JDPA Summer 2016

DPA J

V o l u m e 1 0 • n u m b e r 3 • S UMMER 2 0 1 6 • www.jdpa.org

Journal of Dermatology for Physician Assistants

Dermatology PA News & Notes SDPA State Affiliates 19 __________________________________

CLINIcal dermatology Clinical Snapshots

31

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surgical dermatology Journal Club 35 _________________________________

cosmetic dermatology Cosmetic Pearls 38 __________________________________

professional development Outside & Inside the 9 to 5

41

›› Earn CME credit with this issue CME Update on Management of Hidradenitis Suppurativa

21

Official Journal of the Society of Dermatology Physician Assistants

Volume 10 • number 3 • SUMMER 2016

1

80 mg/mL

START YOUR PATIENTS TODAY Taltz is a targeted interleukin-17A (IL-17A) antagonist indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Taltz can provide high levels of clearance—even complete resolution of plaques (PASI 100) is possible1 TRIAL 2: EFFICACY AT 12 WEEKS

90% 71% 40% PASI 75 vs 2 %

PASI 90 vs 1%

PASI 100 vs 1%

Taltz 80 mg every 2 weeks (n=351)

83%

achieved clear or almost clear skin (sPGA 0,1)

vs 2 %

Placebo (n=168) For all comparisons, P<.001 vs placebo.

ADDITIONAL RESULTS

In Trials 1 and 3, Taltz patients achieved similar results: 89% and 87% of Taltz patients achieved PASI 75 vs 4% and 7% for placebo. Additionally, 71% and 68% of Taltz patients achieved PASI 90 vs 1% and 3% for placebo, and 35% and 38% achieved PASI 100 vs 0% and 0% for placebo. Also, 82% and 81% achieved sPGA 0,1 vs 3% and 7% for placebo.

Taltz is the only approved treatment for moderate to severe plaque psoriasis that includes PASI 100 results in the Prescribing Information1 TRIAL DESIGN The Taltz clinical program included 3 randomized, double-blind, placebo-controlled trials to evaluate the efcacy and safety of Taltz. All patients were ≥18 years of age and had plaque psoriasis with a body surface area involvement of ≥10%, a static Physician’s Global Assessment (sPGA) score ≥3, and a Psoriasis Area Severity Index (PASI) score ≥12, and were candidates for phototherapy or systemic therapy. Participants were randomized to receive placebo or Taltz 80 mg every 2 weeks following a 160 mg starting dose. In Trials 2 and 3, an additional arm of US-approved etanercept (50 mg twice weekly) was included.

Co-primary efcacy endpoints were proportion of patients with an sPGA 0,1 and at least a 2-point improvement from baseline and proportion of patients achieving PASI 75 (at least a 75% reduction in the PASI composite score) at week 12. Nonresponder imputation (NRI) methods were used for categorical efcacy analyses.

Taltz® is a registered trademark of Eli Lilly and Company. PP-IX-US-0722 08/2016 ©LILLY USA, LLC, 2016. ALL RIGHTS RESERVED.

Download savings cards for your patients at taltz.com/hcp IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Taltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.

WARNINGS AND PRECAUTIONS Infections Taltz may increase the risk of infection. The Taltz group had a higher rate of infections than the placebo group (27% vs 23%).

Serious infections have occurred. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, discontinue Taltz until the infection resolves.

Pre-Treatment Evaluation for Tuberculosis Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Taltz. Do not administer to patients with active TB infection. Initiate treatment of latent TB prior to administering Taltz. Patients receiving Taltz should be monitored closely for signs and symptoms of active TB during and after treatment.

Hypersensitivity Serious hypersensitivity reactions, including angioedema and urticaria (each ≤0.1%), occurred in the Taltz group in clinical trials.

If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate therapy.

Inammatory Bowel Disease Crohn’s disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz group (Crohn’s disease 0.1%, ulcerative colitis 0.2%) than in the placebo group (0%) during clinical trials. During Taltz treatment, monitor patients for onset or exacerbations of inammatory bowel disease.

Immunizations Prior to initiating therapy with Taltz, consider completion of all age-appropriate immunizations according to current immunization guidelines. Live vaccines should not be given with Taltz.

ADVERSE REACTIONS Most common adverse reactions (≥1%) associated with Taltz treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections.

IX HCP ISI 22MAR2016

Please see Brief Summary of Prescribing Information on the following pages. Please see Instructions for Use included with the device.

Call The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979) or visit taltz.com for more information about Taltz.

Reference: 1. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2016.

Volume 10 • number 3 • SUMMER 2016

3

Taltz® (ixekizumab) injection Brief Summary: Consult the package insert for complete prescribing information.

INDICATIONS AND USAGE Taltz is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

CONTRAINDICATIONS Taltz is contraindicated in patients with a previous serious hypersensitivity reaction such as anaphylaxis to ixekizumab or to any of the excipients.

WARNINGS AND PRECAUTIONS Infections—Taltz may increase the risk of infection. In clinical trials, the Taltz group had a higher rate of infections than the placebo group (27% vs 23%). Upper respiratory tract infection, oral candidiasis, conjunctivitis and tinea infections occurred more frequently in the Taltz group than in the placebo group (Adverse Reactions). Instruct patients treated with Taltz to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a serious infection or is not responding to standard therapy, monitor the patient closely and discontinue Taltz until the infection resolves.

Pre-treatment Evaluation for Tuberculosis—Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Taltz. Do not administer to patients with active TB infection. Initiate treatment of latent TB prior to administering Taltz.

Consider anti-TB therapy prior to initiating Taltz in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

Patients receiving Taltz should be monitored closely for signs and symptoms of active TB during and after treatment.

Hypersensitivity—Serious hypersensitivity reactions, including angioedema and urticaria (each ≤0.1%), occurred in the Taltz group. If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate therapy.

Inflammatory Bowel Disease—Crohn’s disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz group (Crohn’s disease 0.1%, ulcerative colitis 0.2%) than in the placebo group (0%) during the 12-week, placebo- controlled period. During Taltz treatment, monitor for onset or exacerbation of inflammatory bowel disease.

Immunizations—Prior to initiating therapy with Taltz, consider completion of all age- appropriate immunizations according to current immunization guidelines.

Avoid use of live vaccines in patients treated with Taltz. No data are available on the response to live or inactive vaccines.

ADVERSE REACTIONS The following adverse drug reactions are discussed in greater detail in other sections of the label: • Infections (Warnings and Precautions) • Hypersensitivity Reactions (Contraindications and Warnings and Precautions) • Inflammatory Bowel Disease (Warnings and Precautions) Clinical Trials Experience—Because clinical trials are conducted under widely varying and controlled 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.

Weeks 0 to 12: Three placebo-controlled trials in subjects with plaque psoriasis were integrated to evaluate the safety of Taltz compared to placebo for up to 12 weeks. A total of 1167 subjects (mean age 45 years; 66% men; 94% White) with plaque psoriasis received Taltz (160 mg at Week 0, 80 mg every two weeks [Q2W] for 12 weeks) subcutaneously. In two of the trials, the safety of Taltz (use up to 12 weeks) was also compared with an active comparator, U.S. approved etanercept.

In the 12-week, placebo-controlled period, adverse events occurred in 58% of the Taltz Q2W group (2.5 per subject-year of follow- up) compared with 47% of the placebo group (2.1 per subject-year of follow- up). Serious adverse events occurred in 2% of the Taltz group (0.07 per subject-year of follow-up), and in 2% of the placebo group (0.07 per subject-year of follow-up).

Table 1 summarizes the adverse reactions that occurred at a rate of at least 1% and at a higher rate in the Taltz group than the placebo group during the 12-week placebo- controlled period of the pooled clinical trials.

