Fall 2010 Journal of Dermatology for Physician Assistants

Volume 4 number 4 FALL 2010

SDPA News and Current Affairs

dermatology pa news and notes

clinical dermatology

surgical dermatology

cosmetic dermatology

Professional development

Official Journal of the Society of Dermatology Physician Assistants

Vol. 4, No. 4 FALL 2010

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RETIN-A MICRO® (tretinoin gel) microsphere, 0.04% and 0.1% are indicated for topical application in the treatment of acne vulgaris.

Important Safety Information: RETIN-A MICRO (tretinoin gel) microsphere, 0.04% and 0.1% is contraindicated in individuals with a history of sensitivity reactions to any of its components. The skin of certain individuals may become excessively dry, red, swollen or blistered. If warranted, these individuals should temporarily reduce the amount or frequency of application, or discontinue use temporarily or altogether. Patients should be encouraged to minimize exposure to sunlight, including sunlamps, and to use a sunscreen with a SPF of 15 or higher and protective clothing.

The most common adverse reactions to RETIN-A MICRO 0.04% and 0.1% were limited to mild or moderate irritation of the skin. 1.3% of patients using RETIN-A MICRO 0.04% and 6% of patients using RETIN-A MICRO 0.1% discontinued due to irritation. RETIN-A MICRO 0.04% and 0.1% showed a visible reduction in total mean lesion count in as little as 2 weeks with full benefits seen after 7 weeks.

Please see brief summary of prescribing information on the next page. *Reported at the end of the 12-week P.U.M.P. Study. † Data based on a consumer preference study designed to evaluate preference of Pump versus tube delivery. 104 male and female acne sufferers between the ages of 13 and 36 completed the study.3 References: 1. RETIN-A MICRO 0.04%/0.1% [prescribing information]. Los Angeles, Calif: Ortho Dermatologics; May 2006. 2. Eichenfield LF, Nighland M, Rossi AB, et al; PUMP Study Group. Phase 4 study to assess tretinoin pump for the treatment of facial acne. J Drugs Dermatol. 2008;7(12):1129-1136. 3. Data on file, Ortho Dermatologics. 4. Embil K, Nacht S. The Microsponge ® Delivery System (MDS): a topical delivery system with reduced irritancy incorporating multiple triggering mechanisms for the release of actives. J Microencapsul.

1996;13(5):575-588.

RETIN-A MICRO ® is a brand of Ortho Dermatologics division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. © Ortho Dermatologics division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. 2009 09DD0217 10/09 Printed in the USA

FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE. Brief Summary Retin-A Micro® (tretinoin gel) microsphere, 0.1% and 0.04% is a formulation containing 0.1% or 0.04%, by weight, tretinoin for topical treatment of acne vulgaris. This formulation uses patented methyl methacrylate/glycol dimethacrylate crosspolymer porous microspheres (MICROSPONGE® System) to enable inclusion of the active ingredient, tretinoin, in an aqueous gel.

IMPORTANT NOTE: This information is a BRIEF SUMMARY of the complete prescribing information provided with the product and therefore should not be used as the basis for prescribing the product. This summary has been prepared by deleting information from the complete prescribing information such as certain text, tables, and references.

The physician should be thoroughly familiar with the complete prescribing information before prescribing the product.

INDICATIONS AND USAGE: Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the use of this product in the treatment of other disorders have not been established.

CONTRAINDICATIONS: This drug is contraindicated in individuals with a history of sensitivity reactions to any of its components. It should be discontinued if hypersensitivity to any of its ingredients is noted.

PRECAUTIONS: General: • The skin of certain individuals may become excessively dry, red, swollen, or blistered. If the degree of irritation warrants, patients should be directed to temporarily reduce the amount or frequency of application of the medication, discontinue use temporarily, or discontinue use all together. Efficacy at reduced frequencies of application has not been established.

If a reaction suggesting sensitivity occurs, use of the medication should be discontinued.

Excessive skin dryness may also be experienced; if so, use of an appropriate emollient during the day may be helpful.

• Unprotected exposure to sunlight, including sunlamps, should be minimized during the use of Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, and patients with sunburn should be advised not to use the product until fully recovered because of heightened susceptibility to sunlight as a result of the use of tretinoin. Patients who may be required to have considerable sun exposure due to occupation and those with inherent sensitivity to the sun should exercise particular caution. Use of sunscreen products (SPF 15) and protective clothing over treated areas are recommended when exposure cannot be avoided.

• Weather extremes, such as wind or cold, also may be irritating to patients under treatment with tretinoin.

• Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, should be kept away from the eyes, the mouth, paranasal creases of the nose, and mucous membranes.

• Tretinoin has been reported to cause severe irritation on eczematous skin and should be used with utmost caution in patients with this condition.

Information for Patients: A Patient Information Leaflet has been prepared and is included with each package of Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%.

Drug Interactions: Concomitant topical medication, medicated or abrasive soaps and cleansers, products that have a strong drying effect, products with high concentrations of alcohol, astringents, or spices should be used with caution because of possible interaction with tretinoin. Avoid contact with the peel of limes. Particular caution should be exercised with the concomitant use of topical over-the-counter acne preparations containing benzoyl peroxide, sulfur, resorcinol, or salicylic acid with Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%. It also is advisable to allow the effects of such preparations to subside before use of Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, is begun.

Carcinogenesis, Mutagenesis, Impairment of Fertility: In a 91-week dermal study in which CD-1 mice were administered 0.017% and 0.035% formulations of tretinoin, cutaneous squamous cell carcinomas and papillomas in the treatment area were observed in some female mice. These concentrations are near the tretinoin concentration of these clinical formulations (0.04% and 0.1%). A dose-related incidence of liver tumors in male mice was observed at those same doses. The maximum systemic doses associated with the administered 0.017% and 0.035% formulations are 0.5 and 1.0 mg/kg/day, respectively. These doses are two and four times the maximum human systemic dose applied topically, when normalized for total body surface area. The biological significance of these findings is not clear because they occurred at doses that exceeded the dermal maximally tolerated dose (MTD) of tretinoin and because they were within the background natural occurrence rate for these tumors in this strain of mice. There was no evidence of carcinogenic potential when 0.025 mg/kg/day of tretinoin was administered topically to mice (0.1 times the maximum human systemic dose, normalized for total body surface area). For purposes of comparisons of the animal exposure to systemic human exposure, the maximum human systemic dose applied topically is defined as 1 gram of Retin-A Micro (tretinoin gel) microsphere, 0.1% applied daily to a 50 kg person (0.02 mg tretinoin/kg body weight).

Dermal carcinogenicity testing has not been performed with Retin-A Micro (tretinoin gel) microsphere, 0.04% or 0.1%.

Studies in hairless albino mice suggest that concurrent exposure to tretinoin may enhance the tumorigenic potential of carcinogenic doses of UVB and UVA light from a solar simulator. This effect has been confirmed in a later study in pigmented mice, and dark pigmentation did not overcome the enhancement of photocarcinogenesis by 0.05% tretinoin. Although the significance of these studies to humans is not clear, patients should minimize exposure to sunlight or artificial ultraviolet irradiation sources.

The mutagenic potential of tretinoin was evaluated in the Ames assay and in the in vivo mouse micronucleus assay, both of which were negative.

The components of the microspheres have shown potential for genetic toxicity and teratogenesis.

EGDMA, a component of the excipient acrylates copolymer, was positive for induction of structural chromosomal aberrations in the in vitro chromosomal aberration assay in mammalian cells in the absence of metabolic activation, and negative for genetic toxicity in the Ames assay, the HGPRT forward mutation assay, and the mouse micronucleus assay.

In dermal Segment I fertility studies of another tretinoin formulation in rats, slight (not statistically significant) decreases in sperm count and motility were seen at 0.5 mg/kg/day (4 times the maximum human systemic dose applied topically, and normalized for total body surface area), and slight (not statistically significant) increases in the number and percent of nonviable embryos in females treated with 0.25 mg/kg/day (2 times the maximum human systemic dose applied topically and normalized for total body surface area) and above were observed. In oral Segment I and Segment III studies in rats with tretinoin, decreased survival of neonates and growth retardation were observed at doses in excess of 2 mg/kg/day (17 times the human topical dose normalized for total body surface area).

Dermal fertility and perinatal development studies with Retin-A Micro (tretinoin gel) microsphere, 0.1% or 0.04%, have not been performed in any species.

Pregnancy: Teratogenic Effects: Pregnancy Category C. In a study of pregnant rats treated with topical application of Retin-A Micro (tretinoin gel) microsphere, 0.1%, at doses of 0.5 to 1 mg/kg/day on gestation days 6-15 (4 to 8 times the maximum human systemic dose of tretinoin normalized for total body surface area after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%) some alterations were seen in vertebrae and ribs of offspring. In another study, pregnant

New Zealand white rabbits were treated with Retin-A Micro (tretinoin gel) microsphere, 0.1%, at doses of 0.2, 0.5, and 1.0 mg/kg/day, administered topically for 24 hours a day while wearing Elizabethan collars to prevent ingestion of the drug. There appeared to be increased incidences of certain alterations, including domed head and hydrocephaly, typical of retinoid-induced fetal malformations in this species, at 0.5 and 1.0 mg/kg/day. Similar malformations were not observed at 0.2 mg/kg/day, 3 times the maximum human systemic dose of tretinoin after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%, normalized for total body surface area. In a repeat study of the highest topical dose (1.0 mg/kg/day) in pregnant rabbits, these effects were not seen, but a few alterations that may be associated with tretinoin exposure were seen. Other pregnant rabbits exposed topically for six hours to 0.5 or 0.1 mg/ kg/day tretinoin while restrained in stocks to prevent ingestion, did not show any teratogenic effects at doses up to 17 times (1.0 mg/kg/day) the maximum human systemic dose after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%, adjusted for total body surface area, but fetal resorptions were increased at 0.5 mg/kg. In addition, topical tretinoin in non Retin-A Micro (tretinoin gel) microsphere formulations was not teratogenic in rats and rabbits when given in doses of 42 and 27 times the maximum human systemic dose after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%, normalized for total body surface area, respectively, (assuming a 50 kg adult applied a daily dose of 1.0 g of 0.1% gel topically).

At these topical doses, however, delayed ossification of several bones occurred in rabbits. In rats, a dose-dependent increase of supernumerary ribs was observed.

Oral tretinoin has been shown to be teratogenic in rats, mice, rabbits, hamsters, and subhuman primates. Tretinoin was teratogenic in Wistar rats when given orally or topically in doses greater than 1 mg/kg/day (8 times the maximum human systemic dose normalized for total body surface area). However, variations in teratogenic doses among various strains of rats have been reported. In the cynomolgus monkey, which metabolically is more similar to humans than other species in its handling of tretinoin, fetal malformations were reported for doses of 10 mg/kg/day or greater, but none were observed at 5 mg/kg/day (83 times the maximum human systemic dose normalized for total body surface area), although increased skeletal variations were observed at all doses. Dose-related increases in embryolethality and abortion also were reported. Similar results have also been reported in pigtail macaques.

Topical tretinoin in animal teratogenicity tests has generated equivocal results. There is evidence for teratogenicity (shortened or kinked tail) of topical tretinoin in Wistar rats at doses greater than 1 mg/kg/day (8 times the maximum human systemic dose normalized for total body surface area). Anomalies (humerus: short 13%, bent 6%, os parietal incompletely ossified 14%) have also been reported when 10 mg/kg/day was topically applied. Supernumerary ribs have been a consistent finding in rats when dams were treated topically or orally with retinoids.

There are no adequate and well-controlled studies in pregnant women. Retin-A Micro should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

With widespread use of any drug, a small number of birth defect reports associated temporally with the administration of the drug would be expected by chance alone. Thirty human cases of temporally associated congenital malformations have been reported during two decades of clinical use of Retin-A. Although no definite pattern of teratogenicity and no causal association has been established from these cases, five of the reports describe the rare birth defect category holoprosencephaly (defects associated with incomplete midline development of the forebrain). The significance of these spontaneous reports in terms of risk to the fetus is not known.

Non-Teratogenic Effects: Topical tretinoin has been shown to be fetotoxic in rabbits when administered 0.5 mg/kg/day (8 times the maximum human systemic dose applied topically and normalized for total body surface area), resulting in fetal resorptions and variations in ossification. Oral tretinoin has been shown to be fetotoxic, resulting in skeletal variations and increased intrauterine death in rats when administered 2.5 mg/kg/day (21 times the maximum human systemic dose applied topically and normalized for total body surface area).

There are, however no adequate and well-controlled studies in pregnant women.

Animal Toxicity Studies: In male mice treated topically with Retin-A Micro (tretinoin gel) microsphere 0.1%, at 0.5, 2.0, or 5.0 mg/kg/day tretinoin (2, 8, or 21 times the maximum human systemic dose after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%, normalized for total body surface area) for 90 days, a reduction in testicular weight, but with no pathological changes were observed at the two highest doses. Similarly, in female mice there was a reduction in ovarian weights, but without any underlying pathological changes, at 5.0 mg/kg/day (21 times the maximum human dose). In this study there was a dose-related increase in the plasma concentration of tretinoin 4 hours after the first dose. A separate toxicokinetic study in mice indicates that systemic exposure is greater after topical application to unrestrained animals than to restrained animals, suggesting that the systemic toxicity observed is probably related to ingestion. Male and female dogs treated with Retin-A Micro (tretinoin gel) microsphere, 0.1%, at 0.2, 0.5, or 1.0 mg/kg/day tretinoin (5, 12, or 25 times the maximum human systemic dose after topical administration of Retin-A Micro (tretinoin gel) microsphere, 0.1%, normalized for total body surface area, respectively) for 90 days showed no evidence of reduced testicular or ovarian weights or pathological changes.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Retin-A Micro (tretinoin gel) microsphere, 0.1% or 0.04%, is administered to a nursing woman.

Pediatric Use: Safety and effectiveness in children below the age of 12 have not been established.

Geriatric Use: Safety and effectiveness in a geriatric population have not been established.

Clinical studies of Retin-A Micro did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

ADVERSE REACTIONS: The skin of certain sensitive individuals may become excessively red, edematous, blistered, or crusted. If these effects occur, the medication should either be discontinued until the integrity of the skin is restored, or the medication should be adjusted to a level the patient can tolerate.

However, efficacy has not been established for lower dosing frequencies.

True contact allergy to topical tretinoin is rarely encountered. Temporary hyper- or hypopigmentation has been reported with repeated application of tretinoin. Some individuals have been reported to have heightened susceptibility to sunlight while under treatment with tretinoin.

OVERDOSAGE: Retin-A Micro (tretinoin gel) microsphere, 0.1% and 0.04%, is intended for topical use only. If medication is applied excessively, no more rapid or better results will be obtained and marked redness, peeling, or discomfort may occur. Oral ingestion of large amounts of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A. Rx only.

Patent Nos.: 4,690,825; 5,145,675 & 5,955,109

Distributed by: OrthoNeutrogena DIVISION OF ORTHO-MCNEIL PHARMACEUTICAL, INC. Los Angeles, CA 90045 © OMP 2006 06DD0123 7/06 RETIN-A MICRO® is a registered trademark of Ortho-McNeil Pharmaceutical, Inc. MICROSPONGE® is a registered trademark of Cardinal Health, Inc., Dublin, OH.

EDITORIAL BOARD

Travis Hayden, MPAS, PA-C, Editor in chief Joe R. Monroe, MPAS, PA-C Patricia Ferrer, MPAS, PA-C Gordon Day, R.Ph., PA-C Nancy Primo, MPAS, PA-C Lauren Zajac, MHS, PA-C Michelle DiBaise, MPAS, PA-C P. Eugene Jones, Ph.D., PA-C Kristine Kucera, DHS, MPAS, PA-C Mark Hyde, MMS, PA-C Jeffrey LaDuca, Ph.D., MD Alan Menter, MD

DEPARTMENT EDITORS

Clinical Department Editor Susan E. King-Barry, MPAS, PA-C Drugs in Dermatology Editor Stephen Wolverton, MD Surgical Department Editor Christy Kerr, MPAS, PA-C Cosmetic Department Editor Nancy Primo, MPAS, PA-C Prof Dev Department Editor Abby Jacobson, MS, PA-C

SDPA Board of Directors

PrESiDEnT Abby Jacobson, MS, PA-C PrESiDEnT-ElECT Keri Holyoak, MPH, PA-C iMMEDiATE PAST PrESiDEnT Kristine Kucera, DHS, MPAS, PA-C ViCE PrESiDEnT CaSondra Soto, MPAS, PA-C SECrETAry / TrEASurEr Casey Croes, MPAS, PA-C DirECTors AT lArGE Mark Hyde, MMS, PA-C John Notabartolo, MPAS, PA-C Jennifer Winter, PA-C Jason Roddick, MS, MSPAS, PA-C

Society of Dermatology Physician Assistants, Inc P.O. Box 701461 San Antonio, Texas 78270 1-800-380-3992 SDPA@dermpa.org www.dermpa.org

Publishing Staff

Publisher Travis Hayden, MPAS, PA-C Managing Editor Jennifer M. Hayden, M.Ed Copy Editor Douglas Morris Art Director Angela Simiele Website Design Terry Scanlon

SALES Office

Physician Assistant Communications, LLC P.O. Box 416, Manlius NY 13104-0416 Phone (315) 663-4147 PAC@pacommunications.org www.pacommunications.org editorial missioN: The JDPA is the official clinical journal of the Society of Dermatology Physician Assistants. The mission of the JDPA is to improve dermatological patient care by publishing the most innovative, timely, practiceproven educational information available for the physician assistant profession.

PUBLISHED CONTENT IN THE JDPA: Statements and opinions expressed in the articles and communications herein are those of the authors and not necessarily those of the Publisher or the Society of Dermatology Physician Assistants (SDPA). The Publisher and the SDPA disclaim any responsibility or liability for such material, including but not limited to any losses or other damage incurred by readers in reliance on such content. Neither Publisher nor SDPA verify any claims or other information appearing in any of the advertisements contained in the publication and cannot take responsibility for any losses or other damage incurred by readers in reliance on thereon. Neither Publisher nor SDPA guarantees, warrants, or endorses any product or service advertised in this publication, nor do they guaranty any claim made by the manufacturer of such product or service.

This Issue: of JDPA includes articles that have been reviewed and approved for Category I (Preapproved) CME credit by the American Academy of Physician Assistants. Approval is valid for 1 year from the issue date, and participants may submit the self-assessment at any time during that period.

