesthetics should be tiered with different entry levels; once completed, the professional title should include aesthetic therapist for those with non-medical background and either aesthetic doctor or nurse as with any other medical or surgical speciality.” Following the workshop discussions, Mr Christopher Inglefield, plastic surgeon and medical director of London Bridge Plastic Surgery and Aesthetics Clinic, said, “I feel that the next steps must be to establish the curriculum for training.

This would require the expert group meeting to achieve a consensus of the content for accredited training in non-surgical interventional cosmetics. Once this is achieved, HEE can invite the existing training providers to submit applications for accreditation of their programmes.

HEE must then have clearly defined entry requirements for training programmes and certification which is transparent for the consumer.”

Consultant dermatologist Dr Nick Lowe also attended the workshop, representing the British Association of Dermatologists (BAD). He said, “I am cautiously optimistic that HEE will help to oversee professional training of injectables. Training programmes need to be non-profit, unbiased, and may be supported, but not organised, by the industry.”

The second workshop held in February was for a smaller group of approximately 25 representatives to further develop the findings from the first workshop. Discussions focused on the scope of treatments to be covered, practitioner titles, the training framework, curriculum content and how to raise the public profile of this work.

Carol Jollie, HEE programme manager, said, “Both workshops were really helpful in moving the project forward and we are in the process of setting up an Expert Reference Group with representatives from each professional group, involved in delivering cosmetic non-surgical interventions. The Group will meet in March and April and we will then be preparing a paper on the results of the first phase of our project for a workshop taking place on May 1.”

Aesthetics | April 2014

17

Insider ACE Report

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The Aesthetics Conference and Exhibition 2014 On Saturday 8 and Sunday 9 March the medical aesthetics community came together in London for ACE 2014. We report on some of the many highlights.

Sponsored by

The Aesthetics Conference and Exhibition, formerly Cosmetic News Expo, took place on the weekend of March 8 and 9 at the Business Design Centre in London.

Over the weekend, more than 1600 visitors in total came to see more than 90 exhibitors and listen to a host of internationally acclaimed speakers.

The two days of seminars, masterclasses, clinical workshops, expert clinics and business workshops offered delegates the opportunity to discover new techniques and products, develop their learning and improve their businesses, with up to 59 CPD points available.

Sponsored by Sinclair IS Pharma and Syneron Candela, with Registration and Consumables partner Med-fx and Floorplan sponsor Allergan, the event attracted visitors from across the medical aesthetics profession. The largest groups were cosmetic doctors and nurses who made up 28% and 25% respectively of the total attendance, along with 19% dentists and 2% surgeons. Dermatologists, aestheticians and clinic managers made up the remaining percentage of visitors keen to see the latest in products, treatments and clinical research.

On Saturday, Dr Tracy Mountford opened the conference, chairing a session on the European Perspective, with nurse and Aesthetics editorial board member Sharon Bennett, who is UK Lead on the BSI/CEN Non-Surgical Medical Cosmetic Standard, discussing the on-going CEN review. Following this, indication specific filler treatments were discussed by internationally renowned dermatology specialist Dr Sabine Zenker. Next on the main agenda, ACE steering committee chair Dr Mike Comins introduced a session on Body and Hand Treatments featuring the new and revolutionary VelaShape III, and a seminar on hand rejuvenation by Dr Dennis Wolf. Concurrently, David Gower, Dr Elisabeth Dancey and Aesthetics editorial board member, Dr Sarah Tonks led a masterclass by Medical Aesthetics Group on the role of hyaluronic acid in intimate rejuvenation. Also on Saturday morning, Dr Hugo Kitchen for Galderma offered an entertaining and illuminating masterclass in mid-face rejuvenation with Emervel Deep, including plenty of tips on how to keep patients satisfied and loyal, such as occasionally offering free treatments to longtime customers.

Clinical workshops and expert clinics on the exhibition floor drew large, standingroom-only audiences watching demonstrations including the potential of Sculptra for a full-face rejuvenation, and a live lipolysis demonstration by Dr Martyn King using 3D Lipo. One of the most popular masterclasses was led by Dr Tapan Patel and Dr Raj Acquilla, showcasing the use of Botox, with its new licence for treating crow’s feet, together with the Vycross collection of fillers for total facial rejuvenation and beautification. Dr Acquilla gave an expert presentation on facial anatomy, 18

Aesthetics | April 2014

pointing out that the science of understanding the true anatomical changes of ageing is fast evolving.

It was only in 2012 that a study showed the effects of bone resorption on the eye socket. They spoke about the importance of injecting ‘exquisitely’, with the emphasis on small, subtle changes, placed exactly.

“Beauty is in detail, not in volume,” said Dr Acquilla.

They also recommended the use of a cannula to treat the jawline to avoid nerve injuries. They discussed the high level of tissue integration possible with the Vycross range, and the unique structure of crosslinked, short chain hyaluronic acid. Dr Comins chaired ‘Where Surgery and Medicine Meet’, where Dr Raina Zarb Adami discussed the value of combination treatments for the lower face and neck, and Professor Vishy Mahadevan and Mr Dalvi Humzah provided an informative lecture focusing on facial anatomy with reference to injectables. The vital importance of fully understanding the anatomy was reinforced in a session on Safety in Advanced Facial Techniques, which included a presentation by Julian De Silva, who advised on how to avoid severe adverse events such as necrosis. He pointed out that some treatments need particular care, such as injectables in the nose postrhinoplasty.

Sinclair IS Pharma curated a panel of experts chaired

by Dr Tracy Mountford, throwing a fresh perspective on collagen replenishing treatment Sculptra in their afternoon masterclass. As part of the session, Dr Linda Eve provided a remarkable glimpse into the facial volumising effects of Sculptra with a series of case study images. Dr Eve also detailed the use of cannulas to treat patients with Sculptra, using the newer CanuSculpt technique, of which the benefits include minimum entry points and no need for anaesthesia.

International Sculptra trainer Dr Askari Townshend, celebrating 15 years of the product, went on to detail its history. Specialist nurse Sharron Brown brought a new dimension to the session by speaking on the use of Sculptra in patients with HIV-related facial lipoatrophy, and the way in which it allowed these patients to return to work and regain their confidence in everyday life.

Later on Saturday afternoon, plastic surgeon and Aesthetics board member Mr Adrian Richards presented a lively expert clinic on lip augmentation, beginning with a series of image comparisons to

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assess the symmetry of well-known celebrity faces. Mr Richards maintained a high level of audience participation throughout, repeatedly asking the audience, “What would you do in this situation?”, sparking much discussion amongst both the seated and standing audience. One issue raised was the importance of creating an age-appropriate outcome for the patient, in this case by analysing the width of the lips compared with their height.

New for 2014, the business workshops proved popular throughout the weekend, with talks from Dr Jason Williams on patient retention and John Castro on digital strategy drawing particularly large audiences. The practice development focus complemented the clinical content of the programme, providing advice to delegates on how they could grow their business, ensure they were meeting legal and ethical standards and regulations, and improve service to their patients.

In the evening, after a champagne reception, delegates had the opportunity to attend a unique Question Time session, sponsored by 3D aesthetics and the 3D lipolite programme.

The first of its kind for the medical aesthetics community, the discussion was led by Peter Sissons and a panel of leading industry

figures, comprised of Dr Andrew VallanceOwen, a member of Sir Bruce Keogh’s Cosmetic Interventions Review team, Dr Tracy Mountford, founder and medical director of The Cosmetic Skin Clinic, Mr Dalvi Humzah, a consultant plastic, reconstructive and aesthetic surgeon based at the Plastic Dermatological Surgery, Dr Mike Comins, president of the British College of Aesthetic Medicine, Sharon Bennett, vice-chair of the British Association of Cosmetic Nurses, Dr Martyn King, owner of the Cosmedic Skin Clinic and Dr Leah Totton, Apprentice winner and founder of the Dr Leah clinic.

The session proved extremely popular with delegates and allowed a full discussion of the issues affecting the medical aesthetics industry. The entire panel agreed it was essential that all those involved in aesthetic 20

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medicine work together to improve standards with Dr King saying he felt that, “We can’t rely on regulation from the government”. Dr Mountford suggested that only qualified medical practitioners should be performing injectable treatments, saying, “If you can’t deal with the complications you shouldn’t pick up the needle.” Dr VallanceOwen gave an insight into the workings of the Keogh committee, saying that “Lack of data regarding complications was the real problem,” and that, “A registry to collect data is the only way to protect patients.” Other topics raised included the lack of a register of practitioners, the poor quality of many training courses, and the possibility of adding cosmetic medicine to the undergraduate curriculum.

However, Dr Totton claimed that an informed public would be the key to improved safety. “We can’t stop the hairdresser injectors,” she said. “So we must educate the public about the risks.” Asked about the future of aesthetic medicine, Mike Comins asked ‘Does anyone in the government really care about this industry?”, but Dr VallanceOwen said he believed very strongly that the government would introduce legislation to make fillers prescription-only medical devices and would insist on supervision of non-medical injectors. Sharon Bennett said, “I am optimistic. Associations are already coming together to be stronger.” Dr VallanceOwen called for practitioners to report complications, speak up about bad practice and lobby for a compulsory register. Mr Humzah left the audience considering what he called “The three Ps; your patient, your procedure and whether you are the right practitioner to be doing it – if not, pass it on.”

Day two of the conference began with a session on Skin Health. After an introduction

by Dr Tapan Patel and a presentation on chemical peels by Sharon King, dermatologist Dr Tamara Griffiths gave a fascinating overview of cosmeceutical ingredients, telling her audience, “You owe it to yourself and your customers to understand the science.” She presented vivid evidence of the extent to which the sun creates photoageing, comparing images of skin on the forearm to skin on the inner arm.

She recommended antioxidants to boost the effect of sunscreen. Dr Daron Seukeran Aesthetics | April 2014

presented on rosacea, discussing alternative diagnoses, the use of vascular lasers, and the potential of Mirvaso gel.

Dermatologist Dr Stefanie Williams then spoke powerfully about treating adult acne.

“Acne is not cosmetic, or a rite of passage,” she said, “It is a serious, disfiguring, scarring, skin disease.” She spoke of the importance of early medical treatment to avoid scarring, and said that patients should avoid oils and facials, which in one study worsened acne in 80% of cases. For scarring, she recommended medical needling, used in conjunction with a Clarisonic cleansing brush to make anaesthetic creams work more effectively on patients.

Also on Sunday morning was a masterclass presented by Dr Johanna Ward explaining

both how to use Coolsculpting technology and how introducing it can benefit a clinic financially. Dr Kuldeep Minocha talked about the value of Restylane Skinboosters as a versatile treatment for a broad range of patients. Dr Britta Knoll presented an expert clinic on treating hair loss through the use of mesotherapy, stating that she sees 10 patients a day suffering from the condition.

Dr Knoll, who was trained by mesotherapy founder Dr Michel Pistor, explained the scope of the technique, describing it as a locally targeted treatment in the correct skin layer by multiple microinjections. She emphasised that Dr Pistor’s mantra was “Medication, yes: but a small dose, rarely, and at the right place.” She stressed that mesotherapy succeeds in more than 90% of cases of hair loss; however, if hair bulbs have been

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destroyed by treatment such as chemotherapy, it can be very difficult to regenerate hair growth.

Cosmetic surgeon Dr Sotirios Foutsizoglou’s expert clinic was a thorough examination of nose augmentation. With an introduction on rhinoplasty to give context, Dr Foutsizoglou went on to present a detailed analysis of the anatomy of the nose before demonstrating the stunning effects possible with nonsurgical nose reshaping using dermal fillers. In his demonstration, he used Emervel Deep on a model to increase the size of the nasal dorsum. Dr Foutsizoglou placed recurring emphasis on the importance of good anatomical knowledge, and Dr Foutsizoglou also pointed out the significance of having an artistic eye in this treatment,“The ability to judge what looks good”, and therefore which area to treat and also when to stop treatment.

He concluded, “You are not correcting the problem here, but creating an illusion.”

In the conference auditorium, the final afternoon’s focus turned to body treatments. Dr Johanna Ward chaired, with Dr Richard Brighton-Knight discussing body image and weight loss, specifically focusing on rapport building and patient consultation techniques, shedding light on the importance of body language, and the speed of walking and talking when meeting your patient in the waiting room. Dr Mike Comins then presented on body sculpting, focusing on the benefits and technique of tumescent liposuction (liposculpture), showing some impressive before and after photos, and explaining the mechanisms of Klein’s solution, a combination of saline, lidocaine and adrenaline. In the final conference session of the day, Dr Mike Comins introduced Dr Sujata Jolly who gave a presentation on skin problems, and Dr Konika Patel Schallen, vice president of clinical education at Syneron-Candela, who spoke on laser, radiofrequency and ultrasound, looking at the benefits of each type of treatment along with their results. Answering a question from the audience on IPL versus lasers, Dr Schallen stressed that the IPL needs to be powerful enough for the treatment in question. As visitors left on Sunday evening, the resounding mood was enthusiastic and delegates appeared inspired by what they had seen and heard throughout the weekend. With many delegates already planning their visit next year, we look forward to welcoming you all back to ACE 2015.

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Clinical Practice Special Feature

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Treating Pigmentation In the first of a two-part series on treating pigmentation, we ask a panel of practitioners to discuss the benefits of lasers and lights OUR PANEL:

What are the key patient groups seeking treatment for pigmentation in your practice?

Dr Harold Lancer (HL) Dermatologist and medical director at Lancer Dermatology Dr Robin Stones (RS) Medical director at Court House Clinics for the North of England Lauren Sibley (LS) Clinic manager and lead aesthetic practitioner at Juvea Aesthetics Dr Sanjay Rajpara (SR) Consultant dermatologist and clinical lead at NHS Grampian Dr Maria Gonzalez (MG) Medical director and dermatologist at Specialist Skin Clinic

HL: Pigmentation problems affect everyone from newborn babies to 90 year olds, with all skin types, and I see them all in my clinic. I have 30, 000 current patients.

RS: The most common presentations are ladies of all ages with melasma, and middle-aged and older people of both sexes with photodamage such as solar lentigines. Natural skin blemishes such as seborrhoeic keratoses are also common from middle age and onwards.

SR: Key patient groups for me are Asian, Middle Eastern, African and southern or eastern European and sometimes northern European Women. I also see some men with darker skin types aged 20-40 years.

They want to have lighter skin as they think that having darker skin on the face and some other parts of their body is not normal. Somehow it is in the psyche of many people that only fair skin colour is normal, and media and cinema portrayal of the perfect skin tone and light coloured skin has not helped. In women and men of northern European descent and lighter skin types aged 50-70 years, itâ&#x20AC;&#x2122;s sun induced ageing related pigmentation on the face, hands, neck and upper chest.

Alex TriVantage laser

Where does pigmentation rate on patientsâ&#x20AC;&#x2122; worry scale?

HL: Pigmentation is the number one concern of patients in my clinic. Much more than lines, wrinkles and sagging skin. People want to be the same colour from head to toe and they understand that a colour mismatch can give a more aged look.

LS: It is very common for patients to self-treat. It is amazing what you can buy on the internet. I had one patient who had bought a trichloroacetic acid (TCA) peel from the internet and put it on her skin. Of course that is very risky.

MG: Pigmentation causes quite a significant amount of distress among patients. I am seeing increasing numbers of younger patients, those in their early 20s, already showing signs of photodamage.

How do you counsel patients prior to treatment?

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HL: Pigmentation is the most difficult area in cosmetic medicine. I always see the patient first and start a treatment plan including skincare for the first two to four weeks. The most important thing to realise at this stage is that pigmentation disorders are different in different ethnic ancestries. And if you treat someone with Irish or Swedish ancestry you are likely to have a better result than if you treat someone with Spanish or Moroccan ancestry. Skin colour, eye colour and hair colour are truly unimportant. Ancestry will give you a better guide to who should be treated by what type of instrument, if at all. This is the basis of the Lancer Ethnicity Scale.

LS: Before any treatment for pigmentation I always take a complete medical history but it is also vital to understand the patientâ&#x20AC;&#x2122;s ethnic skin type. This is particularly important with patients who may be of Asian origin because Asian skin has a high epidermal melanin content, which can act as a competing chromophobe for pigment lasers and trigger post-inflammatory hyper pigmentation (PIH).

SR: Laser treatment has risks of hypo/hyperpigmentation, scarring and recurrence. Counselling is very important to explain these risks and weigh the risk/benefit ratio in individual patients. Often I see patients twice for consultation before deciding on any treatment option.

MG: All my patients have a 30 minute consultation before treatment is offered. Patients are never treated on the day of their consultation. All potential side effects and complications are discussed in detail.

I particularly emphasise the issue of sun protection as I believe tanned skin or sun exposure too soon after treatment are the greatest causes of long-term complications.

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Clinical Practice Special Feature

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What product or device do you use and what is the treatment protocol?

RS: There is no one product or device that treats pigmentation. It is wise to use a stepwise pathway starting with the simplest and safest treatments first, as the more aggressive you become, the greater the risk of undesirable complications. For example some freckles respond well to the Alma Harmony AFT and other types of deeper pigmentation respond better to the Harmony i Pixel. For me, the Alma Harmony ClearLift Q-Switched is proving to be an effective treatment for pigment in darker skins types, at the same time producing skin tightening without side effects.

MG: I use the Q switched Nd:Yag system. For solar lentigines I am often able to completely treat individual lesions with one treatment, but I usually review patients at four weeks to see if a second treatment is required. If patients have a number of lesions and other features of photodamage I often carry out a full-face laser peel. My settings of choice for this treatment are 532nm wavelength and 6mm spot size at fluences of 0 .8 -1.2 J/cm2 .

SR: Treatment protocol depends on the underlying cause.