Table 1: Adverse Reactions Occurring in ≥1% of the Taltz Group and More Frequently than in the Placebo Group in the Plaque Psoriasis Clinical Trials through Week 12 Adverse Reactions

Taltz 80 mg Q2W (N=1167) (n%)

Etanercept b (N=287) (n%)

Placebo (N=791) (n%)

196 (17)

32 (11)

26 (3)

163 (14)

23 (8)

101 (13)

Injection site reactions Upper respiratory tract infectionsa Taltz® (ixekizumab) injection

IX HCP BS 22MAR2016

Table 1: Adverse Reactions Occurring in ≥1% of the Taltz Group and More Frequently than in the Placebo Group in the Plaque Psoriasis Clinical Trials through Week 12 (Cont.)

Placebo Adverse Reactions Taltz 80 mg Q2W Etanercept b (N=287) (n%) (N=791) (n%) (N=1167) (n%) Nausea 23 (2) 1 (<1) 5 (1) Tinea infections 17 (2) 0 1 (<1) Upper respiratory tract infections cluster includes nasopharyngitis and rhinovirus infection. b U.S. approved etanercept. a

Adverse reactions that occurred at rates less than 1% in the Taltz group and more frequently than in the placebo group during the 12-week induction period included rhinitis, oral candidiasis, urticaria, influenza, conjunctivitis, inflammatory bowel disease, and angioedema.

Weeks 13 to 60: A total of 332 subjects received the recommended maintenance regimen of Taltz 80 mg dosed every 4 weeks.

During the maintenance period (Weeks 13 to 60), adverse events occurred in 80% of subjects treated with Taltz (1.0 per subject-year of follow-up) compared to 58% of subjects treated with placebo (1.1 per subject-year of follow-up).

Serious adverse events were reported in 4% of subjects treated with Taltz (0.05 per subject-year of follow-up) and none in the subjects treated with placebo.

Weeks 0 to 60: Over the entire treatment period (Weeks 0 to 60), adverse events were reported in 67% of subjects treated with Taltz (1.4 per subject- year of followup) compared to 48% of subjects treated with placebo (2.0 per subject-year of follow-up). Serious adverse events were reported in 3% of subjects treated with Taltz (0.06 per subject-year of follow-up), and in 2% of subjects treated with placebo (0.06 per subject-year of follow-up).

Specific Adverse Drug Reactions: Injection Site Reactions The most frequent injection site reactions were erythema and pain. Most injection site reactions were mild-to-moderate in severity and did not lead to discontinuation of Taltz.

Infections In the 12-week, placebo-controlled period of the clinical trials in plaque psoriasis, infections occurred in 27% of subjects treated with Taltz (1.2 per subject-year of follow-up) compared to 23% of subjects treated with placebo (1.0 per subject-year of follow-up). Serious infections occurred in 0.4% of subjects treated with Taltz (0.02 per subject-year of follow-up) and in 0.4% of subjects treated with placebo (0.02 per subject-year of follow-up) [see Warnings and Precautions (5.1)].

During the maintenance treatment period (Weeks 13 to 60), infections occurred in 57% of subjects treated with Taltz (0.70 per subject- year of followup) compared to 32% of subjects treated with placebo (0.61 per subject-year of follow-up). Serious infections occurred in 0.9% of subjects treated with Taltz (0.01 per subject-year of follow-up) and none in the subjects treated with placebo.

Over the entire treatment period (Weeks 0 to 60), infections were reported in 38% of subjects treated with Taltz (0.83 per subject- year of follow-up) compared to 23% of subjects treated with placebo (1.0 per subject-year of follow-up).

Serious infections occurred in 0.7% of subjects treated with Taltz (0.02 per subject-year of follow-up), and in 0.4% of subject treated with placebo (0.02 per subject-year of follow-up).

Laboratory Assessment of Cytopenia Neutropenia—Over the entire treatment period (Weeks 0 to 60), neutropenia occurred in 11% of subjects treated with Taltz (0.24 per subject-year of follow-up) compared to 3% of subjects treated with placebo (0.14 per subject-year of followup). In subjects treated with Taltz, the incidence rate of neutropenia during Weeks 13 to 60 was lower than the incidence rate during Weeks 0 to 12.

In the 12-week, placebo-controlled period, neutropenia ≥ Grade 3 (<1,000 cells/ mm3) occurred in 0.2% of the Taltz group (0.007 per subject- year of follow-up) compared to 0.1% of the placebo group (0.006 per subject-year of follow-up). The majority of cases of neutropenia were either Grade 2 (2% for Taltz 80 mg Q2W versus 0.3% for placebo; ≥1,000 to <1,500 cells/mm3) or Grade 1 (7% for Taltz 80 mg Q2W versus 3% for placebo; ≥1,500 cells/mm3 to <2,000 cells/ mm3). Neutropenia in the Taltz group was not associated with an increased rate of infection compared to the placebo group.

Thrombocytopenia—Ninety eight percent of cases of thrombocytopenia were Grade 1 (3% for Taltz 80 mg Q2W versus 1% for placebo; ≥75,000 cells/mm3 to <150,000 cells/mm3). Thrombocytopenia in subjects treated with Taltz was not associated with an increased rate of bleeding compared to subjects treated with placebo.

Taltz® (ixekizumab) injection IX HCP BS 22MAR2016

Active Comparator Trials—In the two clinical trials that included an active comparator, the rate of serious adverse events during weeks zero to twelve was 0.7% for U.S.-approved etanercept and 2% for Taltz 80 mg Q2W, and the rate of discontinuation from adverse events was 0.7% for U.S. approved etanercept and 2% for Taltz 80 mg Q2W. The incidence of infections was 18% for U.S. approved etanercept and 26% for Taltz 80 mg Q2W. The rate of serious infections was 0.3% for both Taltz 80 mg Q2W and U.S. approved etanercept.

Immunogenicity—As with all therapeutic proteins there is the potential for immunogenicity with Taltz. By Week 12, approximately 9% of subjects treated with Taltz every 2 weeks developed antibodies to ixekizumab. Approximately 22% of subjects treated with Taltz at the recommended dosing regimen developed antibodies to ixekizumab during the 60-week treatment period. The clinical effects of antibodies to ixekizumab are dependent on the antibody titer; higher antibody titers were associated with decreasing drug concentration and clinical response.

Of the subjects who developed antibodies to ixekizumab during the 60-week treatment period, approximately 10%, which equates to 2% of subjects treated with Taltz at the recommended dosing regimen, had antibodies that were classified as neutralizing. Neutralizing antibodies were associated with reduced drug concentrations and loss of efficacy.

However, the assay to test for neutralizing antibodies has limitations detecting neutralizing antibodies in the presence of ixekizumab; therefore, the incidence of neutralizing antibodies development could be underestimated.

The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of incidence of antibodies to Taltz with the incidences of antibodies to other products may be misleading.

DRUG INTERACTIONS Live Vaccinations—Avoid use of live vaccines in patients treated with Taltz (Warnings and Precautions).

Cytochrome P450 Substrates—The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g., IL-1, IL-6, IL-10, TNF_, IFN) during chronic inflammation. Thus, Taltz, an antagonist of IL-17A, could normalize the formation of CYP450 enzymes.

Therefore, upon initiation or discontinuation of Taltz in patients who are receiving concomitant drugs which are CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for effect (e.g., for warfarin) or drug concentration (e.g., for cyclosporine) and consider dosage modification of the CYP450 substrate.

USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary—There are no available data on Taltz use in pregnant women to inform any drug associated risks. Human IgG is known to cross the placental barrier; therefore, Taltz may be transmitted from the mother to the developing fetus. An embryofetal development study conducted in pregnant monkeys at doses up to 19 times the maximum recommended human dose (MRHD) revealed no evidence of harm to the developing fetus. When dosing was continued until parturition, neonatal deaths were observed at 1.9 times the MRHD [see Data]. The clinical significance of these nonclinical findings is unknown.