Category I CME articles included in JDPA are planned and developed in accordance with AAPA’s CME Standards for Journal Articles and for Commercial Support of Journal Articles.

Since its inception, the JDPA has utilized eco-friendly printing practices. The JDPA is printed on paper obtained from sustainable forests that meet strict environmental standards. Soy-based inks that have a low environmental impact are used during printing of the journal and the journal is printed using 100% renewable energy. SDPA members may join us in our efforts and opt to receive the JDPA in digital format.

JDPA/Journal of Dermatology for Physician Assistants (ISSN 1938-9574) is published quarterly (4 issues per volume, one volume per year) by Physician Assistant Communications, LLC, P.O. Box 416, Manlius NY 13104-0416. Volume 4, Number 4, Fall 2010. One year subscription rates: $40 in the United States and Possessions. Single copies (prepaid only): $10 in the United States (Include $6.50 per order plus $2 per additional copy for US postage and handling).

TM Periodicals postage rate paid at New York, NY 10001 and additional mailing offices. Š 2010 Physician Assistant Communications, LLC. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including by photocopy, recording, or information storage and retrieval system, without permission in writing from the publisher.

Postmaster: Send address changes to Society of Dermatology Physician Assistants, Inc. P.O. Box 701461, San Antonio, Texas 78270; 1-800-380-3992.

THIS ISSUE IS SPONSORED BY

Journal of Dermatology for Physician Assistants

Editor’s Message

Anticipating the Fall Journal of Dermatology for Physician Assistants

The Official Journal of the SDPA

A

utumn has arrived and with it there is an excitement in the air that accompanies the changing of leaves and scenery. As a parent preparing my child for a new school year, I couldn’t help but feel twinges of nostalgia every time I saw school buses out on the roads, smelled a newly opened box of crayons, or heard my daughter talking about how fast her shiny new sneakers made her run. I am sure we all can relate to having the same sort of emotions at one time or another about falling into a new and exciting experience. When I became a dermatology PA, the SDPA’s Annual Fall Conference became one of those anticipated times for me.

A combination of eagerness and enthusiasm is what I felt as a new derm PA preparing to attend my very first SDPA Fall Conference. I can recall being so thrilled to have found a group of PAs who shared in the same passion for working in dermatology. I was eager to branch out, meet my peers, and learn from their experiences about life as a dermatology PA. That first conference and each fall since, I have left more knowledgeable than when I arrived, ready to tackle challenging cases back at work, and energized and motivated about my profession.

While you are at your next SDPA conference catching up with familiar friends and colleagues, be sure to take notice of anyone new around you. They very well could be PA students or new derm PAs attending their first conference. Take a few moments to introduce yourself and share any insights that you feel may be valuable.

Imparting our passion and enthusiasm is a great way to motivate new derm PAs about their future profession and help them feel they can run really, really fast in their new sneakers.

Enjoy the fall season and any special memories it holds for you.

I look forward to seeing old friends and colleagues and making new ones at the upcoming SDPA conferences. I hope to see you there. J

Know a Student who can’t get enough Derm?

Travis Hayden Editor in chief

Remind them to join the SDPA and visit the new dermpa website designed just for them. www.dermpa.org/students Vol. 4, No. 4 FALL 2010

table of contents

15

SDPA Members Only Content A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

A Review of Allergic Contact Dermatitis & Patch Testing

By J. Desiree Douglas, MPA, PA-C

CME

10 Derm PA News & Notes – part one

• Certification Review - All Those Things Inside the Skin You Might Have Forgotten

15 Clinical Dermatology

• CME Article – A Review of Allergic Contact Dermatitis & Patch Testing • Drugs in Dermatology – iPLEDGE FAQs

Departments

30 Surgical Dermatology

04 Editorial Board 05 Editor’s Message 09 SDPA News & Current Affairs 10 Dermatology Market Watch 23 From The Patient’s Perspective 24 Dermatoscopy 25 Clinical Snapshots 31 Surgical Wisdom 40 Notes from your Office Manager 43 Outside & Inside the 9 to 5...

47 The Difference We Make 49 “Derm Quotes” 50 Professional Opportunities and Development

• Beyond the Ellipse – Bilateral Advancement Flaps

32 Cosmetic Dermatology

• Cosmetic Pearls – Top 10 Tips for Healthy Skin, Hair and Nails

35 Professional Development

• The History of the SDPA • Dermatology Billing & Coding – Patch Testing: How to Bill it Correctly

44 Derm PA News & Notes – part two • From the Desk of…

• Supervising Physician Corner

Go Green – Read Online As part of the “Going Green” initiative, the JDPA is now available as an electronic only option to interested SDPA members. To start receiving your copy of the JDPA in digital format please visit the SDPA website and update your membership profile.

Journal of Dermatology for Physician Assistants

Vol. 4, No. 4 FALL 2010

Journal of Dermatology for Physician Assistants

Calendar

FROM THE SPDA News & Current Affairs

of events

2010 NOVEMBER SDPA 8th Annual Fall Conference November 10-13, 2010 Gaylord Texan Resort Grapevine, TX

2011

FEBRUARY 69th AAD Annual Academy Meeting February 4 - 8, 2011 New Orleans, LA june SDPA 2nd Annual Summer Dermatology Conference June 2 - 5, 2011 JW Marriott Hotel Washington, DC NOVEMBER SDPA 9th Annual Fall Conference November 9-12, 2011 Loews Portofino Bay Hotel Orlando, FL

Calendar of Events Submissions

Proposed PA Regulation Change in YOUR STATE

P

icture this: there are proposed regulations in your state that would limit your ability to see new patients, see patients with your physician not on site, or perform procedures without the supervising physician also seeing the patient. Will you have a job if these new regulations get approved? How do you respond? Who do you turn to?

The answer is: Your Society of Dermatology Physician Assistants (SDPA) Think this situation is made up? Well it isn’t – this just happened in New Jersey.

Together, the SDPA, AAPA, and the New Jersey State Society of Physician Assistants responded to proposed regulations that would have placed unprecedented restrictions on PAs working in dermatology and would have had potential repercussions for all PAs in the state who perform any procedures on the skin. Additionally, PA representatives from the SDPA and AAPA met with the leadership of the state physician dermatology society to reassure them that our members will continue to practice under the supervision of board certified dermatologists. The SDPA is committed to protecting the integrity of the dermatologist-PA team. The New Jersey Board of Medical Examiners unanimously rejected the proposed regulatory changes in New Jersey.

This is just one example of is why it is crucial to maintain your yearly SDPA membership and to make sure that every dermatology PA becomes a member. Without members, membership dues, and your support of SDPA conferences, we would not have the ability to respond to critical situations like this. If you have questions or comments please feel free to e-mail me at ajacobson@dermpa.org. J

Send information to: Editor@jdpa.org

Abby Jacobson, MS, PA-C President Society of Dermatology Physician Assistants

Vol. 4, No. 4 FALL 2010

9

Dermatology PA news & notes

Dermatology Market Watch Giving Patients an Edge. . .When It Comes To Itch.

Differin® (adapalene) Lotion, 0.1%,

Physicians and physician assistants now have an important edge when it comes to helping patients deal with the unrelenting itch of skin diseases such as atopic dermatitis. Ferndale Laboratories has just introduced Pramosone E™ Cream Trial Packs.

Pramosone E™ Cream contains hydrocortisone acetate 2.5%, a Class VII steroid with pramoxine HCl 1% in an emollient vehicle.

Each Pramosone E™ Cream Trial Pack contains a 1 oz. tube of Pramosone E™ Cream, one Treatment Assurance Card and a patient education brochure. Patients will be gratified to receive this package as the 1 oz. tube is a regular prescription size and the Treatment Assurance Card is valid for unlimited refills.

The Pramosone E™ Cream Trial Pack is available to validated physicians, and physician assistants, with a signature required. For more information contact Ferndale Laboratories customer service at 1-877.352.6295 or register for the trial pack program at www.doctorpramosone.com

Galderma Laboratories, L.P. announced the U.S. Food and Drug Administration (FDA) approval of Differin® (adapalene) Lotion, 0.1%, the first-ever lotion formulation of the well-tolerated retinoid adapalene, for the treatment of acne. Differin Lotion, 0.1% is formulated for tolerable efficacy, spreads easily and is available in a convenient, easy-to-use pump dispenser. Differin Lotion, 0.1% is indicated for the treatment of acne vulgaris in patients 12 years and older, and can be used on the face and other areas of the body affected by acne.

Approval was based on two 12-week, multicenter, controlled clinical studies of similar design, comparing Differin Lotion, 0.1% to vehicle in 2,141 total acne subjects. Differin Lotion, 0.1% was shown to show statistically significant reductions in total, inflammatory, and non-inflammatory lesion count at week 12 compared to vehicle, respectively.

Ferndale Introduces Pramosone E™ (hydrocortisone acetate 2.5% and pramoxine HCl 1%) Trial Packs

The First Retinoid Available in Lotion Formulation

www.PsoMe.org

National Psoriasis Foundation Launches the First Website Dedicated for Children with Psoriasis and Psoriatic Arthritis It can be tough to be a kid with psoriasis. Some kids have never met others with the disease and feel isolated. Some endure teasing and bullying at school because of their disease.

The National Psoriasis Foundation is pleased to announce the launch of www.PsoMe.org, the first website just for children with psoriasis and psoriatic arthritis. PsoMe pulls together valuable resources that will help your pediatric patients live well with psoriasis and feel confident in their skin.

Introduce www.PsoMe.org to a young patient today and help them discover: • Educational pages that explain their disease in easy to understand terms • Activities that will help them express their feelings and educate others • Opportunities to help find a cure for psoriasis and psoriatic arthritis • Programs and pages that help them connect with other kids just like them including a kids-only bulletin board, art gallery and Pen Pal program PsoMe also has information for parents, with tips and encouragement from other parents, and ideas for getting the entire family involved in raising awareness and helping to find a cure for their child.

10 Journal of Dermatology for Physician Assistants

A clear message for external genital and perianal warts (EGW)...

“I don’t want to see you again.”

VEREGEN® Delivers Complete Clearance With Low Recurrence • Demonstrated complete clearance in 53.6% of all patients studied1

• Only 6.8% rate of recurrence among patients with complete clearance 12 weeks posttreatment1

• Proven effective in clearing both baseline and newly emerging EGW in male and female patients1

The FIRST

BOTANICAL DRUG approved for prescription use in the United States2

VEREGEN

®

(sinecatechins) Ointment,15%

Get out and stay out.

VEREGEN® is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older.

Important Selected Safety Information

VEREGEN® has not been evaluated to treat urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease and should not be used to treat these conditions. Avoid use of VEREGEN® on open wounds. Avoid exposure of VEREGEN®-treated areas to sun/UV-light because VEREGEN® has not been tested under these circumstances. Safety and efficacy of VEREGEN® have not been established in immunosuppressed or pediatric patients, or pregnant women, or for the treatment of external genital and perianal warts beyond 16 weeks or for multiple treatment courses.

The most common adverse reactions are local skin and application site reactions including (incidence ≥ 20%) erythema, pruritus, burning, pain/discomfort, erosion/ulceration, edema, induration, and rash vesicular.

References: 1. VEREGEN® Ointment, 15% [Prescribing Information, 2008]. Melville, NY: PharmaDerm, a division of Nycomed US Inc. 2. Data on file, PharmaDerm.

Please see adjacent page for Brief Summary of full Prescribing Information.

VEREGEN is a registered trademark of MediGene AG, D-82152 Planegg/Martinsried, Germany. ©2010 PharmaDerm, a division of Nycomed US Inc. Melville, NY 11747. All rights reserved. 98NVE400910

Vol. 4, No. 4 FALL 2010 11

Brief Summary of Prescribing Information–See Package Insert for Full Prescribing Information at www.pharmaderm.com

Veregen

USE IN SPECIFIC POPULATIONS

®

Pregnancy

(sinecatechins)

Pregnancy Category C: There are no adequate and well controlled studies in pregnant women. Veregen® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Ointment, 15%

Nursing Mothers

Rx Only

It is not known whether topically applied Veregen® is excreted in breast milk.

Pediatric Use

For Topical Dermatologic Use Only

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use INDICATIONS AND USAGE Veregen® is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older.

The safety and effectiveness of Veregen® have not been established for treatment beyond 16-weeks or for multiple treatment courses.

The safety and effectiveness of Veregen® in immunosuppressed patients have not been established.

CONTRAINDICATIONS None

CLINICAL STUDIES Two randomized, double-blind, vehicle-controlled studies were performed to investigate the safety and efficacy of Veregen® in the treatment of immunocompetent patients 18 years of age and older with external genital and perianal warts. The subjects applied the ointment 3 times daily for up to 16 weeks or until complete clearance of all warts (baseline and new warts occurring during treatment).

Over both studies the median baseline wart area was 51 mm2 (range 12 to 585 mm2), and the median baseline number of warts was 6 (range 2 to 30).

The primary efficacy outcome measure was the response rate defined as the proportion of patients with complete clinical (visual) clearance of all external genital and perianal warts (baseline and new) by week 16, presented in Tables 1 and 2 for all randomized subjects dispensed medication.

Table 1: Efficacy by Region Complete Clearance All Countries (includes the United States) Veregen® 15% (N = 397)

213 (53.6%)

Vehicle (N = 207)

73 (35.3%)

United States Veregen® 15% (N = 21)

5 (23.8%)

Vehicle (N = 9)

0 (0.0%)

Table 2: Efficacy by Gender Complete Clearance Males Veregen® 15% (N = 205)

97 (47.3%)

Vehicle (N = 118)

34 (28.8%)

Females Veregen® 15% (N = 192)

116 (60.4%)

Vehicle (N = 89)

39 (43.8%)

Median time to complete wart clearance was 16 weeks and 10 weeks, respectively, in the two phase 3 clinical trials.

The rate of recurrence of external genital and perianal warts 12 weeks after completion of treatment in subjects with complete clearance is 6.8% (14/206) for those treated with Veregen® and 5.8% (4/69) for those treated with vehicle.

WARNINGS AND PRECAUTIONS Veregen® has not been evaluated for the treatment of urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease and should not be used for the treatment of these conditions.

Use of Veregen® on open wounds should be avoided.

Patients should be advised to avoid exposure of the genital and perianal area to sun/ UV-light as Veregen® has not been tested under these circumstances.

12 Journal of Dermatology for Physician Assistants

Seven patients (1.4%), older than 65 years of age were treated with Veregen® in clinical studies. This, however, is an insufficient number of subjects to determine whether they respond differently from younger subjects.

ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In Phase 3 clinical trials, a total of 397 subjects received Veregen® three times per day topical application for the treatment of external genital and perianal warts for up to 16 weeks.

Serious local adverse events of pain and inflammation were reported in two subjects (0.5%), both women.

In clinical trials, the incidence of patients with local adverse events leading to discontinuation or dose interruption (reduction) was 5% (19/397). These included the following events: application site reactions (local pain, erythema, vesicles, skin erosion/ulceration), phimosis, inguinal lymphadenitis, urethral meatal stenosis, dysuria, genital herpes simplex, vulvitis, hypersensitivity, pruritus, pyodermitis, skin ulcer, erosions in the urethral meatus, and superinfection of warts and ulcers.

Local and regional reactions (including adenopathy) occurring at >1% in the groups treated with Veregen® (N=397) or vehicle (N=207), respectively, were: erythema (70%, 32%), pruritus (69%, 45%), burning (67%, 31%), pain/discomfort (56%, 14%), erosion/ulceration (49%, 10%), edema (45%, 11%), induration (35%, 11%), rash vesicular (20%, 6%), regional lymphadenitis (3%, 1%), desquamation (5%, <1%), discharge (3%, <1%), bleeding (2%, <1%), reaction (2%, 0%), scar (1%, 0%), irritation (1%, 0%), and rash (1%, 0%).

A total of 266/397 (67%) of subjects in the Veregen® group had either a moderate or a severe reaction that was considered probably related to the drug, of which 120 (30%) subjects had a severe reaction. Severe reactions occurred in 37% (71/192) of women and in 24% (49/205) of men. The percentage of subjects with at least one severe, related adverse event was 26% (86/328) for subjects with genital warts only, 42% (19/45) in subjects with both genital and perianal warts and 48% (11/23) of subjects with perianal warts only.

Phimosis occurred in 3% of uncircumcised male subjects (5/174) treated with Veregen® and in 1% (1/99) in vehicle.

The maximum mean severity of erythema, erosion, edema, and induration was observed by week 2 of treatment.

Less common local adverse events included urethritis, perianal infection, pigmentation changes, dryness, eczema, hyperesthesia, necrosis, papules, and discoloration. Other less common adverse events included cervical dysplasia, pelvic pain, cutaneous facial rash, and staphylococcemia.

In a dermal sensitization study of Veregen® in healthy volunteers, hypersensitivity (type IV) was observed in 5 out of 209 subjects (2.4%) under occlusive conditions.

DOSAGE AND ADMINISTRATION Veregen® is to be applied three times per day to all external genital and perianal warts.

Treatment with Veregen® should be continued until complete clearance of all warts, however no longer than 16 weeks.

HOW SUPPLIED/STORAGE AND HANDLING Veregen® is a brown ointment and is supplied in an aluminum tube containing 15 grams (NDC # 10337-450-15) of ointment per tube.

Prior to dispensing to the patient, store refrigerated 2°C to 8°C (36°F to 46°F).

After dispensing, store refrigerated or up to 25°C (77°F). Do not freeze.

Manufactured by: C.P.M. Contract Pharma GmbH & Co. KG Frühlingstrasse 7 D-83620 Feldkirchen-Westerham Germany U.S. Patent Nos. 5795911 and 5968973

Manufactured for:

www.pharmaderm.com

Melville, NY 11747 USA

98NVE390210

Certification Review

All Those Things Inside the Skin You Might Have Forgotten

By James A. Van Rhee, MS, PA-C

Explanation: Community acquired pneumonia is most frequently due to infection with Streptococcus pneumonia. Other etiologies include Haemophilus influenzae, Staphylococcus aureus, and Klebsiella pneumoniae. Presentation consists of a productive cough, shortness of breath, fever, and pleuritic chest pain. Physical examination reveals tachycardia, bronchial breath sounds, and signs of consolidation on a lung exam. The white blood cell

James A. Van Rhee, MS, PA-C, is the Program Director for the Northwestern University Feinberg School of Medicine Department of Family Medicine Physician Assistant Program. Mr. Van Rhee has been involved in physician assistant education for over 13 years. He has served as project director and test item writer for the Physician Assistant Education Association’s (PAEA) Physician Assistant Clinical Knowledge Rating Assessment Tool (PACKRAT) and is the author of the “Physician Assistant: Certification and Re-certification Review Book”, published by Elsevier. For the last ten years, he has been course director and presenter of the Physician Assistant Board Review, which is now being produced live online by Kaplan Medical.