Once medical causes have been excluded, sun protection is the most important consideration followed by topical preparations containing retinoids and sometimes hydroquinone (HQ) under close supervision. Some over the counter (OTC) products are useful in mild pigmentation problems. Treatment with chemical peels or Q switched Nd:Yag laser and fractionated CO2 lasers is the next step in the ladder.

HL: Every patient in my clinic is evaluated by me, then has a treatment plan to see how they respond to topical exfoliating, lightening and rebuilding agents over two to four weeks. Then we use fractional radiofrequency and Advanced Fluorescence Technology (AFT) treatments, which use short wave light. Lasers may never be necessary. I have 32 lasers and light devices in my practice.

My preference is to use a 1064nm picosecond laser.

When would you use IPL over lasers?

RS: Intense pulsed light (IPL) and lasers can both be used. In my experience lasers are safer in some instances, such as for darker skin types, and IPL can be easier to cover larger areas. In my opinion IPL is not safe, and should be avoided, for Fitzpatrick photo types 5 & 6.

Alma Harmony ClearLift Q-Switched Nd Yag laser generates less heat in darker skin types thereby minimising the risk of side effects in this skin type.

lasers. Dermal pigmentation is caused by sun damage and hormones.

SR: We can judge the depth of pigmentation by its colour as it depends on the light reflection from the pigmentation. It is light brown when in the lower part of the epidermis/superficial dermis and gets a bluish tinge as it gets deeper in the dermis. Recurrence risk is higher for treating deeper pigmentation than superficial pigmentation.

What treatments can you use in conjunction with a laser treatment?

RS: I use topical pigment inhibitors such as kojic acid, arbutin, idebenone, tretinoin and also HQ, which is safe when used properly. Cryotherapy for localised lesions and chemical peeling are useful too.

MG: Q-switched lasers provide the best possibility for improvement in most conditions I treat, so I do not find it necessary to combine the treatments with other procedures such as chemical peels or other devices.

What is the role of skincare to prepare skin for treatment?

RS: It is helpful to switch off the melanin production pathway by using topical pigment inhibitors for one or two months before treatment and also after treatment. Sunscreen is essential.

SR: I treat using strict skincare with topical retinoids for four weeks and insist on sun avoidance for four weeks before the laser treatment. Some OTC products by EU regulations have low permeable concentrations of synthetic vitamin A related compounds or HQ, kojic acid, gigawhite or glycolic acid, or thioglycolic acid, lactic acid, vitamin C, salicylic acid, niacinamide, beta arbutin, liquorice extracts, alpha tocopherol or chamomile extracts in different combinations. The alternatives are topical retinoids and HQ containing products on prescription.

MG: I combine treatments with anti-ageing creams especially to treat other features of photodamage. All my patients are required to use SPF 50+ sun protection for the duration of the treatment and afterwards.

LS: I believe that key to best treatment is pre-treatment skin conditioning. Healthy skin always responds better to laser therapies.

Before treatment I recommend a six-week programme of skin conditioning using the ZO range by Dr Obagi. This is one complete skin cycle. For Asian skins and for patients with a lot of melanin, I will suggest treating through three skin cycles, or 18 weeks. I never offer laser treatment alone to patients with pigment problems.

How do you diagnose type and depth of pigmentation in the dermis, and how does that affect treatment?

Ochronosis is a growing issue. How do you treat it?

RS: A Woods light (ultra violet) can help to distinguish between purely epidermal (superficial) pigment and dermal (deep) pigment. However, it doesnâ&#x20AC;&#x2122;t tell you if there is a combination of both superficial and deep pigment, as is often the case in melasma.

LS: The stretch test is quick and easy as a first line of diagnosis.

Pull the skin apart gently, if the pigment disappears it is epidermal, if it remains then it is dermal. Epidermal is much easier to treat. If the pigment is in the epidermis, it is often PIH, for which I use skincare, and

LS: Unfortunately in severe cases there is nothing you can do. But in many cases you can use a retinol-based product first, then use an HQ product, then add peels and laser. I had a patient who used HQ for four years. I put her on retinol for eight-nine months then used baby doses of HQ and did peels and got a great result.

SR: For ochronosis, sun avoidance and avoidance of creams containing HQ would be my first recommendation. It is difficult to treat, but a Q switched alexandrite laser, CO2 laser or TCA peels could be used.

Obagi ZO range by Dr Obagi

Before

After

Before and after HarmonyXL. Courtesy of Fernando Stengel, M.D., Dermatologist, Buenos Aires, Argentina

24

Alma Harmony ClearLift Q-Switched laser

Aesthetics | April 2014

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Clinical Practice Special Feature

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How do you treat melasma?

RS: Lasers and IPL are unpredictable for melasma as the heat from the treatment can stimulate more pigmentation and lead to a worsening of the condition.

SR: Sun avoidance, topical preparations and then laser or chemical peels would be good.

MG: I combine treatments with tyrosinase inhibitors such as HQ 4% cream.

LS: Melasma is the number one pigment-related complaint I see, and is one of the hardest pigmentation conditions to treat. It takes a lot of patient commitment and a lot of time. When treating melasma with Revlite I do a minimum of six treatments at two-week intervals, which I find gives good results. However, in older patients with very thin skin and melasma, it can be impossible to remove the pigment, though you can improve general skin health. It is vital to proceed gently.

Aggressive laser treatment can trigger melanin or even cause hypopigmentation. I use less power and more treatments.

How do you approach treating UV triggered pigment?

LS: I am seeing increasing numbers of patients for sun damage, as they are now of an age to see the effects of sun exposure before the availability of high factor sunscreen. I suggest pre-conditioning, a doctor led chemical peel to resurface and repair damaged DNA, then I use laser to mop up any residual pigment. For freckles I simply do spot treatments using Revlite.

SR: For the sun damage and associated pigmentation, fractionated laser resurfacing is best as it also helps to iron out and reduce wrinkles together with pigmentation.

How can hypo and hyperpigmentation be avoided?

RS: Lasers and IPL can definitely lead to hypo and hyperpigmentation.

Hypopigmentation is mostly seen after ablative laser treatments, especially the CO2 laser, and is permanent. More commonly we see PIH after non-ablative laser, such as in hair removal. This is not usually permanent but can be problematic, and is usually due to the heat from the laser or IPL. Warning signs are darker skin types, especially Fitzpatrick 4-6, and those whose skin shows increased pigmentation as a result of minor trauma such as cuts and scratches, or tendency to pigment after inflammatory conditions of the skin such as acne and eczema. Careful test patches with lower fluences and avoidance of too much erythema are important but do not mean it definitely will not occur.

MG: I advise the usual precautions of avoiding treating patients with a tan (whether real or fake) as this definitely increases the risk of hyperpigmentation in all skin types. Of course caution must be exercised in all patients with pigmented skin because of their higher risk of pigmentation, and I only use the Q-switched 1064nm laser in these patients. The most important aspect of treating all patients is correctly identifying their skin types. Those with intermediate skin types, Fitzpatrick type 3/4, can be quite challenging as results can be unimpressive with the 1064nm wavelength if the correct protocols are not used. Resist the temptation to try the 532nm without careful patch testing, and even then things can go wrong when wider areas are treated.

Before

After

Before and after treatment with Alex TriVantage laser

26

Before

SR: Lasers, chemical peels and creams containing HQ can cause hyper or hypopigmentation as a side effect. That is why it is important to evaluate each patient thoroughly for the possible underlying cause of hyperpigmentation before treatment.

HL: Too many doctors try to treat the problem too aggressively and too quickly. If pigmentation is made worse, then treating it gets more and more difficult. If using a laser I treat a single square centimeter and then monitor it for two to four weeks before treating the entire area.

I have found that if you treat with lasers first, the chance of hypo or hyperpigmentation is at least 50%.

What were your key considerations when choosing a laser?

RS: Courthouse Clinics chose Alma Harmony because of its multi platform technology that allows us to choose the correct type of laser or IPL for the individual patient. Itâ&#x20AC;&#x2122;s a very versatile system that offers all forms of laser and light technology from one platform.

LS: I like Revlite by Cynosure. This is a Q switch laser, Nd:Yag 1060nm with a high melanin absorption rate. It shatters the pigment, which is then taken away by the lymphatic system. Revlite uses a photo acoustic pulse so I do not need additional cooling for pain relief.

MG: When I chose my Q-switched Nd:Yag system, I wanted a laser which had been around for a long time and had been used widely in countries where pigmentary problems dominate. Countries from which I sought feedback from my peers included Singapore, Hong Kong and Japan. I had a lot of good feedback about the Revlite and Trivantage systems.

What kind of follow-up do you offer patients posttreatments?

LS: It is vital to counsel patients to stay out of the sun during and after treatment. I recommend they use a thumbnail size amount of SPF50 on their face every day. I love Heliocare sunscreen. I never do a laser treatment without also offering a melanin control product, whether that contains a HQ or retinol.

What advice would you offer other practitioners when treating pigmentation, and when choosing a device/ treatment programme?

HL: The majority of catastrophes I inherit in my clinic are from doctors who use lasers and lights as the first approach to treating pigmentation. In my opinion it should never be more than a second line defence, after skincare and other modalities. My sincere advice is that if you donâ&#x20AC;&#x2122;t do this every day, then refer to someone who does.

SR: Assess carefully, counsel thoroughly and use single treatment modalities at a time. Proper selection of treatment and realistic expectations are very important.

MG: Ensure you are able to identify the cause of pigmentation, for example post-inflammatory or sun damage, as this dictates the protocol to be used. For patients in whom post inflammatory pigmentation is the main issue, treatment for the underlying problem should be offered either before starting treatment or during the course of treatment.

After

Before and after treatment with Alex TriVantage laser

Aesthetics | April 2014

Before

After

Before and after treatment with Alex TriVantage laser

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Clinical Practice CPD

one point

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Common effective skincare ingredients Dr Sandeep Cliff and Dr Carolina Fernandez provide an in-depth exploration into the common cosmetic ingredients used in cosmeceuticals, and discuss notable new developments The cosmetic industry is a constantly evolving and dynamic arena. New products frequently come into the market harnessing both new and established ingredients. This article investigates commonly used cosmetic ingredients, their application, and the notable developing fields within cosmeceuticals.

HYDROXY ACIDS Hydroxy acids (HAs) have been used for their skincare properties since as far back as ancient Egypt, when Cleopatra reportedly bathed in sour milk, a rich source of lactic acid. Lactic acid is a form of alpha hydroxy acids (AHAs). Other HAs include polyhydroxy acids (PHAs), beta hydroxy acids (BHAs), aldobionic acids (BAs) and aromatic hydroxyl acids (AMAs).

Alpha hydroxy acids AHAs are naturally-sourced non-toxic carboxyl acid.1 Aside from lactic acid, other AHAs include: glycolic acid, which is sourced naturally from sugar cane; citric acid from citric fruits; malic acid from apples and tartaric acid derived from fruits and grape wine.2 AHAs are used in a wide range of cosmetic products. They destroy the desmosomal attachments between corneocytes, and therefore reduce corneocyte cohesion.3 These properties have led to their successful use in xerosis, icthyosis, follicular hyperkeratosis, and in chemical peels as chemical exfoliants. Glycolic acid is a popular AHA used in chemical peels due to its effectiveness and ease of use.4 In addition, one study by Beradesca et al found AHAs reduced irritation by retaining moisture in the skin and thus improving the skin’s natural barrier function.5 The formulations of glycolic acid used in chemical peels can vary from 20-70%, however it is the pH that is key in controlling the depth and efficacy of the glycolic peel. Moy et al found that a pH range between pH 3.5-4 would be safe for home use products.6 Most AHA preparations come in formulations between 4-10% although stronger concentrations of up to 18% are obtainable for home care use. Reactions occur in less than 1% of patients and do not appear to be dose dependent, although care should be taken when using the higher strengths. Alongside the exfoliating properties of AHAs, it has well-established anti-ageing features. Studies by Ditre et al and Bernstein et al demonstrated that AHAs stimulate epidermal cell proliferation, reverse basal cell atypia and redistribute melanin in photo-aged skin.7,8 Bernstein et al found that AHAs improved dermal collagen quality by increasing hyaluronic acid, glycosaminoglycans and improved the properties of elastic fibres.8 In addition to these findings, Okana et al found AHA to increase dermal thickness, a property unique to hydroxy acids and not found in other forms of chemical exfoliants.9 Lactic acid is thought to be gentler on the skin when compared to other AHAs. Wehr et al found lactic acid to be naturally hydrating as it converts to lactate, a component of natural moisturising factor.10 Concentrations of lactic acid are available from 15-50% with the majority of products being formulated with a strength in the range 4-10%.

POLYHYDROXY ACIDS AND BETA HYDROXY ACIDS Further development into HAs has led to the discovery of polyhydroxy acids (PHAs). PHAs contain at least two hydroxyl groups and bionic PHAs have an extra carbohydrate unit.2 Despite bionic PHAs being larger molecules Edison et al found through a 12-week clinical study that PHAs were still able to penetrate and have anti-ageing effects whilst being less irritating when compared to AHA preparation.11 This study assessed the clinical grading of photoaging, had objective and subjective measures Before treatment of irritation as well as measuring pinch recoil, tolerance and a silicone replicas of the crow’s feet area. Edison et al demonstrated AHAs to have superior anti-ageing properties however PHAs were tolerated better, with anti-ageing effects.11 Further evidence to support their gentler profile on the skin comes from Rizer et al, who described PHAs to have enhanced water-binding and gel matrix forming properties that moisturise, protect and soothe the skin, making it suitable for sensitive skin types.12 Additionally, their gentler profile has made them useful for sensitive areas such as use around the eyelids.12,13 After treatment Furthermore, lactobionic acid and maltobionic acid, two common bionic hydroxy acids and similar to PHAs, have antioxidant properties. At the same time, they are stronger humectants compared to traditional AHA.13,14,15 Beta hydroxyl acids (BHAs) are expensive and commercially difficult to obtain. They are lipophilic, making them water soluble and able to penetrate hair follicles and sebaceous glands. They exhibit comedolytic properties, making them suitable in patients with acne.16 Salicylic acid has been referred to as an AMA, however, Draelos classified it as a prototypical BHA.2 Like other hydroxy acids it is used to breakdown the junctions between keratinocytes. It is frequently used in the treatment of acne, seborrhoeic dermatitis and in hyperkeratotic conditions such as psoriasis, calluses, Final formulation study showing treatment of crow’s feet, demonstrating efficacy of corns, keratosis pilaris and warts. Salicylic acid’s comedolytic properties makes it a useful ingredient in acne combined ingredients after 12 weeks medication.16 On application to the skin the salicylic acid frosts, signifying adequate application. Salicylic 28

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peels are often combined with other peeling agents and humectants, as they can be quite drying and irritating if used on their own. Yu and Van Scott17 and Bernstein et al 8 demonstrated that unlike the other hydroxy acids which have been shown to increase dermal thickness, salicylic acid results in a reduction of dermal thickness and thus is not suitable for use in anti-ageing products. It is also essential to note that salicylic acid can cause unwanted hyperpigmentation, which is more commonly reported in Fitzpatrick skin types IV, V and VI.18, 19

ANTIOXIDANTS, SUNSCREENS AND SUN BLOCKS The link between ultraviolet (UV) radiation and permanent skin damage, including skin cancer and ageing, has been well-established.

Lowe et al20 and Fisher et al21 found damage occurring due to two distinct processes. Firstly: oxidative damage from UV radiation induced reactive oxygen species (ROS) causing oxidative damage to cellular lipids, proteins and DNA. This results in increased inflammation and poorly formed collagen and elastin within the dermal matrix. Secondly: direct damage to cellular DNA that can lead to abnormal function including tumor formation.

Antioxidants have a role in anti-ageing products by limiting the damage caused by free radicals from ultraviolet light and environmental toxins. Over time this can manifest clinically as abnormal melanin production, age spots, reduced cell turnover, dryness and rough skin.

The free radical damage to the deeper dermis results in poorly formed collagen and elastin, leading to wrinkles. Potent antioxidants include Vitamin C and E, green tea, soya bean derivative genistein, pomegranate extract, reservatrol, magnesium, selenium and carotenoids. Passi et al22 described how topical antioxidant applications increased the level of antioxidants present in the sebum, whilst oral preparations increase the antioxidant activity in the stratum corneum. This suggests that combination treatment may enhance antioxidant activity throughout the skin and thus limit the extent of damage caused by free radical and ROS. The Council Directive 76/768/ EEC of 27th July 1976 initially listed sunscreens as cosmetic products, and more recently in July 2013 the EU Cosmetic Directive (EC 1223/2009) has set European regulations.23 Sunscreens provide chemical protection, whilst sunblocks provide physical protection against ultra-violet radiation. Zinc oxide, titanium dioxide and iron oxide are some of the commonly used physical sunblocks. They scatter and block UV light penetrating the skin.

The main cosmetic problem with sunblock is that when applied appropriately it leaves a noticeable tint on the skin. New micronised formulations are better at blending in to the skin, however they are not as effective on darker pigmented skin. Chemical sunscreens include phenylbenzimidazole sulfonic acid, avobenzone, octyl methoxycinnamate, salicylates, benzophenones, dibenzoylmethanes, ecamsule and octocrylene. They work solely by absorbing UV light. Additionally, it should be noted that chemical sunscreen use has been linked to the development of both dermatitis and photocontact allergy.24 The Food and Drug Administration (FDA) have monitored closely the sunscreen field. In June 2012 they provided guidance on sun protection. According to these recommendations all sunscreens should provide both UVA and UVB protection of at least sun protection factor (SPF) 15, in order to be labeled as sun protection. Products with SPF between 2 and 14 help only against sunburn and are required to carry a warning for skin cancer and ageing. Sunscreens are not waterproof. The FDA describes sunscreens as, “Very water resistant” if they provide 80 minutes of protection in water, and, “Water resistant” if protection last for at least 40 minutes in water. The National Institute for Health and Care Excellence (NICE) in 2011 stated that SPF 15 is sufficient in strength to protect against sun damage25, however it must be applied at a recommended 2mg/cm². This is technically challenging as a standard adult would require approximately 35ml of sunscreen for adequate coverage, which would need to be repeated every 2-3 hours.