The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Data Animal Data—An embryofetal development study was conducted in cynomolgus monkeys administered ixekizumab. No malformations or embryofetal toxicity were observed in fetuses from pregnant monkeys administered ixekizumab weekly by subcutaneous injection during organogenesis to near parturition at doses up to 19 times the MRHD (on a mg/kg basis of 50 mg/kg/week). Ixekizumab crossed the placenta in monkeys.

In a pre- and post-natal development toxicity study, pregnant cynomolgus monkeys were administered weekly subcutaneous doses of ixekizumab up to 19 times the MRHD from the beginning of organogenesis to parturition. Neonatal deaths occurred in the offspring of two monkeys administered ixekizumab at 1.9 times the MRHD (on a mg/kg basis of 5 mg/kg/week) and two monkeys administered ixekizumab at 19 times the MRHD (on a mg/kg basis of 50 mg/kg/week). These neonatal deaths were attributed to early delivery, trauma, or congenital defect. The clinical significance of these findings is unknown. No ixekizumab-related effects on functional or Taltz® (ixekizumab) injection IX HCP BS 22MAR2016

immunological development were observed in the infants from birth through 6 months of age.

Lactation Risk Summary—There are no data on the presence of ixekizumab in human milk, the effects on the breastfed infant, or the effects on milk production. Ixekizumab was detected in the milk of lactating cynomolgus monkeys. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Taltz and any potential adverse effects on the breastfed infant from Taltz or from the underlying maternal condition Pediatric Use—The safety and effectiveness of Taltz in pediatric patients (<18 years of age) have not been evaluated.

Geriatric Use—Of the 4204 psoriasis subjects exposed to Taltz, a total of 301 were 65 years or older, and 36 subjects were 75 years or older. Although no differences in safety or efficacy were observed between older and younger subjects, the number of subjects aged 65 and over is not sufficient to determine whether they respond differently from younger subjects.

OVERDOSAGE—In the event of an overdosage, monitor the patient for any signs or symptoms of adverse reactions and institute appropriate symptomatic treatment immediately.

PATIENT COUNSELING INFORMATION—Advise the patient/caregiver to read the FDA- approved patient labeling (Medication Guide and Instructions for Use) before the patient starts using Taltz and each time the prescription is renewed, as there may be new information they need to know.

Instructions on Self-Administration-Provide guidance to patients and caregivers on proper subcutaneous injection technique, including aseptic technique, and how to use the autoinjector or prefilled syringe correctly (Instructions for Use).

Infection: Inform patients that Taltz may lower the ability of their immune system to fight infections. Instruct patients of the importance of communicating any history of infections to the healthcare provider, and contacting their healthcare provider if they develop any symptoms of infection. (Warnings and Precautions).

Allergic Reactions: Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions. (Warnings and Precautions).

Additional information can be found at www.Taltz.com.

Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA Copyright © 2016 Eli Lilly and Company. All rights reserved.

IX HCP BS 22MAR2016 Taltz® (ixekizumab) injection

IX HCP BS 22MAR2016

Journal of Dermatology for Physician Assistants

EDITORIAL BOARD Travis Hayden, MPAS, PA-C, Editor in Chief Joe R. Monroe, MPAS, PA Patricia Ferrer, MPAS, PA-C Gordon Day, R.Ph, PA-C Lauren Zajac, MHS, PA-C Michelle DiBaise, MPAS, PA-C P. Eugene Jones, PhD, PA-C Mark Archambault, DHSc, PA-C Kristine Kucera, DHS, MPAS, PA-C Jennifer Winter, PA-C Mark Hyde, MMS, PA-C Jennifer Conner, MPAS, PA-C Jeffrey LaDuca, PhD, MD Alan Menter, MD

DEPARTMENT EDITORS Clinical Department Editors Susan E. King-Barry, MPAS, PA-C Karen Graham, PhD, MPAS, PA-C Dermatology Grand Rounds Editor Cynthia F. Griffith, MPAS, PA-C Dermoscopy Editor John Burns, MSPA, PA-C Drugs in Dermatology Editor Stephen Wolverton, MD Surgical Department Editor Christy Kerr, MPAS, PA-C Cosmetic Department Editor Travis Hayden, MPAS, PA-C Prof Dev Department Editor Abby Jacobson, MS, PA-C

2016-17 SDPA Board of Directors PRESIDENT Jennifer Conner, MPAS, PA-C PRESIDENT-ELECT Jane Mast, MPAS, PA-C IMMEDIATE PAST PRESIDENT Matthew Brunner, MHS, PA-C VICE PRESIDENT Jacki Kment, MPAS, PA-C SECRETARY / TREASURER Joleen Volz, MPAS, PA-C DIRECTORS AT LARGE Matt Dohlman, MHS, PA-C Gina Mangin, MPAS, PA-C Mark Hyde, MMS, PA-C Archana Sangha, MMS, PA-C

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: The 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. going green: 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.

Publishing Staff 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 To read the JDPA publication’s Ethics and Malpractice Statement, please visit www.jdpa.org/write.html. keep current with the SDPA:

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 10, Number 3, Summer 2016. 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). Periodicals postage rate paid at New York, NY 10001 and additional mailing offices. © 2016 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., 8400 Westpark Drive, 2nd Floor, McLean, VA 22102 1-800-380-3992., email SDPA@dermpa.org, www.dermpa.org.

6

Journal of Dermatology for Physician Assistants

Editor’s Message Finding Unexpected Connections Off the Beaten Path This summer the annual SDPA Leadership Retreat was held in Jackson Hole, Wyoming.

My family packed up the car and headed out west on a good old-fashioned family road trip. Along the way we saw some amazing sites, connected with great people, made many new acquaintances, and enjoyed some quality family time. One of the stops we made along the way was at Mt. Rushmore. We were planning to make it a quick stop as we wanted to continue on to our next destination before nightfall. Along the hike that takes visitors around the base of the monument there was a little off the beaten path area for kids. There were benches that were shaded under some ponderosa trees and teepees the kids could explore. This is where we met a park ranger who asked if we were staying to listen to his talk that started in five minutes. Nobody else was around and despite trying to stick to a schedule, we felt inclined to say yes. We were so glad we did! We had the pleasure of happening upon a talk given by Darrell Red Cloud, a U.S. National Park Ranger who is a descendant of the great Lakota Chief, Red Cloud. Mr. Red Cloud was an amazing and captivating speaker. His message of living in harmony with Mother Earth and all who dwell on this planet was one that will stay with my family, and the crowd that eventually gathered, for the rest of our lives. It was an emotional experience for all who were privileged to hear him speak. When Mr. Red Cloud had finished speaking and sang one of his native Lakota tribe’s chants, the audience was moved to tears. We were not anticipating anything like this when we pulled into this national park; it was well beyond our expectations.

I have found myself reflecting on this experience in the weeks following our trip out west. While back at work I had one particular encounter with a patient whom I had been treating for quite some time. She had several previous visits to our office for routine skin checks, but I had not been able to connect with her beyond the typical clinical dialogue. We strictly spoke about her medical situation and had a professional rapport; that was what the patient seemed content with. I always try to make some kind of connection with my patients to help put them at ease and make their appointments as comfortable as possible. Fresh off the heels of our trip, I was enjoying sharing stories about my family’s adventures with my patients. At her most recent appointment, this particular patient seemed to enjoy hearing about the national parks we visited and suddenly opened up and shared with me that it has always been her dream to see a moose in the wild. This was our “off the beaten path” connection. My family and I had been fortunate enough to see three moose during our trip! It turns out that she is an avid traveler herself and loves the national parks; our discussion and interaction level suddenly took on a whole new and deeper level of connection.

This appointment with this patient was a further reminder that the paths we take in our day-to-day clinic routine can seem mundane at times; however we always have the opportunity to veer off the path and make a connection or find a common interest, hobby, or conversational piece that we can share with our patients thereby deepening our connection with them. J

Travis Hayden, MPAS, PA-C JDPA Editor in Chief editor@jdpa.org

Volume 10 • number 3 • SUMMER 2016

7

table of contents 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.

