PRIME Journal Jan/Feb 2023

An update on

NON-INVASIVE FAT REDUCTION

WELCOME TO THE JANUARY/FEBRUARY ISSUE OF PRIME JOURNAL

With 2023 off the starter blocks, we found ourselves contemplating what the next 12 months will bring to the aesthetic medicine industry. How will the industry cope with an impending recession? What other headwinds does the industry face, and what are the trends that will emerge as the year unfolds? These were the questions we put to aesthetic and dermatology industry leaders for our feature on industry trends for 2023 and beyond. You can read the full article on page 20.

Since the pandemic, at PRIME Journal, we have recognised a discernible shift to digital platforms and online communities. With this in mind, we took the opportunity to partner with the Aesthetic Multispecialty Society (AMS), a medical society providing an online platform full of features designed to improve techniques and good practice in the field of Aesthetic Dermatology and Surgery. Membership to the AMS is currently free and brings with it many benefits, including the ability to message and connect with other members, access to scientific webinars and live demonstration videos, 20% off relevant books from CRC Press and Routledge, collaboration tools, jobs and classified ads, and discussion forums.

You can visit the website for more information or become a free member: multispecialtysociety.com.

We have two features on cellulite this issue. The first is a case study by Elena Fasola, MD. In the report, she evaluates the results of treating cellulite with a low molecular weight hyaluronic acid (HA) in combination with six essential amino acids. The aim is to restructure and renew the extracellular matrix, and the combined action of the mixture, along with carbonates and sodium bicarbonates, assists in rebalancing the local pH that underlies the formation of cellulite.

The second feature by Sachin M. Shridharani, MD, FACS, and Joshua Kohan, BA, evaluates the evidence for three novel subcision cellulite treatments: controlled focal subcision, acoustic subcision, and enzymatic subcision, and provides an overview of studies exploring these options.

If you would like to attend AMWC Monaco in person this year, and I highly recommend you do, be sure to book your place at amwc-conference.com. Aesthetic Multispecialty Society Premium Members will receive 20% off their delegate pass to AMWC 2023.

Balraj Juttla Editor, PRIME balraj.juttla@informa.com

Sofwave™ SUPERB™ ultrasound technology is the new non-invasive FDA-cleared way to lift the eyebrow, lift lax submental and neck tissues, improve facial lines and wrinkles, and short-term improvement in the appearance of cellulite

Groundbreaking and proprietary technology with integrated cooling that enables treatment at the optimal depth in the mid-dermis for collagen production, making sure you look more lifted every time you look in the mirror.

What Sets Sofwave™ Apart?

Simple and delegate-able protocol

Patented integrated cooling system

Safe for all skin types

Quick procedure (30-45min)

Non-invasive with no delays to daily routine

WINNER OF

International Journal of Aesthetic and Anti-Ageing Medicine Informa, Floor 4, 24 York St, Sydney, NSW 2000, Australia

ISSN 2159-8908 (print) ISSN 2159-8916

AMWC, THE WORLD’S LEADING AESTHETIC AND ANTI-AGING MEDICINE congress, returns to Monaco on 30 March 2023 for its 21st edition. The event is expected to welcome 14,000 participants from over 120 countries, 300 prominent speakers, and 250 of the industry’s most trusted companies in a bustling exhibition at the Grimaldi Forum.

Held under the scientific supervision of the Aesthetic Multispecialty Society (AMS) and organised by Euromedicom — part of Informa Medical Aesthetics (IM-Aesthetics) — the advanced and highly interactive programme covers all aesthetic and anti-ageing disciplines and is designed to deliver the latest updates in medical research, techniques, and innovations.

In addition to its high-level scientific programme run by world-class opinion leaders and educators, live demonstrations and sponsored workshops, the upcoming AMWC will feature the prestigious AMWC Aesthetic Medicine Awards, now in its 9th edition, celebrating excellence in aesthetics and anti-ageing medicine of physicians and companies. The conference will be preceded by the Monaco Advanced Facial Aesthetic Masterclass on 29 March, an in-depth training on anatomy and innovative injection techniques, designed for high-level doctors in aesthetics.

AMWC’s three-day scientific programme will focus on the safety of aesthetic treatments and offer three expert tracks: minimally invasive surgery, hair restoration, and functional & aesthetic genital rejuvenation. To complete their AMWC experience, attendees will have the opportunity to network with global peers and engage with 250 of the industry’s most trusted companies in a top-tier scientific programme and bustling exhibition.

Parallel to the on-site event, AMWC 2023 will be live-streamed from Monaco, allowing delegates from all over the world to benefit from the programme, participate in Q&A sessions with speakers, explore the virtual exhibition, interact with brand representatives, and network digitally with physicians and aesthetic professionals using a dedicated congress application.

France

Dr Christophe de Jaeger Geriatrics France

Dr Gerd Gauglitz Aesthetic Dermatology Germany

Prof Ilaria Ghersetich Dermatology Italy

Dr Michael H. Gold Dermatology USA

Dr Kate Goldie Aesthetic Physician UK

Prof Eckart Haneke Dermatology Germany

Dr Steven Hopping Plastic surgery USA

Prof Andreas Katsambas Dermatology Greece

Dr Mario Krause Anti-ageing medicine Germany

Dr Marina Landau Dermatology Israel

BOARD MEMBER SPECIALISM COUNTRY

Dr Gustavo Leibaschoff Cosmetic Surgery USA

Dr Sohail Mansoor Dermatology UK

Prof Leonardo Marini Dermatology Italy

Dr Sly Nedic Aesthetic & anti-ageing medicine South Africa

Prof Daniel Pella Cardiology Slovakia

Dr Chariya Petchngaovilai Dermatology Thailand

Prof Ascanio Polimeni Neuro-endocrinology Italy

Dr Herve Raspaldo Facial plastic surgery France

Dr Christopher Rowland-Payne Dermatology UK

Dr Neil Sadick Dermatology USA

Dr Hema Sundaram Dermatology USA

Dr Pakpilai Thavisin Dermatology & Anti-ageing medicine Thailand

Dr Patrick Treacy Aesthetic surgery Ireland

Dr Mario Trelles Plastic surgery Spain

Dr Ines Verner Dermatology Israel

Dr Octavio Viera Anti-ageing medicine Spain

Dr Jean-Luc Vigneron Aesthetic dermatology France

Prof Bernard Weber Genetics Luxembourg

Dr Sabine Zenker Dermatology Germany

Catherine Decuyper Industry expert & consultant France

Wendy Lewis Industry expert USA

Christophe Luino Industry expert & consultant France

Easy-to-use, safe and gentle

Immediate skin freshness and tightness

Stimulates the production of new collagen Little-to-no down-time

No sutures, needles or stitches

NEWS

10 Galderma

their one of a kind AART™ tour across the United States

12 ISAPS Global Survey reports a rise in aesthetic surgery

INDUSTRY INSIDER

14 What aesthetic doctors are excited about in 2023 Wendy Lewis interviewed eight doctors on their top picks

20 Looking ahead: industry trends for 2023 and beyond PRIME Journal spoke to aesthetic and dermatology industry leaders about the trends influencing the market that will drive business across 2023 and beyond

CASE REPORT

24 Cellulite: rebuild rather than destroy Elena Fasola, MD, evaluates the results of treating cellulite with a low molecular weight hyaluronic acid in combination with six essential amino acids and a mix of carbonate and bicarbonate salts

30 Skin tightening of the lower face and neck area using radiofrequency microneedling

Drs Lynhda Nguyen and Katharina Herberger discuss the results they witnessed using Lutronic’s Genius® insulated radiofrequency microneedling system

AESTHETIC FEATURES

36 The uses for long-pulsed Nd:YAG laser in dermatology

Firas Al-Niaimi explores the many uses of the versatile Nd:YAG laser beyond hair removal

42 An update on non-invasive fat reduction

Christopher N. Nguyen, MD, and Michael Gold, MD, review the evidence and provide their clinical experience working with four popular modalities for fat reduction

50 State-of-the-art treatment modalities for cellulite: a comprehensive review Sachin M. Shridharani, MD, FACS, and Joshua Kohan, BA, evaluate the evidence for three subcision treatments aimed at reducing the appearance of cellulite 56

The step by step approach to marionette lines Based on a deep understanding of facial anatomy, Simone Doreian, MD, describes her novel technique to treat marionette lines with injectables

PRIME PROMOTIONS

Sunekos® Performa: the enhanced formula for skin renovation 64 Sofwave™: next generation ultrasound technology for a natural lift 66 SYLFIRM X treatment for porcelain skin

PRODUCT NEWS 68 The latest product news and technologies for the aesthetic and anti-ageing market EVENTS 70 A round-up of the major industry events happening around the world over the next 12 months

dazzle with

had the pleasure of experiencing Galderma’s extraordinary AART Tour that hit four major cities across the US, ending up in New York just before the holiday season. The iconic Hammerstein Ballroom near the theatre district was overflowing with leading dermatologists, plastic surgeons, facial plastic surgeons, oculoplastic surgeons, nurses and nurse practitioners, and physician assistants, who came to experience this glam evening and pick up some pearls from their colleagues.

This impressive initiative was welcomed by practitioners and many members of the Galderma management team. ‘The GAIN AART Tour is one of Galderma’s many offerings to educate and edu-tain our aesthetic injector network. The event, which focuses on patient Assessment, facial Anatomy, product Range, and on-label Treatment (AART), explores the ways in which injectors can advance their skills and master their craft,’ said Carrie Caulkins, Vice President, US Aesthetics Marketing.

A round-up of news stories in the aesthetic and anti-ageing medicine industry

Alphyn Biologics, a clinical-stage dermatology company developing multi-target therapeutics, announced positive results from the first cohort of its Phase 2a clinical trial of AB-101a, a topical therapeutic for mild-to-moderate atopic dermatitis (AD). The trial met all of its primary endpoints, highlighting AB-101a’s potential to be an effective and safe treatment for AD.

The randomised, vehiclecontrolled, double-blind trial

‘Our legacy wouldn’t be possible without our partnerships with aesthetic professionals, and we are honoured to have the opportunity to nurture the next generation of injectors and drive the future of aesthetics forward,’ she adds.

This unprecedented tour offered attendees to gain a deeper understanding and valuable skills for injectable treatments. The topics featured included patient Assessment, Anatomy, Rheology & Reconstitution, and injection Technique and Treatment, thus the moniker, ‘AART’. Galderma’s broad injectable

evaluates the treatment protocol of AB-101a across multiple sites using standard scales for assessing AD.

The trial, conducted in Australia, enrolled 41 AD patients, and treatment was evaluated after four weeks.

‘As a physician who treated 15 percent of the patients in the clinical trial, I am encouraged by the results with AB-101a,’ said Dr. Stephen Shumack, Clinical Associate Professor Dermatology, University

portfolio was featured, which includes hyaluronic acid (HA) fillers, biostimulators, and neuromodulators. The brands available in the US include Restylane®, Sculptra®, and Dysport®.

Galderma assembled an impressive multi-specialty international faculty featuring Raj Acquilla, MD, Andreas Nikolis, MD and Tom van Eijk, MD, as well as Shino Bay Aguilera, DO, Joel L. Cohen, MD, Kay Durairaj, MD, Heather Rypien, RN, Sachin M. Shridharani, MD, Chris Surek, DO, Hermine Warren, DNP, APRN, and G. Jackie Yee, MD. Attention was paid to new techniques for all injectors, including patient selection, to best practices for treating lips, decolletage, chin, cheeks, and more.

According to Miami, FL, plastic surgeon G. Jackie Yee, MD, ‘The GAIN AART tour finale was an overwhelming success. How better than to finish the last stop of the tour in lively New York at the Hammerstein Ballroom. It was so humbling to round out the year by sharing the amazing stage with my diverse co-faculty talking about all things Galderma. The energy emanating from the audience was palpable.’

of Sydney, and Principal Investigator at St George Dermatology & Skin Cancer Centre. ‘I look forward to future trials and gaining a better understanding of AB-101a’s potential benefits for patients.’

‘Patients with mild-to-moderate atopic dermatitis suffer considerably from the symptoms of this often debilitating disease, yet available treatments come with side effects and safety concerns,’ said Alphyn

CEO Neal Koller. ‘We are excited by these results and look forward to the results of our ongoing cohort treating infected AD. We plan to further study AB-101a in a Phase 2b/3 trial this year in conjunction with a Series B financing.’

Enrollment is ongoing in the second cohort of the Phase 2a clinical trial.

AB-101a was developed using Alphyn’s proprietary AB-101 platform.

ISAPS GLOBAL SURVEY REPORTS A RISE IN AESTHETIC SURGERY

REPORT REVEALS A 33% INCREASE OVER THE LAST FOUR YEARS

The International Society of Aesthetic Plastic Surgery (ISAPS) released the results of its annual Global Survey on Aesthetic/Cosmetic Procedures, showing a 19.3% overall increase in procedures performed by plastic surgeons in 2021, with more than 12.8 million surgical and 17.5 million non-surgical, procedures performed worldwide.

Highlights

The 19.3% increase shows recovery from 2020 (which saw an overall drop of -1.8% in all procedures and -10.9% in surgical procedures due to the impact of COVID-19 on global practice).

The report shows a continuing rise in Aesthetic Surgery, with a 33.3% increase over the last four years.

Both surgical and non-surgical procedures showed increases since the last survey (18.5% and 19.9%, respectively), with a significant increase of 54.4% in non-surgical procedures in the last four years.

Aesthetic Procedures

Liposuction was the most common cosmetic surgical procedure in 2021, with more than 1.9 million procedures and a 24.8% increase, overtaking breast augmentation (+3.8%). The top five most popular surgical procedures remain liposuction, breast augmentation, eyelid surgery, rhinoplasty, and abdominoplasty. The top five non-surgical procedures are botulinum toxin, hyaluronic acid, hair removal, skin tightening, and fat reduction.

Breast augmentation remains the most common surgical procedure for women, with only a slight increase of +0.5% in the last four years. By contrast, surgery to remove implants increased by 22.6% (+49.6% in the last four years), and breast lifts by 31.4% in the last year.

Face and head procedures increased by 14.8%, with eyelid surgery being the most common procedure and the most popular surgical procedure among men. Thigh lift showed the highest growth for all surgical procedures (+53.1%). Buttock lifts and buttock augmentation have also increased by 45.7% and 40.5%, respectively, since 2017.

The other most common surgical procedures in women remain liposuction and eyelid surgery. Among men, the other top two

are gynecomastia (increasing notably) and liposuction.

According to Dr. Gianluca Campiglio, Global Survey Editor and plastic surgeon in Italy, “These data clearly reflect the experience of recovery from the previous year’s negative impact of COVID-19 on aesthetic procedures and numbers now exceed the prepandemic ones. We noticed an interesting increase in surgical procedures related to so called “body contouring”, such as liposuction, which is now ranked as the most common procedure, ahead of breast augmentation for the first time in many years, and also a similar emerging trend for abdominoplasty, thigh lift and buttock augmentation. The lower increase in breast augmentation, and related increase in implant removals, also reflects our experience following publication of reports on BIA-ALCL in the preceding year.”

Most breast augmentations (53.1% of the total) and rhinoplasties (63.7%) took place in 19–34-year-olds, whereas botulinum toxin injectables were most popular among those aged 35–50 (47.2% of the total).

Botulinum toxin remains the most common non-surgical procedure for both men and women and across all age groups, with more than seven million procedures performed by plastic surgeons worldwide. This also becomes the most common aesthetic procedure in patients aged 18 years or younger, overtaking rhinoplasty in previous years.

There has been a notable increase in hyaluronic acid injections (+30.3%), and Dr. Campiglio reflects that this may relate to the growing use of this product in other parts of the body, such as the buttock.

Country Statistics

Once again, the USA performed the most procedures worldwide (24.1% of the total), with 30.4% of all non-surgical procedures and 15.5% of all surgical procedures, followed by Brazil (8.9%) and Japan (5.7%). The USA and Brazil are estimated to have the most plastic surgeons, with more than 30% of the world’s total. Asian countries follow with China in third place, Japan in fourth, and South Korea in fifth.

Surgical procedures continue to be performed primarily in hospitals (43.5% worldwide) or office facilities (35.6%).

TRANSPLANTED HAIR FOLLICLES CAN MEND SCARS

Imperial College London researchers have found that hair follicle transplants can promote scar rejuvenation by altering their architecture and genetic makeup.

In a new study involving three volunteers, skin scars began to behave more like uninjured skin after they were treated with hair follicle transplants. The scarred skin harboured new cells and blood vessels, remodelled collagen to restore healthy patterns, and even expressed genes found in healthy unscarred skin.

The findings could lead to better treatments for scarring both on the skin and inside the body, leading to hope for patients with extensive scarring, which can impair organ function and cause disability.

Lead author Dr Claire Higgins of Imperial’s Department of Bioengineering, said: ‘After scarring, the skin never truly regains its pre-wound functions, and until now all efforts to remodel scars have yielded poor results. Our findings lay the foundation for exciting new therapies that can rejuvenate even mature scars and restore the function of healthy skin.’

Compared to scar tissue, healthy skin undergoes constant remodelling by the hair follicle. Hairy skin heals faster and scars less than non-hairy skin and hair transplants had previously been shown to aid wound healing. Inspired by this, the researchers hypothesised that transplanting growing hair follicles into scar tissue might induce scars to remodel themselves.

To test their hypothesis researchers transplanted hair follicles into the mature scars on the scalp of three participants in 2017. The researchers selected the most common type of scar, called normotrophic scars, which usually form after surgery.

They took and microscope imaged 3mm-thick biopsies of the scars just before transplantation, and then again at two, four, and six months afterwards.

The researchers found that the follicles inspired profound architectural and genetic shifts in the scars towards a profile of healthy, uninjured skin.

WHAT AESTHETIC DOCTORS ARE EXCITED ABOUT IN 2023 U

NDOUBTEDLY, MEDICAL AESTHETICS IS all about new, new, new. Practitioners and patients alike are perpetually looking for bigger, faster, better, smarter, and safer treatments and technologies. For this special exclusive PRIME Journal series, we reached out to some savvy doctors from around the world to find out what has their attention this year and why.

WENDY LEWIS is Founder/ President of Wendy Lewis & Co Ltd, Global Aesthetics Consultancy since 1997, author of 13 books, Editor in Chief of beautyinthebag.com, and frequent presenter on the international stage. Her first textbook, Aesthetic Clinic Marketing in the Digital Age (CRC Press) will debut a second edition in 2023.

email: wl@wendylewisco.com

Nezih Karaca, MD Dermatologist, Aesthetic Dermatology Istanbul, Turkey

HairGen Booster, Genosys I am particularly excited about using HairGen Booster in my practice. HairGen Booster is an automatic LED microneedling device for alopecia and hair treatment. Microneedling and irradiation LED ensure an ideal environment for the active ingredients to penetrate to the required depth. The Hairgen Booster is used to help the HR3 Matrix Hair Solution, which includes a hair solution containing growth factors, penetrate into the scalp, and should be used twice a week for 20 weeks for a total of 40 sessions.

The use of low-level laser therapy (LLLT) and microneedling (0.22 μm) allows for the sterile infiltration of a solution containing several growth factors, including human growth hormone (GH), epidermal growth factors (EGF), vasoactive intestinal peptide (VIP), and several

Wendy Lewis interviewed eight doctors on their top picks

it most effective. However, I

polypeptides (sh-Polypeptide-7, sh-Oligopeptide-1, shPolypeptide-71), glycerin, lecithin, polysorbate 60, sodium citrate, citric acid, phenoxyethanol, and water.

Microneedling causes subcutaneous injury. When microneedles are inserted into the skin, microwounds are formed. The microneedling process stimulates the natural production of collagen and elastin as well as supports angiogenesis and the formation of new vessels. More oxygen and nutrients are able to reach the hair follicles, creating a healing response in the body.

LED light is absorbed by the mitochondria of the hair follicles, stimulating the production of energy in the hair cells, which prolongs the hair growth phase. The LED light component helps stimulate anagen re-entry into telogen hair follicles, prolongs the duration of the anagen phase, and increases proliferation in active hair follicles. LED light also helps prevent the early development of the catagen hair phase.

Blue light, with a wavelength of 423 nm, functions as a microbiological control, reducing the size of the sebaceous gland and reducing the production of scalp oil. It also activates the keratin found in the hair shaft.

Red light, with a wavelength of 640 nm, supports cell metabolism, and also improves blood circulation and strengthens the hair.

While mesotherapy can be applied at the same time as microneedling, strengthening the treatment with light therapy saves time. The functionality and ease of use of the device provide a great advantage over other devices. The patient can even practice at home.

I prefer using the HairGen Booster along with the Matrix Hair Solution during hair mesotherapy sessions with my routine patients in the clinic. This is where I find

150K Hair Follicle Serum, DefenAge®

As a longtime fan of DefenAge, I knew it was just a matter of time before this technology was leveraged to treat hair loss. The 150K Hair Follicle Serum is a water-based formulation that contains age-repair defensins paired with other ingredients (including organic pea sprout, azalea-isolated yeast extract, and microalgae extract) to optimise the environment surrounding hair follicles.

I was impressed by the pilot study results that showed a 64% decrease in hair shedding after 3 months, along with an increase in the percentage of anagen hairs of 25% at baseline to 85% at 3 months. This combination of decreased shedding with an increase in the percentage of actively growing hair leads to visible improvement in anyone suffering from hair loss or thinning. I also like that this serum can be combined with other proven topical treatments, such as Minoxidil, Rogaine and others.

Another benefit that patients appreciate with this

I was impressed by the pilot study results that showed a 64% decrease in hair shedding after 3 months, along with an increase in the percentage of anagen hairs of 25% at baseline to 85% at 3 months.

Vivian Bucay, MD

150K Hair Follicle Serum, DefenAge®

The microneedling process stimulates the natural production of collagen and elastin as well as supports angiogenesis and the formation of new vessels. More oxygen and nutrients are able to reach the hair follicles, creating a healing response in the body.

Nezih Karaca, MD HairGen Booster, Genosys

also recommend its use to my patients who live far away for use at home.

Vivian Bucay, MD Dermatologist San Antonio, TX, USA

One of the features that sets it apart from all other microneedling devices is the ability to target multiple depths in one insertion.

Macrene Alexiades MD, PhD Profound Matrix™, Candela® Medical

product is that it is a true multi-tasker. It can be used effectively for treating the beard area, thinning eyebrows, and helps to rejuvenate the scalp and skin under the hair. It is lightweight, gentle on the scalp and hair, non-irritating even for patients who are sensitive, and easy to apply.

The unique DefenAge serum is patentprotected and contains the BioSerum-level of Defensin-molecules, which is the brand’s hero product. It contains 48 proven natural ingredients that have been shown to have clinical efficacy on the scalp and hair.

The serum is supplied in an elegant silver ampule that looks very chic. Our patients are committed to using this formulation long-term because it is user-friendly and they see results.

Macrene Alexiades MD, PhD Dermatologist New York City, US

Profound Matrix™, Candela® Medical Candela’s Profound Matrix system using the Matrix Pro applicator is a cutting-edge radiofrequency microneedling device that combines the sophistication and science of the original deeper version I pioneered called Profound®, with the ease and comfort of superficial penetration. I am credited as having singlehandedly brought RF microneedling to market and partnered with Candela to conduct the basic science and clinical research trial on the new Matrix Pro.

One of the features that sets it apart from all other microneedling devices is the ability to target multiple depths in one insertion. This means I can treat an acne scar or deep wrinkle, or cellulite at all levels of skin in a single pulse, which translates to better efficacy and results.

What makes it stand apart is its unique design, innovative features, new functionality (wavelength, technology, etc.), ease of use, and amazing results. The system is also delegatable to staff and very cost-effective. The Matrix Pro has several best-in-class features. One is the ability to penetrate the needles deeply and to finetune the depth of penetration. Another benefit is that with a single insertion, we can program the device to have the needles slowly withdraw and release energy in successive pulses, therefore targeting multiple predefined depths with a single insertion. This means when treating a deep wrinkle, deep acne scar or cellulite, I can

target the sub-cuticular junction, deep dermis and superficial dermis all in one pulse. This translates into a much higher positive predictive value of attaining a desired clinical improvement.

Another key feature is the sophisticated impedance measurements which are carefully recorded to ensure that the pulse is being well delivered to our target.