JDPA...Your Journal, Your Life.

Write

for the

JDPA

The Journal of Dermatology for Physician Assistants (JDPA) is the first PA specialty publication dedicated specifically to serving the needs of the dermatology PA community.

The journal is a peer-reviewed publication that delivers innovative clinical, surgical, cosmetic and professional content exclusively for dermatology PAs. The JDPA serves as a printed forum in which dermatology PAs can share clinical information, practice tips and other relevant professional insights with an already established network of their colleagues.

WRITE FOR THE JDPA

We are looking for dermatology PAs who are interested in contributing to our profession by writing for the JDPA. There are a variety of subjects to write about in the JDPA. To the right is a list of the sections and their respective topics that are featured in each issue. You can find more detailed information regarding these topics online at: www.jdpa.org.

News and Notes • From the Desk of...

• The Difference We Make Clinical Dermatology • CME Articles • Derm Case Reports • From the Patient’s Perspective (Have your patient’s story published, in their own words)

• Clinical Snapshots • Journal Club (Review an article)

• Drugs in Dermatology Surgical Dermatology • Feature Articles • Journal Club

Cosmetic Dermatology • Feature Articles • Journal Club (Review an article)

• Cosmetic Pearls Professional Development • Feature Articles • Outside & Inside the 9 to 5

(Share the story of the work you do outside of your daily dermatology profession)

• Notes from your Office Manager • Judicial & Ethical Affairs

(Review an article)

• Surgical Wisdom

Vol. 4, No. 4 FALL 2010 13

Dermatology PA news & notes

Question: A healthy 30 year-old presents with a 3-day history of productive cough and fever. On physical examination, patient’s temperature is 101.5°F and crackles and increased tactile fremitus are noted over the left lower lobe. Laboratory testing reveals a white blood cell count of 18,000/mm3 with a left shift.

Which of the following is the treatment of choice for this patient?

A. Ceftriaxone (Rocephin) B. Vancomycin (Vancocin) C. Clindamycin (Cleocin) D. Levofloxacin (Levaquin)

count will be elevated with a left shift and many white blood cells and a predominant organism may be noted on sputum gram stain. Chest x-ray will reveal infiltrate and possible pleural effusion. Treatment consists of supportive care and antibiotics. Antibiotic selection is based on the presence of comorbid conditions. In patients with comorbid conditions such as diabetes, COPD, or heart failure, the patient should be hospitalized and treated with a beta-lactam plus a macrolide or a fluoroquinolone alone. In patients with no comorbid conditions, treatment consists of a macrolide, fluoroquinolone, or doxycycline. J

The correct answer is D.

Are you recertifying soon? Don’t worry – the JDPA is committed to helping you pass your boards.

Issues of the JDPA will feature one board question accompanied by a brief explanation of the answer along with any pertinent test taking tips. Best of luck!

Congratulations to all of our SDPA Diplomates!

After June 2011

All 10 modules need to be completed for Diplomate Status

Enroll today!

Become a SDPA Diplomate! www.dermPA.org/diplomate 1 14 diplomate_001a.indd Journal of Dermatology for Physician Assistants

6/30/10 2:34 PM

Clinical Dermatology

A Review of Allergic Contact Dermatitis & Patch Testing

By J. Desiree Douglas, MPA, PA-C

SDPA Members Only Content A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

CME

This program has been reviewed and is approved for a maximum of .5 hours of AAPA Category I CME credit by the Physician Assistant Review Panel.

Approval is valid for 1 year from the issue date of OCTOBER 2010. Participants may submit the self-assessment exam at any time during that period.

This program was planned in accordance with AAPAâ&#x20AC;&#x2122;s CME Standards for Enduring Material Programs and for Commercial Support of Enduring Material Programs.

SDPA members may access the posttest at www.jdpa.org

Learning Objectives: 1) Review of allergic contact dermatitis.

2) Recognize and understand how to properly diagnose allergic contact dermatitis (using a detailed history and physical examination).

3) Identify and describe the process associated with the thin-layer rapid use epicutaneous (TRUE) test and with comprehensive patch testing.

4) Describe the role the Contact Allergen Replacement Database (CARD) has in patch testing and be able to further assist patients in identifying certain products not listed on the CARD system.

Vol. 4, No. 4 FALL 2010 15

A Review of Allergic Contact Dermatitis & Patch Testing SDPA Members Only Content

CLINICAL Dermatology

A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

16 Journal of Dermatology for Physician Assistants

A Review of Allergic Contact Dermatitis & Patch Testing SDPA Members Only Content

CLINICAL Dermatology

A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

Vol. 4, No. 4 FALL 2010 17

A Review of Allergic Contact Dermatitis & Patch Testing SDPA Members Only Content

CLINICAL Dermatology

A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

18 Journal of Dermatology for Physician Assistants

A Review of Allergic Contact Dermatitis & Patch Testing SDPA Members Only Content

CLINICAL Dermatology

A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

Vol. 4, No. 4 FALL 2010 19

A Review of Allergic Contact Dermatitis & Patch Testing SDPA Members Only Content

CLINICAL Dermatology

A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

20 Journal of Dermatology for Physician Assistants

A Review of Allergic Contact Dermatitis & Patch Testing SDPA Members Only Content

CLINICAL Dermatology

A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

Vol. 4, No. 4 FALL 2010 21

A Review of Allergic Contact Dermatitis & Patch Testing SDPA Members Only Content

CLINICAL Dermatology

A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

J. Desiree Douglas, MPA, PA-C has been a physician assistant for ten years and has worked in dermatology for four years. She is Co-Director of the Occupational and Allergic Contact Dermatitis Clinic at the University of Pittsburgh Medical Center. She has indicated no relationships to disclose relating to the content of this article.

&

Dermatoscopy Q A Q: What is it?

Under Dermatoscopy

Answer on page 24 22 Journal of Dermatology for Physician Assistants

From The Patient’s Perspective What Life Is Like With Psoriasis Life is rough. But life with psoriasis is rougher.

There will always be kids who pick on you no matter where you go. There will always be healthcare providers who will not know how to treat your condition. There are those days that all you want to do is cry. But if you have good friends, doctors whom you feel comfortable with, and a positive attitude, life will not seem as rough.

Kids will tease you, pick on you, and call you names. They will call you things like “Poke-a-dots.”

They will tell you that you have “chicken pox.” Or they will tell you that they’re going to play “connect the dots” on you. If you surround yourself with good friends, those kids will not tease you as much because they can’t hurt you. A good friend will always stick up for you. If a friend is being mean or helping kids pick on you, then he/she is not a real friend. So always pick your friends wisely.

There are many different kinds of healthcare providers out there. Some are so amazing and nice!

There are also providers who will not want to touch you. Your first impression always counts. Tell your parents right away if you do not feel comfortable.

When you do find a good provider, tell your parents right away. They always want to know your opinions.

In life you will have “those days,” days that all you want to do is cry. You want to cry because you do not fit in or someone has been calling you names for weeks. When I had those days, all I wanted to do was curl up into a ball on my mom’s lap and cry. My mom would hold me and rock me until I stopped. It was nice because I could vent and get all those bad feelings out. It is always a good thing to keep your Clarissa Dempsey, age 14 is from Elizabethtown, PA, and has had psoriasis since she was four. She was diagnosed with psoriatic arthritis in the spine at age 13. She has participated in the National Psoriasis Foundation’s Capitol Hill Day and was a youth ambassador. She led a team in the Philadelphia Walk to Cure Psoriasis.

Clarissa was a youth mentor at the Foundation’s 2009 Volunteer Leadership Conference. She wants to help educate others about psoriasis and psoriatic arthritis. She wants other kids to know that your skin doesn’t make you who you are.

head up and tell yourself you are special and you can make it through no matter what.

Life with psoriasis is not that bad if you have good friends, providers whom you feel comfortable with, and a positive attitude. Do special things that make you feel good! Have friends who will stand up for you no matter what. Make sure you and your parents are comfortable with your healthcare providers. Keep a positive attitude on life.

Two phrases have kept me going through the highs and the lows. The first phrase is, “Don’t forget you are beautiful,” by Demi Lovato. The next phrase is from my favorite song, “A little bit longer and I will be fine,” by Nick Jonas. So don’t forget you are beautiful no matter what and that it might take some time but it won’t take long till you’re fine. So keep your head up high and move forward into the spot light! Life is not that rough after all! J

Take Home points for derm pas:

By Steven K. Shama, MD, MPH 1. Wouldn’t it be wonderful to begin talking to a young person with psoriasis about how he/she might be insensitively treated by an acquaintance and end with...”And if that should happen please know that I am here to make you feel better.”

2. Wouldn’t it be wonderful for you to talk to that young person with psoriasis and let him/her know that they may feel like crying sometimes and you be able to say...”It is ok... you have your best friends, your parents, and you have me (your health care provider) to give you a hug.” Remember also to say that you are absolutely sure that he/she is special and unique and...beautiful, outside and inside!

3. Our patients are some of our best teachers. We must remember to listen to them.

Vol. 4, No. 4 FALL 2010 23

CLINICAL Dermatology

By Clarissa Dempsey

&

Dermatoscopy Q A

A: Bowen’s disease that arose in a seborrheic keratosis

CLINICAL Dermatology

Melan A stain

Under Dermatoscopy

SDPA Members Only Content A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

Let them know they’re not alone...

Share a story with your patients.

Visit the Patient’s Perspective library of articles at www.jdpa.org/advocacy.html If you know a patient who would like to share his/her story, please contact us at editor@jdpa.org 24 Journal of Dermatology for Physician Assistants

Clinical snapshots Bed Bugs (Cimex lectularius)

By Travis Hayden, MPAS, RPA-C

A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

Fig. 2

CLINICAL Dermatology

SDPA Members Only Content

Fig. 1

Vol. 4, No. 4 FALL 2010 25

SDPA Members Only Content A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

CLINICAL Dermatology

Travis Hayden, MPAS, PA-C practices dermatology with John Tu, MD at Dermatology Associates of Rochester, New York. He has indicated no relationships to disclose relating to the content of this article.

Drugs in Dermatology iPLEDGE FAQs SDPA Members Only Content A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

iPLEDGE

26 Journal of Dermatology for Physician Assistants

THREE NEW STRENGTHS for More Precise SOLODYN Dosing

40-0%:/ 5BCMFUT NH NH BOE NH GPSNVMBUJPOT BSF BMTP BWBJMBCMF GPS QBUJFOUT XFJHIJOH o MCT o LH o MCT o LH

BOEø o MCT o LH SFTQFDUJWFMZ

40-0%:/ JT JOEJDBUFE UP USFBU POMZ JOn BNNBUPSZ MFTJPOT PG OPO OPEVMBS NPEFSBUF UP TFWFSF BDOF WVMHBSJT JO QBUJFOUT ZFBST PG BHF BOE PMEFS 40-0%:/ EJE OPU EFNPOTUSBUF BOZ FGGFDU PO OPO JOn BNNBUPSZ MFTJPOT 4BGFUZ PG 40-0%:/ IBT OPU CFFO FTUBCMJTIFE CFZPOE XFFLT PG VTF 5IJT GPSNVMBUJPO PG NJOPDZDMJOF IBT OPU CFFO FWBMVBUFE JO UIF USFBUNFOU PG JOGFDUJPOT 5P SFEVDF UIF EFWFMPQNFOU PG ESVH SFTJTUBOU CBDUFSJB BT XFMM BT UP NBJOUBJO UIF FGGFDUJWFOFTT PG PUIFS BOUJCBDUFSJBM ESVHT 40-0%:/ TIPVME CF VTFE POMZ BT JOEJDBUFE

Important Safety Information for SOLODYN Tablets t 5IF NPTU DPNNPOMZ SFQPSUFE TJEF FGGFDUT XFSF IFBEBDIF GBUJHVF EJ[[JOFTT BOE QSVSJUVT t .JOPDZDMJOF MJLF PUIFS UFUSBDZDMJOFT DBO DBVTFøGFUBM IBSN XIFO BENJOJTUFSFE UP B QSFHOBOU XPNBO t 5FUSBDZDMJOF ESVHT TIPVME OPU CF VTFE EVSJOH UPPUI EFWFMPQNFOU MBTU IBMG PG QSFHOBODZ BOE VQ UP ZFBST PG BHF BT UIFZ NBZ DBVTF QFSNBOFOU EJTDPMPSBUJPO PG UFFUI t 1TFVEPNFNCSBOPVT DPMJUJT IBT CFFO SFQPSUFE XJUI OFBSMZ BMM BOUJCBDUFSJBM BHFOUT BOE NBZ SBOHF GSPN NJME UP MJGF UISFBUFOJOH UIFSFGPSF JU JT JNQPSUBOU UP DPOTJEFS UIJT EJBHOPTJT JO QBUJFOUT XIP QSFTFOU XJUI EJBSSIFB TVCTFRVFOU UP UIF BENJOJTUSBUJPO PG BOUJCBDUFSJBM BHFOUT

t *O SBSF DBTFT QIPUPTFOTJUJWJUZ IBT CFFO SFQPSUFE t 4IPVME OPU CF VTFE EVSJOH QSFHOBODZ OPS CZ JOEJWJEVBMT PG FJUIFS HFOEFS XIP BSF BUUFNQUJOH UP DPODFJWF B DIJME DPODVSSFOU VTF PG UFUSBDZDMJOFT XJUI PSBM DPOUSBDFQUJWFT NBZ SFOEFS PSBM DPOUSBDFQUJWFT MFTT FGGFDUJWF t 5IJT ESVH JT DPOUSBJOEJDBUFE JO QFSTPOT XIP IBWF TIPXO IZQFSTFOTJUJWJUZ UP BOZ PG UIF UFUSBDZDMJOFT t 4BGFUZ CFZPOE XFFLT PG VTF IBT OPU CFFO FTUBCMJTIFE

t $FOUSBM OFSWPVT TZTUFN TJEF FGGFDUT JODMVEJOH MJHIU IFBEFEOFTT EJ[[JOFTT BOE WFSUJHP IBWF CFFO SFQPSUFE XJUI NJOPDZDMJOF UIFSBQZ

See following pages for Brief Summary of Full Prescribing Information.

40-0%:/ JT B SFHJTUFSFE USBEFNBSL PG .FEJDJT 1IBSNBDFVUJDBM $PSQPSBUJPO 40- "

/PX XJUI (SFBUFS %PTJOH 1SFDJTJPO Vol. 4, No. 4 FALL 2010 27

BRIEF SUMMARY (see package insert for full prescribing information) SOLODYN® (minocycline HCl, USP) Extended Release Tablets Rx Only KEEP OUT OF REACH OF CHILDREN INDICATIONS AND USAGE Indication SOLODYN is indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older.

Limitations of Use SOLODYN did not demonstrate any effect on non-inflammatory acne lesions. Safety of SOLODYN has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections.

treated early in pregnancy (see Use in Specific Populations).

Pseudomembranous Colitis Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.

Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia.

Studies indicate that a toxin produced by Clostridium difficile is a primary cause of “antibiotic-associated colitis”.

After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of To reduce the development of drugthe drug alone. In moderate to severe resistant bacteria as well as to maintain the cases, consideration should be given to effectiveness of other antibacterial drugs, management with fluids and electrolytes, SOLODYN should be used only as indicated protein supplementation, and treatment (see Warnings and Precautions). with an antibacterial drug clinically effective against Clostridium difficile colitis.

CONTRAINDICATIONS This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

WARNINGS AND PRECAUTIONS Teratogenic Effects A. MINOCYCLINE, LIKE OTHER TETRACYCLINE-CLASS ANTIBIOTICS, CAN CAUSE FETAL HARM WHEN ADMINISTERED TO A PREGNANT WOMAN. IF ANY TETRACYCLINE IS USED DURING PREGNANCY OR IF THE PATIENT BECOMES PREGNANT WHILE TAKING THESE DRUGS, THE PATIENT SHOULD BE APPRISED OF THE POTENTIAL HAZARD TO THE FETUS.

Hepatotoxicity Post-marketing cases of serious liver injury, including irreversible drug-induced hepatitis and fulminant hepatic failure (sometimes fatal) have been reported with minocycline use in the treatment of acne.

Metabolic Effects The anti-anabolic action of the tetracyclines may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline-class antibiotics may lead to azotemia, hyperphosphatemia, and acidosis.

If renal impairment exists, even usual oral or parenteral doses may lead to excessive systemic accumulations of the drug and possible liver toxicity. Under such conditions, lower than usual total doses are indicated, and if therapy is prolonged, serum level determinations of the drug may be advisable.

visual disturbances prior to initiation of treatment with tetracyclines and should be routinely checked for papilledema while on treatment. Concomitant use of isotretinoin and minocycline should be avoided because isotretinoin, a systemic retinoid, is also known to cause pseudotumor cerebri.

Autoimmune Syndromes Tetracyclines have been associated with the development of autoimmune syndromes.

The long-term use of minocycline in the treatment of acne has been associated with drug-induced lupus-like syndrome, autoimmune hepatitis and vasculitis.

Sporadic cases of serum sickness have presented shortly after minocycline use. Symptoms may be manifested by fever, rash, arthralgia, and malaise. In symptomatic patients, liver function tests, ANA, CBC, and other appropriate tests should be performed to evaluate the patients. Use of all tetracycline-class drugs should be discontinued immediately.

28 Journal of Dermatology for Physician Assistants

ADVERSE REACTIONS Clinical Trial Experience Because clinical trials are conducted under prescribed conditions, adverse reaction rates observed in the clinical trial may not reflect the rates observed in practice.

The following table summarizes selected adverse reactions reported in clinical trials at a rate of ≥1% for SOLODYN.