21

Update on Management of Hidradenitis Suppurativa

By Caroline Laggis, MD, Allyson Sorensen, PA-C, and Christopher Hull, MD

›› CME 12 Derm PA News & Notes – part one • Certification Review • Student Corner – Preparing PA Students for Practice • SDPA State Affiliates

21 Clinical Dermatology • CME Article –Update on Management of Hidradenitis Suppurativa

Departments 06 Editorial Board 07 Editor’s Message 11 SDPA News & Current Affairs 12 Dermatology Market Watch 28 From The Patient’s Perspective 31 Clinical Snapshots 36 Surgical Wisdom 38 Cosmetic Pearls 40 Notes from your Office Manager 45 Listening to Patients 49 Dermcast.tv 54 Professional Opportunities and Development

35 Surgical Dermatology • Journal Club: Practice Changing Articles for Dermatology

37 Cosmetic Dermatology • Journal Club: Practice Changing Articles for Dermatology

40 Professional Development • Outside & Inside the 9 to 5…

45 Derm PA News & Notes – part two

Go Green & Read On the Go 8

Journal of Dermatology for Physician Assistants

• Workplace Excellence • From the Desk of…

• Supervising Physician Corner: AAD’s Choosing Wisely Campaign

dermpa.org

Introducing New ULTRAVATE® Lotion

HELP YOUR PATIENTS TAME THE BEAST OF PLAQUE PSORIASIS ULTRAVATE Lotion offers class 1 efficacy in a moisturizing lotion formulation.1

INDICATIONS AND USAGE: ULTRAVATE® (halobetasol propionate) Lotion, 0.05% is indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older.

Treatment beyond 2 weeks is not recommended, and the total dosage should not exceed 50 grams per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.

Discontinue therapy when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

IMPORTANT SAFETY INFORMATION PRECAUTIONS: In a study of 20 adult subjects with moderate to severe plaque psoriasis, ULTRAVATE® Lotion produced HPA axis suppression when used twice daily for 2 weeks in 5 out of 20 (25%) patients. If HPA axis suppression is documented, attempt to gradually withdraw the drug, reduce the frequency of application, or substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.

Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal, rather than noting a clinical exacerbation.

Consider confirmation of a clinical diagnosis of allergic contact dermatitis by appropriate patch testing. Discontinue ULTRAVATE® Lotion if allergic contact dermatitis is established.

If concomitant skin infections are present or develop, an appropriate

antimicrobial agent should be used. If a favorable response does not occur promptly, the use of ULTRAVATE® Lotion should be discontinued until the infection has been adequately treated.

The treated skin area should not be bandaged, covered, or wrapped with occlusive dressings, unless directed by the physician.

The safety and effectiveness of ULTRAVATE® Lotion in patients younger than 18 years of age have not been established.

ULTRAVATE® Lotion is for external use only. Avoid use on the face, scalp, groin, or axillae.

ADVERSE REACTIONS: In controlled clinical trials, the most frequent adverse events reported for ULTRAVATE® Lotion included telangiectasia, application site atrophy, and headache in 1% of patients. Less frequently reported adverse reactions were application site discoloration, herpes zoster, influenza, nasopharyngitis, otitis media acute, throat infection, wound, and increased blood pressure.

This preparation is not for ophthalmic, oral, or intravaginal use.

For external use only.

Please see Brief Summary of full Prescribing Information on following page.

If you experience any Adverse Events you are encouraged to report them to the Drug Safety Department at 1-800-406-7984 or email Drug.Safety@ranbaxy.com. You can also report to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Reference: 1. Ultravate® Lotion. Data on File; Jacksonville, FL: Ranbaxy Laboratories Inc; January 2015.

ULTRAVATE is a registered trademark of Ranbaxy Laboratories Inc.

Ranbaxy Laboratories Inc. Jacksonville, FL 32257 Copyright © 2016 Ranbaxy Laboratories Inc, a SUN PHARMA company.

Printed in USA ULL0008 3/16

Volume 10 • number 3 • SUMMER 2016

9

ULTRAVATE (halobetasol propionate) lotion BRIEF SUMMARY: See package insert for full prescribing information.

1. INDICATIONS AND USAGE ULTRAVATE lotion is indicated for the topical treatment of plaque psoriasis in patients eighteen (18) years of age and older.

2. DOSAGE AND ADMINISTRATION Apply a thin layer of ULTRAVATE lotion to the affected skin twice daily for up to two weeks. Rub in gently. Discontinue therapy when control is achieved. If no improvement is seen within two weeks, reassessment of diagnosis may be necessary.

Treatment beyond two weeks is not recommended and the total dosage should not exceed 50 grams (50 mL) per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis [see Warnings and Precautions 5.] .

Do not use with occlusive dressings unless directed by a physician.

ULTRAVATE lotion is for external use only.

Avoid use on the face, scalp, groin, or axillae.

ULTRAVATE lotion is not for ophthalmic, oral, or intravaginal use.

4. CONTRAINDICATIONS None.

5. WARNINGS AND PRECAUTIONS 5.1 Effects on Endocrine System ULTRAVATE lotion is a topical corticosteroid that has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis.

Systemic effects of topical corticosteroids may include reversible HPA axis suppression, with the potential for glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of treatment of the topical corticosteroid.

The potential for hypothalamic-pituitary adrenal (HPA) suppression with ULTRAVATE lotion was evaluated in a study of 20 adult subjects with moderate to severe plaque psoriasis involving ≥ 20% of their body surface area. ULTRAVATE lotion produced HPA axis suppression when used twice daily for two weeks in 5 out of 20 (25%) adult patients with plaque psoriasis. Recovery of HPA axis function was generally prompt with the discontinuation of treatment [see Clinical Pharmacology (12.2)].

Because of the potential for systemic absorption, use of topical corticosteroids, including ULTRAVATE lotion, may require that patients be evaluated periodically for evidence of HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent corticosteroids, use over large surface areas, prolonged use, occlusive use, use on an altered skin barrier, concomitant use of multiple corticosteroid-containing products, liver failure, and young age. An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression.

If HPA axis suppression is documented, attempt to gradually withdraw the drug, reduce the frequency of application, or substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.

Systemic effects of topical corticosteroids may also include Cushing's syndrome, hyperglycemia, and glucosuria. Use of more than one corticosteroid-containing product at the same time may increase the total systemic exposure to topical corticosteroids.

Pediatric patients may be more susceptible than adults to systemic toxicity from the use of topical corticosteroids due to their larger surface-to-body mass ratios [see Use in Specific Populations (8.4)].

5.2 Local Adverse Reactions Local adverse reactions from topical corticosteroids may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. These may be more likely to occur with occlusive use, prolonged use, or use of higher potency corticosteroids, including ULTRAVATE lotion. Some local adverse reactions may be irreversible.

5.3 Concomitant Skin Infections Use an appropriate antimicrobial agent if a skin infection is present or develops. If a favorable response does not occur promptly, discontinue use of ULTRAVATE lotion until the infection has been adequately treated.

5.4 Allergic Contact Dermatitis Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Consider confirmation of a clinical diagnosis of allergic contact dermatitis by appropriate patch testing. Discontinue ULTRAVATE lotion if allergic contact dermatitis is established.

6. ADVERSE REACTIONS 6.1 Clinical Trials Experience 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.

During randomized, controlled, blinded clinical trials 277 adults with plaque psoriasis were treated with ULTRAVATE lotion twice daily for up to two weeks (up to approximately 50 grams/week).

Table 1 presents adverse reactions that occurred in at least 1% of subjects treated with ULTRAVATE lotion twice daily for up to two weeks, and more frequently than in vehicle-treated subjects.