In my practice, I treat the face and body as well as a range of target audiences, including men and millennials. We can safely treat all skin types, colours and conditions, and it can be used as an adjunct to other treatments. The Matrix Pro has quickly risen to be one of the most advanced, versatile and creative devices in my practice. I can adjust my targeted depths rapidly with each insertion to customise the treatment for each patient. This system allows aesthetic professionals to take their skin rejuvenation practices to the next level.

The global rollout of the Matrix Pro system will start in 2023.

Sherina Balaratnam, MBBS, MRCS, MSc (UCL) Medical Director,

S-Thetics Clinic Buckinghamshire, UK

EMFACE®, BTL Aesthetics

EMFACE is the latest treatment introduced to my practice for non-invasive facial rejuvenation. Combining HIFES (High-Intensity Focused Electrical Stimulation) muscle contraction technology and transcutaneous synchronised radiofrequency for skin and connective tissue heating, I refer to this as ‘Emsculpt Neo for the face’.

Its synchronised technology, which blends HIFES with radiofrequency, has shown to promote neocollagenesis, neovascularisation, and address muscle laxity, improving skin quality while lifting the brow and face.

Sherina Balaratnam, MBBS, MRCS, MSc (UCL) EMFACE®, BTL Aesthetics

HIFES induces an electrical field to selectively contract facial muscles such as the Frontalis, Zygomaticus Major and Minor, and Risorius to supramaximal levels, not achievable through normal facial contractions. The result: fuller, higher cheeks, an elevated brow, a slimmer and well-defined jawline and global facial rejuvenation in a quick 20-minute treatment. A protocol of 4 treatments delivers long-term results.

We have never been able to target the facial muscle layer in this way until now. To be able to do this nonsurgically, needle-free, fast and pain-free is a gamechanger.

EMFACE’s unique features are many. Its synchronised technology, which blends HIFES with radiofrequency, has shown to promote neocollagenesis, neovascularisation, and address muscle laxity, improving skin quality while lifting the brow and face. I am seeing this result consistently in patients of all ages and skin types. My male patients are very open to having this as they enjoy feeling their facial muscles having a workout and notice results immediately with no downtime.

The robust clinical data with over nine clinical publications gives me assurance as a doctor that I have selected the right investment for my practice to deliver results. I can assure my patients of the efficacy by sharing Dr. Brian Kinney’s muscle histology studies which show a 19.2% increase in muscle density and a 19.8% increase in the number of muscle fibres. These are significant results.

EMFACE is perfectly positioned for patients of every age group within my practice: from millennials desiring prejuvenation, to older patients requiring more correction, lift, structure and volume, as well as postfacelift patients looking for longevity post-surgery. EMFACE stands well as a treatment on its own and alongside topicals, other energy devices, and facial injectables. With combination treatments, timing is everything to deliver the best outcome in collagenesis and new muscle fibre growth. Hence consultation, assessment, and detailed treatment planning are key.

Ashraf Badawi, MD, PhD Professor of Dermatology NILES, Cairo University, Egypt

SP Dynamis Pro, Fotona

The SP Dynamis Pro laser from Fotona is my arms and legs. I insist on having it in all clinics I work in around the world. It has two wavelengths and can treat over 150 different applications. This system gives me a free hand to treat any condition I want to address. From my point of view, it is the best available laser system currently in the market.

There are many applications I can treat with this device, but the one I use most frequently is the nonablative rejuvenation application which I perform using a technique called 4D. With this technique, I use two types of lasers, the Nd:YAG 1064nm and the Er:YAG 2940 nm lasers. This technique leads to very effective skin

Lumina®, Lynton Lasers

tightening as well as new collagen formation. What is unique about this 4D treatment is that it is associated with no pain or downtime for patients, which they appreciate. There is no downtime for patients and all skin types can be treated safely.

We typically do three sessions at intervals of one month apart. Each session starts with intraoral treatment to tighten the skin from under the surface with the objective of improving the nasolabial folds and marionette lines. This is followed by using a super extended long pulse with the Nd:YAG laser to tighten the skin from the skin’s surface. Then I will use the short pulse Nd:YAG laser to stimulate new collagen formation and, finally, a very superficial peeling of the skin’s surface with the Er:YAG laser.

In some cases, I will combine this treatment with additional procedures, including microneedling RF to address enlarged pores or acne scars, as well as with PRP in cases in need of skin rejuvenation.

Uliana Gout, MD Aesthetic Medical Doctor LAM Clinic, London, UK

Lumina®, Lynton Lasers

I am a huge believer in mixing technologies, techniques and products in a single session to get the most out of each modality and treat a number of issues at the same time. We are seeing an uptick in requests from patients seeking redness, pigmentation and hydration management to be addressed simultaneously in one session. This is most likely due to the fact that people are increasingly time-poor. After three years of Covid disruption, their skincare routines have been disrupted, and as such, the above skin issues have manifested significantly. The return of wearing masks during the colder months has also given rise to redness and dehydrated skin alongside skin congestion.

My latest combination treatment is based on the Lynton Lumina IPL 650nm/585nm with Fractional 2940nm. By utilising this technology, we are able to target redness, broken capillaries, pigmentation, texture, tone, and pore size. We can also embark on skin re-texturisation and address fine wrinkle softening.

We can then bring in other modalities to assist with volumisation, wrinkle reduction, and facial shaping. A personal favourite of mine to combine during the course of the above devices is the integration of Dermalux TriWave MD (blue 415nm, red 633nm, infrared 830nm) to target redness, spots, and collagen boosting pre and posttreatment with my IPL/Fractional lasers). We may

also

What is unique about this 4D treatment is that it is associated with no pain or downtime for patients, which they appreciate.

Ashraf Badawi, MD, PhD

SP Dynamis Pro, Fotona

By utilising this technology, we are able to target redness, broken capillaries, pigmentation, texture, tone, and pore size. We can also embark on skin retexturisation and address fine wrinkle softening.

Uliana Gout, MD

add Profacial (a combination of aqua-peeling, multipolar RF, ion lifting and ultrasound to maintain the results achieved) in some cases.

With these models, we are able to control patients’ downtime, and most importantly, patients report great results and are very pleased with the experience! Rejuvenation is a journey, and the key is to make each step comfortable, predictable and controlled for us as well as for our patients.

Judith Hellman, MD Dermatologist New York City, US

Morpheus 8, InMode

I am very excited about using the new Morpheus 8 3D body tip. The 40-pin tip can be set to reach from one to seven millimetres deep into the skin or eight millimetres if you consider the heat effect. The treatment aims at improving the appearance of cellulite, utilising radiofrequency to tighten the skin and induce neocollagenesis. It can also reach the subcutaneous fat and tighten the fibrous septae. When the septae straighten out from their haphazard state, they reduce the bulging fat and undulating areas corresponding to cellulite seen in the epidermis. We have seen impressive clinical success with this modality, even in older patients.

The revolutionary 3D configuration ensures an even distribution of the RF during the treatment, thus eliminating the chance of arching. The treatment involves minimal downtime, consisting of tiny needle marks present on the skin for a few days after each treatment. In some patients, as a result of the substantial depth of penetration into the skin, an actual reduction in fat cells can result. Patients appreciate this extra benefit.

Since RF is safe for even the darkest skin colour, this treatment is popular with patients of all Fitzpatrick types. It is easily tolerated, and results are impressive even after just two treatments. It is quickly becoming one of my favourite treatments to do in my practice.

The technology features the ‘burst mode’, where three different depths in the skin can be treated with RF with just one penetration of the needle during the withdrawal of the pins. For example, 7-5-3 mm or 6-4-2 mm, etc. This allows for less mechanical trauma from the pins, with an increased distribution of the thermal effect. It also saves time for the operator and patient because it is like doing three passes with just a single pass. In my hands, this is an advanced technology delivered in a quick, safe, and effective manner.

Jason Pozner, MD, FACS Plastic surgeon Boca Raton, Florida, US

ellacor®, Cytrellis

The ellacor system from Cytrellis is a novel system that features Micro-Coring™ technology designed to remove the skin without scarring. Ellacor is the first and only device designed to eliminate excess skin on the microscale.

My group conducted two of the clinical studies for FDA approval. The system is currently indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face for Fitzpatrick skin types I-IV. In my experience, it works very well for skin tightening, which is what patients are asking for.

It offers a unique, minimally invasive way to improve age-related changes without surgery, which many patients are looking for. Our protocol is a series of two to three treatments depending on the patient’s goals and degree of laxity and facial ageing. I had one treatment done myself, and the healing was very quick. I am planning on a second treatment in the near future.

Some patients who have more severe signs of ageing may request or require ongoing maintenance treatments. Generally, it is a good idea to bring patients back for an annual touch-up to maintain results and stay on top of the ageing process. In our experience, we are seeing that the tightening improvements from these treatments last, but the patient continues to age. Ellacor is also great for patients who are not yet ready for a facelift or those who are post-facelift when the patient has some residual laxity.

We are seeing that patients have some bruising for about one week. It may be red and/or black and blue, depending on their skin type and condition and the extent of the treatment. After 4-5 days, most patients can go out and engage in social activities.

The revolutionary 3D configuration ensures an even distribution of the RF during the treatment, thus eliminating the chance of arching.

Judith Hellman, MD Morpheus 8, InMode

Ellacor is great for patients who are not yet ready for a facelift or those who are post-facelift when the patient has some residual laxity.

Jason Pozner, MD, FACS ellacor®, Cytrellis

LOOKING AHEAD INDUSTRY TRENDS FOR 2023 AND BEYOND

PRIME Journal spoke to aesthetic and dermatology industry leaders about the trends influencing the market that will drive business across 2023 and beyond

THERE’S NO DENYING THAT THE PAST few years have been tumultuous, no matter where on the globe you reside.

The COVID pandemic, coupled with global economic uncertainties and climate change, have changed the way we live our lives. And certainly when it comes to the lifestyles we now follow. Vegan diets and vegan-friendly skincare are becoming the norm; we’re more thoughtful of our carbon footprints (not least because of the growing cost of fossil fuels), and we take better care of our bodies through diet and exercise.

These lifestyle changes as a result of global macrotrends are now starting to reverberate across the global aesthetics industry, with many of the clinicians and industry experts we spoke to agreeing that wellness will be a key driver among patient groups across the next 12–18 months. Patients no longer want to just look good; they want to feel good too — and aesthetic clinicians are ideally placed to deliver on this feeling.

‘It’s all about the overlap of healthy ageing and looking like you’re ageing well,’ said London-based aesthetic doctor Sophie Shotter. ‘During COVID that trend was huge,

with treatments like lymphatic drainage increasing because people wanted to make sure they were at optimum health.

‘There’s definitely an overlap between lifestyle medicine and aesthetics. It’s all well and good having treatments that make you look younger, but it doesn’t count for much if you don’t feel that way. So it’s about feeling good from the inside out, through hormones or supplements, for example.’

That feeling of wellness from the inside-out is big business, with the global wellness industry valued at $4.4 trillion and forecast to reach $7 trillion by 20251. This vast industry encompasses health, sleep, mindfulness, fitness, nutrition and appearance, with the latter three segments accounting for 60% of market share2

Therefore, it’s no wonder that many aesthetic practices are shifting to offer a more rounded and complementary approach beyond helping their patients to look good — though looking good is, of course, inextricably linked to feeling good.

‘There’s a big psychology involved in looking good and rejuvenating the face,’ explained Dr Michael Gold, a boardcertified dermatologist and cosmetic surgeon in

Tennessee, US, and Editor-in-Chief of the Journal of Cosmetic Dermatology. ‘The Journal of Cosmetic Dermatology recently published a paper by Dr Mark Nestor, which found that the perception of illness and feeling healthy was improved with even just a small treatment of botulinum toxin, therefore improving wellbeing and negative emotions3

‘So as we move into 2023, I think the biggest thing for all of us is to be able to keep ourselves healthy, keep our staff healthy, and keep our patients healthy, and work within what’s important for our practices.’

Of course, aesthetic medicine hasn’t solely been the domain of external appearances for many years. While a plastic surgeon may not feel qualified to advise on supplements, many doctors have long taken the approach of looking at the whole patient and working within their budgets to provide a treatment regimen and ongoing skincare routine to enhance their self-worth — digging deep into that feeling of wellness. The psychology surrounding wellness came to the fore when the world was forced to stand still and take stock in the early months of the COVID pandemic.

‘We can blame it partially on COVID, but the focus on wellness really started long before. COVID just catapulted it into the public domain,’ said global aesthetic industry expert, Wendy Lewis. ‘We were all in the same boat; stuck at home on Zoom calls all day, every day, and battling quarantine-15 (so-called as a result of the number of pounds gained in isolation), so wellness became an even bigger thing. People are talking about it more often, and mental health itself is a big issue across all demographics. It has always been a challenge for many people, but it was heightened due to the isolation. Now, when you go to see your internist for an annual checkup, for example, it is common to be asked if you are experiencing any signs of mental illness.’

But this fresh mindset provides a vital opportunity for aesthetic practitioners as we head into 2023, with a global cost-of-living crisis and economic uncertainties looming. Ben Pask, Founder and Managing Director of Rare: Group, an aesthetics research and data organisation that tracks the popularity and demand for aesthetic treatments in the UK, believes that there will be a more holistic offering among aesthetic clinics across the next 12–18 months.

‘It’s a market that innovates often,’ he said. ‘If we look at the services that clinics offer, 82% of all CQC-registered clinics are offering more than three treatments. We believe we’ll continue to see an expansion of multidisciplinary clinics in the future with services that encompass wellness. It would definitely seem that the market is heading that way as a lot of the key

opinion leaders are moving the market in this direction and given the challenges of offering decent holistic preventative health services, I think aesthetics will enter this space before others. But we will have to see what the data tells us!’

Fillers and toxins: key industry drivers

However, what the data does show is that toxins and fillers remain the primary treatment drivers across aesthetics, and all our experts agree that this isn’t likely to change. According to Pask, in the UK alone, 20% of the population is considering an aesthetic treatment at any one time, with 2 million of those contemplating dermal fillers and 5.4 million weighing up treatment with botulinum toxin.

‘We’ve been tracking UK aesthetic market data across the past 18 months, focusing on changes in treatments offered and the consumer demand for different treatments, as well as the brand of product used,’ Pask told PRIME. ‘We track using a range of qualitative and quantitative data points to build a picture of the UK market. What we’ve mainly seen over the last year, in particular, is a shift in the demographics seeking certain treatment modalities. While toxins and fillers dominate the market, there’s been an increase in those aged 33–40 years seeking treatment with toxins, but younger age groups — particularly those aged 25–32 years — are now seeking more treatments with fillers compared with toxins, whereas previously the converse was true.’

That younger age group seeking dermal filler treatment in the UK now accounts for 26% of the market, and those in the 33–40-year bracket who are considering botulinum toxin treatment account for 32% of the market — a significant volume of patients. In fact, according to Pask, overall one-third of those considering treatment fall in an age bracket of just 7 years.

Given the rise of social media and the number of clinicians now promoting their services and expertise across platforms such as Instagram and TikTok, it’s no wonder that a greater number of the population are considering treatments, researching treatments, and more open about the treatments they are having.

‘I think we definitely have a more educated consumer now,’ said Dr Shotter. ‘I think that’s because of increased awareness and conversation, among peers and via social media. There are more educational accounts on Instagram now, mine included, and I think this has led to a shift in the mindset of being honest about treatments.

‘Botox and fillers won’t be going anywhere. But lots of

Patients no longer want to just look good; they want to feel good too — and aesthetic clinicians are ideally placed to deliver on this feeling.

other treatments like biostimulation will complement them. My patients are increasingly asking for things that will turn their body back “on”. People want natural results and understand that there’s no one magic bullet for everything. It’s about combining different things that will keep you looking natural.’

Denmark-based oculoplastic surgeon, Dr Jesper Thulesen, agrees: ‘Our experience is that significantly more patients ask or go for the minor, but very effective aesthetic procedures. Skin texture is also playing a bigger role than before. A sound and youthful appearance of the skin is highly prioritised to complement previous treatments with fillers that many patients have had to prevent the major ageing events in the face.’

This growing demand for fillers and toxins worldwide certainly shows no signs of slowing, with new products set to enter both the US and European markets across the next 12–24 months. Lewis told that she’d never seen anything like the plethora of new injectables entering the market in her 25-year career as a global aesthetics consultant, with the US on-track to have seven toxins available to physicians in the next few years.

The FDA approved Revance Therapeutics’ Daxxify in September 2022, a new botulinum toxin agent to freeze facial wrinkles, which, based on the manufacturer’s evidence, can last for up to 6 months. The formula is stabilised with peptides rather than animal protein or human serum, which paved the way for FDA approval. Revance had hoped for Daxxify to be reviewed and approved back in 2020, but COVID restrictions had put the brakes on its journey.

Product innovation

Laser, which target sebaceous glands with a 1726 nm wavelength, providing physicians with an opportunity to treat acne in a new way and with remarkable results. Then there’s Acclaro’s UltraClear 2610 cold fibre laser, which treats ageing-related concerns and acne scarring in any skin type quickly and with limited downtime and drastically reduced risk of post-inflammatory hyperpigmentation.

Will the Lipstick Factor hold true?

Despite the new entrants to the market and the buzz they bring, they come with a price tag for aesthetic practices— fairly large ones in the case of laser devices. With many global economies on a downward trend and consumer spending following suit, it can be risky to make such a sizable investment if patients reduce their spending and frequency of treatments.

Physicians, particularly those operating in the purely aesthetic space, will have to consider more thoughtful approaches to remaining buoyant across the next 12–18 months.

In previous recessions — 2000, 2008, and the COVID dip — the industry has bounced back and remained strong. Indeed, it’s a long-held view that aesthetics is somewhat recession-proof, with the Lipstick Factor lauded as its saviour. But it certainly feels like something different is in the air given the scale of economic uncertainties and the macrotrends underpinning them. Physicians, particularly those operating in the purely aesthetic space, will have to consider more thoughtful approaches to remaining buoyant across the next 12–18 months.

While the world paused and quarantined, scientific research and product development continued, and the industry is now seeing the fruits of that labour with new entrants to the market. In particular, a number of new devices to treat acne have entered the US market and are also likely to launch in the European market across the next year, if not already.

‘I think we’re in a good spot in dermatology and aesthetics because, during the pandemic, companies continued doing research, so that has continued to the point where we have a lot of new options for our patients,’ said Dr Gold. ‘We’ve continued to expand those offerings in our clinics, and I think the acne world of devices for me as a dermatologist is very important right now. And I think that’ll continue strong in 2023.’

Among the devices Dr Gold is particularly excited about are AccureAcne’s Accure Laser and Cutera’s AviClear

‘I think one thing that will be even more important next year than ever will be the experience we give our patients,’ said Dr Shotter. ‘In the UK, we’re facing a huge cost-of-living crisis, but people are still going to want to care for themselves. However, I think they will be more tied to places that make them feel valued and comfortable. The importance of physical health isn’t going anywhere, but given the levels of stress people are experiencing, they want to feel good and look good. Many of my patients have been loyal for many years. Coming to see me is a pocket of time for them, and I help them to feel good when they leave — that’s not going anywhere.’

‘There is always that concern out there in the aesthetic arena that we may have another dip in patients spending money,’ agreed Dr Gold. ‘And you know, that’s something everybody’s got to prepare for. Whether it comes to fruition here versus in Europe or other places, we’ll have to see. I just think you need to be smart: you need to be smart with staffing; you need to be smart with spending overall, but I think you need to be able to offer technologies where you think they fit into your practice.’

Indeed, practices that offered medical dermatology treatments alongside their more aesthetic treatments

fared well through the COVID pandemic precisely because eczema, acne, and skin cancers didn’t know there was a pandemic and patients still needed treatment. But generally speaking, once COVID restrictions eased, patients returned and spent their money. Therefore, the advice for aesthetic practices remains to watch things closely, manage costs and, above all else, support your teams and don’t compromise on the experience and care offered to patients.

‘We are trying to help our patients as best we can,’ said Dr Shotter. ‘We’re pausing on an increase to our prices and giving value-adds that enhance their experience with us. I think patients will continue to spend on injectables, but will they continue to invest in facials like they used to? That’s what I’m looking at right now. How can we help patients’ money go further so that they feel they’re getting more for it?’

‘I think we have to be realistic and understand that we still may have people who are anxious about getting cosmetic procedures, and that’s fine,’ said Dr Gold. ‘You don’t need to do that $5000 procedure; you can work with them on other things that are within their budgets to make them feel better and look better. The cost of devices has become very expensive, but the technology is there. And for us, it’s the offering to our patients to maintain the fact that we’re on the cutting-edge of aesthetics.’

Future risks

However, an additional risk to traditional aesthetic practices, in the US at least, comes in the form of clinic chains backed by private equity, with multiple offices popping up in single cities before expanding out.

‘Private practice is dead because it’s too expensive to be a solo practitioner anymore,’ Lewis told PRIME. ‘A dermatologist who’s coming out of medical school, and wants to be in aesthetics today, is unlikely to start his or her own practice if you consider the cost of just one laser device, and then rent, malpractice insurance, and staff on top when you may be already in tens of thousands of dollars of debt from medical school. The new model of chains with several locations is very popular, they’re attracting good talent, and they’re going after younger patients because the fees are a little bit lower generally.’

Lewis argues the rise of clinic chains is a big threat to private practice doctors because of the marketing budgets and retail expertise they bring to the business.

‘The industry is going direct-to-consumer now. Many groups are heavily marketed, every one of them offers a loyalty programme, and they’re really following a retail model, which makes a lot of sense because more

consumers see aesthetics as retail. It doesn’t mean that the doctors who have private practices and are very successful are going to go away, but dermatology practices are being picked up by private equity roll-ups daily across the US market.’

She continued: ‘It’s really hard to run a private practice today because of how much it costs. And patients are fickle and, in many cases, especially younger patients, are not very loyal to practitioners. Younger patients are more likely to go for the bargain and the pretty, trendy office; they’re going where their friends go and the clinics they see online. So, patients have a lot of choice, which is good for the industry, but that has changed the face of the industry. There isn’t that one go-to doctor anymore, and the prices for procedures or surgical procedures in some markets are off the charts, especially in New York and Los Angeles.’

Conclusions

There’s no denying that the aesthetic industry has never been so exciting. New entrants to the market in terms of new devices, technologies, and treatment modalities mean that physicians are now able to offer expanded options to their patients. But as the world once again heads into a recession, new market threats could force out even wellestablished clinics if they take their eyes off the one thing at the centre of their practice: their patients. Being able to provide patients with cutting-edge treatments and a gold-star service within personal budgets is no mean feat, but those who are able to rise to the challenge will be rewarded with patient loyalty throughout the year and into 2024. Helping patients to feel good on the inside, as well as look good on the outside, is a feeling that lasts. It’s time to offer an experience like never before.

References

1.

3. Nestor M, Fischer DL, Arnold D. “Masking” our emotions: Botulinum toxin, facial expression, and well-being in the age of COVID-19. Cosmet Dermatol, 2020; 19(9):2154-2160. doi: 10.1111/ jocd.13569

But as the world once again heads into a recession, new market threats could force out even wellestablished

if they take their eyes off the one thing at the centre of their practice: their patients.

CELLULITE REBUILD RATHER THAN DESTROY

ABSTRACT

The global cellulite treatment market is in continuous growth and minimally invasive procedures are replacing invasive surgeries.

The aim of this study is to manage cellulite by restructuring and renewing the extracellular matrix and at the same time reducing local acidosis. This new approach is designed to restore the homeostasis of the skin and adipose tissue thanks to a non-lipoclastic or lipolytic method, using the Across Tension Line Technique (ATLT). The injectable product used is a combination of low molecular weight hyaluronic acid added to a specific mixture of six amino-acids (HY6AA) and carbonate and bicarbonate salts to rebalance the local pH (SuneKOS® Cell 15, CE Medical Device Class III from Professional Dietetics). This compound may promote a deep restructuring at the extracellular matrix level of both the skin and the underlying adipose tissue and the combined action of this mixture with carbonates and sodium bicarbonates, also assists to rebalance the local pH that underlies the pathogenetic mechanism of cellulite.

Conclusions: The injectable treatment with the HY6AA formula added to carbonate and bicarbonate salts has been performed in selected cases and has shown to be safe and effective. These results demonstrate this treatment to be a valid alternative approach which has shown to improve the anti-aesthetic appearance related to cellulite. The outcome is due to a completely new regenerative, albeit heterologous, approach. These encouraging results finally give hope for a valid alternative to the treatment of cellulite using a gentle and ‘reconstructive’ procedure rather than a lipoclastic or lipolytic one.