Selected Treatment-Emergent Adverse Reactions in at least 1% of Clinical Trial Subjects Adverse Reactions SOLODYN PLACEBO (1 mg/kg) N=364 N=674 (%) (%) At least one treatment- 379 (56) 197 (54) emergent event Photosensitivity Headache 152 (23) 83 (23) Photosensitivity manifested by an Fatigue 62 (9) 24 (7) exaggerated sunburn reaction has been Dizziness 59 (9) 17 (5) observed in some individuals taking Pruritus 31 (5) 16 (4) tetracyclines. This has been reported Malaise 26 (4) 9 (3) rarely with minocycline. Patients should minimize or avoid exposure to natural or Mood alteration 17 (3) 9 (3) artificial sunlight (tanning beds or UVA/B Somnolence 13 (2) 3 (1) treatment) while using minocycline. If Urticaria 10 (2) 1 (0) patients need to be outdoors while using Tinnitus 10 (2) 5 (1) minocycline, they should wear loose-fitting Arthralgia 9 (1) 2 (0) clothes that protect skin from sun exposure Vertigo 8 (1) 3 (1) and discuss other sun protection measures Dry mouth 7 (1) 5 (1) with their physician.

Myalgia 7 (1) 4 (1) Postmarketing Experience Serious Skin/Hypersensitivity Reaction Adverse reactions that have been reported Post-marketing cases of anaphylaxis with minocycline hydrochloride use in a and serious skin reactions such as variety of indications include: Stevens-Johnson syndrome and erythema Skin and hypersensitivity reactions: multiforme have been reported with fixed drug eruptions, balanitis, erythema minocycline use in treatment of acne. multiforme, Stevens-Johnson syndrome,

Tissue Hyperpigmentation Tetracycline-class antibiotics are known to cause hyperpigmentation. Tetracycline therapy may induce hyperpigmentation in many organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity (teeth, mucosa, alveolar bone), sclerae and B. THE USE OF DRUGS OF THE heart valves. Skin and oral pigmentation Central Nervous System Effects TETRACYCLINE-CLASS DURING has been reported to occur independently TOOTH DEVELOPMENT (LAST HALF OF Central nervous system side effects of time or amount of drug administration, PREGNANCY, INFANCY, AND CHILDHOOD including light-headedness, dizziness or whereas other tissue pigmentation has vertigo have been reported with minocycline UP TO THE AGE OF 8 YEARS) MAY been reported to occur upon prolonged therapy. Patients who experience these CAUSE PERMANENT DISCOLORATION administration. Skin pigmentation includes OF THE TEETH (YELLOW-GRAY-BROWN). symptoms should be cautioned about diffuse pigmentation as well as over sites driving vehicles or using hazardous This adverse reaction is more common of scars or injury. machinery while on minocycline therapy. during long-term use of the drug but These symptoms may disappear during Development of Drug Resistant has been observed following repeated therapy and usually rapidly disappear Bacteria short-term courses. Enamel hypoplasia when the drug is discontinued.

Bacterial resistance to the tetracyclines has also been reported. TETRACYCLINE may develop in patients using SOLODYN, Benign Intracranial Hypertension DRUGS, THEREFORE, SHOULD NOT BE therefore, the susceptibility of bacteria Pseudotumor cerebri (benign intracranial USED DURING TOOTH DEVELOPMENT. associated with infection should be hypertension) in adults and adolescents C. All tetracyclines form a stable calcium considered in selecting antimicrobial has been associated with the use complex in any bone-forming tissue. A therapy. Because of the potential for of tetracyclines. Minocycline has decrease in fibula growth rate has been been reported to cause or precipitate drug-resistant bacteria to develop during observed in premature human infants the use of SOLODYN, it should be used only pseudotumor cerebri, the hallmark given oral tetracycline in doses of 25 as indicated. of which is papilledema. Clinical mg/kg every 6 hours. This reaction was manifestations include headache and Superinfection shown to be reversible when the drug blurred vision. Bulging fontanels have been As with other antibiotic preparations, use was discontinued. associated with the use of tetracyclines of SOLODYN may result in overgrowth of Results of animal studies indicate that in infants. Although signs and symptoms nonsusceptible organisms, including fungi. tetracyclines cross the placenta, are of pseudotumor cerebri resolve after If superinfection occurs, the antibiotic found in fetal tissues, and can cause discontinuation of treatment, the possibility should be discontinued and appropriate retardation of skeletal development for permanent sequelae such as visual therapy instituted. on the developing fetus. Evidence of loss that may be permanent or severe embryotoxicity has been noted in animals exists. Patients should be questioned for SOLODYN should not be used during pregnancy or by individuals of either gender who are attempting to conceive a child (see Nonclinical Toxicology & Use in Specific Populations).

Laboratory Monitoring Periodic laboratory evaluations of organ systems, including hematopoietic, renal and hepatic studies should be performed.

Appropriate tests for autoimmune syndromes should be performed as indicated.

anaphylactoid purpura, photosensitivity, pigmentation of skin and mucous membranes, hypersensitivity reactions, angioneurotic edema, anaphylaxis.

Autoimmune conditions: polyarthralgia, pericarditis, exacerbation of systemic lupus, pulmonary infiltrates with eosinophilia, transient lupus-like syndrome.

Central nervous system: pseudotumor cerebri, bulging fontanels in infants, decreased hearing.

Endocrine: thyroid discoloration, abnormal thyroid function.

Oncology: papillary thyroid cancer.

Oral: glossitis, dysphagia, tooth discoloration.

Gastrointestinal: enterocolitis, pancreatitis, hepatitis, liver failure.

Renal: reversible acute renal failure.

Hematology: hemolytic anemia, thrombocytopenia, eosinophilia.

Preliminary studies suggest that use of minocycline may have deleterious effects on human spermatogenesis (see Nonclinical Toxicology).

DRUG INTERACTIONS Anticoagulants Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

Penicillin Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin.

Methoxyflurane The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.

Antacids and Iron Preparations Absorption of tetracyclines is impaired by antacids containing aluminum, calcium or magnesium and iron-containing preparations.

Low Dose Oral Contraceptives In a multi-center study to evaluate the effect of SOLODYN on low dose oral contraceptives, hormone levels over one menstrual cycle with and without SOLODYN 1 mg/kg once-daily were measured. Based on the results of this trial, minocycline-related changes in estradiol, progestinic hormone, FSH and LH plasma levels, of breakthrough bleeding, or of contraceptive failure, can not be ruled out. To avoid contraceptive failure, female patients are advised to use a second form of contraceptive during treatment with minocycline.

Drug/Laboratory Test Interactions False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.

USE IN SPECIFIC POPULATIONS Pregnancy Teratogenic Effects: Pregnancy category D (see Warnings and Precautions) SOLODYN should not be used during pregnancy. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus and stop treatment immediately.

There are no adequate and well-controlled studies on the use of minocycline in pregnant women. Minocycline, like other tetracycline-class drugs, crosses the placenta and may cause fetal harm when administered to a pregnant woman.

Rare spontaneous reports of congenital anomalies including limb reduction have been reported with minocycline use in pregnancy in post-marketing experience.

Only limited information is available regarding these reports; therefore, no conclusion on causal association can be established.

Minocycline induced skeletal malformations (bent limb bones) in fetuses when administered to pregnant rats and rabbits in doses of 30 mg/kg/day and 100 mg/kg/day, respectively, (resulting in approximately 3 times and 2 times, respectively, the systemic exposure to minocycline observed in patients as a result of use of SOLODYN). Reduced mean fetal body weight was observed in studies in which minocycline was administered to pregnant rats at a dose of 10 mg/kg/day (which resulted in approximately the same level of systemic exposure to minocycline as that observed in patients who use SOLODYN).

Minocycline was assessed for effects on peri- and post-natal development of rats in a study that involved oral administration to pregnant rats from day 6 of gestation through the period of lactation (postpartum day 20), at dosages of 5, 10, or 50 mg/kg/day. In this study, body weight gain was significantly reduced in pregnant females that received 50 mg/kg/day (resulting in approximately 2.5 times the systemic exposure to minocycline observed in patients as a result of use of SOLODYN).

No effects of treatment on the duration of the gestation period or the number of live pups born per litter were observed. Gross external anomalies observed in F1 pups (offspring of animals that received minocycline) included reduced body size, improperly rotated forelimbs, and reduced size of extremities. No effects were observed on the physical development, behavior, learning ability, or reproduction of F1 pups, and there was no effect on gross appearance of F2 pups (offspring of F1 animals).

evaluate the carcinogenic potential of minocycline. A structurally related compound, oxytetracycline, was found to produce adrenal and pituitary tumors in rats.

contains minocycline hydrochloride equivalent to 65 mg minocycline, supplied as follows:

Mutagenesis—Minocycline was not mutagenic in vitro in a bacterial reverse mutation assay (Ames test) or CHO/HGPRT mammalian cell assay in the presence or absence of metabolic activation.

Minocycline was not clastogenic in vitro using human peripheral blood lymphocytes or in vivo in a mouse micronucleus test.

The 80 mg extended release tablets are gray, unscored, coated, and debossed with “DYN-080” on one side. Each tablet contains minocycline hydrochloride equivalent to 80 mg minocycline, supplied as follows:

NDC 99207-463-30

NDC 99207-466-30

Bottle of 30

Bottle of 30

The 90 mg extended release tablets are Impairment of Fertility—Male and yellow, unscored, coated, and debossed female reproductive performance in with “DYN-090” on one side. Each tablet rats was unaffected by oral doses of contains minocycline hydrochloride minocycline of up to 300 mg/kg/day (which equivalent to 90 mg minocycline, supplied resulted in up to approximately 40 times the as follows: level of systemic exposure to minocycline observed in patients as a result of use of NDC 99207-461-30 Bottle of 30 SOLODYN). However, oral administration of NDC 99207-461-10 Bottle of 100 100 or 300 mg/kg/day of minocycline to The 105 mg extended release tablets are male rats (resulting in approximately 15 to 40 times the level of systemic exposure to purple, unscored, coated, and debossed minocycline observed in patients as a result with “DYN-105” on one side. Each tablet contains minocycline hydrochloride Nursing Mothers of use of SOLODYN) adversely affected Tetracycline-class antibiotics are excreted spermatogenesis. Effects observed at 300 equivalent to 105 mg minocycline, supplied as follows: in human milk. Because of the potential for mg/kg/day included a reduced number serious adverse effects on bone and tooth of sperm cells per gram of epididymis, NDC 99207-467-30 Bottle of 30 development in nursing infants from the an apparent reduction in the percentage tetracycline-class antibiotics, a decision The 115 mg extended release tablets are of sperm that were motile, and (at 100 should be made whether to discontinue green, unscored, coated, and debossed and 300 mg/kg/day) increased numbers nursing or discontinue the drug, taking into of morphologically abnormal sperm cells. with “DYN-115” on one side. Each tablet account the importance of the drug to the Morphological abnormalities observed in contains minocycline hydrochloride mother (see Warnings and Precautions). equivalent to 115 mg minocycline, sperm samples included absent heads, supplied as follows: misshapen heads, and abnormal flagella.

Pediatric Use SOLODYN is indicated to treat only NDC 99207-464-30 Bottle of 30 Limited human studies suggest that inflammatory lesions of non-nodular minocycline may have a deleterious effect The 135 mg extended release tablets are moderate to severe acne vulgaris on spermatogenesis. pink (orange-brown), unscored, coated, in patients 12 years and older.

SOLODYN should not be used by individuals and debossed with “DYN-135” on one Safety and effectiveness in pediatric of either gender who are attempting to side. Each tablet contains minocycline patients below the age of 12 has not conceive a child. hydrochloride equivalent to 135 mg been established. minocycline, supplied as follows: Use of tetracycline-class antibiotics below HOW SUPPLIED/STORAGE AND HANDLING NDC 99207-462-30 Bottle of 30 the age of 8 is not recommended due to How Supplied NDC 99207-462-10 Bottle of 100 the potential for tooth discoloration (see SOLODYN (minocycline HCl, USP) Extended Warnings and Precautions).

Storage Release Tablets are supplied as aqueous Geriatric Use film coated tablets containing minocycline Store at 25ºC (77ºF); excursions are Clinical studies of SOLODYN did not hydrochloride equivalent to 45 mg, 55 mg, permitted to 15º-30ºC (59º-86ºF) [See USP Controlled Room Temperature]. include sufficient numbers of subjects aged 65 mg, 80 mg, 90 mg, 105 mg, 115 mg 65 and over to determine whether they or 135 mg minocycline, are supplied Handling respond differently from younger subjects. as follows.

Keep out of reach of children Other reported clinical experience has not Protect from light, moisture, and identified differences in responses between The 45 mg extended release tablets are excessive heat. the elderly and younger patients. In general, gray, unscored, coated, and debossed dose selection for an elderly patient should with “DYN-045” on one side. Each tablet Dispense in tight, light-resistant container be cautious, usually starting at the low end contains minocycline hydrochloride with child-resistant closure. equivalent to 45 mg minocycline, supplied of the dosing range, reflecting the greater as follows: U.S. Patent 5,908,838* and Patents Pending frequency of decreased hepatic, renal, or *90 mg is also covered by U.S. Patents cardiac function, and concomitant disease NDC 99207-460-30 Bottle of 30 7,541,347 and 7,544,373 or other drug therapy.

NDC 99207-460-10 Bottle of 100 Manufactured for: OVERDOSAGE The 55 mg extended release tablets are Medicis, The Dermatology Company In case of overdosage, discontinue pink, unscored, coated, and debossed Scottsdale, AZ 85256 medication, treat symptomatically and with “DYN-055” on one side. Each tablet institute supportive measures. Minocycline contains minocycline hydrochloride August 2010 is not removed in significant quantities by equivalent to 55 mg minocycline, supplied 17110163 hemodialysis or peritoneal dialysis. as follows: NONCLINICAL TOXICOLOGY NDC 99207-465-30 Bottle of 30 Carcinogenesis, Mutagenesis, The 65 mg extended release tablets are Impairment of Fertility blue, unscored, coated, and debossed Carcinogenesis—Long-term animal with “DYN-065” on one side. Each tablet studies have not been performed to

Vol. 4, No. 4 FALL 2010 29

SURGICAL Dermatology

Beyond the Ellipse...

Bilateral Advancement Flaps

By Douglas DiRuggiero, PA-C and John Chung, MD

SDPA Members Only Content A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

Fig. 1

Fig. 2

Fig. 3

Fig. 4

Fig. 5

30 Journal of Dermatology for Physician Assistants

SDPA Members Only Content A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

Fig. 6

Fig. 7

Douglas DiRuggiero, PA-C has practiced dermatology for 9 years and works with John Chung, MD, who is a board certified dermatologist and fellowship-trained Mohs surgeon.

SURGICAL wisdom

Surgical Terminology

By Mark Hyde, MMS, PA-C

SDPA Members Only Content A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

Mark Hyde, MMS, PA-C is a graduate of the Physician Assistant Program at Midwestern University in Glendale, Arizona. He is a Diplomate of the Society of Dermatology Physician Assistants. He presently resides in Salt Lake City, Utah where he works with the Melanoma and Cutaneous Oncology Program for the Huntsman Cancer Institute at the University of Utah.

Learn more about these surgical terms and others in the upcoming series â&#x20AC;&#x153;Suture Subtleties for Dermatology PAsâ&#x20AC;? available in future issues of the JDPA as well as on dermcast.tv.

Vol. 4, No. 4 FALL 2010 31

SURGICAL Dermatology

Fig. 8

SURGICAL Dermatology

Cosmetic pearls Top 10 Tips for Healthy Skin, Hair and Nails SDPA Members Only Content A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

32 Journal of Dermatology for Physician Assistants

30

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Safety everyone can rely on

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From pediatrics to adults, Cloderm® Cream is the “Class C” topical steroid that demonstrated excellent safety and efficacy in FDA-reviewed clinical studies1 • Cloderm® Cream has no age restriction • Rapid response—as early as day 41 • Class C corticosteroid: no significant cross-reactivity2 • The most common adverse events with Cloderm® Cream include dryness, irritation, folliculitis, acneiform eruptions, and burning.

Cloderm® Cream is contraindicated in patients who are hypersensitive to any of the ingredients of this product. As with all topical corticosteroids, systemic absorption can produce reversible HPA-axis suppression.

Please see Full Prescribing Information on reverse side of page.

References: 1. Data on file, CORIA Laboratories, Ltd. 2. Jacob SE, Steele T. Corticosteroid classes: a quick reference guide including patch test substances and cross-reactivity. J Am Acad Dermatol. 2006;54(4):723-727.

Cloderm is a trademark of CORIA Laboratories, Ltd. ©2007 CORIA Laboratories, Ltd. CL20035-1107

New pump delivery makes dosing easy for patients Vol. 4, No. 4 FALL 2010 33

CONTRAINDICATIONS: Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Laboratory Tests: The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test ACTH stimulation test

PRECAUTIONS: General: Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.

Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.

Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.

Chemically, clocortolone pivalate is 9-chloro-6_-fluoro-11`, 21-dihydroxy-16_ methylpregna-1, 4-diene-3, 20-dione 21-pivalate.

Its structure is as follows:

Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.

CLINICAL PHARMACOLOGY: Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.

Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids.

There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity.

(See PRECAUTIONS-Pediatric Use).

Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

Information for the Patient: Patients using topical corticosteroids should receive the following information and instructions: 1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.

2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed.

3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.

4. Patients should report any signs of local adverse reactions especially under occlusive dressing.

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Pregnancy Category C: Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

OVERDOSAGE: Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

DOSAGE AND ADMINISTRATION: Apply Cloderm (clocortolone pivalate) Cream 0.1% sparingly to the affected areas three times a day and rub in gently.

Nursing Mothers: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have deleterious effect on the infant.

Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate anti-microbial therapy instituted.

Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area body weight ratio.

Store Cloderm Cream between 15° and 30° C (59° and 86° F).

Avoid freezing.

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

HOW SUPPLIED: Cloderm (clocortolone pivalate) Cream 0.1% is supplied in a 30 gram pump bottle, 45 gram and 90 gram tubes.

Distributed by:

CORIA LABORATORIES, LTD. Fort Worth, Texas 76107 Manufactured by: DPT LABORATORIES, LTD. San Antonio, Texas 78215 Reorder No.13548-031-30 (30g) pump bottle Reorder No.13548-031-45 (45g) tube Reorder No.13548-031-90 (90g) tube 128622-0707

PACIFIC DIGITAL IMAGE • 333 Broadway, San Francisco CA 94133 • 415.274.7234 • www.pacdigital.com Filename: 256058gi202rnld1ps05 Operator: poolerer Time: 171244 Colors: lac Date: 100916 LPI: VPS OK:

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sep2010_triplicate_jdpa.indd 1

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34 Journal of Dermatology for Physician Assistants

9/30/10 1:01 PM

Live: 6.25"w x 4.25"h

In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted.