Before treatment

CHEMICAL PEELING AGENTS Chemical peeling agents are another area of vast interest and development within the cosmetics industry. As mentioned earlier hydroxy acids have a long history of use as chemical exfoliants. Other chemical exfoliants include resorcinol, phenol and trichloroacetic acid.

Phenol

After treatment

Phenol peels by themselves or in combination provide a deep peel and are more complex to use. They require appropriate sedation and monitoring with post-treatment care and adequate post-procedure pain relief.26 The mask is removed after a period of between 24-48 hours after which an occlusive biosynthetic material is applied alongside topical antiseptic, antibacterial and steroidal agents. It may take up to three months for the skin to fully heal and like other deep peels should only be performed under specialist supervision e.g. with a dermatologist or plastic surgeon.

Resorcinol

Before and after treatment with 8% lactobionic acid showing increased viable epidermal thickness

Resorcinol, a derivative of phenol, is a commonly used agent in combination peels, e.g. in Jessner’s peels.

Arthur Rook in the Textbook of Dermatology described resorcinol disrupting hydrogen bonds in keratin and also showed it to have a useful role in pigmentation disorders.27 Despite this, resorcinol was linked to adverse reactions including methemoglobinemia and tachycardia.28 Epidemiological studies showed an association between phenol-derived compounds and the development of thyroid dysfunction.29 Recent reviews however, demonstrate no significant evidence to support resorcinol’s relation to thyroid abnormalities.26

Jessner’s solution Both Jessner’s solution and modified Jessner’s solution are popular chemical peels. They are used in combination with other ingredients and this then allows for a reduced concentration and thus reduced toxicity.30 Modified Jessner’s solution omits resorcinol and consists of 17% salicylic acid, 17% lactic acid and 8% citric acid. In contrast the standard Jessner’s solution is composed of 14% resorcinol, 14% salicylic acid and 14% lactic acid.26 Aesthetics | April 2014

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Clinical Practice CPD

Before treatment

After treatment

aestheticsjournal.com Trichloroacetic acid Trichloroacetic acid (TCA) has been used since the 1880s as a moderate peeling agent.31 It can be used alone or in combination with other peeling agents. TCA can be supplied by a pharmacist using a weight in volume dilution, where 30% TCA is produced by adding water to 30g of TCA to make a 100ml solution.26 Low strength TCA (<20%) has been said to reduce fine lines and superficial wrinkles with no response on scars or deeper wrinkles. Care must be taken with TCA at higher strengths, which results in a stronger peel and papillary dermal necrosis. Recognised side effects of TCA chemical peels are post-inflammatory hyperpigmentation, and scarring, with additional care needed in Fitzpatrick type IV to VI skin.4 TCA denatures proteins and when applied creates a white frost from the resulting keratocogaulation.26 In addition, the authors of Colour Atlas of Chemical Peels describe TCA usefulness in treating hypertrophic actinic keratosis and sebhorreic keratosis.26

Retinoic Acid There are three main types of vitamin A formulations, retinol, retinal aldehyde and retinoic acid (tretinoin). They have been used to treat photo-damaged skin, hyperpigmentation and acne. Their formulations can vary from mild in cosmetics to higher doses available on prescription for the treatment of acne.32 Vitamin A peels vary in strength from mild retinol peels to higher strength retinoic acid peels.

Forehead before and after 16-week treatment with combined ingredients One study showed a 1% tretinoin peel applied for six to eight hours in a sample of 15 women aged 23â&#x20AC;&#x201C; final formulation study 40 to be as effective at 2.5 weeks as topical tretinoin used for 4-6 months.33 Patients on retinoids should stop these several days prior to undergoing a chemical peel as they can enhance the penetration of the peel.

The retinoids should only be restarted once the skin has fully healed. 26

NEWER INGREDIENTS PEPTIDES Peptides are chains of amino acids. They have recently become a focus of research in the cosmeceutical field. Peptides have shown anti-ageing, pigment modulating, anti-inflammatory and anti-microbial effects in vitro. They target specific receptors and have select actions, which makes them unique ingredients. Research and development continues into their use, particularly in formulating a product that will penetrate the skin and be clinically effective. Signal peptides are composed of a chain of hydrophobic amino acids. Their role is to signal where peptide actions are required. Matrixyl 3000 is a signalling peptide which is made up of palmitoyl pentapeptide and palmitoyl oligopeptide. Fields et al34 demonstrated that Matrixyl 3000 application, when compared to controls, stimulated pro collagen I and III, fibronectin and fibroblasts.

Neurotransmitter-inhibiting peptides Neurotransmitter-inhibiting peptides are molecules made of amino acids which bind to its receptor and results in inhibitory effects on the release of neurotransmitter. An interesting example of a neurotransmitter peptide is the hexapeptide sequence that is derived from soluble NSF attachment protein 25 (SNAP-25). SNAP 25 is a crucial component of soluble NSF attachment protein receptor (SNARE) complex which is responsible for the release of vesicles containing acetylcholine from the presynaptic nerve terminal. The hexapeptide acts as a competitive inhibitor by mimicking the N-terminal end of SNAP-25 and thus binding SNARE to create a destabilised complex.

Subsequently, acetylcholine release is inhibited, resulting in muscle relaxation. Fields et al described a 30% reduction in wrinkles and depth when a topical 10% argireline preparation was applied for 30 days. The substantial cost and lack of evidence to confirm its actions at the neuromuscular junction is currently limiting its use. This is an interesting area for continued research and development.

Carrier peptides Carrier peptides are transporter molecules which carry trace element around the body. Glycyl L histidyl-L-lysyl (GHK) transports trace metals such as copper. Copper is required by multiple enzymes including superoxide dismutase and tyrosine kinase to function properly. It has been postulated that increased copper levels may result in increased keratinocyte proliferation.

HUMAN DERIVED GROWTH FACTORS Other areas of interest include human derived growth factors, which have been investigated to see if their endogenous healing properties can be used for anti-ageing purposes. Growth factors such as platelet derived growth factor, fibroblast growth factor and granulocyte macrophage colony-stimulating growth factors are all naturally present in wounds. These promote healing and tissue regeneration. As they have a role in collagen, elastin and glycosaminoglycan synthesis they have been investigated as a potential ingredient for anti-ageing products. The growth factor proteins are unfortunately too large to penetrate intact skin, however further research is being conducted to see if topical application combined with non-surgical procedures e.g. peels and microdermabrasion, will lead to better penetration.36 In addition plant hormones have been investigated for their possible anti-ageing effects. Phytohormone is the term used to describe plant hormones; these include isoflavonoids, ligands and terpenoids. Another phytohormone, Kinetin (N6-fururyladenine), has also been described as a powerful antioxidant. Suresh Rattan described an in vitro study where the addition of kinetin to a culture medium of human fibroblasts delayed the onset of the ageing process.37 Further investigation into the clinical effectiveness of phytohormones is still required to confirm their clinical effectiveness.

Stem Cell technology Plant stem cells are being investigated as a potential new cosmeceutical. In contrast to human stem cells, plant stem cells have the ability to differentiate into any type of cell (totipotent). This would theoretically make it possible to completely rejuvenate any structure within 30

Aesthetics | April 2014

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Clinical Practice CPD

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the body. Currently there is interest in the apple stem cells (PhytoCellTec Malus Domestica) from the Uttwiler Spatlauber apple. This is an endangered Swiss apple which lost its popularity in the food market due to its bitter taste but investigated further due to its surprising long shelf life. The apple stem cells are thought to be rich in epigenetic factors and metabolites, which protect stem cells and delay senescence of hair follicles.38 A study conducted by Mibelle AG Biochemistry in 2009 showed the application of PhytoCellTec Malus Domestica to cultures of epidermal stem cells prolonged the stem cells colony-forming efficacy. The role of stem cells is currently an exciting avenue for research.

CONCLUSION It is clear that there is a wide range of cosmetic ingredients on the market for use in a diverse number of conditions. Some ingredients like the hydroxyl acids have been around for several years and have a broad spectrum of applications, from anti-ageing to acne treatment. Chemical exfoliants vary in their strength resulting in different cosmetic effects and varied pre-procedural and post-procedural care. The number of new agents that are currently being investigated is testimony to the amount of interest and research taking place to develop new products. Currently, exciting areas for development include the use of peptides and PhytoCellTec Malus Domestica in anti-ageing preparations. Importantly, it is worth noting that all these products need to be tailored specifically to the individual patient and used in accordance to their skin type and condition, with special care to avoid unwanted side effects.

REFERENCES 1. Van Scott, EJ. Yu, RJ. ‘Hyperkeratinization, corneocyte cohesion and alpha hydroxy acids’, J Am Acad Dermatol,11(5 Pt 1) (1984), 2. Draelos, ZD. Cosmetic Dermatology: Products and Procedures. Wiley-Blackwell, Chichester (2011) 3. Van Scott, EJ. Yu, RJ. ‘Actions of alpha hydroxy acids on skin compartments’, J Geriat Dermatol 3 (suppl A) (1995), pp. 19–24 4. Bauman, L. Saghari, S. Chemical peels. Cosmetic Dermatology: Principles and Practice. 2nd ed. McGraw Hill. New York (2009) 5. Berardesca, E. Distante, F. Vignoli, GP. Oresajo, C. Green, B. ‘Alpha hydroxyacids modulate stratum corneum barrier function’. Br J Dermatol 137(6) (1997), 6. Moy, RL. Luftman, D. Kakita, LS. Glycolic Acid Peels. Marcel Dekker, New York: NY (2002) 7. Ditre, CM1. Griffin, TD. Murphy, GF. Sueki, H. Telegan, B. Johnson, WC. Yu, RJ. Van Scott, EJ. ‘Effects of alpha hydroxyacids on photoaged skin: a pilot clinical, histologic and ultrastructural study’, J Am Acad Dermatol 34(2 Pt 1) (1996), pp. 187–95 8. Bernstein, EF1. Underhill, CB. Lakkakorpi, J. Ditre, CM. Uitto, J. Yu, RJ. Scott, EV. ‘Citric acid increases viable epidermal thickness & glycosaminoglycan content of sun-damaged skin’, Dermatol Surg 23(8) (1997), pp. 689–94 9. Okano, Y1. Abe, Y. Masaki, H. Santhanam, U. Ichihashi, M. Funasaka, Y. ‘Biological effects of glycolic acid on dermal matrix metabolism mediated by dermal fibroblasts and epidermal keratinocytes’. Exp Dermatol 12(suppl 2) (2003), pp.57–63 10. Wehr, R. Krochmal, L. Bagatell, F. Ragsdale, W. ‘Controlled two centre study of lactate 12% lotion and a petrolatum based cream in patients with xerosis’, Cutis 37(3) (1986), pp.

205–9 11. Edison, BL. Green, BA. Wildnauer, RH. Sigler, ML. ‘A polyhydroxy acid skin care regimen provides antiaging effects comparable to an alpha-hydroxyacid regimen’. Cutis 73(2 suppl) (2004), pp. 14–7 12. Rizer, R. Turcott, A. Edison, B. Outwater, S. Trookman, N. Ciociola, A. Kohut, B. ‘An evaluation of the tolerance profile of a complete line of gluconolactone-containing skincare formulations in atopic individuals’. Skin Aging 9(suppl) (2001), pp.18–25 13. Green, BA. Briden, ME. ‘PHAs and bionic acids: next generation hydroxy acids’, in: Draelos Z, Dover J, Alam M, Procedures in Cosmetic Dermatology: Cosmeceuticals, 2nd ed. saunders Elsevier, Philadelphia: PA (2009) 14. Green, BA. Edison, BL. Wildnauer, RH. ‘Maltobionic acid, a plant- derived bionic acid for topical anti-aging’, Am Acad of Dermatol 54(3) (2006), p.37 15. Bernstein, EF. Lee, J. Brown, DB. Yu, RJ. Van Scott, EJ, (2001) ‘Glycolic acid treatment increases type I collagen mrNA and hylauronic acid content of human skin’, Dermatol Surg 27(5) (2001), pp. 1–5 16. Davies, M, Marks, R. ‘Studies on the effect of salicylic acid on normal skin’, Br J Dermatol 95(2) (1976), pp. 187–92 17. Yu, RJ, Van Scott, EJ. ‘A-hydroxyacids, polyhydroxy acids, aldobionic acids and their topical actions’, Baran, R. Maibach, HI. eds. Textbook of Cosmetic Dermatology, 3rd edn. Taylor & Francis group, New York: NY (2005) 18. Roberts, WE. ‘Chemical peeling in ethnic/dark skin’, Dermatologic Therapy 17(2) (2004) pp.196–205 19. Grimes, PE. (1999) ‘The safety and efficacy of salicylic acid chemical peels in darker racial ethnic groups’, Dermatol Surg 25(1) (1999), pp. 18–22 20. Lowe NJ, Meyers DP, Wieder JM, Luftman D, Borget T, Lehman MD, Johnson AW, Scott IR. ‘Low doses of repetitive ultraviolet A induce morphologic changes in human skin’. J Invest Dermatol 105 (1995) pp. 739–43 21. Fisher GJ, Kang S, Varani J, Bata-Csorgo Z, Wan Y, Datta S, Voorhees JJ. ‘Mechanisms

32

Dr Sandeep Cliff is a consultant dermatologist and dermatological surgeon based in London and Surrey. He has lectured extensively both nationally and internationally on facial rejuvenation.

Dr Carolina Fernandez is a clinical teaching fellow in dermatology based at St. Helier Hospital. Prior to this she completed part of her dermatology registrar training at St Helier Hospital.

of photoaging and chronological skin aging’. Arch Dermatol 138 (2002), pp. 1462–70 22. Passi, S, De Pita, O, Grandinetti, M, Simotti, C, Littarru, GP. ‘The combined use of oral and topical lipophilic antioxidants increases their levels both in sebum and stratum corneum’. Biofactors 18 (2003), pp. 289–2897 23. European Commission (2010), Council Directive of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products. [Online] Available from http://tinyurl.com/66zzs8j (Accessed 25 May 2012) In Bowes, Lorna, ‘Understanding the dermal effect of heightened exposure to the sun’, Journal of Aesthetic Nursing 1(1), (2012) p. 30 24. Dean, SW. Lane, M. Dunmore, RH. Ruddock, SP. Martin, CN. Kirkland, DJ. Loprieno, N. ‘Development of assays for the detection of photomutagenicity of chemicals during exposure to UV light--I. Assay development’, Mutagenesis 6(5) (1991), pp. 335-341 25. National Institute for Health and Clinical Excellence (2011), Skin Cancer Prevention: Information, Resources and Environmental Changes, http://tiny.cc/fp09cw (Accessed 24 April 2012) 26. Tosti, A. Grimes, P. De Padova, M. ‘Trichlorocetic acid’, Colour Atlas of Chemical Peels.

2nd ed. Springer-Verlag, Berlin (2012) 27. Rook, A. Wilkinson, DS. Ebling, FJG. Textbook of Dermatology. Blackwell Scientific, Oxford (1972) 28. National Institute for Occupational Safety and Health (2011) Resorcinol. [Online] Available from: http://tinyurl.com/nnj4qv2 [Accessed 28 May 2013] 29. Divi, RL. Deorge, DR. ‘Mechanism-based inactivation of lactoperoxidase and thyroid peroxidase by resorcinol derivatives’. Biochemistry. 16;33(32) (1994), pp. 9668-74 30. Brody, HJ. (1992) As quoted in Bowes, Lorna, ‘An introduction to superficial, medium, deep and combination peels’, Journal of Aesthetic Nursing, 2(5) (2013), pp. 224-230 31. Brody, HJ. Monheit, GD. Resnik, SS. Alt, TH. ‘A history of chemical peeling’. Dermatol Surg 26(5) (2000), pp. 405–9 32. Fromage, G. ‘Topical retinoids: exploring the mechanisms of action and medical aesthetic applications’. Journal of Aesthetic Nursing 2(2) (2013), pp.68–75 33. Cucé, LC. Bertino, MC. Scattone, L. Birkenhauer, MC. ‘Tretinoin peeling’, Dermatol Surg 27(1) (2001), pp. 12-4 34. Fields, K. Falla, TJ. Rodan, K. Bush, L. ‘Bioactive peptides: signaling the future’, J Cosmet Dermatol 8 (2009), pp. 8–13 35. Kang YA1, Choi HR, Na JI, Huh CH, Kim MJ, Youn SW, Kim KH, Park KC. ‘Copper-GHK increases integrin expression and p63 positivity by keratinocytes’, Arch Dermatol Res. 301(4) (2009), p. 301–6 36. Fitzpatrick, RE. Rostan, EF. ‘Reversal of photodamage with topical growth factors: a lipot study’. J Cosmet Laser Ther. 5. (2003), p. 25–34 37. Rattan SI, ‘N6-Furfuryladenine (Kinetin) as a potential anti-aging molecule’, J Anti Ag Med 5(1) (2002), p. 113–6 38. Schmid, D. Schurch, C. Blum, P. Belser, E. Zulli, F. ‘Plant stem cell extract for longevity of skin and hair’. International journal of Applied Science, Accessed from SOFW- journal 134 vol 5 (2008) p30-35 <https://www.mibellebiochemistry.com/pdfs/Plant_Stem_Cell_ Extract_for_Longevity_of_Skin_and_Hair_SFW_05_08.pdf> [Accessed March 14 2014] FURTHER READING Bowes, Lorna, ‘An introduction to superficial, medium, deep and combination peels’, Journal of Aesthetic Nursing, 2(5) (2013), pp. 224-230 Bowes, Lorna, ‘Exploring the science of cosmeceuticals used to achieve optiomal skin health’, Journal of Aesthetic Nursing, 1(5) (2012), pp. 232-241 Bowes, Lorna, ‘The science of hydroxy acids: mechanisms of action, types and cosmetic applications’, Journal of Aesthetic Nursing, 2(1) (2013), p. 77

Aesthetics | April 2014

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References 1. Rzany B et al, Dermatol Surg 2012;38: 1153â&#x20AC;&#x201C;1161 2. Cartier et al, J Drugs Dermatol. 2012; 11 (1)(Supp): s17-s26 (*Results taken from a mean value across all treatments performed in study) 3. Farhi D et al, J Drugs Dermatol 2013; 12: E88-E93

Clinical Practice Treatment Focus

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Treating ageing skin with a growth factor serum Dr. Ahmed Al-Qahtani, president and founder of AQ Skin Solutions, discusses the use of a conditioned growth factor (GF) serum to prevent skin ageing Aside from being the largest human organ, the skin falls under special consideration for being directly exposed to the environment. Being exposed to environmental insults such as ultraviolet radiation and other toxins, means that the skin can also undergo extrinsic ageing.