THE GLOBAL CELLULITE TREATMENT MARKET SIZE WAS VALUED at USD 1.25 billion in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 11.3% from 2022 to 2030 and minimally invasive procedures are replacing invasive surgeries (Figure 1). Increasing demand for cosmetic and aesthetic procedures, along with the rise in the obese population, is anticipated to fuel the industry’s growth. Furthermore, cellulite affects an individual’s psychological, behavioural, and psychiatric characteristics, which is anticipated to increase the market demand. For instance, according to the study published by Surgical and Cosmetic Dermatology regarding the psychology of patients with cellulite, nearly 50% of the study population reported dissatisfaction regarding their appearance, while nearly 78% reported the need to seek treatment. The introduction of novel products in the market is also anticipated to fuel market growth1

KEYWORDS

Cellulite, Hyaluronic Acid, Amino Acids, Carbonates, Bicarbonates, Acidosis, pH, Regenerative Approach, injectable, Elastin, Collagen, Fibronectin

Last but not least is to consider social pressure in the desire to achieve the perfect body shape and associated negative body image is anticipated to increase the number of treatment-seeking individuals, thus supporting the market growth. According to the data published by WHO, in 2019 more than 340 million children and adolescents were either overweight or obese and nearly 650 million adults were obese. Furthermore, cellulite also affects an individual’s psychological, behavioral, and psychiatric characteristics, thereby, it is expected to increase market growth after the Covid pandemic2. Cellulite, defined as EFP (Edematous Fibrosclerotic Panniculopathy)

ELENA FASOLA, MD, MICROSURGEON & AESTHETIC PHYSICIAN, AIGEF General Secretary & Tutor at the Italian post graduate School of Aesthetic Medicine

Elena Fasola, MD, evaluates the results of treating cellulite with a low molecular weight hyaluronic acid in combination with six essential amino acids and a mix of carbonate and bicarbonate salts

by S.B. Curri after a ten-year in-depth histological, chemical, and instrumental study of subcutaneous tissue, is a para-physiological condition of adipose tissue in which alterations of connective tissue and microcirculation are the two key points of its pathogenetic mechanism3

For Curri, the EFP resides in a circulatory defect of the vessels present in the interlobular septa of the adipose tissue, which would first lead to an edematous state followed by sclerosis of the septa and finally to an altered metabolism of the adipocytes4

For other authors, it would instead be a trophic response of the adipocyte to endocrine and/or neuroendocrine stimuli and vascular damage. Oedema and fibrosis would be caused by compression due to the hypertrophy of the lobule itself.

For others, microphotography of specimens from cellulite patients demonstrated the presence of fibrotic septa, which divided up larger clusters of adipose tissue into smaller packets, with the septa acting as a tethering system, thus producing the typical dimpling pattern. Ultrastructural findings showed the proliferation of collagen and elastic fibres down into the cellulite tissue with compression of capillaries and congestion of arterioles, resulting in poor blood flow5

the vessels, alterations in metabolic exchanges and suffering of skin and subcutaneous tissue with the stagnation of toxic catabolites. The skin appears pale, hypothermic and pasty. Paresthesia and sensitivity alterations may appear.

■ Third stage: characterised by fibrosis and fibrosclerosis, and venulo-capillary stasis. Presence of micronodules encapsulated by collagen fibres together with serious alteration of the microcirculation beginning to appear, with a decrease in metabolic exchanges and tissue oxygenation. This condition is typical of initial sclerosis of the dermis and hyperkeratosis, with pain on palpation and an ‘orange peel’ appearance as the main symptoms and signs of this stage.

Instead, for Crewe, there are three dominant contributors to the pathogenesis of dysfunctional adipose tissue (AT): unresolved inflammation, inappropriate extracellular matrix (ECM) remodelling, and insufficient angiogenic potential. The interactions of these processes during AT expansion reflect both a linear progression as well as feed-forward mechanisms. Both inflammation and inadequate angiogenic remodelling can drive fibrosis, which can, in turn, promote the migration of immune cells into adipose depots and impede further angiogenesis (Figure 2)6

■ Fourth stage: the main aspect is structural subversion with macronodules, thick septa, and venular dilatation. In this stage, we have the typical ‘mattress’ appearance. This is the irreversible phase5

The study product used in this protocol does not reverse sclerosis; therefore, the higher percentage of sclerosis, the lower the improvement will be. The proportion of sclerosis increases at every change in stage. The association of contour irregularities and age is

EFP has the following stages:

■ First stage: is characterised by adipose tissue dystrophy; it is still a reversible phase, with initial oedema and slight alteration of the blood vessels. The skin loses its elasticity and becomes pasty, and it is mostly asymptomatic

■ Second stage: the main aspects in this stage are dystrophy of lobules, stromal hypertrophy, and vasomotility deficiency. The presence of intercellular oedema induces hypertrophy and hyperplasia of collagen fibres, with the consequent constriction of

Evolutionary stages of edematous fibrosclerotic panniculopathy

Sunekos Cell: a HY6AA + carbonates / bicarbonates formula with low molecular weight hyaluronic acid (HA)

Increasing demand for cosmetic and aesthetic procedures, along with the rise in the obese population, is anticipated to fuel the industry’s growth.

Figure 2

Pathogenesis of cellulite scheme

• Hormonal status

• Alterations of the microcirculation

• Adipocyte dystrophy

• Low (sub-clinical) and ‘chronic’ inflammation

STAGE 1

STAGE 2

STAGE 3

STAGE 4

The ominous triad of adipose tissue dysfunction: inflammation, fibrosis, and impaired angiogenesis

Clair Crewe, Yu Aaron An, Philipp E. Scherer Published January 3, 2017 - Review Series

REVERSIBLE

• Increased capillary permeability

• Water retention

• Adipocyte dysfunction

• Local alteration of mucopolysaccharides

• Increases of Oxidative Stress (++++ROS)

• Decreases of PH

• Inflammation

• Involvement of the extracellular matrix

• Involvement of the dermis

• Fibrosis

• Sclerosis

also supported by anatomical studies and histological studies demonstrating that skin exhibiting laxities shows dermal atrophy because of loss of collagen and reduced collagen biosynthesis, degradation of elastin fibres, and loss of hydration. The development of late-onset cellulite may be a factor of an underlying anatomical structure that is prone to cellulite, with good skin surface tension (e.g., elasticity) masking the underlying defect when women are younger. The loss of skin elasticity that occurs through the normal ageing process may then ‘unmask’ cellulite7

The predisposing factors and cofactors of cellulite are shown in Figure 3

Extracellular matrix and its components

Although the ECM is made up of five classes of macromolecules (collagen, elastin, hyaluronic acid,

NOT REVERSIBLE

proteoglycans, and glycoproteins such as fibronectin), it can take a rich variety of forms with highly differentiated mechanical properties.

For the skin, one of the effects of the loss of ECM homeostasis is ageing.

The main reasons are: ■ Reduction of the number and activity of fibroblasts ■ Loss of hydration.

Collagen types that are pertinent for this discussion are predominately collagen types IV and VII. They are substantially found in the basal lamina of the dermis.

Their function is to provide cellular and tissue support, anchoring the epithelium to the underlying loose connective tissue. At the skin level, for example, the basement membrane separates the epidermis from the underlying dermis. At this level, the basal lamina also acts as a filter for the passage of molecules with a high molecular weight8

Another important constituent of ECM is elastin which is produced by the fibroblasts in the dermis. Elastin is a protein able to stretch and contract within certain limits without being damaged. In quantitative terms, it represents 2% of the weight of the dermis; secreted in the form of monomer (tropoelastin), it contributes together with the fibrillin microfibrils to form a three-dimensional network that gives the skin a certain elasticity.

Tropoelastin is a high molecular weight protein (about 70,000 Dalton) which is characterised by the presence of amino acids such as proline, glycine, alanine, and valine in precise amounts9

Hyaluronic acid is an unbranched polysaccharide produced by the condensation of thousands of disaccharide units formed in turn by residues of glucuronic acid and N-acetylglucosamine.

Depending on its molecular weight, its properties are different; for example, low molecular weight HA (LMWHA) until 200kDa regulates homeostasis by hydrating due to its capacity to retain water, and the synthesis of structural elements of the dermis (collagen, elastin, and blood vessels) due to stimulation on fibroblasts, and immunomodulatory properties10

Figure 3 Predisposing factors and potential related diseases

PREDISPOSING FACTORS ILLNESSES

• Lumbar hyper-lordosis

• Valgism

• Flat feet

• Drugs (analgesics, anxiolytic tranquilizers, continuous intake of oral contraceptive)

• Irregular menstrual cycle

• Thyroid inbalance

• Adrenal hormones alterations

• Insulin resistance

• Genetic

• Constitutional

• Race

• Familiarity (from mother to daughter)

• Sedentary lifestyle (increase in body weight and circulatory slowdown of the lower limbs)

• Unbalanced diet

• Smoking

• Tight clothes and/or unsuitable shoes

Also, fibronectin provides the homeostasis of ECM thanks to its important role of anchoring between reticular fibres of collagen and between cell membranes and collagen fibres11

Aims of the study

Restructuring rather than destroying

The aim of this research is to treat cellulite in a nonlipoclastic and non-lipolytic way while trying to restructure and renew the extracellular matrix and, at the same time, reduce localised acidosis, which is a co-factor in cellulite. Therefore our goal is to restore the homeostasis of skin and adipose tissue rather than destroy it.

Mechanism of action

Recent studies have shown that 120 hours after the injection of low molecular weight hyaluronic acid (50250 KDa) added to 6 specific amino acids (glycine,

L-proline, L-lysine, L-leucine, L-valine, L-alanine) in the subcutaneous layer, neocollagenesis is activated (collagen types IV and VII, elastin, and fibronectin)9, 11

This allows a deep restructuring and regulation of angiogenesis at the level of the extracellular matrix of both the skin and the underlying adipose tissue.

The combined action of this mixture with carbonates and sodium bicarbonates also assists to rebalance the local pH that also underlies the pathogenetic mechanism of cellulite (Figure 4).

Study design

The open study included a sample population of 20 female volunteers.

Included in the study were healthy female Caucasian subjects with age ranges between 20 and 58 years, with edematous fibrosclerotic panniculopathy (EFP) of stages two to four on the thighs, trochanteric area, and subgluteal area.

Exclusion criteria were pregnancy, lactation, general or local diseases, alcohol, and drug abuse.

Materials and methods

This is a retrospective study conducted by a single physician. The product used, Sunekos Cell, is an injectable medical device CE class III composed of low molecular weight hyaluronic acid (HA) (50-200 KD) and a patented cluster of amino acids (called HY6AA) plus a specific mix of carbonate and bicarbonate salts. The carbonate and bicarbonate salts in the formula may contribute to maintain the physiological pH in the extracellular matrix in both the early and late stages of cellulite

Protocol

The treatment entailed three or four injective sessions at intervals of 2–3 weeks apart with the Across Tension Lines (ATL) cannula technique (Figure 5). In each session, three anatomical areas per side were injected, using 2.5 ml per area, for a total of 15 ml of product. One of the three areas should always be the trochanteric area, while the two remaining areas should be selected following the scheme described in Figure 5 and looking at the patient. The investigative methodologies used were:

■ Mean body weight: measured with an electronic balance

■ Digital pictures all acquired with an iPhone 12 Plus

■ GAIS scale was used to record the objective and subjective improvement of cellulite appearance data. All analyses were carried out at three different time points:

■ T0: baseline

■ T1: after 8 weeks from the first treatment

■ T2: 3 months after the first treatment

Results

Photography was acquired at various timelines with the patient in an orthostatic position. Results appeared to be successful after the first session and lasting for all 3 months in which the photographs were acquired (Figure 6–8). Also, data from the GAIS questionnaire demonstrated an

[1-2] Low molecular weight hyaluronic acid (HA) (200,000 D) Targeted stimulating action on fibroblasts and neoangiogenesis, through binding with specific receptors for HA fragments

[1] HY6AA formula

Optimal neo-synthesis of collagen and elastin

[3] Carbonate + bicarbonate salts

Neutralisation of typical acidosis in latent inflammation that characterises both the early and late stages of the disease

s-s

Lyve-1 CD44 TLR-4 RHAMM s-s s-s

Lamina lucida Cellula epiteliale Basal Lamina

Lamina densa

Reticular Fibres Collagen type III Elastin Anchor Fibrils Collagen type VII Anchor Plaque Collagen type IV

PRODUCT INJECTION

CELLULITE pH pH

= INFLAMMATION = INFLAMMATION

HOMEOSTASIS

1. Amino acid and hyaluronic acid mixtures differentially regulate extra cellular matrix genes in cultured human fibroblasts B De Servi, A Orlandini, E Caviola, M Meloni. Biol Regul Homeost Agents. May-Jun 2018;32(3):517-527. PMID: 29921376 2. Toole BP. Hyaluronan: from extracellular glue to pericellular cue. Nat Rev Cancer.2004;4(7):528-539.

3. The ominous triad of adipose tissue dysfunction: inflammation, fibrosis, and impaired angiogenesis Clair Crewe, Yu Aaron An, Philipp E. Scherer Published January 3, 2017- Review Series

Figure 5 Across Tension Line technique

Trochanteric area Thigh

Scheme of the areas to be treated. Always inject Area A + two other areas looking at the needs of the patient (2.5 ml per area)

Gluteus and thigh

Figure 4 Mechanism of action of HY6AA + carbonate and bicarbonate salt injection

encouraging average improvement of two points. The medium weight loss for all patients was 0.41 kg, and it seems not to be the most significant data of the study and/ or directly related to the treatment, as expected.

Conclusions

Thanks to this treatment with the HY6AA formula, the

neosynthesis of collagen, elastin, fibronectin, and neoangiogenesis adjustment are significantly improved. While thanks to bicarbonate and carbonate salts, the acidosis, the basis of sub-chronic inflammation characterising all stages of cellulite from stage two onwards, is also positively adjusted.

The treatment with the HY6AA formula added to carbonate and bicarbonate salts is safe and effective and is a valid procedure to improve the anti-aesthetic appearance related to cellulite, thanks to a completely new reconstructive approach, in selected cases. By selected cases, we mean that it is not indicated in cases affected only by an excess of localised adiposity for which adequate and often surgical methods are required. This outpatient treatment allows the patient to have the highly demanded ‘cellulite improvement’ in a relatively short time. This procedure results in a restorative non invasive treatment that is not destructive to the tissue.

Declaration of interest Funding for this research was provided by Professional Dietetics

Figure 1 © Grand View Research; Figures 2–8 © Professional Dietetics

The aim of the study is to manage cellulite by restructuring and renewing the extracellular matrix and at the same time reducing local acidosis The

used is a combination of low

weight hyaluronic acid added to a specific mixture of six amino-acids (HY6AA) and carbonate and bicarbonate salts to rebalance the local pH The

Salette Reis - Hyaluronic Acid: A Key Ingredient in the Therapy of Inflammation - Biomolecules 2021, 11(10)

11. Tedesco L., Rossi F. Ruocco C., Ragni M., Carruba M.O., Valerio A., Nisoli E. A designer mixture of six amino acids promotes the extracellular matrix gene expression in cultured human fibroblasts. Bioscience, Biotechnology, and Biochemistry, 2022, Vol. 86, No. 9, 1255-1261.

Figure 7 50 year-old patient (A) before (T0) and (B) after (T2) four treatment sessions. Areas A, 2, and 3

Figure 8 57 year-old patient (A) before (T0) and (B) after (T2) three treatment sessions. Areas A, 1, and 4

Figure 6 37 year-old patient (A) before (T0) and (B) after (T2) three treatment sessions. Areas A, 4, and 5

SKIN TIGHTENING OF THE LOWER FACE AND NECK AREA USING RADIOFREQUENCY MICRONEEDLING

email l.nguyen@uke.de

KEYWORDS

Radiofrequency microneedling, minimal invasive, skin tightening, jawline, neck

ABSTRACT

The ageing face is characterised by increasing wrinkles, skin laxity as well as undefined contours. Radiofrequency microneedling (RFMN) is one of the latest generations of fractional methods in aesthetic medicine. The patient case presented here is a representative excerpt of the treatment method analysed in our prospective clinical study currently published in Dermatologic Surgery and describes a successful treatment for skin tightening of the lower face and neck region.

Case: A 67-year-old patient was treated in one session using an insulated RFMN system. Topical anaesthetic ointment prior to treatment and air cooling during treatment were applied to reduce pain. Follow-up visits three and six months after treatment revealed a distinct improvement in tightening and smoothening of the skin. Volume difference was 4.1 cm3 at the last follow-up visit compared to the baseline. Adverse events included temporary oedema and erythema. The patient was very satisfied with the clinical outcome.

Discussion: In this case study, the RFMN proved to be an effective and safe method for rejuvenation of the lower face and neck region. To adequately assess the long-term effects and safety of RFMN, prospective side-by-side clinical studies are warranted.

PHOTOAGED SKIN OF THE FACE IS CHARACTERISED BY WRINKLES, fine lines, and undefined contours. One of the most effective interventions for rejuvenation of the face is surgical face lifts. However, due to the associated adverse events, downtime as well as financial implications, the current trend is toward minimally invasive procedures. Here, common methods include fractional ablative laser treatments, intense pulsed light, and chemical peels1,2

Radiofrequency microneedling (RFMN) is one of the latest generations of fractional techniques and has already been established to be a clinically applied method in aesthetic medicine. By applying high frequency and frequency-modulated energy into the dermis, wound healing and subsequent remodelling of the extracellular matrix is induced3. Currently, RFMN systems with insulated and non-insulated needles are available. Despite the promising effects, to date, only a few studies have been conducted on this treatment method.

The aim of the present case study is to evaluate the efficacy of RFMN for skin laxity and to discuss its use in light of the current literature.

Cases

We report on a 67-year-old female patient with Fitzpatrick skin type II who had noticed progressive skin laxity around her lower face over the past few years. Especially fine

Drs Lynhda Nguyen and Katharina Herberger discuss the results they witnessed using Lutronic’s Genius® insulated radiofrequency microneedling system

LYNHDA NGUYEN, MD; KATHARINA HERBERGER MD, Laser Department, Department of Dermatology and Venereology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany

lines and sagging of her submental region, which limited her quality of life. She did not wish for a surgical intervention due to the associated adverse events and downtime. The patient decided under informed medical consent for one RFMN treatment session using an insulated radiofrequency microneedling system (Genius®, Lutronic Medical Systems, Hamburg, Germany). Prior to treatment, the regions to be treated were cleansed and disinfected. An anaesthetic ointment (23% lidocaine, 3.5% tetracaine, 3.5% tetracaine-HCl) was applied 60 minutes before treatment. During treatment, air cooling (Cryo 6®, Zimmer Medizinsysteme, Neu-Ulm, Germany) was used. In total, three passes in alternating horizontal and vertical directions were applied with about 50% overlap. In this case, 1474 J/cm2 with 517 impulses were applied. The patient was instructed to have sufficient sun protection after treatment. Three and six months after the last treatment session, follow-up visits were scheduled.

Figure 1 indicates the patient before and six months after treatment. Significant skin tightening and a more defined jawline could be observed. Using a computeraided three-dimensional imaging analysis (VAM; Vectra H2, Canfield Scientific Inc, Parsippany, NJ, US), the volume difference of the submental region was 4.1 cm3 at the last follow-up visit compared to baseline. The patient tolerated the treatment well, with a pain intensity score of 2/10 on the Numeric Rating Scale (NRS). No additional analgesics were necessary. Mild oedema and erythema resolved spontaneously within a few days. Overall, the patient was very satisfied with the treatment outcome and would recommend the treatment.

Discussion

The present case study describes a patient who demonstrated a very good response to RFMN treatment. Overall, the treatment was well tolerated, with only mild and temporary erythema and swelling. This study sets an example of the current development and demand of patients who want to slow down ageing without undergoing surgical procedures. A number of minimally invasive rejuvenation methods have gained increasing popularity in aesthetic medicine, including fractional ablative lasers and peelings. These are proven methods but are limited by skin colour, as darker skin has a higher risk for post-inflammatory dyspigmentation. In our case, we used an RFMN system with insulated microneedles allowing penetration into the dermis while protecting the epidermal layer from thermal damage. By continuously measuring the impedance, the amount of energy delivered to the skin is controlled by the system. As melanin is not the target of RFMN, the treatment is not at odds with skin colour and thus is suited for darker skin types.

To date, only a few prospective clinical studies have been published on RFMN for skin rejuvenation, mostly using non-insulated needles4-6. Gawdat et al. applied RFMN with insulated needles on the neck and reported a significant increase in dermal thickness using an optical coherence tomography7. Our study represents the first

prospective, intraindividual controlled clinical trial that evaluated the efficacy, tolerance, and patient satisfaction of insulated RFMN for skin tightening of the lower face, jawline, and neck region8. Here, patients were treated in one to three consecutive sessions at four to twelve weeks

The aim of the present case

intervals. A volume analysis revealed a mean difference of more than 4 cm3 6 months after the last treatment session. The authors assessed the pain intensity of patients during the treatment and reported a mean

study is to evaluate the efficacy of RFMN for skin laxity and to discuss its use in light of the current literature.

score of around 5.6 / 10 NRS, indicating the need for sufficient pain management and a potential limitation of this treatment modality. In contrast to this study, the present case only had mild pain intensity. This might be to the fact that she reported having a high pain tolerance. The patient, physician, and a blinded independent investigator assessed the clinical results as significantly improved. Interestingly, evaluation scores were even

Figure 1 Before (A, B, C) and six months after (D, E, F) one session of radiofrequency microneedling treatment. Significant skin tightening and more defined contours was achieved.

Key points

Radiofrequency microneedling (RFMN) is one of the latest generations of fractional methods in aesthetic medicine. The authors evaluate the efficacy of RFMN for skin laxity.

analgesics if required. Patients should be educated about the time it takes to witness visible results to provide compliance and patient satisfaction.

Declaration of interest The radiofrequency microneedling system Genius® was provided by Lutronic Medical Systems. Katharina Herberger received lecture fees from Lutronic Medical Systems in the past four years. Lynhda Nguyen has none to be declared.

higher at 6 months, implicating the progression of collagen and elastin remodelling even months after treatment.

The present case study and current literature indicate that RFMN is an effective and safe method for the rejuvenation of photoaged skin. It may act as an alternative to surgical face lifts for patients who do not wish for surgical treatments. Sufficient pain management should be provided using adequate topical anaesthetic ointment, air-cooling devices during treatment and

In this case, 1474 J/ cm2 with 517 impulses were applied. The patient was instructed to have sufficient sun protection after treatment. Three and six months after the last treatment session, follow-up visits were scheduled.

Significant skin tightening and a more defined jawline could be observed. The volume difference of the submental region was 4.1 cm3 at the last follow-up visit compared to baseline.

References

fractionated pulse mode in asians. Lasers Surg Med. 2015;47(8):626-33 6.

M,

M, Rothaus K, et al. Non-insulated smooth motion, micro-needles RF fractional treatment for wrinkle reduction and lifting of the lower face: International study. Lasers Surg Med. 2016;48(8):727-33

7. Gawdat H, Allam R, Hegazy R, et al.

Comparison of the efficacy of Fractional Radiofrequency Microneedling alone and in combination with platelet-rich plasma in neck rejuvenation: a clinical and optical coherence tomography study. J Cosmet Dermatol. 2022;21(5):2038-45

8. Nguyen L, Blessmann M, Schneider SW, et al. Radiofrequency Microneedling for Skin Tightening of the Lower Face, Jawline, and Neck Region. Dermatol Surg. 2022;48(12):1299-305

Our study represents the first prospective, intraindividual controlled clinical trial that evaluated the efficacy, tolerance, and patient satisfaction of insulated RFMN for skin tightening of the lower face, jawline, and neck region.

Figure 1 © Drs Lynhda Nguyen and Katharina Herberger

DermaVTM KTP laser generates more than 3000W (3x the previous “gold standard” 532nm device). 60% higher fluence compared to the next highest 532nm at all spot sizes and pulse durations.