If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Topical corticosteroids can be absorbed from normal intact skin.

Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids.

Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (See DOSAGE AND ADMINISTRATION).

Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

ADVERSE REACTIONS: The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: Burning Itching Irritation Dryness Folliculitis Hypertrichosis Acneform eruptions Hypopigmentation Perioral dermatitis Allergic contact dermatitis Maceration of the skin Secondary infection Skin atrophy Striae Miliaria

Bleed: N/A Trim: 6.75"w x 4.75"h Output @ 100% Giant Creative Strategy

DESCRIPTION: Cloderm Cream 0.1% contains the medium potency topical corticosteroid, clocortolone pivalate, in a specially formulated water-washable emollient cream base consisting of purified water, white petrolatum, mineral oil, stearyl alcohol, polyoxyl 40 stearate, carbomer 934P, edetate disodium, sodium hydroxide, with methylparaben and propylparaben as preservatives.

5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.

100%

FOR TOPICAL DERMATOLOGIC USE ONLY–NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE. WARNING: KEEP OUT OF REACH OF CHILDREN

INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroidresponsive dermatoses.

Professional development

The History of the SDPA

By Patricia Ferrer, MPAS, PA-C

SDPA Members Only Content A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

Patricia Ferrer, MPAS, PA-C graduated from the University of Texas Medical Branch in 1998 and obtained her Masters Degree from the University of Nebraska in 2003 (SDPA scholarship). She is an Associate member of the SDPA and the AAPA. She has been working in dermatology for nine years and is currently working part-time as a dermatology PA for the Tucson VA and volunteers locally and in Mexico. She has no outside relationships with industry to disclose.

Patricia would like to thank all who contributed to this article and those who were instrumental in the development of the SDPA who may not have been mentioned.

Sources for this article include: SDPA newsletters from July 2006 â&#x20AC;&#x201C; June 2010; email correspondences with Kristine Kucera, Bethany Grubb, Travis Hayden, and Terry Arnold; email and phone conversations with Nancy Primo, Greg Buttolph, Gordon Day, and Robert Higham.

Vol. 4, No. 4 FALL 2010 35

SDPA Members Only Content

professional development

A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

36 Journal of Dermatology for Physician Assistants

SDPA Members Only Content

professional development

A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

Vol. 4, No. 4 FALL 2010 37

SDPA Members Only Content

professional development

A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

38 Journal of Dermatology for Physician Assistants

Dermatology Billing & Coding Patch Testing: How to Bill it Correctly

By Inga Ellzey, MPA, RHIA, CDC

SDPA Members Only Content

professional development

A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

Ms. Ellzey, President/CEO of the Inga Ellzey Practice Group, Inc., in Casselberry, FL, is an expert on dermatology coding, documentation and reimbursement. She has more than 35 years of experience in the field of dermatology and is the CEO and founder of two nationwide dermatology billing services. You can reach her at the following number: (800) 318-3271, or email her at: inga@iepg.com.

Vol. 4, No. 4 FALL 2010 39

SDPA Members Only Content

professional development

A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

Notes from your Office Manager Complimentary SDPA Membership for Supervising Physicians

New Benefit for SDPA Fellow Members and Their Supervising Physicians SDPA Members Only Content A complimentary subscription to the JDPA is provided to the members of the SDPA. Please visit www.dermpa.org today to join the SDPA and gain full access to the valuable content of the JDPA.

J

40 Journal of Dermatology for Physician Assistants

For moderate to severe plaque psoriasis

Introducing a real sharpshooter NEW

spray nozzle more precisely hits a range of plaques on the body and scalp • Efficacy of Clobex® Spray confirmed in multiple clinical trials totaling more than 2000 patients1-3 —An average of 80% of patients clear or almost clear at 4 weeks1,2

NEW NOZZLE! Important Safety Information CLOBEX® (clobetasol propionate) Spray, 0.05%, is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older.

Clobetasol propionate has been shown to suppress the HPA axis at the lowest doses tested.

Clobetasol propionate spray should not be used in the treatment of rosacea or perioral dermatitis and should not be used on the face, groin or axillae.

In controlled clinical trials, the following adverse reactions have been reported: burning, pruritus, hyperpigmentation, infections and infestations, nasopharyngitis, upper respiratory tract infection, and skin and subcutaneous tissue disorders.

Treatment should be limited to 4 weeks. Treatment beyond 2 weeks should be limited to localized lesions of moderate to severe plaque psoriasis that have not sufficiently improved after the initial 2 weeks of treatment with CLOBEX® Spray, 0.05%.

CLOBEX® Spray, 0.05%, should not exceed 50 g (59 mL or 2 fl oz) per week.

CLOBEX® Spray, 0.05%, is not recommended for use on anyone younger than 18 years of age. Pregnancy Category C. Please see adjacent page for brief summary of Prescribing Information.

Log on to www.psoriasispro.com Vol. 4, No. 4 FALL 2010 41

CLOBEX

®

(clobetasol propionate) Spray, 0.05%

Rx Only BRIEF SUMMARY

INDICATIONS AND USAGE: CLOBEX® (clobetasol propionate) Spray, 0.05% is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older (see PRECAUTIONS). Treatment should be limited to 4 consecutive weeks. The total dosage should not exceed 50 g (59 mL or 2 fl. oz.) per week.

Before prescribing for more than 2 weeks, any additional benefits of extending treatment to 4 weeks should be weighed against the risk of HPA axis suppression.

Patients should be instructed to use CLOBEX® (clobetasol propionate) Spray, 0.05% for the minimum amount of time necessary to achieve the desired results (see PRECAUTIONS).

Use in patients under 18 years of age is not recommended because safety has not been established and because numerically high rates of HPA axis suppression were seen with other clobetasol propionate topical formulations (see PRECAUTIONS: Pediatric Use).

CONTRAINDICATIONS: CLOBEX® (clobetasol propionate) Spray, 0.05% is contraindicated in patients who are hypersensitive to clobetasol propionate, to other corticosteroids, or to any ingredient in this preparation.

PRECAUTIONS: General: Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the HPA axis at the lowest doses tested.

In studies evaluating the potential for hypothalamic-pituitary-adrenal (HPA) axis suppression, using the Cosyntropin Stimulation Test, CLOBEX® (clobetasol propionate) Spray, 0.05% demonstrated rates of suppression that were comparable after 2 and 4 weeks of twice-daily use (19% and 15-20%, respectively), in adult patients with moderate to severe plaque psoriasis (≥ 20%BSA). In these studies, HPA axis suppression was defined as serum cortisol level ≤18 �g/dL 30-min post cosyntropin stimulation. (See CLINICAL PHARMACOLOGY).

Patients with acute illness or injury may have increased morbidity and mortality with intermittent HPA axis suppression. Patients should be instructed to use CLOBEX® (clobetasol propionate) Spray, 0.05% for the minimum amount of time necessary to achieve the desired results (see INDICATIONS AND USAGE).

Systemic absorption of topical corticosteroids has caused reversible adrenal suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.

HPA axis suppression has not been evaluated in psoriasis patients treated with CLOBEX® (clobetasol propionate) Spray, 0.05% who are less than 18 years old. Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios (see PRECAUTIONS: Pediatric Use). The potential increase in systemic exposure does not correlate with any proven benefit, but may lead to an increased potential for hypothalamic-pituitary-adrenal (HPA) axis suppression.

Conditions which increase systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of adrenal suppression (see laboratory tests below). If adrenal suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.

Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.

If irritation develops, CLOBEX® (clobetasol propionate) Spray, 0.05% should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation, as with most topical products not containing corticosteroids.

In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, use of CLOBEX® (clobetasol propionate) Spray, 0.05% should be discontinued until the infection has been adequately controlled.

CLOBEX® (clobetasol propionate) Spray, 0.05% should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.

Information for Patients: Patients using topical corticosteroids should receive the following information and instructions: • This medication is to be used as directed by the physician and should not be used longer than the prescribed time period.

• This medication should not be used for any disorder other than that for which it was prescribed.

• The treated skin area should not be bandaged, otherwise covered, or wrapped so as to be occlusive unless directed by the physician.

• Patients should wash their hands after applying the medication.

• Patients should report any signs of local or systemic adverse reactions to the physician.

• Patients should inform their physicians that they are using CLOBEX® (clobetasol propionate) Spray, 0.05% if surgery is contemplated.

• This medication is for external use only. It should not be used on the face, underarms, or groin area.

Also avoid contact with the eyes and lips.

• As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician.

• Patients should not use more than 50 g (59 mL or 2 fl. oz.) per week of CLOBEX® (clobetasol propionate) Spray, 0.05%.

Instructions to the Pharmacist: 1. Remove the spray pump from the wrapper 2. Remove and discard the cap from the bottle 3. Keeping the bottle vertical, insert the spray pump into the bottle and turn clockwise until well-fastened 4. Dispense the bottle with the spray pump inserted Laboratory Tests: The cosyntropin stimulation test may be helpful in evaluating patients for HPA axis suppression.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential of clobetasol propionate.

Clobetasol propionate was negative in the in vitro mammalian chromosomal aberration test and in the in vivo mammalian erythrocyte micronucleus test.

The effect of subcutaneously administered clobetasol propionate on fertility and general reproductive toxicity was studied in rats at doses of 0, 12.5, 25, and 50 �g/kg/day. Males were treated beginning 70 days before mating and females beginning 15 days before mating through day 7 of gestation. A dosage level of less than 12.5 �g/kg/day clobetasol propionate was considered to be the no-observed-effect-level (NOEL) for paternal and maternal general toxicity based on decreased weight gain and for male reproductive toxicity based on increased weights of the seminal vesicles with fluid. The female reproductive NOEL was 12.5 �g/kg/day (ratio of animal dose to proposed human dose of 0.03 on a mg/m2/day basis) based on reduction in the numbers of estrous cycles during the pre-cohabitation period and an increase in the number of nonviable embryos at higher doses.

Pregnancy: Teratogenic effects: Pregnancy Category C. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals.

Clobetasol propionate is absorbed percutaneously, and when administered subcutaneously it was a significant teratogen in both the rabbit and the mouse. Clobetasol propionate has greater teratogenic potential than steroids that are less potent.

The effect of clobetasol propionate on pregnancy outcome and development of offspring was studied in the rat.

Clobetasol propionate was administered subcutaneously to female rats twice daily (0, 12.5, 25, and 50 �g/kg/day) from day 7 of presumed gestation through day 25 of lactation or day 24 presumed gestation for those rats that did not deliver a litter. The maternal NOEL for clobetasol propionate was less than 12.5 �g/kg/day due to reduced body weight gain and feed consumption during the gestation period. The reproductive NOEL in the dams was 25 �g/kg/day (ratio of animal dose to proposed human dose of 0.07 on a mg/m2/day basis) based on prolonged delivery at a higher dose level. The no-observed-adverse-effect-level (NOAEL) for viability and growth in the offspring was 12.5 �g/kg/day (ratio of animal dose to proposed human dose of 0.03 on a mg/m2/day basis) based on incidence of stillbirths, reductions in pup body weights on days 1 and 7 of lactation, increased pup mortality, increases in the incidence of umbilical hernia, and increases in

the incidence of pups with cysts on the kidney at higher dose levels during the preweaning period. The weights of the epididymides and testes were significantly reduced at higher dosages. Despite these changes, there were no effects on the mating and fertility of the offspring.

There are no adequate and well-controlled studies of the teratogenic potential of clobetasol propionate in pregnant women. CLOBEX® (clobetasol propionate) Spray, 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Because many drugs are excreted in human milk, caution should be exercised when CLOBEX® (clobetasol propionate) Spray, 0.05% is administered to a nursing woman.

Pediatric Use: Use in patients under 18 years of age is not recommended, because safety has not been established and because numerically high rates of HPA axis suppression were seen with other clobetasol propionate topical formulations. Safety and effectiveness in pediatric patients treated with CLOBEX® (clobetasol propionate) Spray, 0.05% have not been established (see PRECAUTIONS: General).

Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of glucocortisteroid insufficiency during and/or after withdrawal of treatment.

Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.

HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation.

Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Geriatric Use: Clinical studies of CLOBEX® (clobetasol propionate) Spray, 0.05% did not include sufficient numbers of patients aged 65 and over to adequately determine whether they respond differently than younger patients. In the two Phase 3 studies, 21 of the 240 patients (9%) were over the age of 65. In general, dose selection for an elderly patient should be made with caution, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

ADVERSE REACTIONS: In controlled, clinical trials with CLOBEX® (clobetasol propionate) Spray, 0.05%, the most common adverse reaction was burning at the site of application [40% of subjects treated with CLOBEX® (clobetasol propionate) Spray, 0.05% and 47% of subjects treated with Spray Vehicle]. Other commonly reported adverse reactions for CLOBEX® (clobetasol propionate) Spray, 0.05% and Spray Vehicle, respectively, are noted in Table 2.

Table 2 - Commonly Occurring Adverse Events Adverse Reaction

Clobetasol Propionate 0.05% Spray (N=120)

Vehicle Spray (N=120)

50 (42%)

56 (47%)

System Organ Class General disorders and administration site conditions Application site atrophy

0 (0%)

1 (1%)

Application site burning

48 (40%)

56 (47%)

Application site dryness

2 (2%)

0 (0%)

Application site irritation

1 (1%)

0 (0%)

Application site pain

1 (1%)

2 (2%)

Application site pigmentation changes

1 (1%)

0 (0%)

Application site pruritus

4 (3%)

3 (3%)

17 (14%)

12 (10%)

Infections and infestations Influenza

0 (0%)

2 (2%)

Nasopharyngitis

6 (5%)

3 (3%)

Pharyngitis streptococcal

1 (1%)

0 (0%)

10 (8%)

2 (2%)

4 (3%)

2 (2%)

2 (2%)

0 (0%)

Upper respiratory tract infection Skin and subcutaneous tissue disorders Eczema asteatotic

Other adverse events occurred at rates less than 1.0%. Most local adverse events were rated as mild to moderate and they are not affected by age, race or gender. The following additional local adverse reactions have been reported with topical corticosteroids. They may occur more frequently with the use of occlusive dressings and higher potency corticosteroids, including clobetasol propionate. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae and miliaria.

Systemic absorption topical corticosteroids has produced hypothalamic-pituitary-adrenal (HPA) axis suppression manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.

OVERDOSAGE: Topically applied CLOBEX® (clobetasol propionate) Spray, 0.05% can be absorbed in sufficient amount to produce systemic effects. (See PRECAUTIONS).

DOSAGE AND ADMINISTRATION: CLOBEX® (clobetasol propionate) Spray, 0.05% should be sprayed directly onto the affected skin areas twice daily and rubbed in gently and completely. (See INDICATIONS AND USAGE).

CLOBEX® (clobetasol propionate) Spray, 0.05% contains a super-high potent topical corticosteroid; therefore treatment should be limited to 4 weeks. Treatment beyond 2 weeks should be limited to localized lesions of moderate to severe plaque psoriasis that have not sufficiently improved after the initial 2 weeks of treatment with CLOBEX® (clobetasol propionate) Spray, 0.05%.

The total dosage should not exceed 50 g (59 mL or 2 fluid ounces) per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.

Therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Use in pediatric patients younger than 18 years is not recommended because of the potential for HPA axis suppression (see PRECAUTIONS: Pediatric Use).

Unless directed by physician, CLOBEX® (clobetasol propionate) Spray, 0.05% should not be used with occlusive dressings.

HOW SUPPLIED: CLOBEX® (clobetasol propionate) Spray, 0.05% is supplied in a white HDPE bottle with a white polypropylene cap and white LDPE liner in the following sizes: 2 fl oz/59 mL NDC 0299-3849-02 4.25 fl oz/125 mL NDC 0299-3849-04 Store under controlled room temperature conditions of 20˚C - 25˚C (68˚F - 77˚F) with excursions permitted between 15˚C and 30˚C (59˚F and 86˚F). Do not freeze, refrigerate or store above 30˚C. Spray is flammable; keep away from heat or flame.

US Patent Nos: 5,972,920; 5,990,100 and foreign patents pending.

Marketed by: GALDERMA LABORATORIES, L.P., Fort Worth, Texas 76177 USA Manufactured by: CPL, Mississauga, Ontario, Canada L5N 6L6, Made in Canada.

GALDERMA is a registered trademark. www.psoriasispro.com 2003739-0906 Revised: September 2006

References: 1. Clobex® Spray Prescribing Information. September 2006. Galderma Laboratories, L.P. 2. Koo JYM. Relevance of the COBRA Trial in current psoriasis practice. Cutis. 2007;80(suppl 5):4-11.

3. Menter A, Abramovits W, Colón LE, Johnson LA, Gottschalk RW. Comparing clobetasol propionate 0.05% spray to calcipotriene 0.005% betamethasone dipropionate 0.064% ointment for the treatment of moderate to severe plaque psoriasis. J Drugs Dermatol. 2009;8:52-57. © 2010 Galderma Laboratories, L.P. GALDERMA and CLOBEX are registered trademarks.

Galderma Laboratories, L.P., 14501 N. Freeway, Fort Worth, TX 76177 CLO-604 Printed in USA 04/10

42 Journal of Dermatology for Physician Assistants

Outside & Inside the 9 to 5...

Teaching Down Under

By Kristine Kucera, DHS, MPAS, PA-C

Bleed:12.5 in

Largest Trim:12.25 in

Live Area:10 in

Smallest Trim:10.75 in

The Physician Assistant program was developed by Karen Mulitalo, MPAS, PA-C, who serves as the Programme Director. The class started in July 2009 with a total of eighteen students. The majority of the students came from medical backgrounds, with the class having an average of twelve years medical experience. Many of the students have paramedic or nursing backgrounds and a few students are active military members.

system, an Australian Health Ministry steering committee recommended a twelve-month pilot program in which PAs from the United States would participate and provide healthcare services in five Queensland sites. The program took place between May 2009 and May 2010 with five PAs practicing in the areas of cardiology, family practice, emergency care, and aged care. The final report is due August 2010 and will include evaluations from supervising physicians, site employees, and patients who received care from the physician assistants. The University of Queensland’s inaugural class is set to graduate in 2011 and this first group of physician assistants will take Kristine Kucera, DHS, MPAS, PA-C their place as important healthcare providers in the community.