Ageing is the synergistic result of both intrinsic and extrinsic ageing factors, which affect tissue function and structure.1 These ageing processes produce damaging reactive oxygen species, or free radicals2, 3 , particularly as a result of photo damage due to UV light exposure. Consequences of the interwoven molecular pathways of intrinsic and extrinsic ageing include the reduction of procollagen production and increase of collagen degradation in the extracellular matrix (ECM), which manifests as fine lines and wrinkles, discolouration, eyelid bags, circles around the eyes, and sagging of the facial and periorbital areas. With emerging evidence revealing the shared fundamental molecular basis between chronological ageing and damageinduced ageing, exciting new opportunities for the proliferation of effective anti-ageing therapies are within reach. One research breakthrough to combat and reverse the underlying causes of ageing is the use of topical products employing growth factor (GF) technology.

WHAT IS GROWTH FACTOR (GF)?

Growth factors (GFs) are specialised proteins that act as chemical messengers. The GFs discussed presently comprise extensive signalling pathways between the dermal and epidermal layers of the integumentary system.4 They are found naturally in body cells including fibroblasts, which are responsible for the synthesis of the ECM 34

and collagen. Closely related to GFs are cytokines, which are associated with the immune system and play a key role in the modulation of inflammation for wound healing and skin regeneration.5 GFs and cytokines are derived from macrophages, epidermal keratinocytes, and fibroblasts.

Both are involved in cell differentiation, angiogenesis, production and distribution of collagen and elastin, and the regulation of essential cellular activities; therefore, they support healthy skin structure and function by promoting cell growth, organising the ECM and promoting cell recovery. Such topical GF technologies have also been found to produce cosmetic benefits as well.6 AQ serums (AQ Recovery, Active, and Eye Serum) utilise the skinâ&#x20AC;&#x2122;s own renewal mechanisms to reverse the signs of ageing, supplementing healing processes with essential components, which stimulates repair of ageing and photo-damaged skin. They are topical cosmeceuticals featuring GFs, skin conditioning agents, and antioxidants used in combination to improve the appearance of the skin, in terms of fine lines, wrinkles, ages spots, tone and texture.

AQ GF TECHNOLOGY IN WOUND HEALING AND REVERSING THE EFFECTS OF AGEING SKIN My discovery of the use of GFs in aesthetics came as a result of my interaction with thirddegree burn victims in their wound healing and cell regeneration therapies. A healthy skin biopsy was taken from the patient, and fibroblast (skin) cells were isolated using advanced cell sorting technology.

The desired fibroblasts were replicated under sterile conditions and purified to obtain specific growth factors. The growth factors were isolated, purified, and placed Aesthetics | April 2014

Pre-Treatment

Week 1

Figure 1: Visible reduction in facial and periorbital wrinkles in a patient using GF serum (AQ Active and Eye Serum) twice daily

Before

After

Figure 2: Photographs of significant wound healing visible in a patient using GF technology serum (AQ Recovery Serum) over a period of 29 days

under skin grafts and applied at the wound site. This resulted in the regeneration of the wound site and the emergence of new healthy, smoother skin with little to no scarring. Through my extensive research in the use of growth factors for medical application in wound healing and creation of artificial skin grafts, I came to recognise the potential for the application of GFs in the treatment of ageing skin; the molecular pathways of dermal ageing, both intrinsic and extrinsic, bear various similarities to that of a dermal wound, including the induction of inflammation by both acute photodamage and trauma wounds. Knowing that inflammation results in elevated levels of free radicals and proteolytic enzymes, which promote the breakdown of the dermal ECM, I understood that successful wound healing would require a transition of the damaged cells from the inflammatory

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Clinical Practice Treatment Focus

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stage to the granulation stage; such transition involves a variety of GFs and cytokines (i.e. TGF-βs, PDGF, GM-CSF, and Interleukins).7-9 These GFs act as primary signalling molecules, which initiate the repair process by promoting cell growth, and promote the production of the ECM components required for repair. Supporting studies have shown that stimulation of fibroblast growth using GFs and cytokines results in the synthesis of essential ECM components such as collagen, glycosaminoglycans, and elastin.10, 11 Therefore, I set out to formulate a serum containing precisely the composition of cell signalling molecules required to induce healing and regeneration to ageing skin. The correct combination and balance of the various GFs listed (Table 1) seem to play a crucial role in the remodelling and strengthening of damaged dermal tissue. Since ageing results in decreased levels of necessary GFs, reversal of the Table 1: List of growth factors, cytokines and other proteins identified in AQ Recovery, Active, and Eye Serum and their functions in the skin TGF- βs (β1, β2, β3):

Stimulates collagen production Stimulates fibroblast collagenesis Stimulates glycosaminoglycan production Increases fibronectin synthesis Inhibits matrix degradation Facilitates cell chemotaxis Controls fibroblast activation of collagen synthesis

PDGF

Stimulates fibroblast collagenesis and glycosaminoglycan production Stimulates angiogenesis Stimulates wound contraction Facilitates cell chemotaxis

GM-CSF

Improves leukocyte function Activates neutrophils, eosinophils, and monocytes/macrophages Stimulates proliferation and differentiation of haematopoietic cell lines

Interleukins (ILs)

Regulate cell homeostasis

IL-3, IL-6

Enhance neutrophil functions

IL-7, IL-8

Function as anti-inflammatory agents and stimulate wound healing

REFERENCES: 1. Farage M.A., Miller K.W., Elsner P., Maibach H.I., ‘Intrinsic and extrinsic factors in skin ageing: A review’, Int J Cosmetic Sci., 30 (2008), pp. 87-9.

2. Miyachi Y., ‘Photoaging from an oxidative standpoint’, J Derma Sci., 9(2) (1995), pp. 79-86.

3. Berneburg M., Plettenberg H., Krutmann J., ‘Photoageing of human skin’, Photodermatol Photoimmunol Photomed, 16 (2000), pp. 239-244.

4. Babu M. and Wells A., ‘Dermal-epidermal communications in wound healings’, Wounds, 13 (2001), pp. 183-189.

5. Barrientos S., Stojadinovic O., Golinko M.S., Brem H., Tomic-Canic M., ‘Growth factors and cytokines in wound healing’, Wound Rep Reg, 16 (2008), pp. 585-601.

6. Schouest J.M., Luu T.K., Moy R.L., ‘Improved texture and appearance of human facial skin after daily topical application of Epidermal Growth Factor (EGF) Serum’, J Drugs Dermatol, 11(5) (2012), pp. 613-620.

7. Mateo R.B., Reichner J.S., Albina J.E., ‘Interleukin-6 activity in wounds’, Am J Physiol 266 (1994), R1840-R1844.

36

signs of ageing requires supplementation of those GFs involved in skin repair12, and an appropriate medium for adequate delivery and absorption.

MODE OF ACTION OF THE TOPICAL GF SERUM VIA PATENTED AQ GF TECHNOLOGY Although hydrophilic molecules larger than 500 Dalton typically have difficulty penetrating the stratum corneum, GFs and cytokines (>15,000 Dalton) are nevertheless able to penetrate the skin. Unlike collagen and elastin, these molecules do not comprise cytoskeletal proteins, yet they share the ability to create a signalling pathway. This cell-to-cell signalling allows them to communicate more deeply into the skin via epidermal keratinocytes, reaching as deep as the fibroblasts of the dense, irregular, fibrous connective tissue of the dermis.

These molecules possess a further advantage in that they penetrate the skin predominantly along vertical pathways, such as through the pore of a hair follicle, through sweat glands, or through microlesions of the interfollicular stratum corneum.

For the latter avenue, applying our serum in conjunction with microdermabrasion or micro-needling is particularly useful, as GF penetration can be significantly increased. The AQ serum formulation includes a unique delivery system in which conditioned media contains free-floating phospholipids, which can form micelles in aqueous solution, thus aiding the absorption of the larger GFs and cytokines. Soluble proteoglycans, or more specifically, glycosaminoglycans (GAGs), are also present in the media; studies have shown that GAGs can affect the activity and stability of proteins and signalling molecules within the ECM and also serve as lubricants in the ECM.13 Our body produces its own GAGs that hydrate the dermal layer from within and also interact with various families of GFs. The hydrolysed GAGs contained in our formulation are similar to super moisturisers that can penetrate where simple surface moisturisers cannot.

Furthermore, the addition of selected antioxidants and skin conditioning agents to our serum formulation facilitates the regenerative effects of the GFs and cytokines present. In sum, the AQ serum formulation not only allows for optimum penetration and absorption of the skin-regenerative GFs, but is also designed to fully promote the reversal of damage and promotion of health within the skin.

Dr. Al-Qahtani is a National Institutes of Health (NIH) scientist and is accredited with numerous scientific publications as well as his patented GF technology (U.S. Pat. 8,518,879). He is a longstanding member of the American Association of Immunologists and is an assistant professor with the faculty of medicine at United Arab Emirates University.

8. McCartney-Francis N., Mizel D., Wong H., Wahl L., Wahl S., ‘TGF-beta regulates production of growth factors and TGF-beta by human peripheral blood monocytes’, Growth Factors, 4 (1990), pp. 27-35.

9. Rappolee D.A., Mark D., Banda M.I., Werb Z., ‘Wound macrophages express TGFa and other growth factors in vivo: analysis by mRNA phenotyping’, Science 241 (1988), pp. 708- 712.

10. Moulin V., ‘Growth factors in skin wound healing. Review article’, Eur J Cell Biol, 68 (1995), pp. 1-7.

11. Kiritsy C.P., Lynch S.E., ‘Role of growth factors in cutaneous wound healing: a review’, Crit Rev Oral Biol Medical, 4 (1993), pp. 729-760.

12. Canalis E., ‘Skeletal growth factors and aging’, J Clin Endocrinol Metabol, 78(5) (1994), pp.

1009-1010.

13. Georges S., Heymann D., Padrines M., ‘Modulatory effects of proteoglycans on proteinase activities’, Meth Mol Biol, 836 (2012), pp. 307-22.

Aesthetics | April 2014

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*Tribo-Boixareu et al, Cinical and Histological Efficacy of a secretion of C. aspersa in Treatment of Cutaneous Photoageing. Cosmetic Dermatology, 2009 Fabi et al, The effects of the filtrate of the secretion of the C Aspersa on aged skin. J Drugs Dermatol, 2013

Clinical Practice Techniques

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The year of the eye: Allergan reveals its new treatment protocol for total eye area revitalisation Mr Taimur Shoaib, faculty member of the Allergan Medical Institute, discusses the treatment protocol and the training on offer 2014 has been dubbed ‘the year of the eye’ by Allergan, and at the 12th Anti-Aging Medicine World Congress in Monte-Carlo this April, the company will launch a unique new treatment protocol for the periorbital area. Designed to rejuvenate the entire area, safely, effectively and using scientifically proven techniques, this combination approach of botulinum toxin and dermal filler treatments was developed in consultation with twelve leading medical aesthetics practitioners from across Europe. It brings a holistic, individualised and stepwise approach to revitalisation of this most delicate, expressive and important area of the face. A training programme in how to use the new protocol will now be rolled out to over 15,000 medical practitioners across Europe. As a faculty member of the Allergan Medical Institute I am involved in the company’s medical education, and over the course of the next few months I will be conducting training sessions in Scotland and the North of England. There is a clear demand from patients for eye rejuvenation. In a recent survey by Allergan, crow’s feet lines were identified as the most desired area for a facial injectable treatment, with under-eye bags and frown (glabellar) lines ranking closely Mr Taimur Shoaib is a specialist consultant plastic surgeon with over 20 years medical experience. He runs a cosmetic practice at his clinic in Glasgow, and is a faculty memberof the Allergan Medical Institute.

behind in the top six areas of ageing concern.

Yet treating this area has often been linked with complications. With its thin skin, complex anatomy and intricate nerve structure, the periocular area can be an unforgiving area for treatments with Botox and fillers. As part of the training provided with this new protocol, we will endeavour to show practitioners a safe and effective way of rejuvenating this delicate area. This will include expert guidance on periorbital anatomy, patient assessment, treatment with Allergan’s portfolio of Botox and the Juvéderm Vycross collection, as well as how to avoid complications. Key to the protocol is spreading the treatment over two appointments, with the eye area first treated with Botox followed two to four weeks later with dermal fillers. Allergan’s Botox is the only botulinum toxin now approved for the treatment of moderate-to-severe glabellar lines and crow’s feet lines, either alone or simultaneously, while Vycross is a versatile range of HA dermal fillers which can be used in a tailored way to treat the mid-face, infra-orbital and eyebrow areas.

Volbella’s fine texture makes it suitable for the infra-orbital area, while Volift is suitable for middeep contouring in the eyebrow or temple. The mid-face deep fat pads can also be safely treated by gentle volumising using Juvéderm Voluma.

The Protocol Explained Before any treatment, it’s crucial to establish a comprehensive history of the patient. The two most important things we need to discover from our patients is what don’t they like about themselves, and what they are hoping to achieve. I take a full, relevant medical history too. Have they had treatments before? What treatments have they had? What have the results been like from this treatment? Do they have any allergies, are they otherwise fit and healthy? Are they on any medications? Do they smoke? I will then move on to examine the patient’s periocular area, starting at the forehead and moving down to the eyebrows and then into the eyelid region,

© Allergan Ltd.

38

Aesthetics | April 2014

F or m e d i u m to d e e p d e pr e s s i o n s i n clu d i n g na so - l ab ial F o lds . 1

WITH LIDOCAINE

A highly versatile, injectable gel using VYCROSS™ technology.1

reference: 1. Juvéderm VOLIFT with Lidocaine DFU, 2013.

Allergan, Marlow International, 1st Floor, The Parkway Marlow, Buckinghamshire SL7 1YL, UK | May 2013 UK/0658/2013

Clinical Practice Techniques

aestheticsjournal.com

moving down to the lower eyelid-cheek junction and down to the midface where the cheek fat pads lie. I then examine the area in the lateral area of the periocular region where there are crow’s feet and the temporal fossa, where our temporal fat pads undergo atrophy as the ageing process occurs.

Following this, I will then come up with a tailored programme to address these main areas. On day one, Botox is administered into the glabella at five injection points, with four units given in each of these five injection points, giving a total of 20 units of Botox. One injection is given to the procerus muscle and two injections are given to the corrugator supercilii muscle, one on the left and one on the right: five injection points in total, with each injection approximately 1cm apart.

Dr Raj Acquilla, who helped develop the new protocol, discusses patient selection, offers further tips on technique and shares his results

Botox is also then given to the crow’s feet area, 24 units at three injection points into the lateral vertical fibres of the orbicularis oculi muscle, inferior to the tail of the brow, each injection approximately 1cm apart. Botox starts working after a few days, and has its maximal effect after a couple of weeks.

According to Allergan’s clinical studies on the eye area, 59% of subjects were rated by investigators at Day 30 as having none or only mild wrinkles.

87.9% of subjects were rated by investigators as having a 1 grade or more improvement on the Facial Wrinkle Scale at maximum smile on Day 30.

Patients continued to show significant improvement at 4 months.

Two weeks later I review the patient and begin the filler treatment. The majority of people benefit from a brow lift and volume restoration in their midface region at the deep malar fat pads. They also benefit from an enhancement of their orbital rim at the inferior border; the tear trough region.

Some patients may also require temple fillers to treat temple hollowing. My approach in this case would be to lift the eyebrows using Volift – giving 0.5cc of Volift into the lateral brow region – which would lift the brow by 0.25-0.5cm. I would then administer Voluma into the deep malar fat pads in the mid face, in the cheek region, and Volbella into the tear trough region.

Often I would give five injection points of 0.1cc just inferior to the orbital rim.

We don’t want to inject into the eyelids as we don’t want to inject into the deeper structures of the periocular region. These exact injection points will be something we’ll show people during the training courses.

I have been involved in training delegates in periorbital injection techniques using the Juvederm filler portfolio over the last four years. The subsequent development in Vycross technology provided the perfect solution for volume correction and lift in this delicate anatomical region. After producing the first tear trough injection strategy, I was given the opportunity to lead the first large scale tear trough study in France alongside Allergan key opinion leaders. This was the foundation for my periorbital injection protocol. To accompany the protocol, we have also filmed an injection video which will be available via the Allergan Facial Anatomy App. The periorbital area is the aesthetic centre of the face and has become a huge focal point of concern for patients. It is where we first show the signs of © Dr Raj Acquilla facial ageing due to changes in the skin, muscle, fat and bony orbit. It is also where we estimate age and assess emotion in others.