VARIABLE SEQUENTIAL PULSING (VSP)

Various vascular lesions contain an array of vein sizes. With ease, DermaV can treat 30um (small) to 100um (medium) to 150+um (large) vessels, as well as the entire vein with longer single smooth pulses using both 532nm and 1064nm wavelengths. Three distinct pulse modes emulate a “gold standard” pulsed dye laser, a “gold standard” 532nm laser, and a “micro mode”, which is similar to the original pulsed dye laser, for fine vessels.

Fig. 1: VSP Graph

CRYOGEN COOLING

Fig. 2.: Thermal camera image.

DermaV’s 532nm and cryogen cooling combination is the first of its kind. Even after high fluence treatments, DermaV ICD cooling reduces skin temperature by 37 degrees Celsius, 10ms duration at 10Hz (“at speed” – no competitor comes close).

DermaV’s pre and post ICD cooling is unprecedented for a vascular device (the leading pulse dye laser only o ers pre-cooling). Post cooling allows the physician to safely treat pigment while decreasing side e ects and complications that have been problematic other 532nm devices due to extreme heat absorption at the ED junction.

Fig. 2.: Thermal camera image.

Fig. 4: GUI image

(A.R.T)

IntelliTrakTTM& Temperature Sensing:

Large, pigmented areas, such as décolleté, have traditionally been treated with IPL: when using a single pass technique, striping, and stamping outlines are a common side e ect.

DermaV’s unique Accelerated Rejuvenation with Tracking (A.R.T) treatment removes the need for gel, significantly decreases treatment time/ number of sessions, and eliminates striping using IntelliTrak technology. Real-time, computer-controlled overlap can maintain consistently precise shot placement “at speed” – up to 9.24 cm^2/second (twice as fast as the leading IPL). The user has the option to engage pre or post epidermal protection, while delivering sub-milli and sub-micro pulses with a 14mm spot at up to 6Hz.

Fig. 4: GUI image

For more information visit our Symposium at IMCAS, Thursday, 26.01.23, 13:30 (Room 351 - Level 3 ) or on our website: www.Lutronic-Europe.com

NEW LUTRONIC DermaV replace the dye laser

Join LUTRONIC Symposium at IMCAS, Paris “The future is

green – new generation of vascular laser treatments from rosacea to port wine stain”,

PD Dr. Katharina Herberger & Dr. Cathy Dierckxsens

January 26th, 2023 at 13:30 (Room 351 – Level 3)

PD Dr. Katharina Herberger, head of the laser department of dermatology at UKE Hamburg Hospital and Dr. Catherine Dierckxsens, owner of a private practice specialized in laser and cosmetic dermatology in Brussels, are working with Lutronic’s DermaVTM vascular laser, launched in December 2021. After 1 year, both skin experts give us an insight into the advantages of the new technology, the unique selling points and the range of indications it treats.

The DermaVTM has been introduced to the European market 2021. When Lutronic approached you last year with the request to work with the DermaV. Ho did you react?

Katharina: Lutronic approached me with the new DermaV-technology and with it gave me the opportunity to get to know and test the new laser system. We quickly decided to plan a study on port-wine stains with this system – especially since there have not been many innovations in the field of treating this stigmatizing skin change in recent years. Therefore, this treatment is extremely interesting.

Cathy: I was very pleased to be able to work with this new laser that combines KTP & Nd:YAG lasers, especially for vascular indications. I already work with the Clarity II, which is a great device combining Alexandrite and Nd:YAG, but having a powerful KTP is an added value for vascular treatments, especially here in Brussels where we treat a lot of patients with light skin photo-types.

Port-wine stains are unfortunately the most common congenital vascular malformations and then persist into adulthood. A large psychosocial burden-grade even in children. What ages were allowed to participate in this study?

Katharina: As the regulations for con ducting studies including children are significantly more complex, we will treat adults only for now. However, it is expected that the treatment results will be transferable to children, as treating adults is often even more difficult due to the thickness of the lesions. Thus, if the therapy is successful and, of course, well tolerated, it will at least be effective on children.

The DermaVTM is a vascular laser that not only works with two wavelengths and is therefore able to emit ultra-short pulses, but is also the only KTP laser that offers cryocooling or a cryo-spray that can be individually adjusted before and after the laser shot . What is your experience of using this new technology?

Cathy: We all know how much cooling of the skin is important to avoid side effects when treating vascular indications. I have been using a cryospray with a PDL laser in the past and I also have experience with contact cooling and pulsed cold air. Of all the options, I find the cryo-spray cooling very effective and easy to protect the epidermis when treating vascular indications.

PD DR. KATHARINA HERBERGER (D.A.L.M) SENIOR PHYSICIAN & HEAD OF LASER DEPARTMENT OF THE UNIVERSITY HOSPITAL HAMBURG EPPENDORF

In your opinion, what is most revolutionary at DermaVTM ?

Katharina: The IntelliTrakTM Technology is especially interesting for larger areas, such as large port-wine stains, in order to avoid treatment gaps or overlaps. When using it for fractional rejuvenation it is possible to treat facial redness for example, evenly and homogeneously. It makes the treatment faster and more e cient.

What can the audience expect from the DermaVTM Symposium at the IMCAS on 26.01.23, 13:30?

Cathy: Introduction of an innovative vascular KTP-Nd:YAG laser system: understanding the advances in technological development and clinical applications of this laser. I explain the Technology and show clinical cases of Rosacea.

Katharina: Treatment results and therapy protocols with the latest generation vascular laser, the KTP laser, are shown. A special focus will be on

the treatment parameters, expected courses and tolerability of this new therapy system.

Meet us at LUTRONIC booth for further questions. Look for the LUTRONIC red on 2.nd Floor Booth N201.

LUTRONIC DINNER SYMPOSIUM AT PULLMANN EIFFEL TOWER

LUTRONIC invites you to the upcoming Dinner Symposium at IMCAS Paris 2023 on Thursday, 26.01.23 at 19:30. The symposium o ers participants a unique opportunity to learn, share and discuss topics in laser and cosmetic surgery in an exclusive location with amazing view at the Ei el Tower by night and a delicious 3-course dinner. Don’t miss the chance to meet internationally renowned speakers and exchange new ideas, discuss novel research results and discover latest technical solutions. This event takes place at the luxury Pullman Paris Tour Ei el. The seats are limited.

Speakers: Dr. Cathy Dierckxsens, Baby-Face Treatment by Thulium Laser ULTRATM, Dr. Katharina Herberger, Portwine Stain Treatment by DermaVTM KTP Laser.

Please register to the Dinner Symposium by scanning the QR code.

DR. CATHY DIERCKXSENS DERMATOLOGIST & LASERSPECIALIST, BRUSSEL,

Courtesy of: Dr.Jaehyuk Lee

Portwine Stains

1 Month , 1 Treatment

Before After

The Nd:YAG as a wavelength is uniquely positioned in terms of the absorption coefficients of the three main chromophores in the skin, and it is this advantage that makes the Nd:YAG laser popular as a treatment for multiple conditions that require targeting these chromophores.

THE USES OF LONG-PULSED ND:YAG LASER IN DERMATOLOGY

Firas Al-Niaimi explores the many uses of the versatile Nd:YAG laser beyond hair removal

ABSTRACT

The Nd:YAG is a wavelength in the nearinfrared range of 1064 nm and is widely used in hair removal in higher Fitzpatrick scale skin types, given its high safety margin and

relative depth of penetration compared to the shorter wavelengths. In dermatology, this wavelength has multiple uses beyond hair removal, including uses in vascular and non-vascular conditions such as acne,

The Nd:YAG wavelength is a common wavelength used in dermatology, which is generated through the Neodymium-doped yttrium aluminium garnet crystal at a wavelength of 1064 nm in the near-infrared range of the electromagnetic spectrum. The Nd:YAG as a wavelength is uniquely positioned in terms of the absorption coefficients of the three main chromophores in the skin (water, melanin, and haemoglobin), and it is this advantage that makes the Nd:YAG laser popular as a treatment for multiple conditions that require targeting these chromophores1 The effects on the skin depend partly on the pulse duration, which can range from a millisecond down to the ultrashort pulse duration in the picosecond domain.

In this article, we discuss the uses of the long-pulsed Nd:YAG, which is in the microsecond and millisecond range. Hair removal will not be discussed, but it is worth noting that this wavelength is the main wavelength used in hair removal in darker skin types, given its preferential deeper penetration compared to the alexandrite laser and its relatively lower melanin absorption, which decreases the risk of epidermal injury2. In lighter skin types, the Nd:YAG can also be used in tanned individuals for similar reasons.

Vascular uses

As mentioned in the introduction, the Nd:YAG wavelength is absorbed by haemoglobin which is why this laser can be used for a number of vascular conditions in dermatology. In particular, venous lesions respond preferentially to the Nd:YAG compared to the shorter vascular wavelengths (such as the 595 and 532 nm) as they are located deeper in

rejuvenation, warts, onychomycosis and scars. This article discusses using the 1064 nm Nd:YAG wavelength in the microsecond and millisecond pulse modes for a wide range of conditions beyond laser hair removal.

the skin and are rich in deoxyhaemoglobin which is well absorbed by the Nd:YAG wavelength. The combination of these two characteristics makes this wavelength the first choice for venous lesions, such as leg veins, venules on the face and thick or hypertrophic parts of haemangiomas, and port-wine stains3

Venules on the face respond well to the Nd:YAG and are safe to treat using a small spot and starting with low fluences, given the risk of atrophic scarring when a large spot size and high fluences are used. In one study comparing both the Nd:YAG laser against the pulsed dye laser (PDL) for nasal vessels, it was found that the small red telangiectasia responded better to the PDL, whereas the blue venules responded better to the Nd:YAG laser; an observation agreed with by laser experts4

A study on the comparison between the Nd:YAG longpulsed laser against the 532 nm vascular laser in leg vessels showed that the longer penetration of the Nd:YAG wavelength was superior to the 532 nm laser given the deeper uniform heating, which addressed the lower parts of the vessels since only the upper part of some vessels were in interaction with the shorter 532 nm wavelength5 The parameters of the Nd:YAG in leg vessels depend on the size and depth of the leg vessels, with typically smaller vessels requiring a smaller spot size and a shorter pulse duration and larger vessels requiring a slightly larger spot size (maximum 7 mm) and a longer pulse duration6. The clinical endpoint is important, which is colour change, spasm or disappearance of the vessel.

The gold standard treatment for port-wine stains remains the PDL, although there are reports of intense pulsed light (IPL) and 532 nm treatment in this condition.

email: firas55@hotmail.com

KEYWORDS

Acne, Nd:YAG, rejuvenation, rosacea, scar, warts

FIRAS AL-NIAIMI, MSC, MRCP, EBDV, is a world renowned professor in dermatology and the only laser dermatology professor in the UK with a significant academic portfolio and over 220 scientific publications mostly in the laser field. He practices both in London and Denmark.

The hypertrophic component of port-wine stains responds less well to the shorter wavelengths and is preferentially treated with the Nd:YAG wavelength. The hypertrophic blebs and the purple colour of the vessels imply larger calibre vessels located deep in the skin hence their response to the Nd:YAG laser7. Indeed in a study among Chinese patients, it was demonstrated that for the purple component of the port-wine stain, the Nd:YAG was efficient, albeit it should be used with care and expertise8

The treatment of haemangiomas has been transformed over the last decade since the discovery of the efficacy of systemic beta-blockers in this condition. Nevertheless, the Nd:YAG laser has been used in combination with the PDL in the treatment of the deeper component of the haemangiomas with success.

The author uses the Nd:YAG laser from both the Nordlys system (Candela Corporation, Marlborough, MA, USA) as well as the GentleMax Pro platform (Candela Corporation, Marlborough, MA, USA).

Scars

The use of lasers in the treatment of scars has been transformational over the last decade since it was found that fractional lasers remodel scar tissue and improve outcomes such as pliability, colour, and thickness. Vascular lasers play an integral part in laser scar therapy beyond just simply targeting the vascular component of the erythema. The Nd:YAG laser has been used in several studies in hypertrophic and keloid scars with demonstrable changes

acne

at a molecular level in the scar tissue, such as upregulating transforming growth factor beta 3 (TGF-b3) and reduction in collagen type 19. Treatment with the Nd:YAG should take into consideration the scar colour and thickness as well as the background skin type and is typically achieved with mid-spot sizes (4–7 mm) and fluences below the purpuric threshold. The use of microsecond pulse Nd:YAG has also been reported in scars, particularly in the treatment of atrophic scars.

An interesting finding in a study on keloids using the Nd:YAG laser is the benefit this wavelength has on the pain symptoms of a keloid10. The authors attribute this to the deep penetration of the wavelength which reaches the nerve plexus responsible for the pain sensation in some keloids. The use of the Nd:YAG laser in both hypertrophic and keloid scars is a subject of ongoing interest, with studies continuing to examine the utility of this wavelength in the field of scar management.

Warts

The Nd:YAG laser is very effective in the treatment of cutaneous warts and verrucae, and its use in this cutaneous infection has been published in several series, including among higher Fitzpatrick scale skin types in a study from Korea11. One limitation of the treatment could be the relatively high pain sensation this treatment is associated with, but it has been demonstrated to clear cutaneous warts effectively, at times with as little as a single treatment session12. Typical parameters would be a small spot size and a pulse duration of between 20 to 30 ms, and relatively high fluences13. It is thought that the mechanism of action is a combination of papillary vessel coagulation or necrosis together with clefting of the dermo-epidermal junction as a result of the thermal effect, a mechanism explaining the need for relatively high fluences. Overall the recurrence rate seems to be relatively low in this method of treatment, and therefore the Nd:YAG could be an excellent choice of treatment, particularly for resistant or multiple warts unresponsive to topical therapy.

Figure 2 Diffuse redness with mild inflammatory component treated with the Nd:YAG laser

Acne

Acne vulgaris is a common inflammatory skin condition of the pilosebaceous unit. While there are established medical therapies in terms of topical and systemic therapy for this condition, patients with milder forms of acne are increasingly seeking laser treatment given their reluctance for medical therapy14. The Nd:YAG laser has been used in acne for many years, with several studies published on its efficacy in the mild to moderate forms of acne. Both the pulsed millisecond as well as the painting technique with the microsecond pulses have been used15,16. The mechanism involves thermal effects on the sebaceous glands with a degree of microvessel coagulation and the generation of heat shock proteins that recreate a bactericidal effect against the c.acnes bacteria. Combination treatment with other established acne therapies may lead to faster response and synergism in response to treatment.

Rosacea/diffuse redness

Papulopustular acne, as well as diffuse redness and

Figure 1 Inflammatory

treated with the Nd:YAG laser

Vascular

vascular rosacea, have been successfully treated with the Nd:YAG laser in both the millisecond pulsed mode as well as the painting mode with the microsecond pulse17. As discussed earlier, the Nd:YAG wavelength is absorbed by haemoglobin hence its efficacy in diffuse redness due to the photothermal effects leading to vessel coagulation. Particularly the short pulse duration would be more suitable for the treatment of diffuse redness since the small vessel size would have a short thermal relaxation time. In one study among patients with papulopustular rosacea, the use of long-pulsed Nd:YAG led to good clearance of the majority of patients with no complications18,19. In practice, the Nd:YAG laser can be combined with other topical or systemic therapies for rosacea for a synergistic effect.

Onychomycosis

Fungal nail infection is a common problem worldwide, and while there are systemic treatments for this condition, the use of lasers might be an alternative for patients who are unable to or unwilling to take systemic treatment in the form of tablets. The Nd:YAG has been reported in numerous studies to be effective in onychomycosis, with typically several treatments needed at around monthly intervals20 There is some variation in terms of parameters — in particular, the pulse duration — but it is generally the short pulse durations in the nano and microsecond range that tend to be effective21,22. The author prefers to use the microsecond pulse duration with a high repetition rate, with heat generation being the suggested mechanism behind its efficacy.

Hair follicle-related disorders

In addition to laser treatment of hirsutism or unwanted hair for aesthetic reasons, the Nd:YAG laser has been used in a number of follicle-related disorders with or without combination treatment with favourable outcomes. These conditions include hidradenitis suppurativa, pilonidal sinus (particularly post-surgery), dissecting cellulitis, keratosis pilaris, and pseudofolliculitis barbae23

Rejuvenation

The Nd:YAG laser, as mentioned previously, is a wavelength that is absorbed by all three main skin chromophores:

References

1. Gan SD, Graber EM. Laser hair removal: a review. Dermatol Surg. 2013 Jun;39(6):823-38.

2. Kaur Hora M, Choudhary N, Agrawal S, Gupta S, Gandhi J, De A, Chatterjee G. Evaluation of the Efficacy and Safety Profile of Long-Pulsed 1064 Neodymium:Yttrium-Aluminum-Garnet (Nd:YAG) Laser in Hemangioma and Vascular Malformation in Darker Skin Types. Cureus. 2022 Jun 8;14(6):e25742.

3. Bäumler W, Ulrich H, Hartl A, Landthaler M, Shafirstein G. Optimal parameters for the treatment of leg veins using Nd:YAG lasers at 1064 nm. Br J Dermatol. 2006 Aug;155(2):364-71.

4. Adamic M, Troilius A, Adatto M, Drosner M, Dahmane R. Vascular lasers and IPLS: guidelines for care from the European Society for Laser Dermatology (ESLD). J Cosmet Laser Ther. 2007 Jun;9(2):113-24.

5. Akaishi S, Koike S, Dohi T, Kobe K, Hyakusoku H, Ogawa R. Nd:YAG Laser

Treatment of Keloids and Hypertrophic Scars. Eplasty. 2012;12:e1. Epub 2012 Jan 11.

6. Shrestha S , Karn D . Long Pulsed Nd:YAG Lasers in the Management of Cutaneous Warts. Kathmandu Univ Med J (KUMJ). 2018 Jan.-Mar;16(61):60-64.

7. Le HTT, Truong Van C, Nguyen Thi M, Al-Niaimi F. Our experience using 1064 nm Nd:YAG in palmoplantar warts. J Cosmet Laser Ther. 2022 Jul 4;24(1-5):28-32.

8. Han TY, Lee JH, Lee CK, Ahn JY, Seo SJ, Hong CK. Long-pulsed Nd:YAG laser treatment of warts: report on a series of 369 cases. J Korean Med Sci. 2009 Oct;24(5):889-93.

9. Li MK, Liu C, Hsu JTS. The Use of Lasers and Light Devices in Acne Management: An Update. Am J Clin Dermatol. 2021 Nov;22(6):785-800.

10. Chalermsuwiwattanakan N, Rojhirunsakool S, Kamanamool N, Kanokrungsee S, Udompataikul M. The comparative study of efficacy between 1064-nm long-pulsed Nd:YAG laser and

Figure 3 Venous lake on the lower lip treated with the Nd:YAG laser

Key points

The Nd:YAG laser has many uses in dermatology beyond hair removal

Vascular conditions respond well to the Nd:YAG laser, particularly the venous pathology

Acne and inflammatory rosacea both respond well to the Nd:YAG laser

Scars can respond favourably to the Nd:YAG laser particularly in combination with other treatments

Onychomycosis and facial rejuvenation are other examples of uses of the Nd:YAG laser

595-nm pulsed dye laser for the treatment of acne vulgaris. J Cosmet Dermatol. 2021 Jul;20(7):2108-2115.

11. Ballin JS, Uebelhoer NS. The use of the low-fluence 1064 nm Nd:YAG laser in a female with contraindications to systemic anti-acne therapy. J Drugs Dermatol. 2009 Nov;8(11):1025-6.

12. Alam M, Voravutinon N, Warycha M, Whiting D, Nodzenski M, Yoo S, West DP, Veledar E, Poon E. Comparative effectiveness of nonpurpuragenic 595-nm pulsed dye laser and microsecond 1064-nm neodymium:yttrium-aluminumgarnet laser for treatment of diffuse facial erythema: A double-blind randomized controlled trial. J Am Acad Dermatol. 2013 Sep;69(3):438-43.

13. Salem SA, Abdel Fattah NS, Tantawy SM, El-Badawy NM, Abd El-Aziz YA. Neodymium-yttrium aluminum garnet laser versus pulsed dye laser in erythemato-telangiectatic rosacea: comparison of clinical efficacy and effect

haemoglobin, melanin, and water. The absorption by water is particularly enhanced in the short microsecond wavelength where there is little to no melanin and haemoglobin absorption, and with a high repetition rate there can be a build-up of heat in the skin that may eventually with repeated treatments lead to rejuvenation with texture improvement, pore tightening, and some tissue firming and rejuvenation24. In some reports, the procedure uses long pulsed Nd:YAG in the millisecond range25

Conclusion

The Nd:YAG is a near-infrared wavelength that has the unique position of being absorbed by all three main skin chromophores: haemoglobin, water, and melanin. It has, therefore, multiple uses in dermatology, from vascular to hair removal and numerous other conditions such as scars, acne, and warts, to name just a few. The treatments can be combined with other modalities and may, in some cases, require several sessions. The Nd:YAG plays an important role in the field of laser dermatology, and ongoing interest in its uses are still being explored.

on cutaneous substance (P) expression. J Cosmet Dermatol. 2013 Sep;12(3):187-94.

14. Kwon WJ, Park BW, Cho EB, Park EJ, Kim KH, Kim KJ. Comparison of efficacy between long-pulsed Nd:YAG laser and pulsed dye laser to treat rosaceaassociated nasal telangiectasia. J Cosmet Laser Ther. 2018 Oct;20(5):260-264.

15. Say EM, Okan G, Gökdemir G. Treatment Outcomes of Long-Pulsed Nd: YAG Laser for Two Different Subtypes of Rosacea. J Clin Aesthet Dermatol. 2015 Sep;8(9):16-20.

16. Ma W, Si C, Kasyanju Carrero LM, Liu HF, Yin XF, Liu J, Xu Y, Zhou B. Laser treatment for onychomycosis: A systematic review and meta-analysis. Medicine (Baltimore). 2019 Nov;98(48):e17948.

17. Kim MS, Jung JY, Cho EB, Park EJ, Kim KH, Kim KJ. The effectiveness of 1,064-nm long-pulsed Nd:YAG laser in the treatment of severe onychomycosis. J Cosmet Laser Ther. 2016 Oct;18(6):317-22.

18. Okan G, Tarikci N, Gokdemir G. The Effect of Long-Pulsed Nd:YAG Laser for the Treatment of Onychomycosis. J Am Podiatr Med Assoc. 2017 Jan;107(1):54-59.

19. Chiba C, Usui A, Hara H, Ishi Y. Clinical experience in skin rejuvenation treatment in Asians using a long-pulse Nd:YAG laser. J Cosmet Laser Ther. 2009 Sep;11(3):134-

20. Kaya TI, Guvenc U. Long pulse 1,064-nm neodymium-doped yttrium aluminum garnet laser in aesthetic dermatology. Dermatol Ther. 2019 May;32(3):e12907.

21. Hong JS, Park SY, Seo KK, Goo BL, Hwang EJ, Park GY, Eun HC. Long pulsed 1064 nm Nd:YAG laser treatment for wrinkle reduction and skin laxity: evaluation of new parameters. Int J Dermatol. 2015 Sep;54(9):e345-50.

22. Chiba C, Usui A, Hara H, Ishi Y. Clinical experience in skin rejuvenation treatment in Asians using a long-pulse Nd:YAG laser. J Cosmet Laser Ther. 2009 Sep;11(3):134-8.

Declaration of interest Funding for submission of this paper was provided by Candela

Figures 1-3 © Candela Corporation

AN UPDATE ON NON-INVASIVE FAT REDUCTION

Christopher N. Nguyen, MD, and Michael Gold, MD, review the evidence and provide their clinical experience working with

four popular modalities for fat reduction

ABSTRACT

Non-invasive fat reduction is one of the fastest growing areas of aesthetic medicine, given it’s decreased cost, patient down time, and adverse effects when compared to traditional surgical options. The four primary modalities include cryolipolysis, radiofrequency, lasers, and ultrasound. Advancements in software and hardware are continually optimising both the patient and provider experience in this field. Over the last decade, numerous clinical studies have demonstrated the efficacy and safety profile of these modalities. In this update, we highlight modern devices and their features, and summarise recent clinical data that further validate these fat-reducing technologies.