My experience in Australia is one that I will never The Physician Assistant program is designed for forget. The country is clean and beautiful, highly health professionals who have completed postfocused on recycling and being “green,” and the secondary study and have a minimum of one-year people are very warm and friendly. Teaching at recent direct patient care experience. The first year the University of Queensland of didactic content is part time, Physician Assistant Program which allows the students to was a true honor. The students continue to work in their full-time are professional, eager to learn, employment. The majority of and dedicated to the medical the lectures are delivered online profession. I was welcomed with face-to-face classes taking to each class with smiles and place three to four weeks each everyone was attentive to semester. The didactic courses the lectures. I enjoyed the include history and physical opportunity to present many exam skills, pathophysiology, University of Queensland Medical School, different dermatologic disease disease prevention, diagnosis home o f the Physician Assistant Program. states, especially recognizing, and management, medical treating, and preventing skin ethics, healthcare policy and reform, legal issues, cancer.

Australia has significant numbers of skin and cultural diversity. The second year consists of cancers diagnosed each year and the UV rating full-time clinical rotations, which include general is high for the majority of the year. I hope that the practice, internal medicine, emergency medicine, information I presented will be an asset to each and aged care, and surgery. every student that I was able to meet and that they will The physician assistant concept in Australia is being be able to use it in their daily practice. I wish to thank developed with two goals in mind. First is to fill the Karen Mulitalo for dedicating her time to develop shortage of healthcare providers in rural areas and this program and for giving me the opportunity to second is to provide access to specialty care. To be a part of physician assistant history. J see if PAs would fit into Queensland’s healthcare Vol. 4, No. 4 FALL 2010 43

professional development

I recently had the opportunity to teach at the University of Queensland Physician Assistant Program in Australia. Not only do I consider this the opportunity of a lifetime, but I am also honored to be a part of physician assistant history. This class is the inaugural class of the first PA program in Australia.

Dermatology PA news & notes

From the Desk of...

By Catrina Shubert, PA-S SDPA Student Affairs Coordinator

What I Learned at the 2010 SDPA Leadership Summit Students generally lack information regarding professional organizations and even if they are aware of such organizations, they are not inclined towards getting involved. In fact, I believe that a lot of students donâ&#x20AC;&#x2122;t know that professional societies even exist. I realize that awareness of professional organizations increases once a PA begins to work in the field, but I still suspect that many people even after graduating are not aware of how important having organizations like the SDPA is in maintaining as well as advancing our careers as physician assistants.

I have to admit that I assumed that I would always be able to find a job coming out of school and that because there are already PAs working in dermatology, I would automatically be accepted by most practices. What I failed to realize was that my rights and privileges as a future PA are being actively protected by people who believe in the capabilities of PAs. What I witnessed during the 2010 SDPA Leadership Summit was a passionate group of individuals who were collaborating to figure out new ways of promoting PAs, not only in dermatology, but within the profession as a whole. They are continuously striving to increase our credibility as valuable practitioners by building Catrina Shubert, PA-S is currently enrolled at the Salus University Physician Assistant Program in Elkins Park, PA. She currently holds the position of Student Affairs Coordinator for the SDPA. She will be graduating in September 2011 and plans to practice in dermatology.

44 Journal of Dermatology for Physician Assistants

on the foundation of the physician-PA team relationship. This leadership meeting experience helped me to understand that the hard work of people in these organizations helped create the professionally recognized and accepted field I am about to enter.

I did not know what to expect when I was asked to attend the annual SDPA Leadership Summit, but I can confidently say that the experience exceeded anything I could have hoped for. I gained perspective on what it takes to keep the PA profession moving forward, such as planning conferences complete with speakers, creating opportunities to receive numerous CME hours, developing a PA dermatology specific journal, and forming relationships with equipment and pharmaceutical companies.

It is easy to sit back and let other people take on leadership roles and I understand how intimidating getting involved can be. However, I believe that with every risk comes the chance for an even bigger reward and I am grateful for the opportunity to be involved with such an inspiring organization. So, even if you donâ&#x20AC;&#x2122;t have the time to participate directly, I hope that everyone will realize how important it is to be supportive of our professional organizations and how much of a difference these organizations have made in the way that we as PAs practice medicine. Overall, I was extremely impressed with the work ethic and dedication of the SDPA leadership and I would like to thank them for allowing me to take part in this ongoing mission of professional development. J

ACNE REGIMEN

REDEFINED

EPIDUO GEL: A VISIBLE DIFFERENCE* ®

1

Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5%—A unique fixed-dose combination developed for the first-line treatment of inflammatory and comedonal lesions

www.epiduo.com/hcp *In a phase 3 clinical trial of 1670 patients, median reduction in inflammatory lesions was 70% and median reduction in comedonal lesions was 62% at week 12.

Important Safety Information Epiduo® Gel is a retinoid and antimicrobial combination product indicated for the topical treatment of acne vulgaris in patients 12 years and older. The most common adverse events associated with use of Epiduo® Gel are erythema, scaling, dryness, stinging and burning.

In addition, in clinical trials, adverse events reported in greater than 1% of patients treated with the Gel included contact dermatitis and skin irritation. Excessive exposure to sunlight and sunlamps should be avoided during treatment, and use of sunscreen products and protective clothing is recommended. Concomitant use of irritating topical products (like products containing resorcinol, salicylic acid or sulfur) should be avoided. Epiduo® Gel has not been tested in pregnant or nursing women, or with the elderly. Pregnancy Category C.

Please see brief summary of Prescribing Information on next page.

Vol. 4, No. 4 FALL 2010 45

EPIDUO™ Rx only (adapalene and benzoyl peroxide) Gel 0.1% / 2.5% For Topical Use Only Not For Ophthalmic, Oral, or Intravaginal Use. BRIEF SUMMARY INDICATIONS AND USAGE EPIDUO Gel is a combination of adapalene, a retinoid, and benzoyl peroxide, and is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

CONTRAINDICATIONS None.

WARNINGS AND PRECAUTIONS Ultraviolet Light and Environmental Exposure: Avoid exposure to sunlight and sunlamps. Wear sunscreen when sun exposure cannot be avoided.

Erythema, scaling, dryness, and stinging/burning may occur with use of EPIDUO Gel. ADVERSE REACTIONS Observed local adverse reactions in patients treated with EPIDUO Gel were erythema, scaling, dryness, stinging, and burning. Other most commonly reported adverse events (≥1%) in patients treated with EPIDUO Gel were dry skin, contact dermatitis, application site burning, application site irritation, skin irritation.

DRUG INTERACTIONS Exercise caution in using preparations containing sulfur, resorcinol, or salicylic acid, medicated or abrasive soaps and cleansers and products with high concentrations of alcohol or astringents in combination with EPIDUO Gel. Concomitant use of topical products with a strong drying effect can increase irritation. Use with caution.

Pregnancy Pregnancy Category C. There are no well-controlled trials in pregnant women treated with EPIDUO Gel. Animal reproduction studies have not been conducted with the combination gel or benzoyl peroxide. Furthermore, such studies are not always predictive of human response; therefore, EPIDUO Gel should be used during pregnancy only if the potential benefit justifies the risk to the fetus.

No teratogenic effects were observed in rats treated with oral doses of 0.15 to 5.0 mg adapalene/kg/day, up to 25 times (mg/m2/day) the maximum recommended human dose (MRHD) of 2 grams of EPIDUO Gel. However, teratogenic changes were observed in rats and rabbits when treated with oral doses of ≥ 25 mg adapalene/kg/day representing 123 and 246 times MRHD, respectively. Findings included cleft palate, microphthalmia, encephalocele and skeletal abnormalities in rats; and umbilical hernia, exophthalmos and kidney and skeletal abnormalities in rabbits.

Dermal teratology studies conducted in rats and rabbits at doses of 0.6-6.0 mg adapalene/kg/day [25-59 times (mg/m2) the MRHD] exhibited no fetotoxicity and only minimal increases in supernumerary ribs in both species and delayed ossification in rabbits.

Nursing Mothers It is not known whether adapalene or benzoyl peroxide is excreted in human milk following use of EPIDUO Gel. Because many drugs are excreted in human milk, caution should be exercised when EPIDUO Gel is administered to a nursing woman.

Pediatric Use Safety and effectiveness of EPIDUO Gel in pediatric patients under the age of 12 have not been established.

Geriatric Use Clinical studies of EPIDUO Gel did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity, photocarcinogenicity, genotoxicity, or fertility studies were conducted with EPIDUO Gel. Carcinogenicity studies with adapalene have been conducted in mice at topical doses of 0.4, 1.3, and 4.0 mg/kg/day (1.2, 3.9, and 12 mg/m2/day), and in rats

at oral doses of 0.15, 0.5, and 1.5 mg/kg/day (0.9, 3.0, and 9.0 mg/m2/day).

In terms of body surface area, the highest dose levels are 9.8 (mice) and 7.4 times (rats) the MRHD of 2 grams of EPIDUO Gel. In the rat study, an increased incidence of benign and malignant pheochromcytomas in the adrenal medulla of male rats was observed.

No significant increase in tumor formation was observed in rodents topically treated with 15-25% benzoyl peroxide carbopol gel (6-10 times the concentration of benzoyl peroxide in EPIDUO Gel) for two years. Rats received maximum daily applications of 138 (males) and 205 (females) mg benzoyl peroxide/kg. In terms of body surface area, these levels are 27-40 times the MRHD. Similar results were obtained in mice topically treated with 25% benzoyl peroxide carbopol gel for 56 weeks followed by intermittent treatment with 15% benzoyl peroxide carbopol gel for rest of the 2 years study period, and in mice topically treated with 5% benzoyl peroxide carbopol gel for two years.

The role of benzoyl peroxide as a tumor promoter has been well established in several animal species. However, the significance of this finding in humans is unknown.

In a photocarcinogenicity study conducted with 5% benzoyl peroxide carbopol gel, no increase in UV-induced tumor formation was observed in hairless mice topically treated for 40 weeks.

No photocarcinogenicity studies were conducted with adapalene. However, animal studies have shown an increased tumorigenic risk with the use of pharmacologically similar drugs (e.g., retinoids) when exposed to UV irradiation in the laboratory or sunlight. Although the significance of these findings to humans is not clear, patients should be advised to avoid or minimize exposure to either sunlight or artificial irradiation sources.

Adapalene did not exhibit mutagenic or genotoxic effects in vitro (Ames test, Chinese hamster ovary cell assay, mouse lymphoma TK assay) or in vivo (mouse micronucleus test).

Bacterial mutagenicity assays (Ames test) with benzoyl peroxide has provided mixed results, mutagenic potential was observed in a few but not in a majority of investigations. Benzoyl peroxide has been shown to produce single-strand DNA breaks in human bronchial epithelial and mouse epidermal cells, it has caused DNA-protein cross-links in the human cells, and has also induced a dose-dependent increase in sister chromatid exchanges in Chinese hamster ovary cells. In rat oral studies, 20 mg adapalene/kg/day (120 mg/m2/day; 98 times the MRHD based on mg/m2/day comparison) did not affect the reproductive performance and fertility of F0 males and females, or growth, development and reproductive function of F1 offspring.

No fertility studies were conducted with benzoyl peroxide.

PATIENT COUNSELING INFORMATION – Advise patients to cleanse the area to be treated with a mild or soapless cleanser; pat dry. Apply EPIDUO Gel as a thin layer, avoiding the eyes, lips and mucous membranes.

– Advise patients not to use more than the recommended amount and not to apply more than once daily as this will not produce faster results, but may increase irritation.

– EPIDUO Gel may cause irritation such as erythema, scaling, dryness, stinging or burning.

– Advise patients to minimize exposure to sunlight, including sunlamps.

Recommend the use of sunscreen products and protective apparel, (e.g., hat) when exposure cannot be avoided.

– EPIDUO Gel may bleach hair and colored fabric.

Marketed by: GALDERMA LABORATORIES, L.P. Fort Worth, Texas 76177 USA Manufactured by: Galderma Production Canada Inc. Baie d’Urfé, QC, H9X 3S4 Canada Made in Canada.

GALDERMA is a registered trademark.

Revised: December 2008 P51356-0

Reference: 1. Gollnick HPM, Draelos Z, Glenn MJ, et al; Adapalene–BPO Study Group. Adapalene–benzoyl peroxide, a unique fixed-dose combination topical gel for the treatment of acne vulgaris: a transatlantic, randomized, double-blind, controlled study in 1670 patients. Br J Dermatol. 2009;161(5):1180-1189.

Galderma is a registered trademark. ©2010 Galderma Laboratories, L.P. Galderma Laboratories, L.P. 14501 N. Freeway Fort Worth, TX 76177 EPI-317 Printed in USA 01/10

www.epiduo.com/hcp

46 Journal of Dermatology for Physician Assistants

The Difference We Make Saving Face

B:12.25”

T:11”

S:9.5”

“Isotretinoin is one of the best drugs that we Steinbeck alludes to the effect that Pimples’ acne have in our armamentarium to treat severe acne,” a has on his self-esteem writing that, “His whole system dermatologist colleague once told me. “Acne can be and his soul were a particularly violent battleground of disfiguring; it impacts a patient’s self-esteem. To some adolescence.... His mind and his emotions were like his extent, it might influence a person’s face, constantly erupting, constantly career choice, social standing, even raw and irritated.”

“His mind and his emotions his or her mental outlook.”

In the scene where Pimples were like his face, constantly I thought of these words when assists his boss, Juan Chicoy, in I came across a passage in a John repairing the rear end of the bus, erupting, constantly raw Steinbeck novel from the 1940s, the boy finally gets up enough and irritated.”

The Wayward Bus. One character, nerve to make a significant a young man of seventeen, is request: nicknamed “Pimples” for an obvious “What do you want?” Juan asked guardedly. reason, he has an extensive case of cystic acne.

“Mr. Chicoy, could we fix it—I mean—could you fix it With textbook precision Steinbeck describes so you don’t call me Pimples any more?”

Pimples’ skin: “A golden fuzz was on his cheeks, and his Juan saw the craters of old scars and the coming cheeks were rivuleted and rotted and eroded with acne. eruptions and one prime, tight, yellow-headed pustule Among the old scars new pustules formed, purple and about to burst on the cheek. As he looked, Juan’s eyes red, some rising and some waning. The skin was shiny softened. He knew. It came on him suddenly, and he with medicines that were sold for this condition and wondered why he had not known before. which do no good whatsoever.”

“What’s your name?” he asked roughly.

It’s obvious that Pimples fixates on his face: “Pimples “Ed,” said Pimples. “Before I got these in grammar kept his hands at his sides as much as he could, but in school, why, they used to call me Kit.” spite of himself his fingers would move to his pitted From that point on, Juan refers to Pimples as Kit. cheeks until he became conscious of what he was doing Steinbeck describes the impact that this small act of and put his hands down again.” kindness has on the boy by writing, “Near the door When Steinbeck crafted his novel, very few effective where one of the great oaks stood there was a patch of treatments for acne were available. He allows us to peek near darkness. He stood there for a moment, holding his behind the veil of mid 20th century clinical practice breath. He was shaking all over in a kind of chill.” when he writes, “He wrote to every company that Some years ago, another colleague (a pediatrician) advertised an acne cure, and he had been to many shared the story of a classmate who developed an doctors, who knew that they could not cure it but who advanced case of facial acne in high school. The acne also knew that it would probably go away in a few years. eventually subsided, leaving extensive scarring in its They nevertheless gave Pimples prescriptions for salves place. Even after thirty years, the fellow could not bring and lotions, and one had put him on a diet of green himself to attend any of his high school reunions. The vegetables.” acne had left its mark, much more than skin deep.

Brian T. Maurer has practiced pediatric medicine as a physician The ensuing decades have brought better, assistant for thirty years. Over the past two decades Mr. Maurer has more effective drugs to treat acne. Although these explored the illness narrative as a tool to cultivate an appreciation for the delivery of humane medical care. He has published medications are not without risk and require regular numerous vignettes, editorials, and essays in both national and monitoring of the patient who takes them, prescribing international journals. Mr. Maurer has been a contributing author such medications might mean the difference in outcome to the online open-access journal Dermanities (www.dermanities. between a well-adjusted, satisfied adult and one who is com) since its inception. Readers can visit the author on the web at forever destined to resort to saving face. J http://briantmaurer.wordpress.com.

Vol. 4, No. 4 FALL 2010 47

DERmatology pa news & notes

By Brian T. Maurer, PA-C

Supervising Physician CORNER Darrell S. Rigel, MD

DERmatology pa news & notes

By J. Margaret Casey, staff writer

Darrell S. Rigel, MD is a Clinical Professor of Dermatology at New York University Medical Center.

He is the author of over 100 articles and abstracts in professional journals as well as lead author of Cancer of the Skin, the major textbook in this field. He has testified before Congress regarding the effects of ozone depletion on the skin and regularly serves as a resource to Congress on dermatological health issues. He has made over 400 presentations at medical conferences worldwide and regularly chairs conferences and symposia throughout the world. His research and opinions have been cited by many national networks, magazines, and newspapers including CNN, NBC, ABC, CBS, Fox, the New York Times, Wall Street Journal, Washington Post, Time, Newsweek, and People Magazine. He has been named to “Top Physicians in America” and “Best Doctors of New York.”

Dr. Rigel is involved with many professional and charitable organizations related to his research interests. In 1999, he served as President of the American Academy of Dermatology and currently serves as the Co-Chair of the National Dermatology Public Awareness Program. He is also a member of the Board of Directors of the American Cancer Society New York City Division (serving as the Chairman of the Subcommittee on Skin Association).

We recently had the pleasure of interviewing Dr. Rigel. We appreciate him taking time from his busy schedule to speak with us about his experiences Darrell S. Rigel is a graduate of MIT with a BS in Computer Sciences, an MS (MBA) from the Sloan School of Management at MIT and received his MD from George Washington University in 1978. He attended Cornell University Medical Center for Internship in Internal Medicine in 1979 and completed his training at NYU where he was Resident, Chief Resident and Dermatology Surgery Fellow from 1979-1982.

Dr. Rigel has received numerous awards and honors including American Cancer Society’s National Honor Citation for Skin Cancer Programs and a Presidential Citation from the American Academy of Dermatology for public education programs. In addition, Dr. Rigel maintains a private dermatology practice in Manhattan where he specializes in skin cancer, sun damage, and aging problems of the skin.

48 Journal of Dermatology for Physician Assistants

as a dermatologist, the changes he has seen within the field during his twenty-eight years of practice, his commitment to education, and his interest in incorporating a physician assistant into his practice team.

JDPA: Why did you pursue a career in dermatology?