The challenges when treating the periorbital region are based on the sensitive anatomy and critical structures in this area. In particular, thin fragile skin, orbicularis oculi and it’s retaining ligament, complex vascularity, lacrimal apparatus, lymphatic channels and of course the orbital septum which must never be breached. Side effects such as bruising and swelling are more common here however significant adverse events such as Tyndall, lymphoedema, vascular and visual compromise must be avoided at all costs.

I don’t like to give Botox and filler into the same area at the same time. It’s safer to administer these separately as there’s a danger of overfilling or underfilling the areas or seeing too much or too little by way of brow lifting.

I also want to see separately the effects of Botox into the muscles around these regions and filler into the fat pads. Following the treatment the patient then needs reviewing again, to ensure the results meet our expectations, and that the patient has no complications. With this protocol we expect the vast majority will have none whatsoever. However, later complications may occur, such as product migration, swelling, product palpability, and product visibility. Dealing with these is addressed as part of the training. Knowledge of the anatomy of the nerves is crucial to avoid injecting into and around the nerves. Knowledge of the blood vessels and what to do if a blood vessel is inadvertently punctured is also vital to avoid bruising. Training is also given in these aspects. Training for the protocol is delivered to a maximum of five participants at a time. Each session begins with presentations on the entire protocol, followed by a demonstration which I would carry out on a model.

Participants bring in their own models in order to deliver the treatment themselves.

Dr Raj Acquilla is a cosmetic dermatologist with over 11 years experience in facial aesthetic medicine. He is UK ambassador, global key opinion leader and masterclass trainer in the cosmetic use of botulinum toxin and dermal fillers. Dr Acquilla has a clinic and academy in Cheshire and London.

Patient selection is key. I recommend a simple grading tool (mild, moderate, severe). This helps to build an appropriate treatment plan including product selection and appropriate volumes. The protocol starts with the licensed use of Botox / Vistabel in the glabella and crows feet to promote a more open and refreshed orbital show.

Two weeks later we follow with the Vycross collection in the following points:

Patients involved in Allergan’s clinical studies on the eye area claimed that at day 30 they felt they looked younger, more attractive and less tired when treated for crow’s feet lines and glabellar lines simultaneously, versus patients treated for crow’s feet lines alone. I’m very confident that we will be able to train practitioners in the safe and effective delivery of these treatments, minimising side effects and maximising outcomes.

40

Aesthetics | April 2014

1) Voluma/Volift in the zygomatic arch and malar fat compartment.

2) Volbella in the anatomical tear trough and lateral lid/cheek junction.

3) Volift in the lateral brow and temple.

Clinical Practice Techniques

aestheticsjournal.com

The complementary use of Botox/Vistabel alongside the Vycross filler collection produces soft, natural and elegant results both at rest and during animation. This unique effect is possible due to optimum tissue integration and the mechanical blocking of dynamic lines. This has been shown to be desirable to our patients with high levels of satisfaction. When treating the periorbital region the patient must have a detailed consultation regarding the strategy and possible risks and complications. I usually apply topical anaesthetic cream and use a 32G needle at the tear trough and lid/cheek junction or a 30G cannula when gently subcising the orbicularis retaining ligament. I normally correct to 80-90% of the desired volume to allow for any post-injection swelling or hydrophilic rebound which I would touch up and perfect at two weeks.

The results our patients can expect to enjoy following injection using the periorbital strategy can be summarised in the following endpoints: 1. Projection and lift at the zygomatic arch and beautification point.

2. Correction of the tear trough and lateral lid cheek deformity with support and elevation of the lateral canthus promoting a more almond shaped eye.

3. Shortening of the lid cheek junction hence conferring a more youthful appearance.

4. Elevation and support of the lateral brow with correction of resting and dynamic component of crow’s feet lines.

Overall we can expect to see a 360 degree improvement in the beauty of the eye and periorbital area.

We are delighted to share this new periorbital protocol and hope that this will enable injectors of all levels to deliver exceptional results using indirect and direct techniques, depending on their personal skill and experience in this area. We now have such sophisticated and versatile products and techniques to help us deliver optimum results whilst significantly reducing adverse events.

Case studies Before

After

© Dr Raj Acquilla

Before

© Dr Raj Acquilla

This case study shows a 29-year-old actress and model who takes good care of her face and body. The patient had noticed for 12 months that she had dark circles and sunken eyes. This affected her casting and modelling, despite using different eye make-up products. Simple, accurate and low volume treatment has given her full correction of the tear trough. The patient now comments that she looks better without make-up.

Before

After

© Dr Raj Acquilla

After

© Dr Raj Acquilla

This case study shows a 31-year-old who had a sixmonth-old baby at the time. The patient complained of “tired eyes” due to lack of sleep, despite always being complimented on being very beautiful. Her treatment opened the orbital show and gives a look of serenity and being rested, which has restored her confidence.

Before

© Dr Raj Acquilla

This case study shows a 35-year-old (then) bride-to-be.

The patient had experienced ‘eye bags’ since childhood, but had noticed them worsening over the past three years.

The patient had previously been for a blepharoplasty consult but was told she was too young. The patient was getting married in six months and wanted to look her best.

Careful strategic placement of product in the cheek, tear trough and lid cheek junction masks the presence of the eye bag by ‘raising the sea level around the island’.

© Dr Raj Acquilla

After

© Dr Raj Acquilla

© Dr Raj Acquilla

This case study shows a 37-year-old sportsman. The patient has an athletic physique with low body fat percentage. Facial fat is minimal and gives a gaunt appearance. This was a complex case using sequential treatment to delicately restore midfacial and periorbital volume to promote a healthy and vibrant look.

Aesthetics | April 2014

41

Clinical Practice Clinical Focus

aestheticsjournal.com

Patient safety and correct injection protocol Dr Askari Townshend discusses the history and anatomy associated with blindness after facial cosmetic injections Although blindness as a rare risk of facial cosmetic injection has been known about for many years, it has become a hot topic of discussion after a recent incident in the UK. It is crucial to understand the anatomy in order to minimise the risk.

History of blindness Blindness after facial injection was first reported by von Bahr over 50 years ago after scalp injection of a hydrocortisone suspension to treat alopecia.1 The first cases after aesthetic ‘filling’ treatments were reported in the 1980s (four cases), rising to at least 16 reported cases in the 2000s, presumably related to the increase in number of treatments performed. In 2012, the UK reported a case after injection to the temple (the first report with Poly-L-Lactic Acid) which has led to some practitioners and clinics refusing to treat this area.

Image source: Gray’s Anatomy This is disappointing as injection in the temple is one of the least common causes of blindness and an important area for rejuvenation. Last year, the first two cases of bilateral blindness were reported; calcium hydroxyapatite to the nose and hyaluronic acid to the glabella, which also led to cerebral infarction.

Literature review In their 2012 review, Lazzeri et al identified 32 reported cases worldwide of blindness after cosmetic injection.2 Soon after, Woo et al described 12 cases in South Korea (an astonishing number for a country with a population smaller than the UK) and this month, Carle et al reported a further three, bringing the number to at least 50.3,4 The Lazzeri paper tells us that 15 of the 32 cases were after injection of fat. With the majority of these treatments performed by plastic surgeons, it reminds us that none of us are immune to adverse events. Of the remaining 17 cases, only two involved hyaluronic acid and only one was from a temple injection (of silicone oil). By far the most common area was the nose (seven cases). None were as a result of PLLA. Vascular Anatomy The first branch of the internal carotid artery (ICA) is the ophthalmic artery (OA) which in turn branches to the central retinal artery (CRA). This supplies the optic nerve and thus is essential for vision. It is not this deep system that is at risk during facial injection but the OA’s superficial branches and connections.

Supplying the glabella region is the last branch of the OA, the supratrochlear artery (STA), which connects with the dorsal nasal artery. It also anastomoses with the supraorbital artery, a more proximal branch of the OA, supplying the medial aspect of the forehead. There are several anastomotic patterns between branches of the external and ICA in the periorbital region, which enable communication between the OA and the temple and cheek.

Pathophysiology Occlusion of the CRA due to facial injection is likely to be due to retrograde displacement of product. For this to happen, the injection pressure must exceed the arterial pressure, causing product to move through the vasculature against the flow of blood until it passes the origin of the CRA. When pressure from the plunger is released, blood will flow once again pushing the product into the CRA, cutting off blood supply to the optic nerve. The equation for the 42

volume of a cylinder (πr2h) tells us that just 0.01ml of product would be enough to fill a 5cm length of a 0.05cm diameter vessel (assuming that the vessel did not dilate). This combined with our anatomical knowledge explains why injection of the nose and forehead/glabella are the most common causes of blindness.

Minimising risk The only way to completely remove the risk of blindness is to not inject at all. However, we can minimise this already very small risk. Excellent aspiration technique is essential and must be performed before every injection. Do not believe those that say it is not possible with viscous product – if you can move the product out of the BLOOD FLOW syringe, you can pull it back - and if your needle is in a INTRA ARTERIAL patent vessel or near one that INJECTION has been cut, you should see blood. You may only see a small trickle so keep a close eye on the barrel of the needle. Keep absolutely still throughout the procedure to ensure that you are injecting in the same place you aspirated. Watch the skin around your needle as you inject so that you are able to detect blanching.

Ophthalmic emergency Occlusion of the CRA is serious with poor prognosis and a window of just 90 minutes before irreversible damage occurs. If hyaluronic acid is the cause, hyalase should be injected immediately. Ocular massage is a simple manoeuvre to increase arteriolar flow, although this failed in all four attempts in the Lazzeri review. IV diuretic was successful in one case as was systemic and topical corticosteroids. More difficult but unproven therapies include carbogen inhalation and hyperbaric oxygen.

Five facts about blindness after facial injection 1. At least 50 cases have ever been reported in the history of aesthetic facial injections.

2. Of these the most common procedure resulting in blindness is fat transfer.

3. Only two cases have ever been reported after temple injection.

4. The areas of injection that pose the most risk are the nose, glabella and forehead.

5. Injection of less than 0.5mls of product can reach the central retinal artery.

REFERENCES 1. von Bahr G., ‘Multiple embolisms in the fundus of an eye after an injection in the scalp’, Acta Ophthalmol (Copenh.) 41 (1963), pp. 85–91.

2. Lazzeri D., Agonstini T., Figus M., Nardi M., Pantaloni M., Lazzeri S., ‘Blindness following cosmetic injections of the face.’, Plastic Reconstructive Surgery, 129(4) (April 2012), pp. 995-1012.

3. Woo S.J., Park S.W., Park K.H., Huh J.W., Jung C., Kwon O.K., ‘Iatrogenic retinal artery occlusion caused by cosmetic facial filler injections’, American Journal of Ophthalmology, 154(4) (Oct 2012), pp. 653-662.

4. Carle M.V., Roe R., Novack R., Boyer D.S., ‘Cosmetic Facial Fillers and Severe Vision Loss’, JAMA Ophthalmol, (Published online 6 March 2014) <doi:10.1001/ jamaophthalmol.2014.498>

Aesthetics | April 2014

Dr Askari Townshend is an international Sculptra trainer as well as lead UK Sculptra trainer for Sinclair Pharma. In addition, he is the UK medical consultant providing support for Sculptra practitioners.

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*Clinical trial ended at 25 months

THE VOLUMISER DESIGNED TO STIMULATE COLLAGEN WITH RESULTS THAT LAST OVER 2 YEARS* SPRING TIME IS HERE!

Natural & gradual deep tissue regeneration Effective collagen stimulator Natural aesthetic results lasting over 2 years* Sinclair IS Pharma 1st Floor Whitfield Court, 30-32 Whitfield Street London W1T 2RQ. United Kingdom www.sinclairispharma.com

Date of preparation: February 2014 UK/SIPSCU/13/0020

Clinical Practice Spotlight On

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Silhouette Soft: making the new thread lift work for your patients Silhouette Soft is currently attracting a great deal of attention in the aesthetic world. Here, two surgeons discuss the importance of good patient selection and technique The Silhouette thread lift was approved by the FDA in 2006, and is used by surgeons to lift the mid face and tackle early jowling in a minimally invasive way. It uses biocompatible but permanent polypropylene sutures and cones made of a bio resorbable L-Lacticle and Glycolide copolymer. These are anchored in the hairline via an incision in the temporal fascia under local anaesthetic, and sometimes under sedation. This procedure can only be performed by surgeons.

However, in October 2012 a new procedure, Silhouette Soft, was CE marked for use in the European market. This procedure is designed to lift the mid face, jawline, brows and even the nose, via two actions. It immediately lifts via the action of the threads, which become fixed by fibrosis, and then regenerates and volumises the face via a collagen stimulating effect. Silhouette Soft can be performed by cosmetic doctors and dentists and uses new, shorter (30cm) fully resorbable sutures made of polylactic acid (PLA), with eight bi-directional cones. There are four cones on each side of the suture, free floating between knots, and facing in opposite directions. These are also resorbable and made from lactic and glycolic acid. The PLA threads degrade into harmless lactic acid over a period of six to 24 months, and act as a collagen stimulator.

The sutures, normally two to four on each side of the face, are inserted in the subcutaneous skin layer via an entry point in the middle of the suture pattern. Local anaesthesia is used only at the entry and exit points of the suture and, there is no need for a surgical incision or any stitches.

Surgeon Angelica Kavouni, who has experience of both Silhouette Lift and Silhouette Soft, says, “This procedure appeals to patients who do not want to have surgery, and don’t like the idea of any permanent substance being left in their faces. They also like that it is safe and subtle.” However, she adds that patient selection is key to the success of any thread lift technique. “You must be very careful,” she says. “Silhouette Soft is really not suitable for those who have significant loose skin. This usually means patients up to the age of 45, or 50 if they have good quality skin. It is also important to realise that in very thin-skinned patients the suture Before

44

After

may be visible. A good way to check if a patient is suitable is to gently lift and push back the skin of the mid-face towards the ear using your fingers. The amount of skin bunching you get indicates the amount you will get post-procedure. Too much means the patient is not a good candidate. I do this with the patient holding the mirror and when I see a patient who really needs a surgical face lift, a useful tip is to ask them ‘What do you think will happen with this excess skin?’, and they normally agree that the treatment will not work for them.”

Cosmetic surgeon Rosalba Russo, when presenting a live demonstration of Silhouette Soft at this year’s IMCAS, agreed patients with too Before After much sagging skin or excess facial fat are not suitable for the treatment.

The eight-cone suture is the standard for treating the midface, however, Russo said the 16-cone suture, designed for the body, is good for mandibular rejuvenation. “Jowl definition is a very good indication for using this thread and can replace surgery if surgery is too aggressive or the patient does not want it,” she says.

Silhouette Soft may also be used to elevate the tail of the brow.

Russo says this can be used even if Botox is not effective in this area. However, Ms Kavouni says that in her experience, “Eyebrows are difficult. They are so mobile that it is difficult to get a temporal lift. Patients who tend to pull their brows down can dislodge the thread before fibrosis occurs. In my opinion, botulinum toxin is required in order to fix the eyebrows for a period of time.” She says, “In my experience this treatment is most effective in the mid-face, cheeks and jowls. As the threads in Silhouette Soft are not anchored they cannot give as dramatic an instant lift as with the Silhouette Lift, but, particularly if used in combination with injectables and skin tightening treatments it can give impressive results. I personally use it with fillers, Fraxel and with Thermage.”

Post-treatment, patients will be able to see needle marks on their face, and there is, says Kavouni, “Always some degree of bunching up of the skin behind the insertion point for around three days, plus a small dimple where the suture is inserted.”

However, most patients can apply make up to hide any bruises or needle marks and return to activities the following day. Russo said that 150,000 sutures have been used worldwide to date, with no reports of permanent or major complications. According to studies, improvement via fibrosis continues for five months after treatment and lasts up to two years. Future developments include developing threads and protocols for body and breast lifting.

Aesthetics | April 2014

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1. Radiesse Injection Guides RAD058 / 059 / 060 2. Moers-Carpi M et al, Physician and Patient Satisfaction After Use of Calcium Hydroxylapatite for Cheek Augmentation. Dermatol Surg 2012, 38: 1217-1222 3. Moers-Carpi M et al, A multi-centre Randomised Trial comparing Calcium Hydroxylapatite to two Hylauronic Acids for treatment of Nasolabial Folds.

Dermatol Surg 2007; 33 (Supp 2):s144-s151

Call Merz Aesthetics Customer Services now to find out more or place orders: Tel: +44(0) 333 200 4140 Fax: +44(0) 208 236 3526 Email: customerservices@merz.com RAD072/0813/LD Date of preparation: December 2013

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Clinical Practice Clinical Focus

aestheticsjournal.com

Understanding Scientific Evidence in Skincare Dr Mervyn Patterson offers advice on understanding terms used in clinical studies Doctors and nurses providing anti-ageing treatments for their patients should consider the evidence supporting the claims made by the various companies. Practising in private medicine removes many of the checks and balances found within the National Health Service, which protect patients from experimentation and exploitation. Medical professionals should be able to balance their need to make a living, with an ethical requirement to do what is best and scientifically proven for their patients.

An area where there is a great deal of rightful skepticism is the skincare industry, which, in my opinion, tends to excel in marketing jargon and often lacks substantial supporting evidence. A review in 2006 showed that only nine ingredients in skincare products had completed clinical trials, while another 15 ingredients had undergone animal or laboratory testing(1). Another review in 2008 claimed that only eight ingredients had adequate clinical support for wrinkles and 17 herbal products had been shown to produce a visible benefit in treating skin conditions and diseases(2). Of the 8,000 known antioxidants, only 28 had undergone double blind controlled clinical trials and only 14 of these demonstrated efficacy(3,4).