FAT REDUCTION HAS BECOME A COSMETIC AND MEDICAL PRIORITY for many patients over the past decade, particularly considering the obesity epidemic and increasing focus on weight loss in pop culture. In a 2019 survey, more than 80% of Americans reported that they were bothered by excess weight on their body1. The study also found that body contouring was the most frequently sought-after cosmetic procedure. For decades, liposuction has been the only available method to reduce localised adipose tissue. While effective, this approach is invasive, has limitations, and, as with any surgery, poses multiple risks2

More recently, non-invasive fat reduction options have surfaced as an exciting alternative to liposuction. Compared to surgical fat removal, non-invasive options offer a lower cost, preferable safety profile, and speedier recovery2. Because of this, noninvasive fat reduction has exploded in popularity, becoming one of the fastest-growing areas of aesthetic medicine. The American Society for Dermatologic Surgery reported over 1 million body contouring procedures in 2019, compared to less than 150,000 in 2012, representing an over 5-fold increase3. More specifically, non-invasive fat reduction procedures increased by 58% in 2021 from 2020, even in the midst of the COVID-19 pandemic4. In total, the market size in 2021 for non-invasive fat reduction globally was estimated at over 1 billion US dollars and is projected to experience a compound annual growth rate of 16.1% from 2022 to 2030, in part due to the population’s increased disposable income and awareness of procedures5

The premise of nonsurgical fat reduction lies in using cooling or heating technology to induce fat cell destruction. A variety of modalities have been FDA-approved for these purposes and can be separated into four primary techniques:

■ Cryolipolysis, ■ Radiofrequency (RF), ■ Lasers, and ■ Ultrasound.

Each technology has witnessed expansion in the last decade5. The objective of this article is to provide an update on each of these non-invasive fat reduction modalities, focusing on studies performed in the last few years, as well as offer our analyses of the field.

Cryolipolysis

The use of non-invasive freezing for fat reduction was first studied in pigs in 20076. Since then, it has been validated in humans in numerous studies7. Of the four modalities, cryolipolysis — cold-induced fat reduction — is the only one that involves cooling. In the US, the procedure is commonly referred to as CoolSculpting® (Zeltiq Aesthetics, Pleasanton, CA) and was FDA-approved in 20108,9. In 2017, Zeltiq was acquired by Allergan Aesthetics, an AbbVie Company. In 2019, cryolipolysis was the most performed body sculpting procedure, with 257,000 procedures performed in the US alone3. In

CHRISTOPHER

MD, Department of Internal Medicine, Northside Hospital Gwinnett, GA, USA; MICHAEL GOLD, MD, Medical Director, Gold Skin Care Center & Tennessee Clinical Research Center, Nashville, TN, USA

email: christopher.nguyen42@ gmail.com

N. NGUYEN,

The American Society for Dermatologic Surgery reported over 1 million body contouring procedures in 2019, compared to less than 150,000 in 2012, representing an over 5-fold increase.

total, over 4 million cryolipolysis procedures have been performed worldwide10

The precise mechanism is not fully understood but generally entails suctioning of tissue combined with cold temperature (<10°C) application, thereby inducing apoptosis of adipocytes. Scientists have found adipocytes to be more susceptible to cold-induced injury due to their lipid-rich state compared to other cells, which are water-rich. Because the crystallisation of lipids occurs at higher temperatures than the freezing point of water, adipocytes are affected while other cells remain stable8. Following adipocyte apoptosis, cells are gradually cleared by inflammation and macrophages, peaking at around 4 weeks and ending by 12 weeks posttreatment6

In a systematic review of over 1500 patients, all 19 included studies reported significant fat reductions with cryolipolysis in multiple body areas, ranging from 10.3% to 28.5%7. Currently, very few studies have examined the long-term durability of results; however, Bernstein reported persistent and visible fat reduction at 6- and 9-years post-treatment

Over the past several years, new applicators and software systems have been launched aimed at optimising the patient experience and achieving better results. The CoolMini™ is a compact applicator designed to treat smaller areas of fat and demonstrated a mean reduction of 22.30cm3 (P<0.0001) in the submental area11. On the other hand, the CoolAdvantage® applicators have a contoured design with a larger surface area to allow for increased patient comfort with shorter treatment times when covering larger areas. A multinational prospective study endorsed higher patient satisfaction with these newer applicators and found that 89.6% of 112 patients were ‘satisfied’ or ‘very satisfied’12. High rates of satisfaction were found among a diverse patient population independent of body area, number of cycles, and body mass index (BMI). Additionally, the most recent CoolSculpting system, CoolSculpting Elite, was released in 2020 that can deliver two treatments simultaneously. The removable applicators are available in a range of shapes and sizes to accommodate various amounts, locations, and textures of fat. Of note, the novel C-shaped cup redesign of the applicator is better able to conform to natural body curvatures and has demonstrated improved vacuum seal, volume of tissue drawn, and tissue contact, along with reduced patient pain13

Lastly, new clinical and histological evidence suggests

that CoolSculpting triggers dermal remodelling and helps tighten skin as well14

Other countries have also developed their own cryolipolysis devices with features and efficacy like that of the US. The French cryolipolysis device Cristal® (Deleo, Saint Raphael, France) demonstrated a mean fat reduction of 2.8cm (P<0.05)15. Meanwhile, Spain developed and validated the Cooltech system (Sinclair Pharma, London, UK) that cools to -8°C and has the ability to treat multiple areas simultaneously. Studies found average reductions of 19.6% (P=0.001) in the abdominal area, 15.34% in the infraumbilical area, 11.03% in the right flank, and 4.57% in the left flank16,17

Furthermore, in 2019, Marmol et al. investigated the benefits of a newer model (CoolTech Define, Sinclair Pharma, London, UK)18. The updated model provided several advantages: it utilised a cooler temperature of -10°C, as well as 360° complete cooling. In addition, the newer model used a shallower applicator cavity depth, two additional applicators, and increased diversity in applicator shapes and sizes. The newer model provided faster (36% quicker) and more homogenous cooling. The average skinfold change was -7.80 mm (P=1.62x10-28), while the average circumference change was -32.3 mm (P=2.20x10-22). Thus, superior results were achieved while lower temperatures allowed for less treatment time and greater patient comfort. The most recent investigation to optimise this system investigated ischemia produced by the vacuum suction of applicators which affects the biological heat in the tissue19. Investigators were able to develop an accurate mathematical model that determines the blood flow in a treated tissue based on the applicator’s shape and size. This model has been strongly correlated with human studies and is useful for predicting and optimising the efficacy and safety of different applicators19

In 2017, the Korean FDA approved their own device, Cryo-Elsa (Huons Co. Ltd., Seongnam, Korea), and similarly found significant reductions in waist circumference (4.1 cm [P=0.023]) and abdominal subcutaneous fat (4.8 cm2 [P=0.182]). Interestingly, the Lee et al. study was the first to document visceral fat reduction (16.2cm2 [P=0.023]) from cryolipolysis8. A later split-body clinical trial in 2020 found the cross-sectional area of visceral adipose tissue in the treated abdomen decreased by 15.6% (P=0.003), while the untreated abdomen demonstrated no significant changes20

Visceral obesity has been strongly associated with

In a systematic review of over 1500 patients, all 19 included studies reported significant fat reductions with cryolipolysis in multiple body areas, ranging from 10.3% to 28.5%.

metabolic disorders such as diabetes mellitus and coronary heart disease, with significant implications in morbidity and mortality8. So, while cryolipolysis has historically been a cosmetic procedure focusing on the removal of subcutaneous fat, these recent findings suggest visceral fat reduction may be possible as well.

In the above studies and in a systematic review including over 3300 patients, most adverse events (AEs) following cryolipolysis were mild and transient, with erythema, paresthesia, bruising, and oedema composing the most common AEs10. Other serious AEs were rare and isolated events. Sharply demarcated areas with indented or ‘shark bite’ appearances have been occasionally described13. Thus far, histological studies have shown no long-term changes in nerve structure or function, and there have been no reports of permanent nerve damage2,7,10. The vacuum pressure may, in theory, cause complications to pre-existing hernias, but so far there have been no induced hernias in clinical studies7,10 Paradoxical adipose hyperplasia (PAH) is a rare but serious AE characterised by hardened adipose tissue at the treatment site months following the procedure. The incident rate for PAH appears to be lower for newer applicators compared to older models, however, demonstrating an over 75% decrease21. No significant changes in serum lipid levels or liver function tests have been documented7

Radiofrequency

Radiofrequency (RF) technology was initially introduced to treat skin laxity and wrinkles but has expanded to treat cellulite and fat reduction. In 2019, it was reported as the second most frequently used non-invasive fat reduction procedure, with 208,000 treatments performed

In contrast to cryolipolysis, RF relies on heat technology. Radiofrequency is electromagnetic energy, generally ranging in frequency from 3 KHz to 2 MHz, with lower frequencies reaching as far as 1.5 cm into the subcutaneous layer22. Radiofrequency energy induces adipose tissue to generate heat by forcing collisions between charged molecules and ions23. Because adipose cells naturally have high-tissue resistance and low-heat transfer capabilities, heat dispersion is localised, which causes selective apoptosis of adipocytes and minimal risk to the epidermal and dermal layers Following treatment, peak inflammation and necrosis are seen histologically as far as 90 days post-treatment23

Since its advent, there have been numerous RF devices introduced to the market, most of which can be

categorised as either monopolar, unipolar, or multipolar based on the number of electrodes they contain25. One example of a monopolar device is the truSculpt® ID (Cutera, Brisbane, CA). The device is hands-free and utilises short treatment times (15 minutes) without downtime. It can be used to treat a variety of body parts, including multiple areas simultaneously, and can treat areas of skin laxity and those covered by tattoos as well. This device also uses continuous real-time monitoring that maintains skin temperature at 43°C and subcutaneous tissue temperature at least 3–4°C higher to provide consistent results, as well as ensure safety26

Another monopolar RF device is the Exilis Ultra 360™ (BTL Industries, Marlborough, MA), the most recent iteration of Exilis devices. Chilukuri et al. demonstrated efficacy in fat reduction in a variety of body areas with high patient satisfaction and comfort (4.1/5) using combined Exilis monopolar RF and ultrasound technologies in 34 subjects27. This system also houses real-time temperature monitoring and a variety of applicators allowing for the treatment of a wide range of body areas25

The Accent RF System (Alma Lasers, Caesarea, Israel) is a unipolar RF device that has demonstrated average fat reductions of 2.64 mm in the thigh and 1.8 mm in the buttocks in a study of 26 females28

The Accent Prime™ is the latest system combining both unipolar RF technology and ultrasound technology. Kapoor et al. studied 255 patients after three treatment sessions with this system and reported an average reduction of 7.7–8.0 cm in abdominal circumference and a reduction of 2.86–3.18 cm in the thighs (P≤0.0001)22 Other modern platforms are multifunctional and not only perform lipolysis, but other non-invasive body contouring capabilities as well, such as muscle toning, skin surface remodelling, and cellulite reduction. One example of this is the Venus Bliss™ (Venus Concept, Toronto, Canada), which uses both multipolar RF and pulsed electromagnetic field technology29. Advantages of this treatment include a short therapy time (15–20 minutes), the ability to deliver energy to a depth of 4.5 cm, and uniform thermal energy distribution, which also induces collagen production and restructuring in the dermis and hypodermis. This system also features VariPulse™ technology that increases blood flow, enhances lymphatic drainage, and optimises patient comfort25. Similarly, the Evolve Trim (InMode, Irvine, CA) is another platform based on RF technology. The hands-free belt design and variety of applicators in this system allow for multiple areas to be treated

In contrast to cryolipolysis, RF relies on heat technology. Radiofrequency is electromagnetic energy, generally ranging in frequency from 3 KHz to 2 MHz, with lower frequencies reaching as far as 1.5 cm into the subcutaneous layer

distribution.

The most common AEs seen with RF devices are transient erythema, pain, and oedema. However, overall, this technology has shown to be very well-tolerated with minimal to no AEs2. Rarely, burns and blisters are seen, but these are generally due to operator error with realtime monitoring software and homogenous energy distribution helping to reduce discomfort and/or burns23

Lasers

In 2019 alone, there were 48,000 laser lipolysis treatments performed, with numbers increasing by over 600% in the last decade3. In general, there are two types of lasers used for non-invasive fat reduction. The first iteration, low-level laser therapy (LLLT), was FDA-approved for fat reduction in 201030. An older laser technology, LLLT uses a 635 nm wavelength and, rather than raising the temperature of the tissue, creates pores in the adipocyte cell membrane, allowing for lipid leakage. This causes near-immediate emptying of adipocytes, resulting in a reduction in cell size with maximal effects immediately post-treatment. However, since there is no cell death, some argue this is the reason for diminishing results in the months posttreatment and eventual fat recurrence, in contrast to other modalities that cause adipocyte apoptosis and/or necrosis2

Newer generation 1060 nm hyperthermic lasers were FDA-approved for non-invasive fat reduction in 201531 This specific wavelength penetrates to the depth of the subcutaneous tissue and is preferentially absorbed by adipocytes, heating cells to a controlled temperature between 42–47°C and sparing the overlying skin, dermis, and other surrounding cells. Because it does not target melanocytes, it can treat all skin types. Exposure to heat over tens of minutes damages the cell’s structural integrity. Over the next few months, the injured fat cells and cell debris are permanently removed by macrophages. Histologic studies have confirmed these findings, with inflammation gradually progressing up to a month after the treatment and lasting up to 6 months after treatment. The 1060 nm laser device has demonstrated equivalent reductions in fat thickness as compared to cryolipolysis32

The SculpSure® device (Cynosure, Westford, MA) has been approved for the abdomen, flanks, back, inner thigh,

outer thigh, and, most recently, the submental area. The hands-free device allows for treatment of up to four sites at one time with a customisable applicator.

Advantages of SculpSure include fast treatment time (25 minutes), no downtime, a cooling apparatus that maintains skin temperature at 15°C to prevent damage, and a uniform distribution of heat with no ‘hot spots.’ The efficacy of SculpSure in the flank was demonstrated in a prospective study of 49 patients showing an average fat reduction of 13% (p<.001), 96% patient satisfaction, and an average discomfort of 4/1033,34. Similar results have been demonstrated on the abdomen, thighs, and back35. Sixmonth follow-up showed persistent fat reduction as well36 SculpSure’s utility in the submental area was validated in a recent multi-centre study of 58 patients, demonstrating a 23% reduction in fat thickness with 91% patient satisfaction and an average treatment pain of 3.4/1037

Another device, Venus Bliss™ (Venus Concept, Toronto, Canada), utilises a 1064 nm diode laser for lipolysis. Similar to SculpSure, Venus Bliss has a 25-minute treatment time, intended to be used every 4–6 weeks for 1–3 treatments. This system has four applicators, a watercooling system, and a belt design for hands-free operation. Touch sensors are present to allow for confirmation of proper placement and skin contact. Like other programmes, it uses uniform energy delivery to maximise safety, comfort, and results. A 2021 study of 29 patients showed an average fat reduction of 4.92% (p<0.001) and 8.6% (p<0.0001) at 6 and 12 weeks, respectively, with a 72% patient satisfaction rate38. There was less discomfort with this device (2.6/10), potentially due to increased cooling and changes in energy distribution as compared to other devices. Preliminary results from an ongoing study with the new Venus Bliss Max show a 90% improvement based on Global Aesthetic Improvement Scale (GAIS) assessment. Since these results are 1 month post-treatment and maximal results are seen after 3 months, these are expected to improve.

The most commonly reported AE with laser lipolysis was transient tenderness23,30. There were no serious or unexpected AEs in the mentioned studies. Self-limited nodules were seen rarely38. The homogenous energy distribution reduces the risk of burns/blisters and ‘shark bite’ demarcations, as seen with cryolipolysis. There have been no reports of abnormalities with serum lipid or liver chemistries.

SculpSure’s utility in the submental area was validated in a recent multicentre study of 58 patients, demonstrating a 23% reduction in fat thickness with 91% patient satisfaction and an average treatment pain of 3.4/10.

Ultrasound

Long used for other pathologies, such as kidney stones or fibroids, ultrasound began being studied for fat reduction purposes in pigs in 201139. Since then, the technology has grown in popularity; a total of 134,506 ultrasound procedures were performed in 20193. Ultrasound devices can be categorised as either low-frequency or highfrequency.

Low-frequency ultrasound devices apply non-thermal, pulsed ultrasound waves that induce cavitations with minimal elevation temperature in the treated tissue. The mechanical disruption selectively destroys fat cell membranes, resulting in fat cell death and subsequent removal by the body’s natural mechanisms31. The surrounding tissue, blood vessels, and nerves are unharmed.

High-frequency ultrasound devices cause direct heating by precisely focusing ultrasound energy at a controlled depth to induce vibrations of adipose tissue molecules. This generates heat, raising the temperature of subcutaneous tissue higher than lasers, ranging from 56°C to as high as 70°C. The high heat induces coagulative necrosis of fat cells while sparing nearby nerves and vessels. Ultrasound energy also stimulates collagen remodelling and has thus been used to tighten skin as well30 However, the higher temperature also has the potential for nonselective cell necrosis, and the procedure can require analgesia, as opposed to other modalities.

UltraShape® (Syneron Candela, Wayland, MA) and LipoSonix® (Solta Medical, Bothell, Washington) are the only low- and high-frequency ultrasound devices, respectively, that have been FDA-approved for lipolysis. Significant changes in abdominal circumference, ranging from -2.1cm to -4.7cm, have been reported in multiple studies involving hundreds of patients with both devices2,40-46. For example, Jewell et al. performed a randomised sham-controlled study with Liposonix in 180 patients demonstrating an average waist circumference reduction of 2.10 cm (P=0.04) and 2.52 cm (P=0.002) at 47-J/cm2 and 59-J/cm2 energy levels, respectively, and a 75.5% (P<0.001) improvement on the GAIS40. Ultrasound devices do, however, show lower satisfaction rates when compared to other lipolysis devices, ranging from 47.5–85%2

Several studies combine ultrasound with other technologies, such as RF22,47. As discussed previously, the new Accent Prime platform combines both ultrasound and RF technologies to provide fat reduction, body contouring, and skin tightening. This system utilises ‘hot’ compression ultrasound waves and ‘cold’ shear ultrasound waves, which propagate waves at a perpendicular angle to target fat cells and protect the rest of the skin. The results have shown higher differences

than HIFU studies alone, but head-to-head studies are needed for definitive conclusions.

Ultrasound devices are well-tolerated with little pain, though high-frequency devices may cause more discomfort during treatment due to the high temperature48. As with other modalities, the procedure is safe with minimal to no serious AEs. Common AEs include transient erythema, pain, and bruising. Longterm follow-up safety data revealed no dimpling, indurations, burns, or scars. Like other devices, no changes in serum lipid, markers of inflammation, or liver function studies have been reported2,30

Discussion

Non-invasive, energy-based fat reduction procedures have become increasingly popular and more widely available as compelling alternatives to surgical approaches. Ample data exists to support the capability of these devices to induce a clinically significant reduction of stubborn areas of fat that may be otherwise resistant to diet and exercise.

Multiple devices have demonstrated consistent fat reduction in various areas of the body and in patients of all skin types, races, ages, and sexes. Furthermore, the data supports the long-term durability of results spanning years.

The technologies currently in use have proven to be extremely safe with a limited side effect profile and are well-tolerated by most patients. Recent innovative product developments in software and hardware have reduced AEs and optimised patient comfort as well. Serious AEs are rare, isolated events, and seem to be reduced further by newer models.

Patient satisfaction constitutes a key metric in evaluating device efficacy. Indeed, numerous investigations and multifaceted assessments have revealed high levels of satisfaction with this technology. Even so, it remains important for providers to select patients appropriate for the procedure and to set realistic expectations prior to the initiation of therapy. Suitable candidates for non-invasive fat reduction include nonobese patients with localised, discrete collections of fat. Using the data, providers can estimate a modest amount of fat removable with a single session, keeping in mind that multiple sessions may be needed. Furthermore, it should be emphasised to patients that fat reduction is gradual and takes place over weeks to months posttreatment.

The four different modalities discussed differ by mechanism and have varying side effect profiles but have all been proven to be effective options for noninvasive lipolysis. Eventually, it may be unnecessary to choose between modalities, since many advanced systems are equipped with multiple technologies that

Lowfrequency ultrasound devices apply non-thermal, pulsed ultrasound waves that induce cavitations with minimal elevation temperature in the treated tissue.

can provide combination treatments to deliver even more individualised treatment regimens. Already, newer multifunctional designs can tighten and smooth skin, improve cellulite, and tone muscle in addition to removing fat.

Despite the breadth of supporting evidence, further research is needed. At the time of this review, there remains a shortage of large randomised clinical trials, which can provide more reliable results with a higher statistical power. Furthermore, there is considerable heterogeneity among existing studies, making it difficult to conduct meta-analyses and strengthen conclusions. Uniform experimental parameters with standardisations in treatment protocol, follow-up time, and outcome measurements may enhance findings. The specifics of protocols, such as post-treatment massage and the optimal number of treatments remain unknown and could be further investigated. In addition, newer systems and applicators should be analysed to validate improvements in efficacy and patient comfort. Head-to-head studies directly comparing various existing technologies, as well as combination studies, will assist in determining optimal technology for specific patients and potential synergistic effects. Overall, larger-scale, more longitudinal studies will aid with confirmation of the durability of fat reduction and the discovery of any long-term sequelae.

References

1. American Society for Dermatologic Surgery, 2019. Consumer Survey. https://www.asds.net/Portals/0/ PDF/consumer-survey-2019-infographic.pdf. Accessed May 9, 2022.

2. Kennedy J, Verne S, Griffith R, Falto-Aizpurua L, Nouri K. Non-invasive subcutaneous fat reduction: a review. J Eur Acad Dermatol Venereol. 2015;29(9):1679-1688. doi:10.1111/jdv.12994

3. American Society for Dermatologic Surgery, 2019. Survey on Dermatologic Procedures. https://www. asds.net/portals/0/PDF/procedures-survey-resultspresentation-2019.pdf. Accessed May 9, 2022.

4. Aesthetic Plastic Surgery, 2021. National Databank Statistics 2020-2021. https://cdn.theaestheticsociety. org/media/statistics/2021TheAestheticSocietyStatistics.pdf, Accessed May 9, 2022.

5. Grand View Research, 2022. Non-invasive Fat Reduction Market Size, Share & Trends Analysis Report By Market Technology (Cryolipolysis, Ultrasound, Low Level Lasers), By End Use (Hospitals, Stand Alone Practices, Multispecialty Clinics) By Region And Segment Forecasts, 2022 – 2030. https:// www.grandviewresearch.com/industry-analysis/ non-invasive-fat-reduction-market, Accessed May 9, 2022.

6. Manstein D, Laubach H, Watanabe K, Farinelli W, Zurakowski D, Anderson RR. Selective cryolysis: A novel method of noninvasive fat removal. Lasers Surg Med. 2008;40:595–604.

7. Ingargiola MJ, Motakef S, Chung MT, Vasconez HC, Sasaki GH. Cryolipolysis for fat reduction and body contouring: safety and efficacy of current treatment paradigms. Plast Reconstr Surg. 2015;135(6):1581-1590. doi:10.1097/PRS.0000000000001236

8. Lee D and Lee K. Abdominal Fat Reduction through Cryolipolysis. Journal of Biosciences and Medicines. 2018;6(1):44-52. doi:10.4236/ jbm.2018.69005

9. Bernstein EF. Long-term efficacy follow-up on two cryolipolysis case studies: 6 and 9 years post-treatment. J Cosmet Dermatol. 2016;15(4):561564. doi:10.1111/jocd.12238

10. Hedayati B, Juhász M, Chu S, Mesinkovska NA. Adverse Events Associated With Cryolipolysis: A Systematic Review of the Literature. Dermatol Surg. 2020;46 Suppl 1:S8-S13. doi:10.1097/ DSS.0000000000002524

11. Jain M, Savage NE, Spiteri K, Snell BJ. A 3-Dimensional Quantitative Analysis of Volume Loss Following Submental Cryolipolysis [published correction appears in Aesthet Surg J. 2021 Jul 14;41(8):985]. Aesthet Surg J. 2020;40(2):123-132. doi:10.1093/asj/sjz145

12. Tan T, Snell B, Braun M, et al. High Participant

Key points

All four modalities (cryolipolysis, radiofrequency, lasers, and ultrasound) demonstrate significant fat reduction in various areas of the body and in patients of all skin types, races, ages, and sexes

Non-invasive fat reduction boasts high levels of patient satisfaction

Modern software and redesigned applicators allow for more versatile, comfortable, and individualised treatment regimens

Non-invasive fat reduction is extremely safe and serious adverse events are rare, isolated events that seem to be further reduced by newer models

Satisfaction Achieved Using Cryolipolysis for Fat Reduction of the Abdomen and Flanks [published online ahead of print, 2021 Dec 17]. Aesthet Surg J. 2021;sjab421. doi:10.1093/asj/sjab421

13. CoolSculpting® Elite System User Manual. Pleasanton, CA; Zeltiq Aesthetic, Inc. August 2020.

14. Stevens WG, Gould DJ, Pham LD, Jimenez Lozano JN. Molecular and Histological Evidence Detailing Clinically Observed Skin Improvement Following Cryolipolysis. Aesthet Surg J. 2022;42(1):56-67. doi:10.1093/asj/sjab226

15. Naouri M. Fat removal using a new cryolipolysis device: a retrospective study of 418 procedures. J Eur Acad Dermatol Venereol. 2017;31(3):e158-e160. doi:10.1111/jdv.13899

16. González MV, Castro D, Urdiales CF, Pérez ML, Mármol GV. Study on the Reduction of the Localized Panniculus Adiposus (Adipocyte Lysis) Through the Use of a Controlled Cooling System. International Research Journal of Pharmacy and Medical Sciences. 2019;2(5):4-9.