Table 1. Adverse Reactions Occurring in ≥ 1% of Subjects Treated with ULTRAVATE Lotion for up to Two Weeks ULTRAVATE Lotion (N=277) Vehicle Lotion (N=259) Adverse Reaction % % Teleangiectasia 1% 0% Application site atrophy 1% <1% Headache 1% <1% Less common adverse reactions (incidence less than 1% but greater than 0.1%) that occurred in subjects treated with ULTRAVATE lotion included application site discoloration, herpes zoster, influenza, nasopharyngitis, otitis media acute, throat infection, wound, and increased blood pressure.

Ranbaxy Laboratories Inc. Jacksonville, FL 32257 Copyright © 2016 Ranbaxy Laboratories Inc., a SUN PHARMA company.

10 Journal of Dermatology for Physician Assistants

8. USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no data on topical halobetasol propionate use in pregnant women to inform any drug-associated risks for birth defects or miscarriage. In animal reproduction studies, halobetasol propionate administered systemically during organogenesis to pregnant rats at 13 and 33 times the human topical dose and to pregnant rabbits at 3 times the human topical dose resulted in teratogenic and embryotoxic effects [see Data]. The clinical relevance of the animal findings is not clear.

The background risk of major birth defects and miscarriage for the indicated population are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

8.2 Lactation Risk Summary There are no data on the presence of halobetasol propionate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production after topical application to women who are breastfeeding.

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 human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ULTRAVATE lotion and any potential adverse effects on the breastfed infant from ULTRAVATE lotion or from the underlying maternal condition.

Clinical Considerations Advise breastfeeding women not to apply ULTRAVATE lotion directly to the nipple and areola to avoid direct infant exposure.

8.4 Pediatric Use Safety and effectiveness of ULTRAVATE lotion in patients younger than 18 years of age have not been established.

Because of higher skin surface area to body mass ratios, 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 adrenal insufficiency during or after withdrawal of treatment. Adverse reactions including striae have been reported with use of topical corticosteroids in infants and children [see Warnings and Precautions (5.1)].

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 an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema [see Warnings and Precautions (5.1)].

8.5 Geriatric Use Clinical studies with ULTRAVATE lotion included 89 subjects aged 65 years and over. No overall differences in safety or effectiveness were observed between these patients and those younger than 65 years. Clinical studies of ULTRAVATE lotion did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

10. OVERDOSAGE Topically applied ULTRAVATE lotion can be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1)].

13. NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential of halobetasol propionate. In a 90-day repeat-dose toxicity study in rats, topical administration of halobetasol propionate lotion at dose concentrations from 0.05% to 0.1% or from 0.25 to 0.5 mg/kg/day of halobetasol propionate resulted in a toxicity profile consistent with long-term exposure to corticosteroids including adrenal atrophy, histopathological changes in several organ systems indicative of severe immune suppression, and opportunistic fungal and bacterial infections.

A no observable adverse effect level (NOAEL) could not be determined in this study. Although the clinical relevance of the findings in animals to humans is not clear, sustained glucocorticoid-related immune suppression may increase the risk of infection and possibly the risk of carcinogenesis.

Halobetasol propionate was not found to be genotoxic in the Ames/Salmonella assay, in the Chinese hamster CHO/HGPRT assay, in the mouse micronucleus test, in the sister chromatid exchange test in somatic cells of the Chinese hamster, or in the chromosome aberration test in somatic cells of Chinese hamsters. Positive mutagenicity effects were observed in two genotoxicity assays: Chinese hamster nuclear anomaly test and mouse lymphoma gene mutation assay in vitro.

Studies in the rat following oral administration at dose levels up to 50 µg/kg/day indicated no impairment of fertility or general reproductive performance.

17. PATIENT COUNSELING INFORMATION This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all administration instructions or all possible adverse or unintended effects.

Advise patients using ULTRAVATE lotion of the following information and instructions: Important Administration Instructions Instruct patients to discontinue ULTRAVATE lotion when psoriasis is controlled. ULTRAVATE lotion should not be used for longer than 2 weeks. Advise patients to contact the physician if no improvement is seen within 2 weeks. Inform patients that total dosage should not exceed 50 grams per week [see Dosage and Administration (2)].

Instruct patients to avoid bandaging, wrapping or otherwise occluding the treatment area(s), unless directed by physician. Advise patients to avoid use on the face, scalp, groin, or axillae [see Dosage and Administration (2)].

Inform patients that ULTRAVATE lotion is for external use only. Advise patients that ULTRAVATE lotion is not for ophthalmic, oral, or intravaginal use [see Dosage and Administration (2)].

Breastfeeding women should not apply ULTRAVATE lotion directly to the nipple and areola to avoid directly exposing the infant [see Lactation (8.2)].

Rx Only ULTRAVATE is a trademark of Ranbaxy Laboratories, Inc. Manufactured for Ranbaxy Laboratories, Inc., Jacksonville, FL 32257 By: Ferndale Laboratories, Inc., Ferndale Ml 48220 U.S. Patent 8,962,028

Printed in USA

ULL0008

03/16

FROM THE SDPA

News & Current Affairs

CALENDAR OF EVENTS 2016

NOVEMBER SDPA 14th Annual Fall Dermatology Conference November 3 – 6, 2016 Caesars Palace Las Vegas, NV

2017 March 75th AAD Annual Academy Meeting March 3 – 7, 2016 Orlando, FL JUNE SDPA Summer Dermatology Conference June 1 – 4, 2017 Manchester Grand Hyatt San Diego, CA

We are entering a very exciting time for the PA profession. Lately there has been quite a bit of discussion about PA certification and practice, and only time will tell how these things will turn out. It is very important to know that no matter what the issue is, your voice and your opinion matter. Take a few moments to consider what you have done or are doing to give back to your profession. Do you quietly sit on the sidelines, or are you willing to work to find solutions to the issues the PA world faces?

I am forever grateful for the PA leaders who have paved the way for our profession, and especially those who have worked hard to solidify our role in dermatology. There have been many challenges for PAs in dermatology throughout the years, and the progress we have made has only been possible because PAs were willing to take action and induce change. There are unlimited opportunities to be a leader for your profession, and I encourage you all to give back at some point in your career. Your contribution at the local, state, or national level will help ensure the PA profession continues to thrive for the generations to come.

One of the most common questions SDPA leaders get from members who have an interest in joining a committee or taking on a leadership role is how to find the time. The truth is that none of us really know the answer to that question. The PAs you see in leadership positions at the local, state, and national levels are often working fulltime, balancing family and social lives as well. The easiest way to find the time is to dedicate yourself to something you are passionate about. I challenge all SDPA members to take a few moments to really think about the issues our profession faces and that you have strong opinions or ideas about. Take that passion and just dive in. You won’t regret it! J

Jennifer Conner, MPAS, PA-C SDPA President, Diplomate

Volume 10 • number 3 • SUMMER 2016 11

Dermatology PA news & notes

Dermatology Market Watch Research Indicates that Many are Using Sunscreen Incorrectly AAD Recommends Comprehensive Sun Protection for Skin Cancer Prevention How well do you understand sunscreen? For many consumers, the answer is not so well. According to new research, many people are still puzzled by the wide range of SPF numbers on product labels, and some may not be using sunscreen properly, which could increase their skin cancer risk.

In a 2016 American Academy of Dermatology (AAD) survey, only 32 percent of respondents knew that an SPF 30 sunscreen does not provide twice as much protection as an SPF 15 sunscreen. Moreover, only 45 percent knew that a higher-SPF sunscreen does not protect you from the sun longer than a lower-SPF sunscreen.

“It’s important that everyone understands what they are seeing on a sunscreen label,” says board-certified dermatologist Abel Torres, MD, JD, FAAD, president of the AAD. “A sunscreen with an SPF of 30 blocks up to 97 percent of the sun’s rays. Higher SPFs block slightly more rays, but a highernumber SPF does not allow you to spend more time outdoors without reapplication; all sunscreens should be reapplied every two hours, or after swimming or sweating.”