The proof for evidence-based medicine consists of human clinical trials. The gold standard for clinical testing is double blinded, prospective, randomised, controlled, human clinical trials against placebo or an approved prescription product, conducted by a third party research group, using the final finished formulation. In an ideal world, all cosmeceutical companies would provide this sort of evidence, but in reality we see a rather different approach.

Phrases such as clinical evidence, clinical studies, dermatologically tested, proven ingredients, pharmaceutical grade, well-researched and cutting edge science are just a few phrases of the hundreds used by companies and their marketing teams to convey the impression that their products are evidence-based and thus effective. Pharmaceutical companies are required to undergo several phases of rigorous clinical trials and the first includes trials involving 20 to 80 people, with the number recruited sufficient to determine statistical significance. The goal of these trials is to get some measure of effectiveness and safety.

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Key terms used for clinical trials Open label vs. single blind vs. double blind: In open label, also known as a pilot study, both the patient and the researcher know which treatment is received. In a single blind study the patient doesnâ&#x20AC;&#x2122;t know what they are getting and in a double blind trial neither the patient nor the researcher knows which treatment is received.

This information can be retrieved in an emergency.

Prospective vs. retrospective: Trials that gather data as they progress are prospective; retrospective trials gather data after the trial is complete.

Randomisation: In randomised trials, a computer decides which patients receive the active product or the control.

Placebo control: One group of patients will receive a dummy product, which looks like the study drug but doesnâ&#x20AC;&#x2122;t contain the active ingredients.

In vitro vs. in vivo: In vitro are tests done in a laboratory using test tubes or petri dishes. In vivo trials for skincare products involve using human or animal skin at predetermined test sites.

Single centre vs. multi centre: At a single centre trial there is only one researcher group running this study at one centre. In a multi centre study there is more than one research site. These multiple test centres are developed to test for population, geographical and climatic variations.

Split face vs. full face parallel: Split face studies are where half of the face receives the tested product and the other half receives the control product. Full face parallel studies are different in that a proportion of the study panelists receive the test material and the others receive the placebo or active control. A split face study requires fewer patients to reach statistical significance. Full face parallel studies test both groups at the same time.

Some basic statistical knowledge p-value: This is the measure of how much evidence is needed to compare to no change or no effect. This value is a measure of probability. As an example a p-value of 0.5 is the measure of probability that if the clinical study were to be conducted 100 times, 95% of the time the result would be the same. A p-value of 0.10 means the same result would occur 90% of the time and a p-value of 0.20 means the same result occurs 80% of the time. A p-value of 0.05 or less indicates statistical significance.

Statistically significant: When a result is statistically significant it means that there is enough difference between the two groups to produce a predictable result.

Smaller p-values indicate more significant results. A p-value of 0.05 or less is Aesthetics | April 2014

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0800 0195 322 info@aestheticare.co.uk PRESCRIBING INFORMATION LMX4 Lidocaine 4% w/w Cream is a topical anaesthetic containing 4% w/w Lidocaine in a liposome base. Indication: Venous cannulation or venipuncture: Adults including the elderly and children over one month of age. Local anaesthetic for topical use to produce surface anaesthesia of the skin prior to venous cannulation or venipuncture. Dose and method of use: Apply 1 to 2.5g of LMX4 Cream to the area of the skin where the procedure will occur. No more than 1g of cream should be applied to children under 1 year of age, 1g of cream equates to approx. 5cm of cream squeezed from the 5g tube or approximately 3.5cm of cream squeezed from the 30g tube. The LMX4 Cream should remain undisturbed on the skin and can be covered with an occlusive dressing to prevent disturbance. Adequate anaesthesia should be obtained after 30 minutes, but the LMX4 Cream can be applied for up to 5 hours under a dressing. Shortly before starting the procedure the LMX4 Cream should be removed with clean gauze and the procedure site prepared in the usual manner. Maximum application time for 1 year and above should not exceed 5 hours. Maximum application time for 3 month up to 12 month infant should not exceed 4 hours and maximum application time for 1 month up to 3 month infant should not exceed 60 minutes. Indication: Painful topical treatments on larger surface areas of intact skin: Adults, including the elderly. Local anaesthetic for topical use to produce surface anaesthesia of the skin prior to painful topical treatments on larger surface areas of intact skin. Apply approx. 1.5g to 2g LMX4/10cm2 of skin up to a maximum of 900cm2. Apply until response is achieved which is generally between 30 to 60 minutes. Typical estimated quantities are 30-40g/200cm2 (approx.

© AesthetiCare® 2013 6501/03.14

10cm x 20cm or covering a face), 45-60g/300cm2 (approx. 10cm x 30cm or covering an arm), 135g-180g/900cm2 (approx. 30cm x 30cm, or covering torso or back). The LMX4 Cream should be applied evenly at the specified dose with a uniform thickness across the area where the treatment will occur.

Measures may be taken to ensure the cream remains undisturbed. Shortly before starting the topical treatment the LMX4 cream should be removed and the site for treatment prepared in the usual manner. Contraindications: Hypersensitivity to Lidocaine, or any of the amide-type local anaesthetics, or any of the excipients. Precautions and warnings: For external use only. Do not apply to irritated skin or if excessive irritation develops. Avoid contact with eyes. Do not use in large quantities or for longer times than those recommended. LMX4 Cream should not be applied to wounds, mucous membranes, or on atopic dermatitis as there is no clinical data relating to its use on such areas. Lidocaine should not be used in any clinical situation in which its penetration or migration beyond the tympanic membrane into the middle ear is possible. Repeated doses of Lidocaine may increase blood levels of Lidocaine. Patients with severe hepatic disease are at greater risk of toxic plasma concentrations of Lidocaine. Production of surface anaesthesia can block all sensations in the treated skin and trauma to the treated area such as exposure to extreme temperatures should be avoided until complete sensation returns. Interactions: Lidocaine should be used with caution in patients receiving Class 1 anti-arryhthmic drugs. Pregnancy and lactation: LMX4 should be used during pregnancy only if clearly necessary. Caution should be exercised when LMX4 is administered to a nursing mother.

Undesirable effects: Application of Lidocaine can cause transient local blanching followed by transient erythema and other effects can include irritation, redness, itching or rash of the skin. In rare cases local anaesthetics have been associated with allergic reactions including anaphylactic shock.

Systemic toxicity is unlikely but signs of systemic toxicity are blurred vision, dizziness, difficulty breathing, trembling, chest pain or irregular heart beat.

Basic NHS Price: LMX4 5g £2.98, LMX4 30g £14.90. Legal classification: P MA number and holder: PL 20685/0034, Ferndale Pharmaceuticals Ltd, 12 York Place, Leeds, LS1 2DS. Prescribers should consult the Summary of Product Characteristics for further information. Date of revision: July 2013.

Adverse events should be reported.

Reporting forms and information can be found at www.mhra.gov.uk/yellowcard Adverse events should also be reported to Ferndale Pharmaceuticals Ltd. contact details below Ferndale Pharmaceuticals Ltd, Unit 740 Thorp Arch Estate, Wetherby, West Yorkshire, LS23 7FX, Phone: 01937 541122, Fax 01937 849682, email info@ferndalepharma.co.uk

REFERENCES * LMX4 Summary of Product Characteristics (Date of Revision 28 June 2013) † Taddio et al, CMAJ 2005;172(13) 1691-1695 Date of preparation: July 2013 Item code: LMX4ACare0713

Clinical Practice Clinical Focus

aestheticsjournal.com

recognised as the cut off point where statistical significance and therefore efficacy can be claimed. This has been determined by multiple regulatory agencies including the EU. The phrase ‘trend towards significance’ is used where the difference between the two groups produced a less than 0.10 p-value.

Statistically vs. numerically superior: In some studies, companies claim superiority over another product or placebo but no p-value is provided. When a claim is made of superiority, look for the p-value; if it isn’t present then be highly suspicious that the results were numerically better but are not significantly better, thus no more effective.

Picking through the marketing hype Some companies claim to have clinical data but refuse to provide detail regarding the studies. Often when you look deeper at websites and company information, the clinical evidence turns out to be a series of before and after images. Failure to provide robust supporting clinical evidence should raise alarm bells amongst medical practitioners. Many companies refer to studies on individual ingredients but you cannot assume that activity will be maintained when that ingredient is mixed with multiple other ingredients. Has the biological activity of the ingredient been affected and has incorporating it into a new product altered the concentration? Given the complex formulations and multiple ingredients added to create cosmetic elegance, it is highly likely that many active ingredients could be rendered useless within current skincare brands. Only clinical trials such as the ones outlined above will prove effectiveness. Much of the testing referred to is in vitro but this does not ensure that activity is maintained on real skin or that the ingredient is in a high enough concentration to achieve an effect.

It is important to consider who conducted the study. On many occasions companies will claim sponsored studies that are actually conducted by in-house laboratories. This may reduce the chance of the data being truly objective.

The length of the study is also an important issue. For clinical relevance to skin and all skin cells, including melanocytes, the study must be a minimum of 12 weeks and preferably four to six months. Many studies have been published that have been as short as three to six weeks. This time duration is too short to properly assess the skin’s response and safety of the product with chronic use.

Take care with studies where the improvements are measured from baseline but fail to include any comparison to placebo or a prescription active. Many studies test products on areas of the body such as the forearm or back and ask you to believe that similar effects will be seen on the face. Given that the skin is significantly different in lipid concentration in different areas, this means that similar results may not be seen. Many companies will refer to tests on the eye area but this skin is very sensitive to changes in expression, humidity and placebo products such as glycerin. In short it is easy to get ‘improvements’ in the eye area but these may not relate to ‘active’ ingredients in the test product. A study claiming that panelists could see a difference is not significant if experts cannot determine any statistical change. An important issue to consider is who reviewed the data. A summary by a dermatologist or expert investigator will mean that the data has been analysed appropriately. Acceptance of the study in a peer-reviewed journal or on a poster exhibit at international meetings helps to support the validity of the work.

Testing for safety in cosmeceuticals All clinicians involved in using skincare to help their patients achieve significant results must consider not just how effective, but how safe the products are. Regardless of how effective a product is, if it triggers significant disease or side effects then it may not be suitable for use. The minimum in scientifically valid safety testing is a repeat insult patch test on 50 patients to determine if the finished product will cause allergic or contact irritation reactions. This test involves applying the final finished product daily to the skin of the back or inner arm, then covered with semi-occlusive dressing. It is performed on normal subjects with normal skin. The test site is then checked daily for evidence of pink or red colour changes, scaling, blistering, pustules or bumps. Additionally, the patient is asked about itching or burning. If a reaction occurs within the first two weeks it is a contact allergic reaction. If a reaction occurs after this then it is a contact allergen(5). All practising clinicians should question the skincare companies that they intend to use about the safety data surrounding their products.

As a co-owner of Woodford Medical, Dr Mervyn Patterson is a highly experienced aesthetic doctor providing a wide range of nonsurgical treatments. Financial disclosures: Medical director at Eden Aesthetics, distributor of Epionce / Agera skincare, Colorescience mineral make up, and Dermagenesis microdermabrasion and Dermafrac micro-needling machines. @drmervpatterson

The most important things to look for in a clinical study • • • • • •

double blind prospective randomised controlled human test subjects against placebo or an approved prescription product • conducted by a third party research group • with the finished product • p-value

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REFERENCES 1. Rabe J.H., Mamelak A.J. et al., ‘Photoageing: mechanisms and Repair’, J Am Acad Derm, 55 (2006), pp. 1 – 19.

2. Yarosh D., The New Science of Perfect Skin, (NY: Broadway Books, 2008), pp. 62 – 73, pp. 100.

3. Pinnell S.R., ‘Cutaneous Photodamage, Oxidative stress and topical antioxidant protection’, J Am Acad Derm, 48 (2003), pp. 1-19.

4. Thornfeldt C.R., ‘Review of effective cosmeceuticals’ (Pending publication) 5. Grief M., ‘A Cosmetic regulatory overview’, Drug Cosm Ind, 124:42 (1979)

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Clinical Practice Abstracts

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A summary of the latest clinical studies Name: Comparison of a Fractional Bipolar Radiofrequency Device and a Fractional Erbium-Doped Glass 1,550-nm Device for the Treatment of Atrophic Acne Scars: A Randomized Split-Face Clinical Study Authors: Rongsaard N and Rummaneethorn P Published: Dermatologic Surgery, 2014 Jan Keywords: acne scars, radiofrequency Abstract: The objective of the study was to compare the clinical effectiveness and side effects of fractional bipolar RF with those of fractional erbium-doped glass in atrophic acne scar treatment.

Twenty Thai subjects with atrophic acne scars received three splitface monthly treatments, one side with fractional bipolar RF and the other with fractional erbium-doped glass. Three independent physicians and patients evaluated improvement in acne scars four weeks after the last treatment. Side effects were recorded after each treatment. The study found significant improvement in acne scars after treatment with fractional bipolar RF and with a fractional erbium-doped glass device without a statistically significant difference between the two devices. The side effects of both devices were pain, transient facial erythema, and scab formation. The pain score with fractional erbium-doped glass was higher than that with fractional bipolar RF, but duration of scab shedding was shorter. One case had post-inflammatory hyperpigmentation on only the side treated with fractional erbium-doped glass. In conclusion fractional bipolar RF and fractional erbium-doped glass have similar effectiveness for the treatment of atrophic acne scars.

Name: Application of Intense Pulsed Light in the Treatment of Dermatologic Disease: A Systematic Review.

Authors: Wat H, Wu DC, Rao J, Goldman MP Published: Dermatologic Surgery, 2014 Feb Keywords: IPL, FDA, dermatology Abstract:The Food and Drug Administration (FDA) has approved intense pulsed light (IPL) devices for the treatment of a variety of benign pigmentary and vascular lesions, but the range of disease amenable to IPL treatment continues to expand, and there are no evidence-based clinical guidelines for its use in FDA-approved and off-label indications. The objective of the study was to provide evidence-based recommendations to guide physicians in the application of IPL for the treatment of dermatologic disease. A literature search of the CENTRAL (1991 to May 6, 2013), EMBASE (1974 to May 6, 2013), and MEDLINE in-process and nonindexed citations and MEDLINE (1964 to present) databases was conducted. Studies that examined the role of IPL in primary dermatologic disease were identified, and multiple independent investigators extracted and synthesized data. Recommendations were based on the highest level of evidence available. Level 1 evidence was found for the use of IPL for the treatment of melasma, acne vulgaris, and telangiectasia. Level 2 evidence was found for the treatment of lentiginous disease, rosacea, capillary malformations, actinic keratoses, and sebaceous gland hyperplasia. Level 3 or lower evidence was found for the treatment of poikiloderma of Civatte, venous malformations, infantile hemangioma, hypertrophic scars, superficial basal cell carcinoma, and Bowenâ&#x20AC;&#x2122;s disease. IPL is an effective treatment modality for a growing range of dermatologic disease and in some cases may 50

represent a treatment of choice. It is typically well tolerated. Further high-quality studies are required.

Name: Histometric Analysis of Skin-Radiofrequency Interaction Using a Fractionated Microneedle Delivery System Authors: Zhenlong Zheng, Boncheol Goo, Do-Young Kim, Jin-Soo Kang, and Sung Bin Cho Published: Dermatologic Surgery, 2014 Feb Keywords: microneedle, dermatology, radiofrequency Abstract: Fractionated microneedle radiofrequency (RF) devices have been reported to be effective in treatment of various dermatologic disorders.The objective of the study was to analyze histometric changes in skin-RF interactions using a fractionated microneedle delivery system. RF energies were delivered using a fractionated microneedle device to an in vivo minipig model with penetration depths of 0.5, 1.0, 1.5, 2.0, 2.5, and 3.5 mm; RF conduction times of 20, 50, 100, and 1,000 ms; and energy levels of 5.0, 10.0, 20.0, 25.0, 37.5, and 50.0 V. Immediately after treatment, skin samples showed that the RF-induced coagulated columns in the dermis formed a cocoon-shaped zone of sublative thermal injury. Four days after the treatment, skin specimens demonstrated reepithelialization, and the dermal RF-induced coagulated columns showed mixed cellular infiltration, neovascularization, and granulation tissue formation.

Microneedle depth and RF conduction times, but not energy level, significantly affected histometric values of RF-induced dermal coagulation. Microneedle RF treatment affected adnexal structures by coagulating follicular epithelium and perifollicular structures.

Name: Autologous platelet rich plasma: topical versus intradermal after fractional ablative carbon dioxide laser treatment of atrophic acne scars Authors: Gawdat HI, Hegazy RA, Fawzy MM, Fathy M. Published: Dermatologic Surgery, 2014 Feb Keywords: PRP, acne scars, FCL Abstract: A proposal has recently been made regarding the potential adjuvant use of platelet-rich plasma (PRP) with fractional carbon dioxide laser (FCL) for the correction of acne scars. The objective of this study was to compare the efficacy and safety of two administration modes of autologous PRP (intradermal injection (ID) and topical application) after FCL with that of FCL alone in the treatment of atrophic acne scars. 30 patients were randomly divided into two groups. Both underwent split-face therapy. Group 1 was administered FCL followed by ID PRP on one side and FCL followed by ID saline on the other. In group 2, one cheek was treated with FCL followed by ID PRP, and the other received FCL followed by topical PRP. Each patient received three monthly sessions. The final assessment took place at six months. Combined PRP- and FCL-treated areas had a significantly better response (p = .03), fewer side effects, and shorter downtime (p = .02) than FCL-treated areas, but there were no significant differences in ID- and topical PRP-treated areas in degree of response and downtime (p = .10); topically treated areas had significantly lower pain scores. The current study introduces the combination of topical PRP and FCL as an effective, safe modality in the treatment of atrophic acne scars with shorter downtime than FCL alone and better tolerability than FCL combined with ID PRP.