Dr. Rigel: I actually started out with the intent of becoming a cardiologist. I fell into a melanoma research project and have never regretted my pursuit of dermatology from that point.

JDPA: As President of the AAD in 1999, what was your greatest accomplishment? What are some changes you have seen within the field since that time?

What are additional changes that you would like to see take place?

Dr. Rigel: As President of the AAD, my greatest accomplishment was focusing on meeting the needs of the members. Since my time as President, healthcare has changed. I would like to see a continued focus on the needs of membership.

JDPA: What do you see as the greatest challenge facing those practicing dermatology?

Dr. Rigel: Being taken seriously. We need to continue to be respected as a serious specialty. If we all pull together we can do our best with the many issues facing us as a specialty.

JDPA: What has been your experience working with PAs within dermatology?

Dr. Rigel: I teach anyone who wants to learn. I feel it is my responsibility to teach anyone who wants to learn to be the best so that patients in turn benefit.

JDPA: Does your practice currently utilize PAs? Dr. Rigel: Not currently. I recognize that the paradigm of how healthcare is being delivered is changing and that we need to have a mix of physicians and PAs working together.

JDPA: What qualities/skills would you look for in a potential PA for your practice?

Dr. Rigel: Someone with really good people skills who wants to learn.

JDPA: What is your vision or philosophy for the utilization of PAs within your practice?

“

Dr. Rigel: Do good work. I learned this from one of my teachers, Alfred Kopf. When you are starting out people only remember if you are good or not. Work hard and be the first one in to work in the morning and the last one to leave. This approach will pay off.

JDPA: Outside of the office, what is your favorite pastime or anything interesting that the readers may be surprised to know about you?

Dr. Rigel: I like to golf and fly fish. I enjoy skiing in Vail, Colorado. I like good wines and fantasy football.

One of my biggest weaknesses is chocolate chip cookies.

J the JDPA: Any thoughts you would like to share with readers that we haven’t already discussed?

Dr. Rigel: There is a changing paradigm with the latest healthcare bills. I am not sure exactly how the current bills will impact dermatologists. I do know that our challenge for the future is to work to keep the field of dermatology respected as specialty and provide access to people trained properly in dermatology. J

”

Derm Quotes

What we have to realize is, our profession, our Society, can not move forward unless everybody donates a little bit of time to the SDPA.” Abby Jacobson, MS, PA-C, SDPA President Speaking about the importance of volunteering for the SDPA. Dermcast.tv – August 4th, 2010

I would urge PAs to stay in touch with the AAPA via our website (www.aapa.org) and our advocacy center on the website.

Bill Leinweber, Executive Vice President/CEO of the AAPA Speaking about how PAs can get involved in helping the AAPA with regards to healthcare reform.

Dermcast.tv – July 9th, 2010

Vol. 4, No. 4 FALL 2010 49

DERmatology pa news & notes

Dr. Rigel: I envision a PA will provide leverage for what I am able to do within my practice, allowing me to focus on more global tasks. I would want a PA at my practice to be the best at what they do. A physician and a PA should function as a team in order to provide quality care to patients. I believe that the key to any team is mutual respect and shared goals.

JDPA: What is your favorite part of your day?

Dr. Rigel: When I am able to make a difference and have a positive impact on someone’s life. For example when I diagnose a melanoma in a patient.

JDPA: What advice would you give to dermatology providers who are interested in becoming involved with legislation and/or educating the public about dermatological conditions?

Dr. Rigel: This is critical. We need to focus on better collaboration between PAs and dermatologists. The current administration in Washington wants to see more and more PA involvement in the healthcare system, so we need to work together to achieve this.

JDPA: What would be your advice to new providers working in dermatology?

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DIFFERIN® (adapalene) Gel, 0.3% BRIEF SUMMARY

Rx only

For topical use only. Not for ophthalmic, oral or intravaginal use.

INDICATIONS AND USAGE: DIFFERIN® Gel, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

CONTRAINDICATIONS: DIFFERIN® Gel, 0.3% should not be administered to individuals who are hypersensitive to adapalene or any of the components in the gel vehicle.

PRECAUTIONS: General: Certain cutaneous signs and symptoms of treatment such as erythema, scaling, dryness, and stinging/burning may be experienced with use of DIFFERIN® Gel, 0.3%. These are most likely to occur during the first four weeks of treatment, are mostly mild to moderate in intensity, and usually lessen with continued use of the medication. Depending upon the severity of these side effects, patients should be instructed to either use a moisturizer, reduce the frequency of application of DIFFERIN® Gel, 0.3% or discontinue use.

If a reaction suggesting sensitivity or chemical irritation occurs, use of the medication should be discontinued.

Exposure to sunlight, including sunlamps, should be minimized during use of adapalene. Patients who normally experience high levels of sun exposure, and those with inherent sensitivity to sun, should be warned to exercise caution. Use of sunscreen products and protective clothing over treated areas is recommended when exposure cannot be avoided. Weather extremes, such as wind or cold, also may be irritating to patients under treatment with adapalene.

Avoid contact with the eyes, lips, angles of the nose, and mucous membranes. The product should not be applied to cuts, abrasions, eczematous or sunburned skin. As with other retinoids, use of “waxing” as a depilatory method should be avoided on skin treated with adapalene.

Information for Patients: Patients using DIFFERIN® Gel, 0.3%, should receive the following information and instructions: 1. This medication is to be used only as directed by the physician.

2. It is for external use only.

3. Avoid contact with the eyes, lips, angles of the nose, and mucous membranes.

4. Cleanse affected area with a mild or soapless cleanser before applying this medication.

5. Moisturizers may be used if necessary; however, products containing alpha hydroxy or glycolic acids should be avoided.

6. Exposure of the eye to this medication may result in reactions such as swelling, conjunctivitis, and eye irritation.

7. This medication should not be applied to cuts, abrasions, eczematous, or sunburned skin.

8. Wax epilation should not be performed on treated skin due to the potential for skin erosions.

9. During the early weeks of therapy, an apparent exacerbation of acne may occur. This may be due to the action of the medication on previously unseen lesions and should not be considered a reason to discontinue therapy.

Drug Interactions: As DIFFERIN® Gel, 0.3% has the potential to induce local irritation in some patients, concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices, or lime) should be approached with caution. Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid in combination with DIFFERIN® Gel, 0.3%. If these preparations have been used, it is advisable not to start therapy with DIFFERIN® Gel, 0.3%, until the effects of such preparations have subsided.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenicity studies with adapalene have been conducted in mice at topical doses of 0.4, 1.3, and 4.0 mg/kg/day, and in rats at oral doses of 0.15, 0.5, and 1.5 mg/kg/day. These doses are up to 3 times (mice) and 2 times (rats) in terms of mg/m²/day the potential exposure at the maximum recommended human dose (MRHD), assumed to be 2.5 grams DIFFERIN® Gel, 0.3%. In the oral study, increased incidence of benign and malignant pheochromocytomas in the adrenal medullas of male rats was observed.

No photocarcinogenicity studies were conducted. Animal studies have shown an increased risk of skin neoplasms with the use of pharmacologically similar drugs (e.g., retinoids) when exposed to UV irradiation in the laboratory or to sunlight. Although the significance of these studies to human use is not clear, patients should be advised to avoid or minimize exposure to either sunlight or artificial UV irradiation sources.

Adapalene did not exhibit mutagenic or genotoxic effects in vitro (Ames test, Chinese hamster ovary cell assay, mouse lymphoma TK assay) and in vivo (mouse micronucleus test).

Reproductive function and fertility studies were conducted in rats administered oral doses of adapalene in amounts up to 20 mg/kg/day (up to 26 times the MRHD based on mg/m² comparisons). No effects of adapalene were found on the reproductive performance or fertility of the F0 males or females. There were also no detectable effects on the growth, development and subsequent reproductive function of the F1 offspring.

Pregnancy: Teratogenic effects. Pregnancy Category C. Retinoids may cause fetal harm, when administered to pregnant women. Adapalene has been shown to be teratogenic in rats and rabbits when administered orally (see Animal Data below). There are no adequate and well-controlled studies in pregnant women. DIFFERIN® Gel, 0.3% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The safety and efficacy of DIFFERIN® Gel, 0.3% in pregnancy has not been established.

1. Human Data In clinical trials involving DIFFERIN® Gel, 0.3% in the treatment of acne vulgaris, women of child-bearing potential initiated treatment only after having had a negative pregnancy test and used effective birth control measures during therapy. However, 6 women treated with DIFFERIN® Gel, 0.3% became pregnant. One patient elected to terminate the pregnancy, two patients delivered healthy babies by normal delivery, two patients delivered prematurely and the babies remained in intensive care until reaching a healthy state and one patient was lost to follow-up.

2. Animal Data • No teratogenic effects were seen in rats at oral doses of 0.15 to 5.0 mg/kg/day adapalene representing up to 6 times the maximum recommended human dose (MRHD) based on mg/m² comparisons. Adapalene has been shown to be teratogenic in rats and rabbits when administered orally at doses 25 mg/kg representing 32 and 65 times, respectively, the MRHD based on mg/m² comparisons. Findings included cleft palate, microphthalmia, encephalocele and skeletal abnormalities in the rat and umbilical hernia, exophthalmos and kidney and skeletal abnormalities in the rabbit.

• Cutaneous teratology studies in rats and rabbits at doses of 0.6, 2.0, and 6.0 mg/kg/day exhibited no fetotoxicity and only minimal increases in supernumerary ribs in both species and delayed ossification in rabbits.

Systemic exposure (AUC0-24h) to adapalene 0.3% gel at topical doses of 6.0 mg/kg/day in rats and rabbits represented 5.7 and 28.7 times, respectively, the exposure in acne patients treated with adapalene 0.3% gel applied to the face, chest and back (2 grams applied to 1000 cm2 of acne involved skin).

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when DIFFERIN® Gel, 0.3% is administered to a nursing woman.

Pediatric Use: Safety and effectiveness in pediatric patients below the age of 12 have not been established.

Geriatric Use: Clinical studies of DIFFERIN® Gel, 0.3% did not include subjects 65 years of age and older to determine whether they respond differently than younger subjects. Safety and effectiveness in geriatric patients age 65 and above have not been established.

ADVERSE REACTIONS: In the multi-center, controlled clinical trial, signs and symptoms of local cutaneous irritation were monitored in 258 acne patients who used DIFFERIN® Gel, 0.3% once daily for 12 weeks. Of the patients who experienced cutaneous irritation (erythema, scaling, dryness, and/or burning/stinging), the majority of cases were mild to moderate in severity, occurred early in treatment and decreased thereafter. The incidence of local cutaneous irritation with DIFFERIN® Gel, 0.3% from the controlled clinical study is provided in the following table: Table 2: Physician assessed local cutaneous irritation with DIFFERIN® Gel Incidence of Local Cutaneous Irritation with DIFFERIN® Gel, 0.3% from Controlled Clinical Study (N=253*) Maximum Severity Scores Higher Than Baseline Erythema Scaling Dryness Burning/Stinging

Mild 66 (26.1%) 110 (43.5%) 113 (44.7%) 72 (28.5%)

Moderate 33 (13.0%) 47 (18.6%) 43 (17.0%) 36 (14.2%)

Severe 1 (0.4%) 3 (1.2%) 2 (0.8%) 9 (3.6%)

* Total number of subjects with local cutaneous data for at least one post-Baseline evaluation.

Table 3: Patient reported local cutaneous adverse events with DIFFERIN® Gel DIFFERIN® (adapalene) Gel, 0.3% Related* Adverse Events Dry Skin Skin Discomfort Desquamation

Vehicle Gel

N=258

N=134

57 (22.1%) 36 (14%) 15 (5.8%) 4 (1.6%)

6 (4.5%) 2 (1.5%) 0 (0.0%) 0 (0.0%)

* Selected adverse events defined by investigator as Possibly, Probably or Definitely Related Related adverse events from the controlled clinical trial that occurred in greater than 1% of patients who used DIFFERIN® Gel, 0.3% once daily included: dry skin (14.0%), skin discomfort (5.8%), pruritus (1.9%), desquamation (1.6%), and sunburn (1.2%). The following selected adverse events occurred in less than 1% of patients: acne flare, contact dermatitis, eyelid edema, conjunctivitis, erythema, pruritus, skin discoloration, rash, and eczema.

In a one-year, open-label safety study of 551 patients with acne who received DIFFERIN® Gel, 0.3%, the pattern of adverse events was similar to the 12-week controlled study.

OVERDOSAGE: DIFFERIN® Gel, 0.3% is intended for topical use only. If the medication is applied excessively, no more rapid or better results will be obtained and marked redness, scaling, or skin discomfort may occur. Chronic ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of vitamin A. Marketed by: GALDERMA LABORATORIES, L.P. Fort Worth, Texas 76177 USA Manufactured by: DPT Laboratories, Ltd. San Antonio, Texas 78215 USA GALDERMA is a registered trademark.

Revised: June 2007 325089-0607

Reference: 1. Thiboutot D, Pariser DM, Egan N, et al; Adapalene Study Group. Adapalene gel 0.3% for the treatment of acne vulgaris: a multicenter, randomized, double-blind, controlled, phase III trial. J Am Acad Dermatol. 2006;54:242-250.

Marketed by: GALDERMA LABORATORIES, L.P. References: 1. Thiboutot D, Arsonnaud S, Soto P. Efficacy and tolerability of adapalene 0.3% gel Fort Worth, Texas 76177 USA compared to tazarotene 0.1% gel in the treatment of acne vulgaris. J Drugs Dermatol. 2008;7 Manufactured by: (6)(suppl):S3-S10.

2. Data on file. Galderma Laboratories, L.P. A 3-week, single-center, randomized, DPT Laboratories, Ltd. investigator/evaluator-blinded, San Antonio, Texas 78215 USA bilateral (split-face) comparison, clinical study of adults 18 years of age GALDERMA is ahealthy registered and older with skintrademark.

(N=30).

Revised: June 2007 325089-0607 Differin andisGalderma aretrademark. registered trademarks.

Galderma a registered ©2007 Galderma Laboratories, L.P. ©2010 Galderma Laboratories, L.P. Galderma Laboratories, L.P. Galderma Laboratories, L.P. 14501 N. Freeway 14501 N. Freeway Fort Worth, TX 76177 Fort Worth, TX 76177 DIFF-088 Printed03/10 www.differin.com DIF-888 in USA 11/07

Vol. 4, No. 4 FALL 2010 51

When comedonal acne is your primary concern…

PRESCRIBE DIFFERIN® GEL, 0.3%

Primarily comedonal acne: EXAMPLE A

EXAMPLE B

POWERFUL EFFICACY

HIGH PATIENT SATISFACTION

From baseline to week 12, lesion reduction (total, noninflammatory, and inflammatory) was similar to tazarotene gel, 0.1%1*

86% of patients on adapalene gel, 0.3% were satisfied or very satisfied vs 69% on tazarotene gel, 0.1%1* Local tolerability scores comparable to tretinoin gel microsphere, 0.04%2†

*A phase 3b, 12-week, noninferiority, multicenter, investigator-blinded, controlled clinical study of patients 12 to 35 years of age with acne vulgaris (N=172). At the end of 12 weeks, neither product was found to be inferior. 160 patients participated in the satisfaction survey.

A single-center, randomized, investigator/evaluator-blinded, bilateral (split-face) comparison of healthy subjects ≥18 years of age (N=30). Subjects received Differin® Gel, 0.3% on one half of the face and tretinoin gel microsphere, 0.04% on the other half for 22 days.

†

Important Safety Information Of the patients who experienced cutaneous irritation (erythema, scaling, dryness, and/or stinging/burning) during the clinical trial, the majority of cases were mild to moderate in severity, occurred early in treatment, and decreased thereafter. Adverse events that occurred in greater than 1% of the subjects included dry skin (14.0%), skin discomfort (5.8%), pruritus (1.9%), desquamation (1.6%), and sunburn (1.2%). Pregnancy Category C. Concomitant use of potentially irritating products or overexposure to sunlight or sunlamps, extreme wind or cold, may increase the potential for irritation. Use of sunscreen and protective clothing over treated areas are recommended when exposure cannot be avoided.

Please see brief summary of Prescribing Information on adjacent page.

52 Journal of Dermatology for Physician Assistants

www.differin.com

l of Medicine

Supported by Coria Laboratories is a division of Valeant Pharmaceuticals North America.

Participants

Supplement to Skin & Aging

◆

July 2010

3

O Jay On PA-C O Jay graduated from Stanford

ACNE MANAGEMENT: PRACTICAL CONSIDERATIONS AND THERAPEUTIC OPTIONS

University’s PA program and has been practicing in dermatology for 21 years. He lectures for Stanford’s PA/NP program in dermatology and is a site visitor for their program. He has also

Supplement to JDPA Fall 2010

been a proctor for the National Physician Assistant Boards.

Joe Capasso PA-C Joe graduated from University of Texas Southwestern Medical Center in 2002 and has been practicing dermatology for 8 years in Grand Prairie, Texas.

John V Notabartolo MPAS PA-C John graduated in 1998 from University of Nebraska through the first Interservices PA training program at Fort Sam Houston TX, receiving his Master of PA Studies in 1999. He has been a PA with Woodson Dermatology in Las Vegas NV for over 10 years.

Malia Tilton MSPAS PA-C Malia graduated from Midwestern University in Arizona with a Master of Medical Science Degree in PA Studies. Since

What aspects of patient management are the most important considerations in your successful treatment of acne?

completing the program in 2007 she has been practicing general and surgical dermatology in North San Diego County with Dermatology Specialists, Inc. Keri L Holyoak MPH MPAS PA-C Keri received her master’s degree in Public Health Physician Assistant Studies from George Washington University. She serves as the President –Elect for the Society of Dermatology Physician’s Assistants and adjunct Professor for the University of Utah PA program in Salt Lake City, UT. Writing and editorial support provided by Brian Bulley, MSc .

Joe Capasso: patient education is the most important issue.

We must give our patients reasonable expectations of what is going to happen with their treatment, why we are treating them, what we are treating them with, and why we are using what we are using. Spending time with patients explaining everything at the start is key to our success.

John Notabartolo: in situations where product efficacy and tolerability are similar, giving the patient the confidence to use, and continue to use the product is critical. As Joe said, you need to establish up front what is going to happen and what is the timeline for success. Patients need as much information as they can get their hands on. Then they know what to expect and they will be more compliant.