17. Urdiales CF, Ruiz LC, Soria JM, González MV, Viera-Mármol G. Assessing the Efficacy of Cryoadipolysis with the Cooltech® System: Case Study. EJMI. 2020;4(1):126-133.

18. Mármol GV, Ochoa CC, Pérez MD, Garcia JV, Lamas RV, Rosas MA, Gómez NA, Law J. Safety, Efficacy and Patient Tolerance of the New 360º Cryoadipolysis Device for Multiple-Area Fat Removal. EJMI. 2020;4(1):41-50.

19. Garcia JV, Mármol GV, Ochoa CC, Lamas RV, Gomez NA, Rosas MA, Bordera GB. Preliminary clinical validation of cryoadipilysis treatment under effects of ischemia simulated by COMSOL Multiphysics software. Aesthetic Medicine. 2020;6(4):30-35.

20. Hwang IC, Kim KK, Lee KR. Cryolipolysis-induced abdominal fat change: Split-body trials. PLoS One. 2020;15(12):e0242782. Published 2020 Dec 29. doi:10.1371/journal.pone.0242782

21. Nikolis A, Enright KM. A Multicenter Evaluation of Paradoxical Adipose Hyperplasia Following Cryolipolysis for Fat Reduction and Body Contouring: A Review of 8658 Cycles in 2114 Patients. Aesthet Surg J. 2021;41(8):932-941. doi:10.1093/asj/sjaa310

22. Kapoor R, Shome D, Ranjan A. Use of a novel combined radiofrequency and ultrasound device for lipolysis, skin tightening and cellulite treatment. J Cosmet Laser Ther. 2017;19(5):266-274. doi:10.1080/14 764172.2017.1303169

23. Beasley KL, Weiss RA. Radiofrequency in cosmetic dermatology. Dermatol Clin. 2014;32(1):79-90. doi:10.1016/j.det.2013.09.010

24. Boisnic S, Divaris M, Nelson AA, Gharavi NM, et al. A clinical and biological evaluation of a novel, noninvasive radiofrequency device for the long-term

Conclusion

The current evidence confirms both the safety and efficacy of existing non-invasive fat reduction technologies. Cryolipolysis, RF, laser, and ultrasound have proven to be fantastic alternatives to traditional surgical methods for measurable and reproducible fat reduction. Growing demand is driving ongoing advancements in the field, including more effective, comfortable, and individualised treatments. Although multiple studies have corroborated the efficacy of these therapies, there remains a need for more randomised controlled trials with larger sample sizes and standardised treatment protocols to further validate these results and optimise patient outcomes.

Declaration of interest Dr. Michael Gold is a consultant and performs clinical research for the following: Allergan Aesthetics, an AbbVie Company, Cutera, Venus Concepts, Cynosure, Alma Lasers

reduction of adipose tissue. Lasers Surg Med. 2014;46:94–103.

25. Lee CL, Gold MH. Updates on radiofrequency devices for skin tightening and body contouring. Dermatol Rev. 2020;1(3):75-83. doi:10.1002/der2.31

26. Cutera truSculpt Operator’s Manual. Brisbane, CA; Cutera, Inc. February 2018

27. Wanitphakdeedecha R, Sathaworawong A, Manuskiatti W, Sadick NS. Efficacy of multipolar radiofrequency with pulsed magnetic field therapy for the treatment of abdominal cellulite. J Cosmet Laser Ther. 2017;19(4):205-209. doi:10.1080/14764172. 2017.1279332

28. Chilukuri S, Denjean D, Fouque L. Treating multiple body parts for skin laxity and fat deposits using a novel focused radiofrequency device with an ultrasound component: safety and efficacy study. J Cosmet Dermatol. 2017;16:476-479.

29. Emilia del Pino M, Rosado RH, Azuela A, et al. Effect of controlled volumetric tissue heating with radiofrequency on cellulite and the subcutaneous tissue of the buttocks and thighs. J Drugs Dermatol. 2006;5(8):714-722.

30. Mazzoni D, Lin MJ, Dubin DP, Khorasani H. Review of non-invasive body contouring devices for fat reduction, skin tightening and muscle definition. Australas J Dermatol. 2019;60(4):278-283. doi:10.1111/ ajd.13090

31. Murgia RD, Noell C, Weiss M, Weiss R. Body contouring for fat and muscle in aesthetics: Review and debate. Clin Dermatol. 2022;40(1):29-34. doi:10.1016/j.clindermatol.2021.08.009

32. Decorato J, Chen B, Sierra R. Subcutaneous adipose tissue response to a non-invasive hyperthermic treatment using a 1,060 nm laser. Lasers Surg Med. 2017;49:480–9.

33. Katz B, Doherty S. Safety and Efficacy of a Noninvasive 1,060-nm Diode Laser for Fat Reduction of the Flanks. Dermatol Surg. 2018;44(3):388-396. doi:10.1097/DSS.0000000000001298

34. Katz B, Bass L, Doherty S. Objective evaluation of non-invasive fat reduction with a 1060nm diode laser for treatment of the thighs and back. Paper presented at: American Society for Laser Medicine and Surgery; April 2016, Boston, MA.

35. Bass LS, Doherty ST. Safety and Efficacy of a Non-Invasive 1060 nm Diode Laser for Fat Reduction of the Abdomen. J Drugs Dermatol. 2018;17(1):106-112.

36. Bass L, Katz B, et al. A Multicenter Study of a Non-invasive 1060nm Diode Laser for Fat Reduction of the Flanks and Abdomen – Six Month Follow-up. Paper presented at: American Society for Laser Medicine and Surgery; April 2016, Boston, MA.

37. Katz B, Bass L, Geronemus R. Safety and Efficacy

of a Noninvasive 1,060-nm Diode Laser with a Petite Mask (10.49cm2) for the removal of submental fat. Paper presented at: 24th World Congress of Dermatology; 2019, Milan, Italy.

38. Kislevitz M, Wamsley C, Kang A, et al. Clinical Evaluation of the Safety and Efficacy of a 1060-nm Diode Laser for Non-Invasive Fat Reduction of the Abdomen. Aesthet Surg J. 2021;41(10):1155-1165. doi:10.1093/asj/sjaa418

39. Jewell ML, Desilets C, Smoller BR. Evaluation of a novel high-intensity focused ultrasound device: preclinical studies in a porcine model. Aesthet Surg J. 2011;31(4):429–34. doi: 10.1177/1090820X11405026.

40. Jewell ML, Baxter RA, Cox SE, et al. Randomized sham-controlled trial to evaluate the safety and effectiveness of a high-intensity focused ultrasound device for noninvasive body sculpting. Plast Reconstr Surg. 2011;128(1):253-262. doi:10.1097/ PRS.0b013e3182174278

41. Shek SY, Yeung CK, Chan JC, Chan HH. Efficacy of high-intensity focused ultrasonography for noninvasive body sculpting in Chinese patients. Lasers Surg Med. 2014;46:263–269.

42. Solish N, Lin X, Axford-Gatley RA, Strangman NM, Kane M. A randomized, single-blind, postmarketing study of multiple energy levels of high intensity focused ultrasound for noninvasive body sculpting. Dermatol Surg. 2012;38:58–67.

43. Fatemi A, Kane MA. High-intensity focused ultrasound effectively reduces waist circumference by ablating adipose tissue from the abdomen and flanks: a retrospective case series. Aesthetic Plast Surg. 2010;34:577–582.

44. Hotta TA. Nonsurgical body contouring with focused ultrasound. Plast Surg Nurs. 2010;30:77–82;quiz 3–4.

45. Teitelbaum SA, Burns JL, Kubota J et al. Noninvasive body contouring by focused ultrasound: safety and efficacy of the Contour I device in a multicenter, controlled, clinical study. Plast Reconstr Surg. 2007;120:779–789; discussion 90.

46. Chang SL, Huang YL, Lee MC et al. Combination therapy of focused ultrasound and radio-frequency for noninvasive body contouring in Asians with MRI photographic documentation. Lasers Med Sci. 2014;29:165–172.

47. Ko EJ, Hong JY, Kwon TR, et al. Efficacy and safety of non-invasive body tightening with high-intensity focused ultrasound (HIFU). Skin Res Technol. 2017;23(4):558-562. doi:10.1111/srt.12371

48. Guth F, Bitencourt S, Bedinot C, Sinigaglia G, Tassinary JAF. Immediate effect and safety of HIFU single treatment for male subcutaneous fat reduction. J Cosmet Dermatol. 2018;17(3):385-389. doi:10.1111/ jocd.12466

STATE-OF-THEART TREATMENT MODALITIES FOR CELLULITE

A COMPREHENSIVE REVIEW

Sachin M. Shridharani, MD, FACS, and Joshua Kohan, BA,

evaluate the evidence for three subcision treatments aimed at reducing the appearance of cellulite

ABSTRACT

Background: Cellulite is a multifactorial condition characterised by a dimpled, ‘orange peel’ appearance of the skin. While the aetiology of cellulite has not yet been entirely elucidated, subcision treatments targeting fibrous septae have demonstrated efficacy and continue to be the mainstay of treatment.

Objectives: To evaluate the evidence for three novel subcision treatments: controlled focal subcision, acoustic subcision, and enzymatic subcision, and provide physicians and practitioners with an overview of studies examining these therapeutic options.

Methods: For enzymatic subcision, peer-reviewed articles containing data on the efficacy of cellulite treatments from in vivo human studies were considered. In total, seven articles written in English were analysed for the following information: therapeutic

CELLULITE IS A

MULTIFACTORIAL

condition characterised by a dimpled, ‘orange peel’ appearance of the skin and is associated with histologic changes in the dermis, adipose tissue, and fibrous septae1. The aetiology of cellulite has not yet been fully elucidated; however, the efficacy of treatment strategies targeting fibrous septae suggests that these structures play a significant role in its development1

intervention utilised, presence of a control group, randomisation, blinding, sample size, description of statistical methods, results, and level of evidence and statistical power. However, of the seven articles, three randomised control trials (RCTs) were suitable for review. Clinical data on controlled focal subcision and acoustic subcision were obtained directly from the manufacturers.

Conclusion: The advent of new subcision-based treatments is an exciting development for the treatment of cellulite. The studies reviewed suggest that these new treatments are safe and efficacious. Of the three approaches, enzymatic subcision has robustly designed RCTs that demonstrate efficacy. The clinical data for acoustic and controlled focal subcision modalities remains limited and warrants further investigation through future research.

physical and psychological well-being3. Idealised, retouched photos on social media alter the human perception and standards of beauty while simultaneously underestimating the true incidence of cellulite in the public consciousness2–3. In regions of the world where there is more frequent body exposure, up to 80% of individuals have reported feeling pressure to seek cellulite treatment4. These treatments have targeted some combination of adipose tissue, dermis, and fibrous septae, with varying degrees of success1

email: sms@luxurgery.com

KEYWORDS

Cellulite, subcision, acoustic subcision, focal fibrous septa release, collagenase

Estimates suggest that cellulite affects approximately 80–90% of post-pubertal women of all races2. No direct associations with morbidity or mortality have been identified, leading to the consideration of cellulite as a secondary gender-related characteristic of females rather than a disease process or pathological state. However, aesthetic concerns remain closely related to

This review will evaluate the evidence for three novel subcision treatments aimed at reducing the appearance of cellulite by targeting fibrous septae. These treatments are controlled focal subcision (Avéli™, Revelle Aesthetics, Inc.; Mountain View, CA), acoustic subcision (rapid acoustic pulse device, Resonic™, Soliton, Inc.; Houston, TX), and collagenase-based enzymatic subcision

SACHIN M. SHRIDHARANI, MD, FACS, Department of Surgery, Division of Plastic and Reconstructive Surgery, Washington University – St. Louis, School of Medicine, St. Louis, MO; LUXURGERY, New York, NY; JOSHUA KOHAN, BA, The Larner College of Medicine at the University of Vermont, Burlington, Vermont

Idealised, retouched photos on social media alter the human perception and standards of beauty while simultaneously underestimating the true incidence of cellulite in the public consciousness.

(collagenase clostridium histolyticum-aaes, QWO®, Endo Aesthetics‚ LLC, Malvern, PA). The objective of this review is to provide practitioners with an overview of the literature examining these therapeutic modalities and further the understanding of cellulite and the available treatment options available to plastic surgeons and dermatologists.

Materials and methods

In June 2022, we performed a comprehensive search review via PubMed and ScienceDirect databases using various combinations of the following search terms, ‘Collagenase’, ‘Cellulite’, ‘Collagenase Clostridium Histolyticum’, ‘fibrosclerotic panniculopathy’, ‘gynoid lipodystrophy’, and ‘adiposis edematosa’. Only original articles in English with data on the efficacy of this treatment from in vivo human studies were considered. The review team assessed each article and its references. Conference papers and abstracts were excluded as per PRISMA guidelines. Three randomised control trials were included in the final review of collagenase clostridium histolyticum-aae literature. In addition, two published articles on the controlled focal subcision device and one article on the rapid acoustic pulse device were obtained from their respective manufacturers; however, no published RCTs are yet available on these treatment modalities. Collectively, a total of 6 articles were reviewed using the following variables: therapeutic intervention, presence of a control group, randomisation, blinding, sample size, description of statistical methods, results, level of evidence, and statistical power.

Treatment modalities

Subcision-based treatments

Subcision is a surgical technique first described in 1995 in which subcutaneous fibrous septal bands tethered to the reticular dermis are divided5. The resulting redistribution of mechanical tension and adipose tissue contributes to a smoother appearance of the skin. Subcision techniques

include manual6, vacuum-assisted7, and laser-assisted8 However, these have been noted to have limitations, including operator dependence, bruising, hyperpigmentation, and the persistence of postprocedural pain9. In the subsequent section, we will address three novel approaches designed to minimise these adverse effects.

Novel subcision-based treatments

Controlled focal fibrous septa release device

Controlled focal fibrous septa release is a minimally invasive method designed for in-office use. The device is a single-use instrument for the manual release of fibrous septa. Cellulite depressions are marked with the patient in a relaxed, standing position. For the procedure, the patient is placed in the prone position and local anaesthesia is applied to the marked areas. The device is inserted into the subcutaneous adipose tissue and advanced to the marked areas. A light shining perpendicularly to the plane of the skin allows the operator to correctly locate the distal end of the device. Once at a marked area, the operator can deploy a blunt hook to engage the target septa. If correctly engaged, the depression will be reproduced, and the septa can then be divided using a sharpened link stored in the device shaft. The steps are repeated until the operator is unable to reproduce the depression and can proceed to the next appropriate marked location. This technique is designed to allow multiple depressions to be accurately and comprehensively treated through a small entry point, minimising the risk of pain, scarring and adverse events.

An open-label, multi-centre study evaluated female patients (n=20) aged 21–55 with moderate-to-severe cellulite on the buttocks and thighs that underwent controlled focal fibrous septa release. Baseline and interval images post-procedure were reviewed by an independent, blinded assessor against a modified Cellulite Severity Scale (CSS) score. Efficacy was measured by the primary endpoint of a ≥1 point reduction in CSS. 95% (n=18) of patients achieved the primary endpoint at day 180 post-procedure, with a mean improvement of 2.6. In unblinded scoring of baseline and day 180 follow-up images, 100% (n=19) of patients were rated as ‘much improved’ or ‘very much improved’ against the Global Aesthetic Improvement Scale (GAIS). 85% of patients reported satisfaction with the outcome, with low pain scores post-procedure day 7. No serious or unexpected adverse events were recorded.

Video analysis of the procedures demonstrated that a mean of 8.4 cuts were performed per depression. The investigators concluded that in contrast to the idea of a single fibrous strand for each depression, the septa structure is three-dimensional and complex, with webbing and branching structures observed in the video analysis.

In an earlier feasibility study, female patients (n=10) aged 21–55 with moderate-to-severe cellulite underwent the same procedure unilaterally on the buttocks and thighs11. The primary feasibility endpoint was the number of subjects achieving a GAIS score improvement of ≥1

Subcision is a surgical technique first described in 1995 in which subcutaneous fibrous septal bands tethered to the reticular dermis are divided.

point 90 days post-procedure and a secondary endpoint was reached if more than 50% of subjects had a noticeable improvement in GAIS scores at day 90. The researchers reported that at day 90, most regional treatment areas (84.6%) demonstrated an improvement of ≥1 point in GAIS scores, while 90% of subjects achieved an improvement of ≥2 points.

These studies suggest that controlled focal septa release is safe, efficacious, and acceptable to patients. However, it is important to note that both studies have several design limitations, including the lack of a control group, single blinding, small study population (total n=30), limited follow-up, and were not powered for assessment of statistical significance. Both studies were sponsored by the device manufacturer.

Larger, independently-funded, double-blinded studies with longer follow-up periods are required to provide statistically significant information on the efficacy of this treatment modality. The implementation of standardised baseline and endpoint measures would assist further, enabling direct comparison of results across future studies.

Acoustic therapies for cellulite

Acoustic wave therapy (AWT) has an established range of clinical applications and is widely utilised as a treatment for renal calculi and a range of musculoskeletal conditions12. The use of AWT as a treatment approach for cellulite is also well-documented in the literature. AWT has been demonstrated in small-scale studies to statistically improve neocollagenesis, microcirculation, and lymphatic drainage13. Several studies have sought to ascertain the efficacy of AWT using endpoint measures, such as biophysical measurements and photographs. In these studies, several potential mechanisms and targets have been proposed, such as remodelling of collagen14, stimulation of metabolic activity in subcutaneous fat tissues15, dermal strengthening16 or improved microcirculation13, and lymphatic drainage17. These mechanisms have been hypothesised to be secondary to the activation of C nerve fibres in the skin by shock waves with the subsequent release of substance P18

Generally, study results examining AWT as a treatment for cellulite have been inconsistent; however, three randomised control trials13,17,19 demonstrated a significant improvement in the appearance of cellulite. It is important to mention while these studies were designed to evaluate the effects of AWT on cellulite, none examined the effects on fibrous septa. One study did, however, hypothesise that the therapeutic benefits could have been in part due to the mechanical disruption of fat components, fibrous septae or both19

Rapid acoustic pulse device

Acoustic subcision is a non-invasive approach to cellulite treatment utilising a rapid acoustic pulse device. The device is designed to use rapid acoustic pulses to noninvasively disrupt fibrous septae leading to tissue release that results in the improvement of cellulite appearance.

Like the previously mentioned acoustic devices, the manufacturers also hypothesise that effects on the dermal extracellular matrix promote neocollagenesis leading to an improved appearance by reducing skin laxity.

The rapid acoustic pulse device comprises three components — a console, handpiece, and disposable cartridge. The console houses the power supply and transmits high voltage to electrodes housed in the cartridge. The cartridge can be removed and replaced when the electrodes wear out. The console also contains a system for circulating saline to cool the cartridge. For treatment, target areas are identified on the buttocks or thighs and the patient is positioned on a bed in a prone or lateral decubitus position. An acoustic coupling hydrogel pad and hydrogel are applied to the marked treatment areas before 1-minute doses of acoustic therapy are administered. No local anaesthesia is required for this procedure.

In an open-label, multi-centre trial, female patients (n=56) aged 18–50 with moderate-to-severe cellulite on a six-point CSS, as determined by investigators, were enrolled to receive a single office-based acoustic subcision treatment using the rapid acoustic pulse device20. A total of 9–15 treatment areas were identified and 1–2 minute-long doses of 50Hz were administered to each area. Baseline and 12-week photographs were taken under standardised conditions and analysed by three blinded, independent reviewers. The primary efficacy endpoint was a reduction of a simplified CSS score of ≥1.

Secondary efficacy endpoints were the correct identification of >60% of post-treatment photographs by reviewers, an average improvement of cellulite appearance in GAIS scoring, and an average improvement of skin laxity in GAIS and skin Laxity Scale (LS).

The baseline CSS score was 3.41 (±0.89) and investigators reported that a statistically significant mean CSS reduction of 1.01 ±0.5 (p<0.0001) was noted by reviewers at 12 weeks compared to baseline images.

At 12 weeks, 90.9% of the treated cellulite sites were noted as appearing ‘improved’, ‘much improved’, or ‘very much

The use of AWT as a treatment approach for cellulite is also well-documented in the literature. AWT has been demonstrated in small-scale studies to statistically improve neocollagenesis, microcirculation, and lymphatic drainage.

improved’ using a GAIS score for cellulite appearance. A mean LS reduction of 0.57 from baseline was noted in treatment sites — a 27.9% reduction from the baseline score. The difference between the baseline and 12-week LS was statistically significant (p<0.0001). Reviewers rated 67.3% of the treated sites as appearing ‘improved’, ‘much improved’ or ‘very much improved’ using GAIS; however, no further statistical analysis was provided with this score. 98.2% (n=55) of patients found the procedure tolerable and average pain scores during treatment were 2.4 on a 1–10 scale. The highest pain during the procedure was recorded as six. The patients largely found the procedure comfortable (76.8%) and felt their cellulite appearance had improved (92.9%). All adverse effects (AEs) were mild and selfresolving and no serious or unexpected AEs were noted.

This study, sponsored by the device manufacturer, suggests that acoustic subcision is effective, tolerable, and safe. It is worth noting that no data was provided on the percentage of patients that achieved the efficacy endpoints. Instead, data on individual treatment sites was given. While site treatment effects are important, global appearance is a more pertinent outcome for patients undergoing these procedures and the inclusion of patient-reported providers’ clinical support system (PR-PCSS) could provide valuable insight. Other limitations of the study design include single blinding, the lack of a control group, the potential for recruitment bias, a non-representative cohort of patients (92.9% of patients were white) limiting the generalizability of these findings and a short followup period of 12 weeks.

Robustly designed, independent, randomised control trials are required to obtain evidence of efficacy in white and non-white patients, with longer follow-up periods. Furthermore, as previous studies of AWT modalities did not examine the effects on fibrous septa, focused analysis on their utility for acoustic subcision would enable more direct comparison with the other novel treatment modalities available for cellulite.

Enzymatic subcision

Collagenase clostridium histolyticum-aaes (CCH) is composed of two injectable, purified bacterial collagenases, AUX-I and AUX-II (clostridial class I and II collagenases, respectively), that act locally to break down Types I and III collagen21–23

CCH has previously been investigated as a nonsurgical treatment for the release of Dupuytren’s contracture, a fixed flexion deformity in the digito-palmar fascia caused by excessive collagen deposition24

In cellulite treatment, injection of CCH into target areas

has been associated with localised enzymatic degradation of mature collagen-rich septae, reorganisation of adipose tissue and neocollagenesis in human and porcine histological studies25

CCH was approved by the US FDA in 2020 for the treatment of moderate-to-severe cellulite in the buttocks of adult women. As a treatment for thigh cellulite, it

Two identically designed, phase-3, randomised, double-blind, placebo-controlled, multi-centre studies (23) (RELEASE-1 and RELEASE-2) involving female patients (n=843) aged 18-78 with moderate-to-severe cellulite on both buttocks on the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) were analysed. Participants were randomised to receive up to three treatments of CCH 0.84mg or placebo in both buttocks, and one buttock was randomly assigned as the target buttock to assess the primary efficacy endpoint. Standardised digital photographs for evaluation of cellulite severity were taken at screening, on each of the three treatment days (days 1, 22, and 43), and 28 days post-treatment (day 71).