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In Practice Consultation Protocols

aestheticsjournal.com WHY IS IT SO IMPORTANT?

Imaging in Aesthetics Nicolas Miedzianowski-Sinclair, managing director of Surface Imaging Solutions, explains why taking patient photos is not just beneficial, but crucial for your clinic The aesthetics industry is all about fulfilling the emotional appearance; questions often asked include, “How do I look?”, “How am I perceived by my peers?” and “How do I compare with my peers?” In consultations, patients often bring in an image of the appearance they desire, an old photo of themselves, a photograph of a celebrity torn from a magazine, or a brochure image. Yet even today some practitioners in the industry believe that they do not need to collect visual data or, alternatively, will collect the bare minimum. The minimum must be images of their patients before and after the course of their treatment programme(s).

I believe this is a huge error of judgement and would go so far as to say that the key to any successful aesthetic engagement is the baseline image plus the most recent image. We need to establish how the patient currently looks and understand how they feel about themselves, in order to understand their motivation behind wanting aesthetic treatment and their emotional state, before initiating change. It is a disaster waiting to happen if you don’t have the baseline pre-image, and if you do not insist on follow-up imaging as mandatory. In order to i) build trust between yourself and your patient, ii) to collect quality data on the efficacy of your treatments and techniques, and iii) to protect yourself against litigation by engaging in good practice, good quality before and after images are essential.

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You may believe that just looking at a patient or accepting their subjective opinion regarding the outcome of a treatment is validation enough. You may also believe that the product brochure sets out achievable results, or that patients do not want to see their photographs, therefore it is not worth taking them. However, it is not unknown for a patient to have a treatment, such as laser, and become convinced that they have a new mark or flaw as a result and that then becomes your fault. Without a good quality patient image portfolio, how can you prove you did not cause the mark? Additionally, people quickly adjust to their new appearance, and can become convinced there has been no change or improvement. Again, without imaging, how can you say otherwise? I have seen cases where the patient has facial swelling after an augmentation treatment, and once the swelling subsides, they become convinced there has been no volumising. Imaging is essential in proving that there has been a change.

Variables such as skin tone change, ambient lighting or make up can disguise changes in volume or skin profile.

With a quality 3D imaging system you can remove these variables and show the true effect of volumising or a change in shape of an area such as the nose or breast.

Images are also an essential part of record keeping.

Aesthetic treatments are not a ‘one-off’; they are a journey through time as the patient changes with age, and vary from resolving acute conditions to the maintenance of their appearance, and hence emotional state. Without proper and reliable imaging, a clinic is unable to effectively manage their outcomes. If the industry is to project itself as responsible, it must ensure the highest levels of record keeping to prove continued competence (be it equipment, products, therapists or physicians) and have a continued focus on safety. Evidence on continued training is necessary, and includes preventing patients from choosing unwise or excessive treatments.

For some practitioners, the fear factor prevents them from using good quality imaging, many thinking, “What if there are no visible results from a particular treatment; will I create an unhappy patient?” However, the risk that a treatment may not work or may go wrong is not a reason to avoid imaging. Professional standards exist which mean you must ensure you communicate risk with your patients, and have a policy for what you do if there is no improvement. If the potential of the treatment is very marginal, or you repeatedly have patients who do not respond, then you might consider how ethical it is to offer that treatment in the first place.

Investment in good quality imaging, together with assessment and analysis systems, offers patients a chance to see themselves more objectively in 2D and in 3D. This can be a powerful motivating tool for them to engage in the treatment(s), and to stick with treatment

Aesthetics | April 2014

In Practice Consultation Protocols

aestheticsjournal.com

Visia imaging system

plans, as they see the objective changes to their physical appearance and their skin quality.

This builds trust and loyalty, which will then have financial benefits for your practice.

WHAT IS ETHICAL IMAGING? Ethical imaging is repeatable, reliable, and consistent imaging that enables comparisons between timelines and is capable of being objectively assessed and measured. It is not a quick before-photo taken in variable lighting or against a background at an unflattering angle, with the patient wearing no make-up, compared to an after-photo taken with warm light, a more flattering angle, a different background, and with the patient wearing make-up.

REQUIREMENTS FOR IMAGING: Visia imaging scanner

Choose your location carefully, considering lighting, background and positioning. You are going to take a series of images, not just one.

• Remember that you are not taking a social image but one associated with clinical records.

You may present it to your peers in the future, and it can showcase your excellence.

• Invest in a consultation with a professional photographer who will undertake a survey of your clinic with you and who will help select, install and train you and your team. Ask your potential supplier if they will provide this. Remember there will be a fee but it is a key investment in your future success and protection. Take a look at The Institute of Medical Illustrators’ website (www.imi.org.uk) as they too offer assistance.

It is tempting to rely on smartphones for imaging as these days they have a good quality in-built camera. They are certainly better than nothing but you do need to manage the colour balance between timelines, and this is true of any camera system. You can also use your iPad, using apps such as the Consentz iPad tablet app. The Canfield VEOS portfolio can transform an iPhone 4/4s/5/5c into a dermatoscope that enables you to capture high-resolution images to be retained within the patient record, as well as examine tattoos, lesions, scars and capillaries. If required, images may be sent to a GP or dermatologist to be examined.

My company, Surface Imaging Solutions, offer a comprehensive system called the IntelliStudio; having taken all the requirements of a professional imaging studio, Canfield turned them into Aesthetics | April 2014

53

In Practice Consultation Protocols

aestheticsjournal.com

an integrated, movable system. If you are offering a range of invasive and minimally invasive aesthetic/cosmetic treatments and procedures, which involve different mechanical devices, injectables, topical peels and products, you will need more than a single digital image at each encounter. For treatments that treat under the skin, such as laser and IPL, an imaging system such as VISIA is invaluable; though a Woods lamp is useful as a starting point. Suppliers will bring the VISIA to your clinic and undertake skin analyses of your patients; we at Surface Imaging Solution offer an in-clinic ‘Jump Start’, a 12-hour day using either the VISIA or REVEAL Imager. Publicise this as an event for your patients, and repeat quarterly, half-yearly or yearly without the

initial capital outlay until you are ready to invest. You will receive the analyses reports and images to keep within your patient management system. Perhaps the most state-of-the-art imaging is the single capture 3D imaging. This offers patients and doctors the chance to plan treatments with a dynamic 3D-simulation application while they are still reversible. At The Cosmetic Imaging Studio, we offer aesthetic practitioners the opportunity to refer patients for a 3D scan plus VISIA complexion analysis, as well as to engage in a dynamic 3D-simulation consultation, which will communicate desired outcome and will be shared with the referring practice or practitioner so that they can agree on the care pathway.

The Cosmetic Imaging Studio - London

DATA PROTECTION

Your permission has to be given before images are taken. This form gives permission for your image to be taken and states for what purpose you allow your images to be used.

The most important thing to remember when you have taken a photograph of a patient is that you are now liable under The Data Protection Act 1998 and you must make sure that you have a secure image management environment that enables you to protect the images you have taken as well as find them and compare them. If you handle and store information about identifiable, living people – your patients – you are legally obliged to protect that information and must:

Consent Form for Digital Surface Imaging

If, in the future, you wish to withdraw this consent, you have the right to do so at any time by writing to: The Cosmetic Imaging Studio Limited, Queen Anne Street Medical Centre, London W1G 8HU Person Obtaining Consent Name: ...................................................................................................Title: .................................................

Location:................................................. ................. .....................................................................................

Signature: ........................................................................................ Date:

/

/

To be filled out by patient or guardian

Consent type A: Open publication Clinical photographs, including 2D and 3D digital surface images, play a key role in the education of medical staff at all levels. Although you will not benefit from giving your consent, the use of your images may benefit future patients.

I understand the images may be used for publication in a journal, textbook, as part of a display or information leaflet or on an open access web site, which may be seen by members of the general public as well as medical professionals. To this I give my consent.

If you do not fully understand any of the above, please ask. NB Your choice of consent level will not effect in any way your treatment.

Signature: .................................................................................................... Date:

/

/

Name of patient: ..........................................................................................

Name of signatory (if different): .................................................................. Status: patient/guardian/next of kin/other

Consent type B: Restricted educational use

I also understand that the images requested here may be useful for the purposes of medical teaching and research and in view of the explanation given to me, I agree that the images may be shown to appropriate professional staff.

If you do not fully understand any of the above, please ask. NB Your choice of consent level will not affect your treatment in any way.

Signature: .................................................................................................... Date:

/

/

Name of patient: ..........................................................................................

Name of signatory (if different): .................................................................. Status: patient/guardian/next of kin/other

Consent type C: Case notes only

I understand that the 2D/3D images requested here, to which I have agreed, will form part of my confidential treatment records. No identifiable images will be used without my explicit consent.

If you do not fully understand any of the above, please ask. Your choice of consent level will not effect in any way your treatment .

Signature: .................................................................................................... Date: / / Name of patient: ..........................................................................................

Name of signatory (if different): .................................................................. Status: patient/guardian/next of kin/other

© The Cosmetic Imaging Studio 2012/13/14

• only collect information that you need for a specific purpose • keep it secure • ensure it is relevant and up-to-date • only hold as much as you need, and only for as long as you need it • allow the subject of the information to see it on request IMAGES AND CONSENT: It is not unusual for doctors to show patient images to each other and indeed to other patients. Unless you have explicit consent from your patients, this action could be a breach of the Act, and a patient who discovered you had done this with your images could seek legal redress. The Cosmetic Imaging Studio consent form was set down in association with the ethics committee at Imperial College as part of a study we were supporting in our facility. It is reproduced here. I strongly advise you create a comprehensive consent form specifically for imaging purposes and ask patients to sign it at the same time as taking images.

Nick Miedzianowski-Sinclair is the managing director of Surface Imaging Solutions who have, since 2004, been the UK & Irish distribution partner for Canfield Imaging Systems. Nick is also the founder of The Cosmetic Imaging Studio – London, which offers a unique 2D/3D imaging service to surgeons, aesthetic practitioners, the public and the media, and counts top plastic and reconstructive surgeons as its clients.

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Aesthetics | April 2014

In Practice Documentation

aestheticsjournal.com in writing, so for very simple procedures, consent could be purely verbal. However it is strongly advisable for clinicians to obtain consent in writing so that they are able to provide documentary evidence to demonstrate that they have explained the procedure to their patients, including all associated risks, should they be challenged by a regulatory body or in court.

The art of consent Dr Natalie Blakely and specialist lawyer Mandy Luckman answer key questions about the ethical and legal issues involved in obtaining consent from patients Should you re-consent before every procedure?

Informed consent is a fundamental legal requirement with any form of medical procedure undertaken, with many legal disputes centred around the information that was given to the patient at the initial consultation. As aesthetic practitioners we are often in the position of giving the same, regular treatment to the same patient.

So, should we re-consent before every procedure?

Undoubtedly, the first time you get consent for any treatment is the most important. It is advisable to provide the patient with literature detailing all aspects of the procedure, including the risks and benefits. This literature should form the basis of the consent form that should be signed by the patient prior to undergoing the procedure. The practitioner should also talk through the details of the procedure with their patient until they are satisfied that they understand it in full.

If the procedure is one that may be required on a regular basis, such as botulinum toxin or fillers, the consent form should inform the patient that the treatment is temporary and that to maintain the result, regular treatment is required. If your initial consultation and consent form is thorough enough this should 56

be sufficient. If in doubt, consent before every procedure. However if the primary consent form is comprehensive then subsequent forms can be simpler, referencing the original literature provided to the patient.

Remember that you should ask your patient at each appointment about any changes to their health, for example, if they have developed any allergies, if they are taking any new medication or any other changes since they last saw you.

Should we consent for everything we do, however minor?

Some doctors do not consent for small procedures, for example, skin tag removal, because the patient has given implicit consent by allowing the doctor to do the procedure. However, without consent, invasive actions and medical intervention would be considered an assault; so it is vital that the clinician provides their patients with all the information they need to understand each procedure, thus giving them the opportunity to make an informed decision.

It is advisable to obtain consent for all procedures no matter how simple the procedure, but this becomes more important where there are adverse risks.

Consent can be given either verbally or Aesthetics | April 2014

Is it a legal requirement for consent forms to be signed by both practitioners and patients?

General Medical Council guidance says that it is your responsibility to keep clear, accurate and contemporaneous patient records, which report the information discussed with and given to the patient, specific requests by the patient, decisions made and actions agreed. This should be recorded along with information regarding who is making the decisions and who is agreeing the actions1.

Therefore it is important for the practitioner to sign the consent form as well as the patient.

Should consent forms be timed and dated?

GMC guidance states that all records should be timed and dated and such records may be crucial if a claim arises in the future.2 Therefore it is important that you are able to demonstrate that informed consent was obtained contemporaneously within reasonable proximity of the procedure or treatment.

Should the person consenting the patient have the technical skills to carry out the procedure?

The British Association of Aesthetic Plastic Surgeons says it believes that ethically, consultation should be carried out by the surgeon undertaking the procedure3.

However, this is not a legal requirement; indeed, in the NHS it is standard practice for junior doctors to consent patients for operations performed by the consultant.

There is currently little regulation in place in respect of who should be responsible for consulting with the patient; but the person taking the consent must be fully aware about what the treatment involves, and should be able to provide the patient with all necessary information, including the benefits and risks, whether there are reasonable alternative treatments, and what will happen if the treatment does not go ahead.

Can data be stored in the cloud, and are digital signatures valid?

The Electronic Communications Act 20004

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In Practice Documentation

aestheticsjournal.com

recognises the legal validity of e-signatures in the UK and provides guidance on data storage, encryption services, and electronic communications for residents of England, Scotland, and Wales. This means that electronic signatures have the same legal consequences as the more traditional forms of executing documents.

In accordance with the Data Protection Act 1998, confidential information should be stored safely and securely.5 This includes the use of secure servers where there are firewalls in place and documentation can be appropriately encrypted. If appropriate security is in place, documentation may be stored electronically but only for as long as necessary. Cloud storage is a model of virtual storage generally hosted by third parties. In using the cloud, practitioners must ensure that the virtual facility is recognised as being secure. The patient’s information including their e-signature may be stored anywhere which is considered to be secure. It is likely that storage in the cloud is more secure than storage on a device such as a laptop or tablet which can be more easily lost, stolen or accessed inappropriately. If the cloud is to be utilised, it is important to ensure that access to this data is limited and closely controlled.

Will a signed consent form prevent you from ending up in court if something goes wrong?

If there is an issue mentioned on the consent form, for example, the risk of necrosis after filler, and it unfortunately occurs and the patient wants to sue you, the consent form alone will not keep you out of court. The fact that you have obtained a signed form from your patient does not mean that the treatment proposed has been completely understood or accepted, and therefore the quality of consent can never be determined just by the signed form. For consent to be legally valid, it must be voluntary and fully informed, and the person consenting must understand the information that they have been given and have the capacity to make the decision. Additionally, if there is evidence to suggest that the procedure was carried out below a reasonably competent standard, then legal action may still be sought by the patient, whether or not informed consent can be proven.

Who owns the consent forms?

Many aesthetic practitioners are self-employed and work from more than one clinic, so do not have control of the storage of their patients’ consent forms. The legal position is that consent forms are part of a patient’s medical records. The patient owns the information contained within the medical records but the healthcare provider owns the paperwork that contains the information. The provider therefore has a duty to protect the confidential information contained within. In the case that the practitioner works from several clinics, he or she would keep the clinical records and the clinic or hospital would keep other records, such as the nursing notes and patient co-ordinator records.

Patients have a legal right to access their medical records under the Data Protection Act 1998.6 If a problem results in legal proceedings, a patient is able to authorise their lawyer to access their records on their behalf. In order to do so, the patient will need to sign a consent form authorising their lawyer to make this request.

If a request is made by the patient, healthcare providers are expected to co-operate with the terms of the Pre-action Protocol for the Resolution of Clinical Disputes, which requires disclosure of medical records within 40 days of the request. The lawyers will be responsible for reasonable copying/administration charges under the provisions of the Data Protection Act 1998. This will be at a maximum charge of £50 but is proportionate to the actual amount of copying undertaken.7 58

Four things that can make consent invalid • Patient lacks capacity e.g. they lack capacity to manage their own affairs or have been drinking • Patient is not properly informed e.g. the images of the effects of the procedure are unrealistic • Patient has been placed in a pressurised situation e.g. there is a time limit for a discount on a procedure, or a friend is present with the patient who is trying to persuade them • Patient is demonstrating signs of body dysmorphia

Case Study The English Court of Appeal (O’Keefe v. HarveyKemble)8, recently held that a surgeon had failed to inform his patient of the risks associated with her breast implant procedure prior to undertaking the operation, most notably the high risk of encapsulation. When this risk materialised the patient brought a claim on the basis that the surgeon had not informed her that this was a potential risk. The court decided that it was more than probable that the patient would have chosen not to undergo the surgery had she been made fully aware of the risks. This case also highlights the importance at the initial consultation of clinicians assessing patient expectations and providing clear written advice and information about risks for patient consideration at a later date. Consent must be obtained before the procedure so that patients are able to consider the information presented to them and voice any concerns or queries that they may have.