And while 85 percent of participants in the AAD survey knew that sunscreen needs to be reapplied after swimming, a new study from the Johns Hopkins University School of Medicine, published in the Journal of the American Academy of Dermatology on May 16, indicates that some people may not be using sunscreen correctly. In studying 758 people with a history of nonmelanoma skin cancer (NMSC) and 34,161 control subjects, the authors found that those with a history of NMSC were more likely to seek shade, wear protective clothing and apply sunscreen, but they still received sunburns as often as those without a history of NMSC. While seeking shade and wearing protective clothing were associated with lower odds of sunburn, sunscreen use was not.

“While it makes sense that people with a history of skin cancer were more likely to practice sun protection, we were surprised to see that their methods were not always effective,” says board-certified dermatologist Anna L. Chien, MD, FAAD, one of the study’s co-authors. “Our results reinforce the importance of everyone using multiple types of sun protection; people who rely only on sunscreen may not be applying enough, covering all their exposed skin or reapplying often enough to shield themselves from the sun’s harmful UV rays.”

The AAD recommends that everyone protect themselves from the sun by seeking shade; wearing protective clothing, such as a long-sleeved shirt, pants, a wide-brimmed hat 12 Journal of Dermatology for Physician Assistants

and sunglasses; and using a broad-spectrum, water-resistant sunscreen with an SPF of 30 or higher, applying enough to cover all exposed skin — for most adults, this is about 1 ounce, or enough to fill a shot glass. Sunscreen should be applied 15 minutes before sun exposure and reapplied every two hours, or after swimming or sweating.

For more information about how to prevent and detect skin cancer, including instructions on how to perform a skin self-exam, visit SpotSkinCancer.org. There, you can download a body mole map for tracking changes in your skin and find free SPOTme® skin cancer screenings in your area.

SPOT Skin Cancer™ is the AAD’s campaign to create a world without skin cancer through public awareness, community outreach programs and services, and advocacy that promote the prevention, detection and care of skin cancer. J

BY THE NUMBERS

According to a 2016 American Academy of Dermatology (AAD) survey: • Only 32% of respondents knew that an SPF 30 sunscreen does not provide twice as much protection as an SPF 15 sunscreen • Only 45% of respondents knew that a higher-SPF sunscreen does not protect you from the sun longer than a lower-SPF sunscreen.

• 85% percent of participants in the AAD survey knew that sunscreen needs to be reapplied after swimming.

About the AAD’s Survey The survey was conducted by Relevant Research Inc. of Chicago on Jan. 4 and 5, 2016. A total of 1,020 respondents completed the online survey. Data were weighted by sex, age, race/ethnicity and income according to the 2014 U.S. Census Bureau’s American Community Survey for adults ages 18-64. The margin of sampling error at the 95 percent confidence level is ± 3.1 percent.

TELL US WHAT MOTIVATES YOU TO MAKE SURE YOUR SKIN IS #LookingGoodin2016 Skin cancer is the most common form of cancer in the United States, and it is estimated that one person dies from melanoma – the deadliest form of skin cancer – every hour. The American Academy of Dermatology (AAD) encourages everyone to make sure their skin is “Looking Good in 2016” by protecting it from the sun’s ultraviolet rays and checking it for signs of skin cancer.

@AADskin

AADskin

AADskin

Tell us what motivates you to make sure your skin is "Looking Good in 2016."

Use the hashtag #LookingGoodin2016 on social media.

only isotretinoin therapy supported with “The PROMISE” Living with severe recalcitrant nodular acne

is challenging enough. Let The Promius PromiseTM program help guide your patients through the requirements. ZenataneTM (Isotretinoin Capsules USP) is the only isotretinoin with The Promius Promise. Support to help your patients stay on track: • A live, US-based call center available weekdays 8AM-11PM ET and Saturdays 9AM-3PM ET • Answers to questions regarding requirements and insurance coverage • Automatic application of $0 co-pay or money-saving rebates for eligible patientsa • Facilitation of no-cost shipping anywhere patients are located in the contiguous United States

Please call 1-888-959-7600 for eligibility requirements.

a

TM

Talk to your patients about ZENATANE with The Promius Promise Zenatane (Isotretinoin Capsules USP) 10 mg, 20 mg, 30 mg and 40 mg Capsules INDICATION Zenatane is indicated for the treatment of severe recalcitrant nodular acne. Because of significant adverse effects associated with its use, Zenatane should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, Zenatane is indicated only for those female patients who are not pregnant, because Zenatane can cause severe birth defects.

CAUSES BIRTH DEFECTS

DO NOT GET PREGNANT CONTRAINDICATIONS AND WARNINGS Zenatane must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Zenatane in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected.

There are no accurate means of determining whether an exposed fetus has been affected.

Birth defects which have been documented following Zenatane exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. Cases of IQ scores less than 85 with or without other abnormalities have been reported.

There is an increased risk of spontaneous abortion, and premature births have been reported.

Documented external abnormalities include: skull abnormality; ear abnormalities (including anotia, micropinna, small or absent external auditory canals); eye abnormalities (including microphthalmia); facial dysmorphia; cleft palate. Documented internal abnormalities include: CNS abnormalities (including cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, cranial nerve deficit); cardiovascular abnormalities; thymus gland abnormality; parathyroid hormone deficiency. In some cases death has occurred with certain of the abnormalities previously noted.

If pregnancy does occur during treatment of a female patient who is taking Zenatane, Zenatane must be discontinued immediately and she should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling.

Special Prescribing Requirements Because of Zenatane teratogenicity and to minimize fetal exposure, Zenatane is approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration. This program is called iPLEDGE™. Zenatane must only be prescribed by prescribers who are registered and activated with the iPLEDGE program. Zenatane must only be dispensed by a pharmacy registered and activated with iPLEDGE, and must only be dispensed to patients who are registered and meet all the requirements of iPLEDGE (see PRECAUTIONS).

Other serious side effects include depression, psychosis and rarely, suicidal ideation, suicide attempts and suicide, aggressive and/or violent behavior, pseudotumor cerebri, pancreatitis, hearing impairment, inflammatory bowel disease, skeletal changes, hyperostosis, premature epiphyseal closure, vision impairment, corneal opacities and decreased night vision.

Please see adjacent page for Brief Summary of Prescribing Information or visit www.zenatane.com for Full Prescribing Information. iPLEDGETM is a trademark owned by McKesson Specialty Arizona Inc. Questions about iPLEDGE? Call 1.866.495.0654 or visit www.ipledgeprogram.com Copyright© 2015. Marketed by Promius Pharma, a wholly owned subsidiary of Dr. Reddy’s Laboratories, Inc. Princeton, NJ 08540 Based on PI: 150058463 Revised 11/2014. Printed in the U.S.A. ZNT-1015-139 11/15

Volume 10 • number 3 • SUMMER 2016 13

BRIEF SUMMARY OF PRESCRIBING INFORMATION See package insert for Full Prescribing Information, Medication Guide and iPLEDGE R.E.M.S. information or visit www.zenatane.com.

CAUSES BIRTH DEFECTS

DO NOT GET PREGNANT

CONTRAINDICATIONS AND WARNINGS Zenatane™ must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Zenatane™ in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected.

Birth defects which have been documented following Zenatane™ exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. Cases of IQ scores less than 85 with or without other abnormalities have been reported. There is an increased risk of spontaneous abortion and premature births have been reported.

Documented external abnormalities include: skull abnormality; ear abnormalities (including anotia, micropinna, small or absent external auditory canals); eye abnormalities (including microphthalmia); facial dysmorphia; cleft palate. Documented internal abnormalities include: CNS abnormalities (including cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, cranial nerve deficit); cardiovascular abnormalities; thymus gland abnormality; parathyroid hormone deficiency. In some cases death has occurred with certain of the abnormalities previously noted.