The primary efficacy endpoint was the percentage of women with composite improvement from baseline ≥2 levels in both CR-PCSS and PR-PCSS scores at day 71. Safety assessments included monitoring of adverse events, vital signs, clinical laboratory parameters, and immunogenicity testing. In a pooled analysis, women treated with CCH were 5.5 times as likely as placebotreated women to be a 2-level composite responder (6.6% vs 1.2%) and 4.7 times as likely (9.9% vs 2.1%) in either buttock at day 71 (p<0.001). CCH group patients were 2.7 times as likely to be ≥1-level composite responders in the target buttock vs placebo group (39.4% vs 14.6%) and 2.6 times as likely as the placebo group (48.1% vs 18.6%) in either buttock (p<0.001). In subgroup analyses, higher response rates were observed in those of lower age and with a BMI <32 kg/m2

These findings confirmed those of an earlier phase 2, randomised, double-blind, placebo-controlled RCT(26) of 375 women aged 18–60 with moderate-to-severe cellulite (CR-PCSS). Participants were randomised to receive up to three treatments of CCH 0.84 mg or placebo injections in one buttock or thigh. As with the RELEASE trials, the primary efficacy endpoint was the percentage of ≥2-point improvement in CR-PCSS and PR-PCSS scores at day 71. In the treatment group, 10.6% of participants achieved the primary efficacy endpoint compared to 1.6 in the placebo group (p<.001). 44.6% of participants in the CCH group achieved the secondary endpoint of ≥1-level composite response (p<.001).

Across these RCTs, CCH was generally safe and welltolerated and discontinuations due to AEs were approximately 4%. In Sadick et al.,26 82% of the CCH group

experienced AEs such as injection site bruising (75%), pain (59%), and nodules (14%). In RELEASE-1 and 2, 88% of women in the CCH treatment group experienced one or more AEs, the majority of which were related to injectionsite bruising (84%), pain (48%) or injection-site nodule (33%). 93% of the AEs were mild or moderate and reduced in incidence, intensity, and duration of AEs at subsequent treatment sessions. No safety signals were identified in pooled or subgroup analysis.

These robustly designed RCTs provide strong evidence for the efficacy and safety of CCH as a treatment for cellulite. However, some limitations have been identified. The study by Sadick et al.26 is limited by its homogeneous patient population. All three RCTs used subjective endpoints and included only patients with moderate-to-severe cellulite; therefore, no conclusions on the efficacy of CCH on mild cellulite can be made.

Funding for all three RCTs was obtained by Endo Aesthetics. Future studies should aim to include objective measures to quantitatively assess changes in skin quality.

Discussion

This review evaluated the existing scientific evidence regarding the efficacy of three novel subcision-based cellulite treatments. For the controlled focal fibrous septa release and rapid acoustic pulse device technologies, the existing level of evidence from the studies provided on their efficacy is low (level 4). No detailed statistical analysis is possible from the data provided on these treatments and a comprehensive assessment of efficacy is challenging in studies that did not include doubleblinding, randomisation, and comparison with placebo in their design. The use of intra-patient designs (assessment of treatment areas rather than patient response) can contribute to increasing the data points for analysis; however, it must be noted that as cellulite causes emotional distress and negatively affects the quality of life, it could be argued that these outcome measures do not reflect the holistic impact on patients4. The studies of

References

1. Bass LS, Kaminer MS. Insights Into the Pathophysiology of Cellulite: A Review. Dermatol Surg. 2020;46 Suppl 1(1):S77-s85.

2. Luebberding S, Krueger N, Sadick NS. Cellulite: an evidence-based review. Am J Clin Dermatol. 2015;16(4):243-56.

3. Henriques M, Patnaik D. Social Media and Its Effects on Beauty. 2020.

4. Hexsel D, Siega C, Schilling-Souza J, Stapenhorst A, Rodrigues T, Brum C. Assessment of psychological, psychiatric, and behavioral aspects of patients with cellulite: A pilot study. Surgical and Cosmetic Dermatology. 2012;4:131-6.

5. Orentreich DS, Orentreich N. Subcutaneous incisionless (subcision) surgery for the correction of depressed scars and wrinkles. Dermatol Surg. 1995;21(6):543-9.

6. Hexsel DM, md, Mazzuco R, md. Subcision: a treatment for cellulite. International Journal of Dermatology. 2000;39(7):539-44.

7. Kaminer MS, Coleman WPI, Weiss RA, Robinson DM, Coleman WPI, Hornfeldt C. Multicenter Pivotal Study of Vacuum-Assisted Precise Tissue Release for the Treatment of Cellulite. Dermatologic Surgery. 2015;41(3):336-47.

8. DiBernardo BE, Sasaki GH, Katz BE, Hunstad JP, Petti C, Burns AJ. A Multicenter Study for Cellulite Treatment Using a 1440-nm Nd:YAG Wavelength Laser

CCH reviewed are large, robustly designed, doubleblinded, multi-centre RCTs.

In all the studies reviewed, women with mild cellulite severity were excluded, presumably to detect larger posttreatment improvements; however, it is important to note that this is unlikely to be representative of the heterogeneity in pre-procedure cellulite severity in women seeking this treatment. Further studies should aim to include participants with mild cellulite to give a comprehensive range of information on the efficacy of these treatments. Additionally, only RELEASE-1 and 2 included patients with a diverse range of Fitzpatrick skin types.

The lack of universally accepted and standardised measures of cellulite severity and biophysical measurement techniques also poses a challenge for the comparison of quantitative effects across studies of cellulite treatments. The implementation of such measures would augment the scientific rationale guiding patients as well as practitioners.

Conclusion

The advent of new subcision-based treatments is an exciting development for the treatment of cellulite. The studies reviewed suggest that the new treatments are both safe and efficacious. Of the three modalities discussed, the enzymatic subcision intervention has robustly designed RCTs that demonstrate efficacy. The level of evidence for acoustic and controlled focal subcision is of lower quality. More independently-funded, large, multi-centre RCTs with high-quality trial design and robust statistical analysis are recommended to support conclusive recommendations about their efficacy.

Declaration of interest None

Key points

Cellulite is a multifactorial condition characterised by a dimpled, ‘orange peel’ appearance of the skin

Three novel subcision treatments remain pivotal in the treatment of cellulite: controlled focal subcision, acoustic subcision, and enzymatic subcision

Subcision is a surgical technique in which subcutaneous fibrous septal bands tethered to the reticular dermis are divided

Of the three approaches described, enzymatic subcision has robustly designed RCTs that demonstrate efficacy

The clinical data for acoustic and controlled focal subcision modalities remains limited and warrants further investigation through future research

with Side-Firing Fiber. Aesthetic Surgery Journal. 2016;36(3):335-43.

9. Friedmann DP, Vick GL, Mishra V. Cellulite: a review with a focus on subcision. Clin Cosmet Investig Dermatol. 2017;10:17-23.

10. Stevens WG, Kaminer MS, Fabi SG, Fan L. Study of a New Controlled Focal Septa Release Cellulite Reduction Method. Aesthet Surg J. 2022.

11. Layt C. A Study of a Novel Controlled Focal Septa Release Method for Improving Cellulite. Plast Reconstr Surg Glob Open. 2022;10(4):e4237.

12. Ogden JA, Tóth-Kischkat A, Schultheiss R. Principles of Shock Wave Therapy. Clinical Orthopaedics and Related Research. 2001;387:8-17.

13. Adatto M, Adatto-Neilson R, Servant JJ, Vester J, Novak P, Krotz A. Controlled, randomized study evaluating the effects of treating cellulite with AWT/ EPAT. J Cosmet Laser Ther. 2010;12(4):176-82.

14. Angehrn F, Kuhn C, Voss A. Can cellulite be treated with low-energy extracorporeal shock wave therapy? Clin Interv Aging. 2007;2(4):623-30.

15. Christ C, Brenke R, Sattler G, Siems W, Novak P, Daser A. Improvement in Skin Elasticity in the Treatment of Cellulite and Connective Tissue Weakness by Means of Extracorporeal Pulse Activation Therapy. Aesthetic Surgery Journal. 2008;28(5):538-44.

16. Kuhn C, Angehrn F, Sonnabend O, Voss A. Impact

of extracorporeal shock waves on the human skin with cellulite: a case study of an unique instance. Clin Interv Aging. 2008;3(1):201-10.

17. Russe-Wilflingseder K, Russe E, Vester JC, Haller G, Novak P, Krotz A. Placebo controlled, prospectively randomized, double-blinded study for the investigation of the effectiveness and safety of the acoustic wave therapy (AWT(®)) for cellulite treatment. J Cosmet Laser Ther. 2013;15(3):155-62.

18. Klonschinski T, Ament SJ, Schlereth T, Rompe JD, Birklein F. Application of local anesthesia inhibits effects of low-energy extracorporeal shock wave treatment (ESWT) on nociceptors. Pain Med. 2011;12(10):1532-7.

19. Knobloch K, Joest B, Krämer R, Vogt PM. Cellulite and focused extracorporeal shockwave therapy for non-invasive body contouring: a randomized trial. Dermatol Ther (Heidelb). 2013;3(2):143-55.

20. Tanzi EL, Capelli CC, Robertson DW, LaTowsky B, Jacob C, Ibrahim O, et al. Improvement in the appearance of cellulite and skin laxity resulting from a single treatment with acoustic subcision: Findings from a multicenter pivotal clinical trial. Lasers Surg Med. 2022;54(1):121-8.

21. Bhatia AC, McLane MP, Priestley T, Vijayan S, Gelbard MK. Human Pharmacokinetics and Safety of Subcutaneous Collagenase Clostridium Histolyticum in Women. J Drugs Dermatol. 2020;19(9):852-6.

22. French MF, Mookhtiar KA, Van Wart HE. Limited

proteolysis of type I collagen at hyperreactive sites by class I and II Clostridium histolyticum collagenases: complementary digestion patterns. Biochemistry. 1987;26(3):681-7.

23. Bass LS, Kaufman-Janette J, Joseph JH, Kaminer MS, Clark J, Fabi SG, et al. Collagenase Clostridium Histolyticum-aaes for Treatment of Cellulite: A Pooled Analysis of Two Phase-3 Trials. Plast Reconstr Surg Glob Open. 2022;10(5):e4306.

24. Peimer CA, Wilbrand S, Gerber RA, Chapman D, Szczypa PP. Safety and tolerability of collagenase Clostridium histolyticum and fasciectomy for Dupuytren’s contracture. J Hand Surg Eur Vol. 2015;40(2):141-9.

25. Sachin S, Bhatia A, Dalton S, Vijayan S. Enzymatic Subcision and Remodeling after Collagenase Clostridium histolyticum-Aaes Subcutaneous Injection: Updated Evidence from Porcine and Human Studies. Plast Reconstr Surg Glob Open. 2021;9(10S):21-2.

26. Sadick NS, Goldman MP, Liu G, Shusterman NH, McLane MP, Hurley D, et al. Collagenase Clostridium Histolyticum for the Treatment of Edematous Fibrosclerotic Panniculopathy (Cellulite): A Randomized Trial. Dermatol Surg. 2019;45(8):1047-56.

THE STEP BY STEP APPROACH TO MARIONETTE LINES

Based on a deep understanding of facial anatomy, Simone Doreian, MD, describes her novel technique to treat marionette lines with injectables

ABSTRACT

Treating the marionette folds non-surgically can be unpredictable. Non-surgical approaches include direct injection of the lines with filler, indirect approaches augmenting the mid-face or revolumising the lateral face, injection of filler along the mandible, chin augmentation, and thread lifting. A simple logical approach is needed. In the author’s experience, a direct approach to the marionette line is more effective, durable and efficient in the use of product compared to indirect approaches. The ‘Step by Step’ approach views the marionette lines as a set of two steps, an upper

step lateral and a lower step medial to the fold. The goal of this approach is to minimise the height differential of the two steps and provide support, strengthening and blending of the two areas. Step 1: relax the depressor anguli oris muscle (DOA) using botulinum toxin A, responsible for constant downward tugging upon the oral commissure. Step 2: 2–3 weeks later, lift the medial lower step towards the upper step of the fold, minimising the height differential of the two areas using hyaluronic acid filler. Step 3: inject and strengthen the step edge along the labiomental crease. Total dose: 2ml hyaluronic acid filler and minimal botulinum toxin A.

KEYWORDS

MARIONETTE LINES, FOLDS, OR grooves are the downward running folds of skin or wrinkles originating from the oral commissures and head inferiorly towards the mandible. They are so named after the marionette puppet, the mid-18th century puppets, which became more and more life-like with articulated chins allowing the puppet to ‘talk’. These folds of articulation in humans are perceived to create a sad, dissatisfied or tired resting appearance and are a common presentation for which patients seek cosmetic treatment. As with any cosmetic treatment, there are multiple approaches to the treatment of this region. This article describes what I believe to be a common sense approach to the non-surgical treatment of marionette lines in a step-by-step approach, described further below (Figure 1).

Anatomy of the marionette region

The marionette lines or folds begin at the oral commissure and end in the labiomental false ligament, which is not a true ligament but rather an attachment area for muscle fibres. In a staircase analogy, the top step described is formed by the jowl fat lateral to the marionette line, hanging over and against this labiomental attachment area. The bottom step, medial to the marionette fold, is perioral. The shadow cast by the top step and the height differential creates the step-like appearance of the marionettes and the impression of a downturned mouth and visually segregated chin region.

The surrounding muscles of the region and their cutaneous attachments are also involved in the formation of marionette lines. As mentioned, the labiomental ligament is a site of attachment. The medial edge of the DAO attaches along the line by cutaneous ligaments, and both the depressor labii inferioris muscle (DLI) and DAO have many cutaneous ligament attachments to the overlying skin. DAO is a triangle

Hyaluronic Acid Filler, treatment marionette lines, Filler techniques, botulinum toxin A

The marionette lines or folds begin at the oral commissure and end in the labiomental false ligament, which is not a true ligament but rather an attachment area for muscle fibres.

SIMONE DOREIAN, MD, Cosmetic Physician, Cosmetic Physicians Society of Australasia Inc, Dr. Simone Doreian Private Clinic, 3 Harold St, Sandringham, Victoria 3191 Australia

CONTRIBUTING FACTORS TO THE DEVELOPMENT OF MARIONETTE LINES

BONE Hypoplastic mandible MUSCLE

Hyperactivity and cutaneous attachments of the DAO

SOFT TISSUE

Fat loss in the lower step as well as fat descent from the top step

SKIN

Loss of elasticity and ageing

shape, with its base originating from the mandible border and point inserting into the modiolus, tugging the corners of the mouth downward. It is situated lateral to the mandibular fold. The DLI is a parallelogram shape. It originates deep to the DAO along the mandibular border as well and inserts into the tubercle of the lip, pulling the lip down. With repeated facial movement, these cutaneous attachments contribute to the creases that develop with ageing (Figure 2).

Deep and subcutaneous fat also contributes to the step-like appearance of the marionette fold. There is a fat differential between the upper step and the lower step of the marionette region. Lateral to the marionette line, we have a large amount of fatty tissue. Medially in the perioral region, there is minimal fatty tissue. Jowl fat can increase with age. Hence the jowl fat hangs upon the ligament area, creating a step1

The facial artery should be avoided when injecting; running superiorly, from deep to superficial, over the mandible just anterior to the masseter muscle towards the oral commissure, sending its ILA branch across to the lower lip and deep to the muscles.

Marionette grading scale

DLI

DAO DAO

the downward pull of the DAO. The injections must begin lateral of the marionette fold in a lateral direction and remain superficial to avoid injecting the DLI (red dotted triangle of cross over)

Carruthers et al.2 developed a useful grading scale. This will help explain to the patient the severity of their problem compared to others and help us predict the likely success and amount of product necessary. For higher grades (involving more severe marionette lines), I find it useful to discuss surgical options in order to set expectations appropriately low. Fillers can only offer a partial and temporary benefit for higher grade lines, and for extremely heavy, sagging marionette lines that extend all the way to the mandible with jowls hanging laterally, surgery is likely a more reasonable suggestion.

Indirect treatments

Indirect treatments, i.e., treating other areas of the face in order to impact the marionette lines, do not tend to perform efficiently or with longevity, in my experience and opinion. These include:

■ Thread lifting: in my experience, the effect is temporary and expensive with an unacceptably high level of complications. I have formed my opinion over time from anecdotes of surgical colleagues, my own patient cases, and literature3

■ Indirect approaches using dermal fillers to treat the mandible body and chin. In spite of augmentation of a vertically and anteriorly deficient chin, readers can see in Figure 3 that despite improvement in the definition of the jawline and lengthening with chin and mandible augmentation, there has been little improvement in the marionette folds.

The step by step approach to marionette lines

My preferred non-surgical treatment of the marionette region is to treat the marionette fold directly using a stepby-step approach, which I will go on to describe.

Figure 1 Marionette folds have a step-like formation, consisting of an upper step laterally and a lower step medially. The height differential creates a shadow and fold

Figure 2 The step of the marionette fold (white dotted line) and its relationship with the DLI medially and DAO laterally. The DAO can be remembered to lie outside and over the DLI. The mentalis muscle is a paired muscle located at the tip of the chin. These relationships are important when injecting botulinum toxin to target

Figure 3 (A) Before and (B) immediately after jawline injection of filler along and posterior to the mandibular bone and chin; even with post procedure swelling, there is no change to the marionette line

DLI

Marionette fold AESTHETIC FEATURE | INJECTABLES | 58 ❚ January/February 2023 | prime-journal.com

Method of treatment using the step by step approach

The step by step approach to marionette lines addresses the causes of the step:

■ Reduce the downward tugging of the DAO upon the oral commissure using botulinum toxin

■ Elevate the lower step of the marionette line

■ Strengthen the skin across the step edge

Step 1: Relax the muscles

To relax the DAO muscle, I use 2–3 units per side of OnabotulinumtoxinA or 5–8 units of AbobotulinumtoxinA into the belly of the DAO. Placement is essential to avoid accidentally affecting the DLI muscle. The placement of toxin in the DAO is superficial and laterally, in line with the nasolabial folds, injecting in a lateral direction slowly. The black dots in Figure 4 are placed as an injection point for the DAO. Note the relationship between the two muscles from the front view of the patient and the side profile anatomically in Figure 2. The DAO lies superficial to the deeper DLI and is more lateral to the marionette fold. A useful tool to remember this is ‘DAO lies over and outside. DLI is inside and interior.’

Step 2: Elevate the lower step upward

I use a cannula technique for marionette folds grade 2 and above, where a fold of skin creates a shadow, to elevate the sunken lower level of the marionette fold. If there is no shadow and simply a wrinkle in the skin, I skip this and simply proceed to step 3.

For grades 2 and above, I map out the area of shadowing I can see along the marionette line and across to the mental crease and prejowl sulcus. My entry point for a 50mm 25G cannula is 0.5cm above and lateral to the oral commissure or within the jowl fat on the inferior margin of the mandible. I blunt dissect space in the subcutaneous fat plane first within the shape of the shadow, aiming to temporarily detach and break some of the retinacular attachments to create a smooth injection plane. It is important that the cannula glides easily; this is how I know I am in the correct layer. Literature supports the use of volume in the subcutaneous layer to improve correction in the perioral region4. I then place a fan of filler across the marked area, approximately 0.5ml per side and massage. This lifts the lower step up toward the upper step of the jowl. See Figure 5, left image.

Product selection

I choose to use HA fillers of medium firmness and good cohesivity, for example, Restylane Volume medial to severe folds or Defyne, Teoxane’s RHA 3, or Stylage XL in less severe folds in my clinic.

Step 3: Strengthen skin at the step edge

In mild cases where only a skin crease is present with minimal shadowing, I use a direct approach with a needle. My product of choice, in this case, is Restylane. It has a high G’ and, when injected in a fern technique5, is extremely efficient and long-lasting.

Figure 4 DAO injection site: in line with nasolabial fold, lateral to marionette line. I prefer to have the patient contract the muscle by ‘looking sad’, palpate the area and inject whilst contracting. Inject in a lateral direction, superficially at 25 degree angle to avoid injecting DLI muscle.

In grades 2 or higher, where a fold and shadow were present, and we have detached the cutaneous attachments along the marionette region and elevated the lower perioral step area, as above, I use a direct approach with a needle again. Beginning at the oral commissure, using my non-dominant hand, I pull the skin lateral and superiorly, stretching out the marionette line. With the mouth half open, I inject a vertical line of filler from below and immediately lateral to the oral commissure in the deep dermis, as close to the corner of the mouth as possible. A second injection, to form a cross shape, injected lateral to the commissure, in an oblique direction medially into the lateral edge of the lower lip. You will see the oral commissure lifting and opening as you inject. I then perform a series of

Figure 5 (A) Step 1. Inject DAO superficially and lateral of the marionette fold. step 2: elevate the lower step by blunt dissection of the shadowed area in the lower perioral region, paying particular attention to the upper region of the marionette fold, then fill the area with HA filler 0.5-1ml with the bulk of the product placed superiorly and laterally under the oral commisure. (B) Step 3. Pull the oral commisure open, then inject a cross shape, using 2 linear retrograde injections , vertically next to the oral commisure, and obliquely , into the edge of the lower lip. This lifts the oral commisure, then proceed to use oblique V shapes down the marionette line to strengthen and blend the upper and lower steps .

I use a cannula technique for marionette folds grade 2 and above, where a fold of skin creates a shadow, to elevate the sunken lower level of the marionette fold.

V-shaped oblique injections deep along the line to blend the edge of the step, strengthening the area of cutaneous attachments, making it less likely to buckle in future. I massage using gloves from the inside and outside of the mouth, ensuring to change gloves between sides and before again touching the patient. See the right-side image in Figure 5

Discussion

The lower face is often the region that is hardest to treat non-surgically. The result of the heaviness of tissue, the descent of soft tissue of the mid and lateral face with ageing, loss of bone support throughout the mandibular and maxillary region, increase in jowl fat, and hyperactivity of perioral muscles due to shifting mechanics as bone resorbs, is a segmented, jowly, sad or

The step by step approach to marionette folds is a logical and sequential treatment of the three contributing factors to marionette lines.

disgruntled looking appearance. In an ideal cosmetic world, surgery would be available with no risk, cost, downtime or social stigma to correct marionette lines. However, we can make a very reasonable, cost-effective difference in the appearance of our patients, softening and reversing the downturn of the mouth and shadowing due to the stepped marionette fold, using non-surgical techniques and carefully placed dermal fillers. Many will argue that thread lifting holds a place, and it does for the physicians who have found this to be a long-lasting, lowcomplication-rated procedure; however, in my experience, this has not been the case.

We also need to remember that in treating the marionette folds, we continue to add volume to the lower face. We should only do this in areas that lack volume and be aware of when we need to offer a referral for surgery.

Conclusion

The step by step approach to marionette folds is a logical and sequential treatment of the three contributing factors to marionette lines. It avoids unnecessary treatment of other areas that are not effective or efficient, for example, treating along the jawline, or extending the chin in the forlorn hope of providing opposite forces along the mandible, to attempt to stretch the marionette fold.

Step 1, in relaxing the input of the DAO, the recurrent downward pull upon the oral commissure is reduced, elevating the resting position of the oral commissure and sparing the HA filler from repetitive, strong sheer forces, potentially extending its duration of action.

Figure 6 (A) Before and (B) after treatment following the Step by Step approach to marionette lines

Key points

Marionette folds are like steps: there is an upper step (jowl fat) and lower step (inferior to oral commisure and medial to marionette line)

STEP 1. DAO muscle injection with neurotoxin to reduce the dynamic component of marionette lines

STEP 2. Elevate the lower step to meet the upper step with HA filler. Use of cannula to first dissect a subcutaneous space where the greatest shadowing is in the prejowl region and placement of HA filler subcutaneously concentrating on upper third.

STEP 3. Strengthen and blend the step edge between the upper and lower steps of the marionette line. Use HA filler by needle, to elevate beneath the oral commisures, then continue with intersecting deep dermal or subcutaneous oblique V shaped injections along the step edge down the marionette lines.

With Step 2, in elevating the lower step, the height differential is reduced between the upper step — the jowl hanging against the labiomental cutaneous false ligament, and the lower step— the perioral tissue. This reduces shadowing and the appearance of segmentation of the lower face and the puppet-like sad appearance.