The statements, opinions, and/or views expressed in this professional educational supplement are those of the authors and do not necessarily reflect the opinions or recommendations of Coria Laboratories, the publisher, the Journal of Dermatology for Physician Assistants (JDPA), or the Society of Dermatology Physician Assistants (SDPA).

Do we need to re-train our patients about basic skincare?

O Jay On: There is a certain ‘belief system’ patients have about their skin (not just acne). A lot of women believe that if they don’t use a night cream the dryness they may experience through the night is going to give them wrinkles. As a result most of them have a nightly routine.

Joe Capasso: I see a lot of patients that come in, especially young women, who believe in a ‘system’ of creams/lotions and this can be irritating to the skin. When you already have an inflammatory condition you are not helping by adding to the inflammation. We have to drive home that beyond their medication there are other things they have to do for their skin. People come in and say that their face doesn’t feel clean. They are associating clean with astringency; when they don’t need to scrub and scrub. I give them a gentle cleanser like CeraVe® and tell them that it will help their acne medications work better, be more tolerable and that they are going to notice improvement quicker.

I recommend CeraVe moisturizer right after gentle face wash twice a day and tell them to apply their medicines as appropriate.

John Notabartolo: I agree. I ask them to take a step back and we talk about basic skincare - wash their 2

face twice a day with a mild gentle cleanser, no scrubbing, then moisturize twice a day. I go through this with them before I talk about how we are going to treat their acne. I want patients to know ‘this is what you have to do every day’; the medications we may end up getting away from, but you need to take care of your skin.

Do your educational strategies differ depending on patient’s age, gender and ethnicity?

Joe Capasso: Indeed, with younger patients you need to talk at a level they will understand. You need to explain simply “if you don’t use your medicine this is what is going to happen”.

Adult patients are usually more motivated to be there and be treated.

How do you tie the parent in?

John Notabartolo: You are treating a patient, you are not treating a condition and you are not treating their

parents. Most times I don’t address the parent at all until the end. Mom has already bought in; they pay the copay and for the prescription.

The patient wants me focused on their needs and I have to get their buy-in.

Even if Mom puts their medication in the bathroom they are not going to use it, they are going to squeeze the tube into the sink. We are seeing more early-onset puberty patients with acne and I love the fact that Atralin® is indicated for kids as young as 10. You have got to make it simple and pertinent to their world. If they don’t understand, or what you ask them to do something that isn’t part of their daily routine, they’re not going to do it.

Malia Tilton: Their parents often dominate the conversation, asking a lot of questions. The first thing I ask the patient is ‘how aggressive do want to be and how do you feel about this?’ It is important to get their input and go from there.

Patient education is key. We must give them reasonable expectation and comprehensive information about their treatment. Spending time with them at the start is critical.

O Jay On

BenzaClin® is a registered trademark of Aventis Pharmaceuticals, Inc., Acanya® is a registered trademark of Dow Pharmaceutical Sciences, Inc. Atralin® and CeraVe® are registered trademark of Coria Laboratories, Ltd. Duac® is a registered trademark of Stiefel Laboratories, Inc. Retin A Micro® is a registered trademark of Ortho-McNeil Pharmaceuticals, Inc. Accutane® is a registered trademark of F Hoffman-La Roche Ltd.

Joe Capasso: I turn my back to the parents and sit facing the patient (not to exclude the parents, I will look back and talk to them occasionally) to address and engage them. We don’t hand the samples or instructions to the parent.

Mom and Dad will have a role. I tell all my patients “Mom, Dad this is not your job” and to the patient “if you want this to get better we have awesome medications and a plan that will work if you do stick it.”

Keri Holyoak: Absolutely, you need a support group to treat acne. It is a family role and for some people you have to absolutely include the parent.

How about follow-up?

When do you typically see your acne patient back?

Joe Capasso: 4 weeks – I used to do 6 weeks but I have found I get much better compliance now I see them at 4 weeks. Also, say there is an issue with irritation, how many times do you say ‘call me and ask’ and they don’t. Maybe they aren’t using their medication correctly. You catch so much more and we save treatment time if they come in a four weeks.

John Notabartolo: I agree. I see then after a month. I tell them during the initial consultation that I will see them at 4 weeks and the improvement I expect to see, and that I will see them again at 8 weeks (and what 3

improvement I expect at that stage). If we are not seeing improvement at 4 weeks they are on the wrong medications or not using them properly, which I like to identify early on. I tell them at the beginning that if I don’t see improvements when they come back to see me I will change things.

John Notabartolo: I see a lot of acne patients because of my patient volume, but also because patients find it easier to get an appointment within 3-4 days rather than waiting to see the dermatologist.

Keri Holyoak: 10 weeks works great for me. I spend as much as 20 minutes with my new acne patients on the first visit, so I feel I have the time to educate them. I really try to build a relationship with them and understand their emotional and physical needs. I get good compliance. Do they call me? Sure. Do I get a lot of calls? No. I tell them what they are going to see along the way by 6 weeks, but I don’t tell them to expect much before 6 weeks.

Joe Capasso: I am not sure what to expect. I worry most about Managed Care and the products we will have to treat acne rather than our role. Will there be less choice? Is everyone going to get generic retinoid and BPO over the counter?

What is the primary role of the PA?

John Notabartolo: I see a lot of generic clindamycin used, especially with pediatricians, where patients got better the first couple of weeks then their acne came

Joe Capasso: We are very much the first line in acne treatment.

How do you see the role changing?

Keri Holyoak: Does anyone have concerns about resistance and the way we treat acne? I have seen tolerance to clindamycin and see a lot of patients who have used clindamycin.

Keri Holyoak: I agree. My doctors don’t want to see any acne. I see them all.

As Physician Assistants we are very much the first line in acne treatment.

Joe Capasso

right back. This gives us an educational challenge when we come to prescribe a fixed combination product with clindamycin in it.

BPO obviates the development of clindamycin resistance.

What are the main reasons for call-backs?

John Notabartolo: Cost is a huge issue. Some of our patients have sizable copays, so when you prescribe a combination medication with single co-pay rather than two products they are much happier.

Malia Tilton: Medicines that aren’t covered/access - this is the biggest issue for callbacks.

John Notabartolo

You are treating a patient – not a condition and not “Vivamus porta their parents. We are estmore sedearlyest.” seeing onset puberty patients with acne and you have to make things simple. I love the fact that you Atralin® is indicated for kids as young as 10 years.

Tolerability, irritation and dryness are main reasons for callbacks. Sometimes it is the medication and sometimes the way it is used. I make sure they wait 15 minutes after washing and apply to dry skin.

Atralin is so well tolerated.

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John Notabartolo: A close second would be tolerability, irritation and dryness in particular. Sometimes this isn’t just the medication, but because they are not following the instructions I gave them to wait 15 minutes after you have washed your face and apply to dry skin.

O Jay On: When my patients call to say ‘I’m red’ I always ask them ‘but are you clearer? Do you have a lot less bumps even though you are red?’ I need to know how they are tolerating their medication, but I also need to know if they are getting better.

What are the most common reasons why fixed-combination products are used in your practice to treat acne?

John Notabartolo: Simplicity Malia Tilton: You are combining two effective products in one.

Joe Capasso: Synergy. They are working on different mechanisms for their antibacterial effect, plus adding

O Jay On: What about cost?

Keri Holyoak: In addition, there is usually more than one child in the family on acne therapy so cost adds up. The biggest reason why I started prescribing Acanya® was because of the cost. I was very skeptical about Acanya, but because of the $25 co-pay I started writing it. I have been very pleased with the results.

Joe Capasso: When it first came out I wondered why it took a company so long to introduce a fixed combination with only 2.5% BPO. I was aware of the clinical data showing that 2.5% BPO was just as effective as 5% and 10%. I didn’t really understand why BenzaClin® and Duac® were introduced in the first place with 5% BPO. When Acanya, a fixed-combination of 2.5% BPO and 1.2% clindamycin phosphate, came out I was ecstatic. Then when the copay card came out that was even better. In my experience, Acanya is a very well tolerated medication and the price is right.

Cost is a huge issue.

Some patients have sizable co-pays, so when you prescribe a combination medication with a single co-pay they are much happier.

Many of my patients just stopped using 5%BPO combination products altogether because of irritation.

When Acanya® came out with 2.5%BPO I was ecstatic. Then the $25 co-pay convinced me. In my experience, Acanya is very well tolerated and the price is right.

I use Acanya almost exclusively, in at least 70% of my patients with mild to moderate acne. I am delighted it will soon be available in a pump.

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How common a problem in practice is skin irritation/dryness with fixed combinations containing 5% BPO? Joe Capasso: When I was using the 5% BPO combination products a lot more I used to tell my patients that you might get a little irritation and you might have to start the retinoid first and wait a couple of weeks. It was certainly a problem.

Malia Tilton: Many patients just stopped using the 5% BPO combination products altogether because of irritation.

What types of coping mechanisms do patients adopt?

Malia Tilton: People like to ‘spot treat’, even though there is no such thing.

John Notabartolo: I don’t discourage spot treatment, if it is not hurting/irritating them. They like to put their medication on in the morning and an extra little dab before they go to bed. I tell them that localized use is doing them absolutely no good whatsoever. Of more concern is that I see patients ‘stop-go’ quite a bit, using their medication every other day or only once a week. I wish patients who are having irritation/tolerability issues would call back.

Sometimes they stop using or just don’t come back at all.

That is one of the reasons I like the short follow-up. I can judge where they are at with

their medication, and what we need to do. If you are still seeing irritation at 4 weeks then there is something wrong. Either the patient is applying it wrong or the medication is wrong.

Sometimes they will have switched to another product (‘it worked for him it will work for me’) or they see an ad for something on TV. Joe Capasso: Seeing them back within a month I usually notice their coping issues, and if they are having irritation problems we can fix it. In my experience, they are either using too much or not waiting 15-20 minutes after washing. They even have misconceptions about using a moisturizer. Patients think it dilutes their medication – they need reassuring that it doesn’t and their medication might work better, also it doesn’t matter when they use the moisturizer; you get just as good efficacy results putting you medication on before or after moisturizer use compared to not using any moisturizer at all.

Keri Holyoak: I get a lot of patients who might try using it every other day rather than once a day.

John Notabartolo: I agree, but it also depends on the age group and their motivation, and whether Mom brought them to see you.

Malia Tilton: I give my card to all my patients and tell them to call me if they have any problems

What has your experience been with Acanya®?

Malia Tilton: I have found Acanya to be very tolerable, very efficacious and it works really well in all types of patients (mild, moderate, severe). But some people will come in and tell you they thought it was supposed to make your skin flake otherwise it wasn’t working.

My patients like Acanya because it is very easy to put their make-up on top of it.

John Notabartolo: My initial use of Acanya has been with patients who have had a hard time with a retinoid, were very sensitive and not clearing up as well as I would like to see. These are patients where I would use a BPO-clindamycin combination anyway and I will go with the more gentle, better-tolerated one. I am seeing great results with Acanya. As with all BPO products you always warn them beforehand about potential bleaching and tell them to use an old pillowcase they don’t care about. I make sure they are using the right amount of medication (pea-sized) and have not seen any bleaching with Acanya.

Joe Capasso: I use Acanya almost exclusively, in at least 70% of my patients for mild to moderate acne. The overall response I get has been very good. Patients really like Acanya. They don’t like the jar and I am delighted that Acanya will soon be available in a pump 6

(they feel that they might be contaminating it by putting their finger in the jar).

Keri Holyoak: I exclusively use it at nighttime. It is pretty awesome that the 2.5% BPO is the same irritancy level as the 1% BPO. I think it is important to lay the foundation that Acanya isn’t going to make their skin tight. If I switch my patients from BenzaClin® to Acanya they complain that it doesn’t make them feel as tight/irritated. Almost as though they expect it.

John Notabartolo: This is where I address Mom or Dad as they are more familiar with the old BPO products containing 10-20% BPO - put it on your face and it just exploded. Then I tell them that now all we need is 2.5% BPO. Great way of getting the patient on board with something that appears to be less than what they were getting from pharmacy before.

Joe Capasso: To that point it is also important to explain that you are giving them two products that work together and are different than what they can get over the counter – they are coming to you because they want professional help.

Barrier repair is the foundation of all acne therapy.

CeraVe® has been a life-saver.

How important is the efficacy/tolerability balance to you when deciding which retinoid to use?

John Notabartolo: Important issues are patient age and perceived compliance level; their ability to tolerate retinoids. If the patient is really motivated they are going to use whatever you throw at them. But we need to provide more patient education with retinoids.

Joe Capasso: I agree. I like to tell patients the rationale for why I am using what I am using and what they might expect. If you have a patient with a few comedones and a few erythematous papules you’re not going to give them a strong retinoid. It is certainly an individualized treatment. There is also an expectation/misconception that their acne is going to get worse before it gets better. If it gets worse, it is going to get worse whether you are using a medicine or not. There is no data to show that your acne gets worse on an acne treatment – there is no mechanism for that. Education at the start is key.

John Notabartolo: I tell my patients that they might experience some dryness and flaking and the lesions they have on their face right now are going to become redder, a little inflamed and more noticeable, but they are not going to get new ones.

John Notabartolo: The problem patients are the ‘pickers’. I tell them ‘you know that zit you picked at, it is going to go away in a week if you leave it alone, but if you keep picking it you will get a scar -leave it alone’.

Malia Tilton

When CeraVe® PM came out I told all my patients to use it right after their nighttime retinoid to minimize irritation and dryness.

Keri Holyoak: I tell them as well their face will become smoother, not necessarily one color, the bumps will become smaller, you’ll still see them O Jay On: Acne patients judge how they are doing by how they look in the mirror. They might see a lot of post-inflammatory hyperpigmentation where the lesions were and smoothness, because they are gone, but they tell you they are not any better, or they have scars. You need to get them to touch their face Joe Capasso: I tell them that not only is it not a scar, but that the retinoid they are using will help speed up the resolution – helping the acne and the discoloration. It is a huge relief to them as scarring is the #1 worry of acne patients.

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Keri Holyoak: I love to take pictures, before and at 10 weeks showing them that they are so much better

Does your retinoid use differ depending on gender/age etc?

Joe Capasso: It is a very individual thing. It is important to assess what their skin looks like – is it oily or dry? What is their perception about their acne and what do you think they are going to be able to use?

What is the severity of their acne?

John Notabartolo: I find that female patients are much more likely to follow a multiple medication regimen. Guys just want one tube, one fix once a day. I always ask the patient ‘what do you want to achieve?’

Especially those that Mom has dragged in who may already have a low self esteem. By asking questions like ‘how much better do you want to get?’ and ‘what are you willing to do?’ they can help guide you as to what you are going to prescribe.

O Jay On: When would you use a retinoid all by itself?

Malia Tilton: Post Accutane® (step down).

John Notabartolo: Comedonal acne only. Prepubescent.

Keri Holyoak: really busy boys who only want one treatment regimen (at night).

Joe Capasso: if you have to pick one you will use the retinoid – you won’t get results as quickly but you will get results.

O Jay On: How might you use a retinoid and combotherapy together?

John Notabartolo: I am more likely to start two medications at the same time. They have already been to see somebody else, either their primary care provider or pharmacist and I want them clear/almost clear as soon as possible. If I have to back-off something later that’s fine. I tell them I am going to get them clear/almost clear in 8-12 weeks, ‘you give me that much time and I will give you the skin that you want’.

What has been your experience with cutaneous tolerability and compliance with retinoids?

Joe Capasso: Education is again key. I tell patients that they don’t have to scrub hard, just put water on you face. Also, if they put it the retinoid on straight after they have washed

Joe Capasso

Accutane® (where I am looking long-term benefit). I have been almost exclusively Retin-A Micro, but my patients have dryness issues and I am using more and more Atralin. I like the formulation and the fact that the efficacy is just as good as the 0.1% Retin-A Micro.

Keri Holyoak

In about 80% of cases the irritation problems are caused when patients don’t wait until their face is dry. I tell them to moisturize after use (sometimes helpful beforehand), every other day and titrate up on usage.

John Notabartolo: I would perhaps start with a lower strength retinoid. I tell my patients to wash their face and moisturize after dinner and then apply the retinoid before they go to bed at night.

Keri Holyoak: Unfortunately they get tired and lazy at night so it might help if they can wash earlier. I have some patients mix the retinoid with their moisturizer and for those boys who won’t wash their face I have them use a baby wipe.

How does efficacy/tolerability of Atralin® compare to Retin-A Micro®?

John Notabartolo: I find Atralin better tolerated than Retin-A Micro. It’s a great vehicle and much nicer for the patient. They don’t experience as much dryness/irritation. My biggest use of monotherapy is in post8

Keri Holyoak: I see the same, definitely better tolerated and it is great there is no degradation combining with BPO. Joe Capasso: I’ve noticed it is way more tolerable than the Retin-A Micro products and I find it just as efficacious. I just don’t like to use the Retin-A Micro products because they are just so irritating. Patients will never use them. They will use Atralin and I can see a benefit in their acne pretty quickly. It’s a great product that works really well.

What about the importance of the skin barrier and acne management?

Keri Holyoak: Barrier repair is a foundation to all of our acne therapy. Without barrier repair you won’t see results. All my patients get a sample of CeraVe® lotion. It has been the life-saver in my acne therapy.

Malia Tilton: I agree, especially if it increases compliance. When CeraVe® PM came out I told all my patients to use it right after their nighttime retinoid,

because some people get irritation and dryness from retinoids. I find adding a nighttime moisturizer like CeraVe® PM, which also has niacinamide, helps with the inflammation-associated dryness. Before the CeraVe® PM came along I was using CeraVe® cream. It really works well, so I have stuck with it.

John Notabartolo: I inform my patients that their skin serves two purposes…it keeps the insides in and the outside out. You need the natural oil barrier other wise anything; including their own sweat will cause irritation.

CeraVe is a great, mild cleanser that moisturizes at the same time. My first impression of CeraVe was it was a me-too moisturizer. As I started using it and started seeing the differences and seeing the clinical data it became very clear that this was my preferred product. It does a lot more.

Joe Capasso: Acne is in a large part an inflammatory disorder. If the skin barrier function isn’t working it is a problem. In atopic dermatitis their skin isn’t built right – they don’t make the ceramides for their skin to work correctly. When I saw the data on CeraVe and tried the samples it all made sense; and an important option for patients that it is over the counter. Not only are patients appreciative, but also they tell us ‘this is the best’. I have seen the flare-ups become less frequent and less severe.

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