If pregnancy does occur during treatment of a female patient who is taking Zenatane™, Zenatane™ must be discontinued immediately and she should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling.

Special Prescribing Requirements Because of Zenatane™ teratogenicity and to minimize fetal exposure, Zenatane™ is approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration.

This program is called iPLEDGE™.

Table 1 Monthly Required iPLEDGE Interactions Female Patients of Childbearing Potential

Male Patients, And Female Patients Not of Childbearing Potential

PRESCRIBER Confirms patient counseling

X

Enters the 2 contraception methods

X

Enters pregnancy test results

X

X

PATIENT Answers educational questions before every prescription

X

Enters 2 forms of contraception

X

PHARMACIST Contacts system to get an authorization

X

X

INDICATIONS AND USAGE Severe Recalcitrant Nodular Acne Zenatane™ is indicated for the treatment of severe recalcitrant nodular acne.

Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe,” by definition means “many” as opposed to “few or several” nodules. Because of significant adverse effects associated with its use, Zenatane™ should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, Zenatane™ is indicated only for those female patients who are not pregnant, because Zenatane™ can cause severe birth defects.

CONTRAINDICATIONS Pregnancy: Category X. Allergic Reactions - Zenatane™ is contraindicated in patients who are hypersensitive to this medication or to any of its components.

WARNINGS Psychiatric Disorders Zenatane™ may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts, suicide, and aggressive and/or violent behaviors. No mechanism of action has been established for these events.

Prescribers should read the brochure, Recognizing Psychiatric Disorders in Adolescents and Young Adults: A Guide for Prescribers of Isotretinoin.

Prescribers should be alert to the warning signs of psychiatric disorders to guide patients to receive the help they need. Therefore, prior to initiation of Zenatane™ therapy, patients and family members should be asked about any history of psychiatric disorder, and at each visit during therapy patients should be assessed for symptoms of depression, mood disturbance, psychosis, or aggression to determine if further evaluation may be necessary. Patients should stop Zenatane™ and the patient or a family member should promptly contact their prescriber if the patient develops depression, mood disturbance, psychosis, or aggression, without waiting until the next visit. Discontinuation of Zenatane™ therapy may be insufficient; further evaluation may be necessary. A referral to a mental health professional may be necessary. The physician should consider

whether Zenatane™ therapy is appropriate in this setting; for some patients the risks may outweigh the benefits of Zenatane™ therapy.

Pseudotumor Cerebri Zenatane™ use has been associated with a number of cases of pseudotumor cerebri (benign intracranial hypertension), some of which involved concomitant use of tetracyclines. Concomitant treatment with tetracyclines should therefore be avoided.

Serious Skin Reactions There have been post-marketing reports of erythema multiforme and severe skin reactions [e.g., Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN)] associated with Zenatane™ use.

Pancreatitis Acute pancreatitis has been reported in patients with either elevated or normal serum triglyceride levels.

Lipids Elevations of serum triglycerides in excess of 800 mg/dL have been reported in patients treated with Zenatane™.

Hearing Impairment Impaired hearing has been reported in patients taking Zenatane™.

Hepatotoxicity Clinical hepatitis considered to be possibly or probably related to Zenatane™ therapy has been reported.

Inflammatory Bowel Disease Zenatane™ has been associated with inflammatory bowel disease in patients without a prior history of intestinal disorders.

Skeletal Bone Mineral Density Effects of multiple courses of Zenatane™ on the developing musculoskeletal system are unknown. There is some evidence that long-term, high-dose, or multiple courses of therapy with Zenatane™ have more of an effect than a single course of therapy on the musculoskeletal system.

Hyperostosis A high prevalence of skeletal hyperostosis was noted in clinical trials for disorders of keratinization with a mean dose of 2.24 mg/kg/day. Additionally, skeletal hyperostosis was noted in six of eight patients in a prospective study of disorders of keratinization.

Premature Epiphyseal Closure There are spontaneous reports of premature epiphyseal closure in acne patients receiving recommended doses of Zenatane™.

Vision Impairment Visual problems should be carefully monitored. All Zenatane™ patients experiencing visual difficulties should discontinue Zenatane™ treatment and have an ophthalmological examination.

Corneal Opacities Corneal opacities have occurred in patients receiving Zenatane™ for acne and more frequently when higher drug dosages were used in patients with disorders of keratinization.

Decreased Night Vision Decreased night vision has been reported during Zenatane™ therapy and in some instances the event has persisted after therapy was discontinued. Because the onset in some patients was sudden, patients should be advised of this potential problem and warned to be cautious when driving or operating any vehicle at night.

PRECAUTIONS Zenatane™ must only be prescribed by prescribers who are registered and activated with the iPLEDGE program. Zenatane™ must only be dispensed by a pharmacy registered and activated with iPLEDGE, and must only be dispensed to patients who are registered and meet all the requirements of iPLEDGE. Registered and activated pharmacies must receive Zenatane™ only from wholesalers registered with iPLEDGE. Prescribers To prescribe Zenatane™, the prescriber must be registered and activated with the pregnancy risk management program iPLEDGE. Prescribers can register by signing and returning the completed registration form. Prescribers can only activate their registration by affirming that they meet requirements and will comply with all iPLEDGE requirements. Isotretinoin must only be prescribed to female patients who are known not to be pregnant as confirmed by a negative CLIA-certified laboratory conducted pregnancy test.

soles, photoallergic/photosensitizing reactions, pruritus, pyogenic granuloma, rash (including facial erythema, seborrhea, and eczema), Stevens-Johnson syndrome, sunburn susceptibility increased, sweating, toxic epidermal necrolysis, urticaria, vasculitis (including Wegener’s granulomatosis), abnormal wound healing (delayed healing or exuberant granulation tissue with crusting).

Special Senses Hearing: hearing impairment, tinnitus.

Vision: corneal opacities, decreased night vision which may persist, cataracts, color vision disorder, conjunctivitis, dry eyes, eyelid inflammation, keratitis, optic neuritis, photophobia, visual disturbances.

Urinary System: glomerulonephritis, nonspecific urogenital findings.

Laboratory Elevation of plasma triglycerides, decrease in serum high-density lipoprotein (HDL) levels, elevations of serum cholesterol during treatment Increased alkaline phosphatase, SGOT (AST), SGPT (ALT), GGTP or LDH Elevation of fasting blood sugar, elevations of CPK, hyperuricemia Decreases in red blood cell parameters, decreases in white blood cell counts, elevated sedimentation rates, elevated platelet counts, thrombocytopenia White cells in the urine, proteinuria, microscopic or gross hematuria Drug Interactions • Vitamin A: Patients should be advised against taking vitamin supplements containing vitamin A to avoid additive toxic effects.

• Tetracyclines: Concomitant treatment of tetracyclines should be avoided because Zenatane™ use has been associated with a number of cases of pseudotumor cerebri (benign intracranial hypertension).

• Micro-dosed Progesterone Preparations: Micro-dosed progesterone preparations may be an inadequate method of contraception during Zenatane™ therapy. It is not known if hormonal contraceptives differ in their effectiveness when used with Zenatane™. Therefore, it is critically important for female patients of childbearing potential to select and commit to use two forms of effective contraception simultaneously, at least one of which must be a primary form.

• Norethindrone/ethinyl estradiol: In a study of 31 premenopausal female patients with severe recalcitrant nodular acne receiving OrthoNovum® 7/7/7 Tablets as an oral contraceptive agent, Zenatane™ at the recommended dose of 1 mg/kg/day, did not induce clinically relevant changes in the pharmacokinetics of ethinyl estradiol and norethindrone and in the serum levels of progesterone, follicle-stimulating hormone (FSH) and luteinizing hormone (LH).

• St. John’s Wort: Zenatane™ use is associated with depression in some patients.