Step 3 strengthens the step edge and provides a blending and strengthening of the medial and lateral areas of the marionette line, creating a smoother contour between the lateral lower face and chin region.

The ‘Step by Step’ approach also targets deep to superficial layers in a step-by-step fashion: muscles, the subcutaneous level, and the skin.

This article is written to provide the reader with a simple direct injection approach using toxin and dermal fillers, and the writer is the first to acknowledge that surgery will, of course, deliver superior and longer lasting results in higher grade folds, but also that some patients wish to avoid the risk and down time and cost of surgical intervention. Therefore there is a great benefit to having a rational, targeted non-surgical temporary approach. Declaration of interest Dr Doreian is a key opinion leader for Galderma, sits on a number of advisory boards, and presents at various independent conferences as an independent speaker. Dr Doreian has not been paid for this article.

sutures:

4. Gierloff M, Stöhring C, Buder T, Wiltfang J. The subcutaneous fat compartments in relation to aesthetically important facial folds and rhytides. Journal of plastic, reconstructive & aesthetic surgery. 2012 Oct 1;65(10):1292-7.

5. van Eijk T, Braun M. A novel method to inject hyaluronic acid: the Fern Pattern Technique. J Drugs Dermatol. 2007 Aug;6(8):805-8. PMID: 1776361

SUNEKOS® PERFORMA THE ENHANCED FORMULA FOR SKIN RENOVATION

SUNEKOS® PERFORMA IS an injectable treatment which gives rise to a renewal of the dermal tissue through regeneration of the extracellular matrix (ECM) using a unique patented combination of hyaluronic acid and specific amino acids which lead to new collagen and elastin production. Collagen and elastin form a large bulk of the ECM. The homeostasis of the ECM is crucial for the optimal functioning of cells and organs and leads to ageing when it is lost in the skin.

Skin ageing occurs as a result of extrinsic and intrinsic factors, which not only reduce the amount of collagen available within the dermis but the composition too. For example, type III collagen forms 50% of the collagen in neonatal skin but only 5% of the collagen in ageing adult skin. Also, type IV collagen, which forms anchor plaques between structural collagen types in

the dermis, decreases with age after 35 years and the epithelial basement membrane thickness increases with age, suggesting a reduction in cell turnover. Along with this, we have a reduction in the number of fibroblasts leading to a decreased amount of collagen and elastin production along with an increase in collagen and elastin degradation through the action of Matrix Metalloproteinases (MMP). There is a loss of hydration due to a reduction in hyaluronic acid, which occurs as a result of a reduced number of fibroblasts, increased hyaluronidase activity and down-regulation of CD44 and RHAMM membrane receptors, leading to a reduction in gene transcription for hyaluronic acid1

Sunekos® Performa

Sunekos® Performa is a new injectable by Professional Dietetics that can be used to improve the appearance of the skin of the face, neck, décolletage and hands, so it is a very versatile product. It results in skin that looks plumper, tighter, brighter and more hydrated, with a reduction in the appearance of fine lines and wrinkles and an improvement in the appearance of dark circles and eye bags. It has replaced Sunekos® 200 in the injection protocols, which have been updated recently to reflect the new patented formula within Sunekos® Performa. The updated formula consists of the same six specific amino acids and low molecular weight hyaluronic acid (HY6AA+ Formula) but in a different ratio of HA vs AA. The new formula has been clinically shown to cause a 40%

reduction in the degradation of hyaluronic acid by hyaluronidase through the hydrophobic action of the specific amino acid formula. It has been clinically shown to prolong the beneficial action of hyaluronic acid at the injection site to stimulate receptors on the fibroblasts for longer and produce more collagen IV, elastin and fibronectin, producing more constituents of the ECM, resulting in improved skin elasticity and firmness, further hydration and producing an increased antioxidant action2-4

Sunekos® Performa consists of a 3.5ml premixed vial composed of 35 mg of non-crosslinked LMWHA ranging between 50–250kDa and 128 mg of the six specific amino acids. The mixture has been shown to help rebuild the ECM effectively by stimulating the production of elastin, all the main types of reticular collagen fibres of the dermis and Type IV and Type VII collagen. The expression of fibronectin mRNA levels was also found to be increased after 72 hours of treatment compared to untreated cells. The combination of higher amounts of collagen type IV and VII along with fibronectin (the latter plays an important role in cell adhesion and anchoring reticular collagen fibres and cells) leads to an improvement in skin firmness1,3,4

Study method

A pilot study which looked at the effect of Sunekos® Performa on facial skin ageing showed that in 10 female patients aged between 40–67 years old recruited to the study, there was an improvement in skin texture, dyschromia, skin elasticity and

Dr Rita Nandi discusses the evidence and her experience

of wrinkle reduction and skin texture improvement using Sunekos® Performa

RITA NANDI, MBCHB, BSC (HONS), MRCGP (2015), Cosmetic Doctor, NHS GP

appearance of fine lines and wrinkles. They each claimed not to have had any other aesthetic treatments during the last year. Each patient was injected three times with a two-week gap between treatments. Evaluations were made at baseline and every two weeks before injection. A fourth evaluation was made four weeks after the third treatment session. Each treatment involved being injected with a total of 3.5 ml of the premixed HY6AA+ Formula using the High Performance Technique (HPT), injecting 0.1ml boluses into the deep dermis over the whole face, including the periocular area and forehead, perpendicular to the natural tension lines of the skin (Langer Lines).

Results

VISIA analysis of the treated patients showed an overall 71% reduction in the appearance of wrinkles on the forehead and a 44% reduction in wrinkles in the periocular area. Skin texture had visibly improved and skin dyschromia due to photo-ageing had improved by 16%. Skin elasticity was assessed via the use of a standardised Pinching Test and the VAS scale was utilised to evaluate the progress of skin tension and elasticity with each treatment. All patients noticed a significant improvement in skin tension and elasticity. According to the Global Aesthetic Improvement Scale (GAIS), all patients noticed an improvement in appearance. After the first treatment, 28% of patients noted a moderate improvement in appearance and the remaining patients noticed a significant improvement in appearance.

None of the patients reported any worsening or lack of improvement. The study concluded that undergoing treatment with the patented formula HY6AA+ Formula showed an

improvement in the texture, colour and firmness of the skin. It was also interesting to note that despite the product being non-crosslinked, the tissue volume had also improved. There were minimal side effects reported and the patients tolerated the treatment very well1

Sunekos® Performa can be used along with Sunekos® 1200 as part of their injection protocols to treat the face and hands. The protocols vary depending on the problem areas being treated. The higher molecular weight of Sunekos® 1200 acts as a free radical scavenger offering protection to the constituents of the dermis.

Discussion

I, as a medical aesthetics practitioner, treat patients in clinic with Sunekos® frequently. I use it for patients presenting with signs of ageing over the face, neck, décolletage and hands. What sets it apart from other injectable treatments I am trained in is that it can be used to treat the riskier areas of the forehead and delicate periocular area and that there have not been any reported cases of vascular occlusion with its use so far. I have received great feedback from patients and they often see a benefit after the first treatment, which encourages them to complete the recommended course. I use it frequently in the periocular area and have seen an improvement even in older patients with pseudoherniated orbital fat with a reduced appearance of their ‘eye bags’ after treatment. The product comes as a generous 3.5ml vial, so patients are more satisfied that they are getting value for their money as they can have more problem areas treated with one vial. Despite the large volume of product, it is

relatively thin and has low resistance when being injected, so treatments can be carried out quickly and with ease. There is minimal pain on injection and the patient can have numbing cream applied to the skin beforehand if they wish. Downtime is again minimal, and the patient can resume their day as normal other than the usual aftercare. I have noticed superior results in the clinic since using Sunekos® Performa compared to when using their older Sunekos® 200. Sunekos® can be bought in EU countries starting from January 2023.

References

Bioscience, Biotechnology, and Biochemistry, 2022, Vol. 86, No. 9, 1255-1261

publication]

B De Servi, Orlandini A, Caviola E, M

Meloni. Amino acid and hyaluronic acid mixtures differentially regulate extra cellular matrix genes in cultured human fibroblasts. Biol Regul Homeost Agents. 2018;32(3):517-527.

4. Tedesco L., Rossi F. Ruocco C., Ragni M., Carruba M.O., Valerio A., Nisoli E. A designer mixture of six amino acids promotes the extracellular matrix gene expression in cultured human fibroblasts.

Figure 1 Evaluation after one treatment out of a two-treatment session course (A) Before, and (B) after treatment

“I have received great feedback from patients and they often see a benefit after the first treatment, which encourages them to complete the recommended course.”

SOFWAVE™: NEXT GENERATION ULTRASOUND TECHNOLOGY FOR A NATURAL LIFT

Sofwave™ is the breakthrough technology ready to meet the ever-increasing demand for non-invasive treatments that deliver noticeable results. Today’s patients who show mild to moderate skin laxity but are not quite ready for a surgical facelift find their way into aesthetic practices as they search for treatments with visible results and little to no downtime.

Perhaps they’ve had dermal fillers before but worry about looking overfilled; maybe they’ve thought about microneedling but don’t want to be stuck with needles thousands of times, requiring multiple treatments and days of downtime.

For those who avoid dermal fillers for fear of looking unnatural and feel that microneedling isn’t for them, Sofwave™ fits the demand as it delivers noticeable wrinkle reduction, eyebrow and neck lifting, and improves the appearance of lax tissue in the submental.

A more holistic approach

Sofwave™ cleverly manages to be both holistic and antiaging— helping patients roll back the clock while still looking like themselves. Dr. Dev Patel, medical director of Perfect Skin Solutions, acknowledges the importance of reassuring patients. ‘The biggest psychological hurdle is the fear of looking unnatural. We can say to patients: 100% you will not look unnatural. You will maintain your identity. You will just slowly transform into a healthier version of yourself.’

Patients will never look unnatural because Sofwave™

uses their own collagen and elastin to lift the skin and smooth fine lines and wrinkles from the inside out— no needles, minimal downtime, and safe for all skin tones.

The proof is in the science

Sofwave™ is FDA-cleared to improve facial lines and wrinkles and to lift the brow, neck and the submental. In a multi-center clinical study, 72% of trial patients rated the results on facial wrinkles and necklines as improved to very much improved after one Sofwave™ treatment at the 12-week mark1. Adding Sofwave™ to your practice will soon pay for itself: it’s easy to use, a single full-face treatment only takes 30–45 minutes, and can be delegated to non-physician team members.

Dr. Munir Somji, Director of DrMediSpa, stresses the importance of FDA approval for practitioner confidence. ‘Sofwave™ is proven to work and has FDA approval for eyebrow lifting, and that’s very rare. It gives me, as a clinician, peace of mind to know a treatment works and that we are also helping a patient

in their daily activities.’

Remodeling collagen the Sofwave™ way

Sofwave™ has many advantages over HIFU for both the practitioner and the patient. It uses proprietary SUPERB™ (synchronous parallel ultrasound beam) technology with SofCool™ to deliver ultrasound in a completely different way, making it faster, more efficient, and less painful, with no side effects and a proven safety record.

The technology is far more controlled, delivering seven parallel high-energy beams simultaneously in the mid dermis at precisely 1.5 mm depth without risk of injury to the bones, facial fat, nerves, or blood vessels1 Instead of heating the skin in tiny pinpoints, the beams cover a larger area more uniformly in half the time of other technologies. The controlled injury in the mid-dermis stimulates new collagen production, giving the skin a gradual but effective lift. Unlike RF microneedling devices, the skin remains intact, with minimal downtime.

The safety profile is strong, and no device-related adverse events were reported in the clinical study. This is partly because SofCool™, an integrated cooling mechanism, protects the epidermis from injury and allows the precise targeting of the mid-dermis for optimal results.

Dr. Patel prefers SUPERB™ technology. ‘Sofwave™ sits much better in my mind in terms of safety profile, and it delivers much more uniform and widespread heat, so the regenerative process is bound to be superior.’

Dr. Sophie Shotter, medical director of Illuminate Skin Clinic, makes an important point

Sofwave offers collagen remodelling and natural-looking results using its proprietary ultrasound technology

Figure 1 A) before and (B) 6 months post treatment. Photo courtesy of Gilly Munavalli, MD

regarding future treatments. ‘It’s treating within the dermis and not targeting SMAS, which is an important consideration for anyone considering surgical options in the future.’

Dr. Shotter adds that there is no anti-aging protocol for perimenopausal women, but Sofwave™ is an excellent choice for stimulating collagen and remodeling lax skin. ‘Every face is different; there is no magic formula that fits any one face. But one thing we can say is that your collagen levels, by the age of forty to fifty, especially as a woman who is going through perimenopause, will decline significantly.’

Many of her patients are turning to Sofwave™ to hold off surgery as long as possible. ‘They can feel the difference in the skin; they can see it. My patients notice it most around the eyes and the neck,’ says Dr. Shotter.

Sofwave™ doesn’t just delay surgery, says Dr. Patel. ‘Sofwave™ offers something surgery cannot. It is improving the architectural age of the skin itself. It improves skin quality. Surgery does not do this. So even if someone wants surgery now or in the future, Sofwave™ will benefit them.’

A natural option

Although fillers can be used to lift contours subtly, they can’t do everything too much

after a certain age can make patients look puffy and distorted. Dr. Shotter says this won’t happen with Sofwave™. ‘With injectables, some people are anxious. Some people are just afraid they are going to look different. With Sofwave™, you’re not going to have that. You can’t go wrong. You’re going to look like you but fresher, brighter, and rested.’

Dr. Somji explains that Sofwave is a more natural option. ‘It’s like when you are putting sheets over your pillowcase. If the pillow is too small for the pillowcase, it will be a little crinkly. You can either plump that up from the inside and look quite puffy or shrink it. That’s what Sofwave™ essentially does.’

Denser collagen plumps up the skin in a different way, says Dr. Somji. ‘There will always be a place for dermal fillers when you lose volume, but when I look at the before and afters of Sofwave™, the skin becomes thicker, so the health of your skin gets better, and you get that bit of a youthful glow, a little bit of youthful plumpness, which is what filler was designed for in the first place.’

Prejuvenation

Dr. Shotter notes that Sofwave™ is a popular prejuvenation treatment as well as a corrective one. ‘Nowadays, our patients are very aware that collagen and elastin levels decline with age and are keen to take a preventative approach from a young age. I’ve

got patients who are having Sofwave around the age of 30 to address early signs of aging, like tech neck, and also just to bank collagen.’

She makes an interesting comparison with microneedling: ‘The degree of collagen stimulation from a single Sofwave™ will be more than from a single microneedling treatment.’ Dr. Patel agrees that it’s a good alternative to microneedling for banking collagen and elastin as part of a prejuvenation treatment plan. ‘Sofwave improves skin surface quality too, with patients reporting smaller pores, fewer wrinkles, and plumper skin.’

Conclusion

Sofwave™ helps physicians and aesthetic practices deliver targeted energy to simultaneously coagulate more tissue area more efficiently. Physicians are empowered through a high-touch approach and dedicated expert team and best-in-class, innovative technology. Aesthetic practices who desire to expand their portfolio of treatments will benefit from Sofwave™.

References

1. Amir R. A novel approach to treating wrinkles and laxity of the face and neck using Intense Ultrasound Beam. Sofwave white paper, 2020. Available at: https://sofwave-static-images.s3-accelerate. amazonaws.com/2021/12/PB00030-4_White-PaperFINAL.pdf

Figure 2 (A) Before and (B) 10 months post treatment. Photo courtesy of Craig Colville, MD

“Sofwave offers something surgery cannot. It is improving the architectural age of the skin itself. It improves skin quality. Surgery does not do this.”

Figure 3 (A) Before and (B) 1 months post treatment. Photo courtesy of Beauty Within Medi Spa

SYLFIRM X TREATMENT FOR PORCELAIN SKIN

YOO, MD,

NOWADAYS, interest and efforts for porcelain skin are increasing all over the world. When it comes to porcelain skin, you can think of so-called flawless skin which refers to clear, smooth, and blemish-free skin regardless of skin color. In dermatologic and aesthetic fields, it is considered an approach to skin quality that can be analyzed from visual, topographical, and mechanical angles. There are various presentations that affect skin quality that are often encountered in clinics, such as pigmentation and skin texture, but I would like to focus on acne, rosacea and enlarged pores and the treatments for these symptoms.

Various methods are used to treat the above symptoms, one of which is RF (radiofrequency) microneedling. It works by creating microdamages with needles in a controlled manner to deliver an RF thermal effect to induce a healing response and is non-chromophore dependent, which is safe for use on all Fitzpatrick skin types. I use SYLFIRM X, which is a dual wave of RF microneedling developed and manufactured by ViOL, Co., Ltd.

SYLFIRM X is an FDA and CE cleared device and has several unique technologies that differentiate it from other RF microneedling devices. It is equipped with a dual wave that can be used for both continuous wave (CW) and pulsed wave (PW),

enabling to effectively treat various skin conditions with a single device, and each wave is subdivided into four modes according to pulse duration, so operators can use it intuitively. The needle depth can be adjusted by 4 mm and a unique needle length of 300 µ m can be used to target the papillary dermis where senescent fibroblasts,

capillaries, and type III collagen are present.

Acne

Acne vulgaris is one of the most common dermatologic conditions we see in clinics, and nearly 85% of teenagers are affected by acne at some point. Acne is caused by follicular hyperkeratinization,

Jinah Yoo, MD, shares her clinical experience using SYLFIRM X to treat acne, enlarged pores and rosacea

JINAH

Consultant Dermatologist and Director at Dr Jinah Yoo Dermatology, London, UK; Honorary Lecturer, University of Manchester, UK

Figure 1 Rosacea patient, (A) before and (B) after 3 sessions of SYLFIR M X

Cutibacterium acne colonization, sebum production, and inflammation that are often triggered by hormones and stress, and different treatment methods are used depending on the target causes.

Medications such as topical or oral antibiotics and retinoids are generally used according to AAD guidelines 2016 but usually require long-term use and can be associated with serious side effects.

Non-pharmacological treatments used for acne vulgaris are either alone or in combination with energy-based device treatments, including PDL (pulsed dye laser), 1450 nm diode laser, and IPL (intense pulsed light) using a photothermal effect.

Another way to use thermal damage to reduce sebum production and sebaceous gland activity is RF microneedling. In addition, it can induce wound healing by inducing the secretion of cell mediators and growth factors due to the thermal effect on the dermis. When treating acne with SYLFIRM X, I use the PW4 mode. I often combine SYLFIRM X treatment with other methods for quick and effective results in acne treatment. Antibiotics and benzoyl peroxide face wash are used with monthly SYLFIRM X treatment, or long pulsed Nd:YAG laser and SYLFIRM X are alternately used every 2 weeks. Furthermore, skin boosters, such as exosome-based boosters with antiinflammatory effects or NCTF Cytocare with moisturizing and brightening effects, are applied immediately after SYLFIRM X treatment so that they can be well absorbed through the microchannels created by microneedling in order to reduce downtime and maximize therapeutic effect.

Enlarged pores

Pores are tiny openings around hair follicles that are involved in the secretion of sebum and sweat. The

main causes of enlarged pores are high sebum excretion in those with acne and oily skin, decreased elasticity around pores due to aging, and increased hair follicle volume. Treatments to address these causes typically include topical retinoids, Botox, lasers (ablative/ non-ablative lasers), or RF microneedling. When using SYLFIRM X for enlarged pores, I use the CW2 mode and needle depth of 1.0–1.5 mm to target sebaceous and sweat glands. As a combination therapy with SYLFIRM X for the treatment of enlarged pores, Botox, widely used for enlarged pores, can be applied topically after SYLFIRM X treatment. Additionally, the effect of improving enlarged pores can be maximized by using the thulium laser targeting the superficial skin layers with SYLFIRM X targeting the deeper skin layer.

dermis. As you know, there are 4 types of rosacea: erythematotelangiectactic, papulopustular, phymatous, and ocular. The management methods are different depending on the type of rosacea.

The papulopustular type is often managed with medical treatments such as topical brimonidine, oral propranolol, or clonidine, whereas the erythematotelangiectactic type is frequently treated with energy-based devices, but patients with dark skin type may not be able to be safely treated with IPL, KTP or PDL due to the cross proximity of melanin absorption curve to that of oxyhemoglobin. For these patients, treatment can be maintained with a long-pulsed Nd:YAG laser, but RF microneedling could be an alternative treatment which is not affected by chromophores. When treating rosacea with SYLFIRM X, different PW modes are used depending on the symptoms: use PW 2 mode to treat diffuse facial erythema to selectively disrupt the vessels with high electrical conductivity, and use PW4 mode to treat papulopustular rosacea to reduce inflammatory components.

Conclusion

Rosacea

Rosacea is another common condition that can sometimes be difficult to diagnose in dark skin types. Although rosacea may have similar clinical presentations to acne, it has very a different pathogenesis. This is a disease in which the skin barrier is impaired, and the skin becomes sensitive, itchy, rough, scaling or swollen. It is primarily accompanied by persistent or intermittent diffuse facial erythema due to vasodilation, lymphatic dilatation and angiogenesis impacting the mid and upper

In summary, SYLFIRM X is a dual-wave RF microneedling device with multiple but intuitive modes, making it a versatile, clinically ideal device to improve overall skin quality and treat a wide range of skin concerns. In particular, the PW mode is effective for treating skin conditions related to diffuse erythema and inflammation of all skin types, and is easy to treat in combination with SYLFIRM X and other methods, and can help treat challenging chronic skin conditions such as acne and rosacea.

For more information, visit www.violmedical.com

“SYLFIRM X is a FDA and CE cleared device and has several unique technologies that differentiate it from other RF microneedling devices.”

When treating acne with SYLFIRM X, I use the PW4 mode. I often combine SYLFIRM X treatment with other methods for quick and effective results in acne treatment.

product news

The latest product news and technologies for the aesthetic and anti-ageing market

PROFESSIONAL DIETETICS

SuneKOS PERFORMA

Application Skin Renovation

SuneKOS PERFORMA is the new enhanced formula for skin renovation from Professional Dietetics. It is an injectable CE Medical Device Class III composed of Low Molecular Weight Hyaluronic Acid and the patented cluster of Amino Acids, the HY6AA formula, in a new ratio 'AA vs HA' allowing a 40% reduction of the hyaluronidase action.

SuneKOS PERFORMA rebuilds the Extra Cellular Matrix in a more effective and complete way, by stimulating:

• Elastin

• Collagen, including all main types of reticular collagen fibres of the dermis and Type IV and Type VII (anchoring types, plaques, and fibres)

• Fibronectin.

SuneKOS PERFORMA is an already premixed formula that:

• Restores ECM homeostasis in the ageing process by regenerating it;

• Counteracts the oxidative stress typical of the ageing process and repairs damage from UVA exposure through the process of the reconstruction of multiple molecules;

• Restores skin elasticity and natural volume.

Contact Professional Dietetics ● www.professionaldietetics.com

CANDELA MEDICAL Frax Pro™

Applications Skin resurfacing, acne scars, surgical scars, actinic keratosis, and striae

MESOESTETIC

mesohyal™ redenx

Application Skin rejuvenation and wrinkle treatment

mesohyal™ redenx is the intradermal treatment that improves gravitational wrinkles, enhances density and firmness. It is global anti-ageing solution that combines a tripeptide and a tetrapeptide to activate the synthesis of ECM proteins. The mesohyal™ line is the broadest range of CE-marked intradermal medical devices (class III), which have been tested in vitro and in vivo to ensure maximum therapeutic response and very good skin tolerance.

Contact mesoestetic Pharma Group, s.l. ● www.mesoestetic.com

The Frax Pro system is a scalable, advanced diode laser system that delivers highly targeted 1550 nm and 1940 nm wavelengths for dual-depth skin resurfacing and treatment of acne scars, surgical scars, actinic keratosis, and striae. The Frax 1940 handpiece delivers a 1940 nm wavelength laser beam for a shallow, epidermal approach, with focal reach extending to approximately 200 μm in depth. The 1550 nm wavelength penetrates deeper, with histological analysis showing up to 800 μm penetration. The system boasts sophisticated software with treatment data retrieval, remote wi-fi service capability, and customizable settings to meet individual needs. In addition, the system’s SoftCool™ air cooling sends a focused stream of cool air for greater comfort during and after the treatment.

Contact Candela Medical ● www.candelamedical.com

● marketing.emea@candelamedical.com