REFERENCES 1. Good Medical Guidance (The General Medical Council) <http://www.gmc-uk.org/guidance> 2. Good Medical Practice (The General Medical Council) <http://www.gmc-uk.org/Good_ medical_practice___English_0313.pdf_51527435.pdf> 3. Helping define the shape of things to come (London: British Association of Aesthetic Plastic

Surgeons, 2012) <http://baaps.org.uk/about-us/press-releases/1560-helping-define-the- shape-of-things-to-come> 4. The Electronic Communications Act 2000 (legislation.gov.uk) <http://www.legislation.gov.uk/ ukpga/2000/7/contents> 5. The Data Protection Act 1998 (legislation.gov.uk) <http://www.legislation.gov.uk/ ukpga/1998/29/schedule/1> 6. The Data Protection Act 1998 (legislation.gov.uk) <http://www.legislation.gov.uk/ ukpga/1998/29/section/7> 7. The Data Protection (Subject Access) (Fees and Miscellaneous Provisions) Regulations

2000 (legislation.gov.uk) <http://www.legislation.gov.uk/uksi/2000/191/regulation/6/made> 8. O’Keefe v. Harvey-Kemble Court of Appeal (Civil Division) 24 April 1998 (1998) EWCA Civ 701 RELEVANT LINKS: (Medical Protection Society) <http://www.medicalprotection.org/uk>

Aesthetics | April 2014

Dr Natalie Blakely is medical director of the Light Touch Clinic in Surrey and founder of the Consentz patient record app. While developing Consentz she became fascinated by the legal issues surrounding consent and how practitioners can improve their consenting processes, helping to protect both themselves and their patients.

Mandy Luckman is a partner in the Medical Law & Patients Rights team at Irwin Mitchell in Birmingham. Mandy leads a team that acts exclusively for claimants in clinical negligence cases and is regularly contacted by the media to quote on developments and regulation within the field of cosmetic surgery.

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In Practice Revalidation

aestheticsjournal.com always happens. It is vital that all people involved in the care of the patient can read and understand what has been written about a patient’s medical history and treatment.

2. Safety and Quality

Taruna Chauhan explains how you can successfully incorporate the General Medical Council’s four domains of Good Medical Practice into your business processes

Good Medical Practice All General Medical Council (GMC) registered medical practitioners are expected to meet the Good medical practice (GMP) guidelines, which were updated in 2013.

“Patients must be able to trust doctors with their lives and health. To justify that trust you must show respect for human life and make sure your practice meets the standards expected of you in four domains.”1 Even for clinics that are not required to be registered by the Care Quality Commission (CQC), incorporating the four domains of GMP into their daily processes can help them meet the guidelines. Using them will reflect well on your clinic and will also help with revalidation and appraisal. Ultimately, and most importantly, this will also be for the benefit of your patients.

The four domains of Good medical practice 1. Knowledge, skills and performance • DEVELOP AND MAINTAIN YOUR PROFESSIONAL PERFORMANCE: Practitioners should be making sure that they keep up-to-date with new techniques. When performing new techniques however, you should look at areas for development through training before administering the treatment.

Development is personal to each practitioner, and you should plan how you will meet targets. Continuing Professional Development (CPD) should be related to both a practitioner’s professional development and also what improvements are required within the services that their particular practice provides. Keeping up-to-date with competence does not necessarily always mean going on a course and can also be achieved by reading relevant articles from established journals.

• APPLY KNOWLEDGE AND EXPERIENCE TO PRACTICE: A medical practitioner should work within their areas of expertise and competence. If you decide to expand your practice, then this will have implications in terms of the service you offer and developments that need to be made. For example if you have previously just done facial treatments and wish to start offering body contouring treatments then you need to ensure you have been on a relevant and accredited training course.

Additionally, you might be experienced in treating the face but would like to start offering a new procedure for facial rejuvenation, in which case you should attend the appropriate training course.

• RECORDING WORK CLEARLY, ACCURATELY AND LEGIBLY: Practitioners should also understand what the patient requires by gathering a thorough medical history such as allergies, current medication and any treatments they may have had in the past. Having a proper process in place for you or your clinic staff to record this information ensures that this 60

• CONTRIBUTE TO AND COMPLY WITH SYSTEMS TO PROTECT PATIENTS: It is important to contribute to, and comply with, quality assurance and quality improvement systems such as adverse event reporting. Ensure staff and patient safety in terms of equipment, infection control and the environment.

• RESPOND TO RISKS TO SAFETY: In every practice, there will be a time when something goes wrong or complications arise. There should be a clear and simple procedure in place for you and your staff to follow in this instance. For example if you are using a piece of equipment and something is not working properly, you would stop the procedure (and use another piece of equipment if possible), apologise to the patient, make all staff aware that the piece of equipment is un-useable, and log the time and date of the incident along with details of what has happened. Records of the incident should be kept both in the patient file and in the adverse event recording file. How much investigation follows depends on the severity of incident. If something major happens, obviously there needs to be a thorough investigation.

You can learn from these events and improve your practice by taking action to negate risks wherever possible. Risk assessments should be carried out regularly, either by yourself or an external provider.

• PROTECT PATIENTS AND COLLEAGUES FROM RISKS POSED BY YOUR HEALTH: Even if you are doing a simple procedure in clinic then you need to be sure that you are not putting your patient at risk if you have a health condition. Decide whether you should ask your colleague to see your patients instead if you believe they might be at risk.

3. Communication, partnership and teamwork • COMMUNICATE EFFECTIVELY: Ensure that you and your colleagues are communicating clearly and effectively both with each other and with patients. Lack of information or clarity can lead to misinterpretation, which can cause problems.

• WORK COLLABORATIVELY WITH COLLEAGUES TO MAINTAIN OR IMPROVE PATIENT CARE: Working collaboratively with colleagues to provide the best patient care will develop partnership and teamwork in your practice. Staff with the appropriate knowledge and skills should work together to provide the best treatment. This domain is about understanding that everybody’s role is important. I’ve worked at big trusts, and the porter is just as important as the consultant. In clinic the first person the new patient will see is the receptionist, and they may well have already spent considerable time speaking with front of house staff on the phone.

Look at the service holistically; don’t look at it in small segments.

Try to get away from the hierarchical structure and instead employ a matrix structure to promote good teamwork. We all have different knowledge and skills to bring to the table, and it is about utilising this within your practice.

Aesthetics | April 2014

In Practice Revalidation

aestheticsjournal.com • TEACHING, TRAINING, SUPPORTING AND ASSESSING: Partnership and teamwork also covers training of staff, and senior members mentoring junior members of staff. Regular assessment of staff is crucial in order to identify areas for both encouragement and development.

• CONTINUITY AND COORDINATION OF CARE: In this time of integration of care, when multiple providers are involved, the patient should feel that their care has been seamless, and this is possible when patient information is shared appropriately. In a clinic this would apply if a practitioner is on leave and another colleague will be taking care of the patient in their absence.

• ESTABLISH AND MAINTAIN PARTNERSHIPS WITH PATIENTS: Check that patients have fully understood the procedure that you have explained to them and that they are aware of any potential risks. Due to the nature of non-surgical aesthetic procedures, you will most probably see the same individual on a fairly frequent basis, thus enabling you to build a strong patient-practitioner relationship.

to pursue an improper emotional relationship with a patient, and not expressing your own personal views and beliefs in a way that could take advantage of their vulnerability or could distress or upset them. Ensure you provide the appropriate treatment for the patient without prejudice, and be honest about financial dealings; honesty and integrity are vital. If your care has caused a patient to suffer distress or harm,, be sure to put things right if possible, apologise to them and explain to them in detail what has happened, as well as the short and long-term effects. By following the Good Medical Practice guidelines of the GMC, you can help to assure safety and peace of mind for yourself, your colleagues and your patients. For examples of case studies which highlight the consequences of not following the guidelines, visit the GMC website.4

4. Maintaining Trust

REFERENCES 1. General Medical Council, Good Medical Practice (2013) (GMC, 2013) <http://www. gmc-uk.org/guidance/good_medical_practice.asp> 2. Care Quality Commission, The scope of registration (CQC, 2013) <http://www. cqc.org.uk/sites/default/files/media/documents/20130717_100001_v5_0_scope_ of_registration_guidance.pdf> 3. Care Quality Commission, Guidance about compliance: Essential standards of quality and safety (CQC, 2010) <http://www.cqc.org.uk/sites/default/files/media/ documents/essential_standards_of_quality_and_safety_march_2010_final_0.pdf> 4. General Medical Council, When doctors don’t follow the guidance (GMC, 2014) <http://www.gmc-uk.org/guidance/21204.asp>

• •

SHOW RESPECT FOR PATIENTS TREAT PATIENTS AND COLLEAGUES FAIRLY AND WITHOUT DISCRIMINATION • ACT WITH HONESTY AND INTEGRITY This is a broad domain revolving around confidentiality, consent, respecting the patient, and being open when things go wrong.

Showing respect includes not using your position as a professional

Taruna Chauhan is a systems, project and administration professional at T Chauhan Consultancy Limited, who helps healthcare professionals quality assure their processes before CQC inspection. She has been involved in helping medical professionals prepare for accreditation inspections, manage quality assurance, ,clinical governance and map patient and system pathways for a number of years.

Aesthetics | April 2014

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In Practice In Profile

aestheticsjournal.com

“For me, quality is king” Dr Tracy Mountford, founder and medical director of The Cosmetic Skin Clinic in Buckinghamshire reveals the importance of caution, how to deal with unhappy patients and the vital importance of ethics and leadership in cosmetic medicine “All we had was collagen, collagen and more collagen. I didn’t even have Botox,” recalls Dr Tracy Mountford of the state of aesthetic medicine when she began her career, 23 years ago. Like many of the UK’s early aesthetic doctors, Mountford’s career was inspired by a trip to the US. “I’d trained as an anaesthetist, but took time off to travel in America, where I discovered and became fascinated with non-surgical aesthetic treatments. When I came home I started offering collagen, skin peels and skin care from a GP’s surgery in Stoke Poges in Buckinghamshire a few sessions a week.” Since founding The Cosmetic Skin Clinic 15 years ago, both Dr Mountford’s practice and her profile have grown considerably. For two years now she has been the leading European user of CoolSculpting, and for three years running has won The Black Diamond Award for being the busiest Thermage clinic in the UK. She was also recently awarded The UK’s Sculptra Clinic Of Excellence. Alongside her work as a key opinion leader and board member for companies including Sinclair Pharmaceuticals, Zeltiq, Allergan, Galderma, and Solta, her practice has also grown considerably. She now has nine clinical rooms, employs six medics, two managers and six receptionists in her Buckinghamshire clinic, plus has a regular Harley Street clinic.

She has also been a witness to the rapid growth of the industry in recent years.

“Botox was revolutionary for us all,” she says. “It It completely changed the way we treated patients. Then came the first hyaluronic fillers and collagen stimulators such as Sculptra. The choice, reliability and predictability of products and treatments have improved dramatically over the years.” Despite this, Dr Mountford says she has never been an early adopter. “My view is that new isn’t always necessarily better. I often watch the market for one or two years after a treatment has entered the public domain, and maybe even after it has gained FDA clearance. During this time any problems will emerge and protocols get refined.”

Dr Mountford says patient care is absolutely key to a clinic’s success. “I am honest, open, clear and direct in my approach. I’m often brutally frank, but I know people respect that and trust you more for it. Recently I had a 21-year-old girl sobbing because I refused to give her preventative Botox. She looked about 17. There are arguments for and against preventative treatments, but I will never do what I feel is morally wrong. Also, whatever the treatment, I always promise I will do my very best, but cannot guarantee an outcome. I put my hands up if there has been a problem and work to fix it. We select patients very carefully, but if our clinical photographs show a treatment has had a marginal result, then we are likely to re-treat. This is always worth it, as this doesn’t just build loyalty with existing patients, but demonstrates a professional approach.” To ensure service levels remain high, she says, “I have patient and customer service meetings with my staff every day. To be a success in this industry, you have to be far more than just a decent injector. For me, quality is king.”

While Dr Mountford remains ambitious she makes it clear that she will never sacrifice her ethics for financial gain. “It’s a privilege to be a doctor; people confide in you and you have the potential to improve their lives. But running a cosmetic practice is also a business, and combining that with being a true clinician was the hardest thing to get my head around when I started out. Whilst I want to expand the business further, I don’t want to franchise my name or open lots of clinics. In my opinion, that’s a fast way to lose what made you good. I am a workaholic, but I’m driven by success, not by money. I want to be the best I can be.”

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Aesthetics | April 2014

“To be a success in this industry, you have to be far more than just a decent injector.”

Dr Tracy Mountford reveals the new treatments she’s most excited about: 1. I am interested in advances in RF skin tightening treatments. I think we will see leaps in technology and protocols meaning we get more predictability of outcome.

2. CoolSculpting is the only FDA cleared Cryolipolysis fat freezing treatment available in the UK today and has proven safety and efficacy. Now there is a new non-vacuum applicator treatment head called the ‘CoolSmooth’ that will treat outer thighs or ‘saddlebags’. Its unique design allows the applicator to fit the individual shape. Since the CoolSmooth applicator does not rely on suction to treat areas of excessive fat it can now freeze the fat on almost all areas of the body.

3. I am excited about the possible return of collagen as a filler. I loved using collagen, it was particularly good for fine, fair skins and I shall be watching developments with great interest.

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In Practice The Last Word

aestheticsjournal.com

The last word Data transparency regarding treatments and procedures would aid patients and practitioners, argues Simon McMillan Two years on from the Sir Bruce Keogh review, do we really know how much cosmetic surgery and how many clinical treatments take place in the UK? There is no central register of procedures and no obligation to report activity levels to regulatory bodies like the Care Quality Commission (CQC), so how do we know how big the sector is?

Research specialists Keynote and Mintel produce annual reports on the cosmetic surgery sector but their findings are significantly different in market size estimates, with one reporting the size as being a third of the other. The British Association of Aesthetic Plastic Surgeons (BAAPS) annually produce an overview of cosmetic surgery procedures carried out in the UK but this only relates to their members, who account for only a proportion of cosmetic surgeons. On MYA Cosmetic Surgery’s website, more detailed procedure information and clinical data is published but most companies are afraid to publish their data, perhaps for fear that it makes them commercially weaker.

The Competition Commission has been tasked over the last few years with looking into the broader subject of private healthcare; this has captured some activity levels but that was not the principal aim.

Cosmetic Surgery only accounts for 3-4% of the five largest private hospital groups’ overall activity. Therefore, this information shows only a fraction of the UK cosmetic surgery activity and much of this work is already accounted for, as BAAPS surgeons 64

typically work from those facilities.

What has come out of the Competition Commission is the requirement of transparency around private healthcare activity. If an organisation the size of the NHS is publishing increasingly more clinical data then there should be no excuse for the private sector not to do so.

This is important in terms of monitoring quality and allowing patients to objectively assess quality. The Private Healthcare Information Network (PHIN) has been tasked by private healthcare providers to collate and publish data. This is still in its infancy but larger specialist cosmetic surgery providers like MYA are now working with PHIN to see how to successfully incorporate cosmetic surgery data so that a better understanding of the sector is realised. The contributing parties, including MYA, plan to go a step further and not just look at volumes of activity but also clinical complications like revision rates, surgical site infections and return to theatre rates. At this stage this is voluntary and not all companies are willing to contribute. This type of information will then allow for a better understanding of national averages, which can then be used as a benchmark that organisations and surgeons can be compared to.

Different procedures will have different complication rates and typically the more experienced a surgeon is, the more they will have developed their skills.

An experienced surgeon conducting a procedure reduces the likelihood Aesthetics | April 2014

of a complication happening, or if a complication does occur, the chance of them knowing how best to deal with the situation is increased. However, if a surgeon has carried out a lot of breast enlargement procedures, it does not mean that they are automatically skilled to carry out a nose reshaping procedure.

If a consistent and auditable way to present data comes into existence, then this would allow an objective element to be introduced to the patient’s decisionmaking process. The more prospective patients there are who understand this, then the more important it will become to surgeons and providers.

If it is made a requirement of the CQC registration that any surgeon operating from an aesthetic clinic must have evidence of up-to-date data that is accessible to prospective patients, and this is combined with clear recording and reporting of any implant devices, then quality will be improved. The CQC will then, through their unannounced inspections, have a good indication of the safety of the premises and procedures, and a good idea of the clinic’s policies, and will be aware of patient complaints that have not been addressed. Each registered provider should also be required to use the CQC widget, which highlights in an easy-to-understand format whether the clinic is meeting all of the required standards. At MYA, we collect data at provider and surgeon level and use this as an indicator of performance and publish our clinical data on our website www.mya.co.uk. I am not aware of any other organisation in the UK that has this level of transparency but I hope they will now follow our lead and not wait for the government to force the issue.

With a newfound patient awareness of clinical excellence, clinics and surgeons will need to provide evidence of quality in order to increase patient retention, thus raising standards throughout medical aesthetics.

Simon McMillan is marketing and operations director at MYA Cosmetic Surgery and qualified solicitor. He was part of the founding team behind MYA, one of the largest cosmetic surgery providers in the UK. Simon is an active member of the Independent Healthcare Advisory Services (IHAS) and regularly participates in activities to improve quality and transparency in cosmetic surgery.

DISTINGUISH YOUR BUSINESS AND REPUTATION FOR ADVANCED AESTHETIC SKIN CARE Sally Durant is widely recognised for providing excellence in advanced training for the skin care practitioner.

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Aesthetics | April 2014

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Heritage – Over 16 year’s experience in aesthetic treatments Superior Lifting – Firmness that gives shape and definition 1 Lasting Effect – Clinical studies demonstrate duration up to 36 months with just two maintenance treatments 2,3

Galderma (UK) Ltd, Meridien House, 69-71 Clarendon Road, Watford, Hertfordshire WD17 1DS Galderma Switchboard: 01923 208950 Email: info.uk@galderma.com For more information visit www.galderma-alliance.co.uk

RES/031/1113a Date of prep: Feb 2014

References: 1 – Edsman K et al. Dermatol Surg 2012;38:1170-1179.

2 – Narins RS et al. Dermatol Surg 2008;34(Suppl 1)S2-8.

3 – Narins RS et al. Dermatol Surg 2011;37(5):644-650.