Patients should be prospectively cautioned not to self-medicate with the herbal supplement St. John’s Wort because a possible interaction has been suggested with hormonal contraceptives based on reports of breakthrough bleeding on oral contraceptives shortly after starting St. John’s Wort. Pregnancies have been reported by users of combined hormonal contraceptives who also used some form of St. John’s Wort.

• Phenytoin: Zenatane™ has not been shown to alter the pharmacokinetics of phenytoin in a study in seven healthy volunteers. These results are consistent with the in vitro finding that neither isotretinoin nor its metabolites induce or inhibit the activity of the CYP 2C9 human hepatic P450 enzyme. Phenytoin is known to cause osteomalacia. No formal clinical studies have been conducted to assess if there is an interactive effect on bone loss between phenytoin and Zenatane™. Therefore, caution should be exercised when using these drugs together.

• Systemic Corticosteroids: Systemic corticosteroids are known to cause osteoporosis. Therefore, caution should be exercised when using these drugs together.

OVERDOSAGE In humans, overdosage has been associated with vomiting, facial flushing, cheilosis, abdominal pain, headache, dizziness, and ataxia. These symptoms quickly resolve without apparent residual effects. Zenatane™ causes serious birth defects at any dosage. Female patients of childbearing potential who present with isotretinoin overdose must be evaluated for pregnancy. Patients who are pregnant should receive counseling about the risks to the fetus. Nonpregnant patients must be warned to avoid pregnancy for at least one month and receive contraceptive counseling.

Educational materials for such patients can be obtained by calling the manufacturer.

Because an overdose would be expected to result in higher levels of isotretinoin in semen than found during a normal treatment course, male patients should use a condom, or avoid reproductive sexual activity with a female patient who is or might become pregnant, for one month after the overdose. All patients with isotretinoin overdose should not donate blood for at least one month.

Pharmacists Isotretinoin must only be dispensed by a pharmacy registered and activated with the pregnancy risk management program iPLEDGE and only when the registered patient meets all the requirements of the iPLEDGE program. The Responsible Site Pharmacist SPECIFIC POPULATIONS must register the pharmacy by signing and returning the completed registration form. Pregnancy: Category X. Nursing Mothers ADVERSE REACTIONS It is not known whether this drug is excreted in human milk. Nursing mothers should Clinical Trials and Post-marketing Surveillance not receive Zenatane™.

The adverse reactions listed below reflect the experience from investigational studies Pediatric Use of Zenatane™ and the postmarketing experience. The relationship of some of these The use of Zenatane™ in pediatric patients less than 12 years of age has not been events to Zenatane™ therapy is unknown. studied. The use of Zenatane™ for the treatment of severe recalcitrant nodular Dose Relationship acne in pediatric patients ages 12 to 17 years should be given careful consideration, Cheilitis and hypertriglyceridemia are usually dose related. Most adverse reactions especially for those patients where a known metabolic or structural bone disease reported in clinical trials were reversible when therapy was discontinued; however, exists. some persisted after cessation of therapy.

Geriatric Use Body as a Whole: allergic reactions, including vasculitis, systemic hypersensitivity, Clinical studies of isotretinoin did not include sufficient numbers of subjects aged edema, fatigue, lymphadenopathy, weight loss.

65 years and over.

Cardiovascular: palpitation, tachycardia, vascular thrombotic disease, stroke.

Endocrine/Metabolic: hypertriglyceridemia, alterations in blood sugar levels HOW SUPPLIED/STORAGE AND HANDLING Gastrointestinal: inflammatory bowel disease, hepatitis, pancreatitis, bleeding and Zenatane is supplied in 10 mg, 20 mg, 30 mg and 40 mg Capsules. inflammation of the gums, colitis, esophagitis/esophageal ulceration, ileitis, nausea, Store at 68° to 77°F (20° to 25°C). [See USP Controlled Room Temperature]. and other nonspecific gastrointestinal symptoms.

Protect from light.

Hematologic: allergic reactions, anemia, thrombocytopenia, neutropenia, rare reports of agranulocytosis.

Please see www.zenatane.com for Full Prescribing Information.

Musculoskeletal: skeletal hyperostosis, calcification of tendons and ligaments, premature epiphyseal closure, decreases in bone mineral density, musculoskeletal Rx Only symptoms (sometimes severe) including back pain, myalgia, and arthralgia, transient Manufactured by: pain in the chest, arthritis, tendonitis, other types of bone abnormalities, elevations Cipla Limited of CPK/rare reports of rhabdomyolysis.

Kurkumbh Village Neurological: pseudotumor cerebri, dizziness, drowsiness, headache, insomnia, Pune – 413 802 INDIA lethargy, malaise, nervousness, paresthesias, seizures, stroke, syncope, weakness Manufactured for: Psychiatric: suicidal ideation, suicide attempts, suicide, depression, psychosis, Dr. Reddy’s Laboratories Limited aggression, violent behaviors, emotional instability.

Bachupally– 500 090 INDIA Of the patients reporting depression, some reported that the depression subsided with discontinuation of therapy and recurred with reinstitution of therapy.

OrthoNovum 7/7/7 is a registered trademark of Ortho-McNeil Pharmaceuticals, Inc. Reproductive System: abnormal menses.

Respiratory: bronchospasms (with or without a history of asthma), respiratory iPLEDGE™ is a trademark owned by McKesson Specialty Arizona, Inc. infection, voice alteration.

Questions about iPLEDGE? Call 1.866.495.0654 or visit www.ipledgeprogram.com Skin and Appendages: acne fulminans, alopecia (which in some cases persists), Copyright© 2015. Marketed by Promius Pharma, a wholly owned subsidiary of bruising, cheilitis (dry lips), dry mouth, dry nose, dry skin, epistaxis, eruptive Dr. Reddy’s Laboratories, Inc. Princeton, NJ 08540 xanthomas,erythema multiforme, flushing, fragility of skin, hair abnormalities, Based on PI: 150058463 Revised 11/2014. Printed in U.S.A. ZNT-1015-139. 11/15. hirsutism, hyperpigmentation and hypopigmentation, infections (including disseminated herpes simplex), nail dystrophy, paronychia, peeling of palms and

14 Journal of Dermatology for Physician Assistants

Dermatology Market Watch ...continued from page 12 The U.S. Food and Drug Administration approved in July 2016 Differin Gel 0.1% (adapalene) for the over-thecounter (OTC) treatment of acne in people 12 years of age and older.

Differin Gel 0.1% is the first retinoid to be made available OTC for the treatment of acne, and contains the first new active ingredient for acne treatment for OTC use since the 1980s. Differin Gel 0.1% was originally approved in 1996 as a prescription product for the treatment of acne vulgaris in patients 12 years of age and older.

Women who are pregnant, planning to become pregnant, or breast-feeding should ask a health care provider before use. While topical retinoid products are often prescribed as first-line therapies for acne of all levels of severity, either alone or in combination with other treatments, Differin Gel 0.1% is the first retinoid acne treatment to be made available OTC. While there have been no adequate and well-controlled studies of Differin Gel 0.1% in pregnant women, there is no specific evidence that Differin Gel 0.1%, when used topically as directed, causes birth defects in humans. Some other retinoid drugs have been shown to cause birth defects.

Differin Gel’s safety and efficacy were initially established based on five clinical trials in people with mild to moderate acne. To support approval for OTC marketing, the data accrued from 1996-2016 on post-marketing safety, data from consumer studies (a label comprehension study, a self-selection study, and an actual use trial), and data from a maximal use trial were submitted.

Overall, results from the consumer studies showed that consumers can understand the information on the OTC label, appropriately select whether the product is right for them, and use the product appropriately. The maximal use trial, a study of absorption of the drug through acneaffected skin when applied daily over a large surface area (face, shoulders, upper back, and chest), demonstrated that absorption is limited, thus supporting safe use of Differin Gel 0.1% by people using it OTC. Consumers are advised to follow the Drug Facts label and consult with their health care providers if their symptoms do not improve. The drug should be applied once daily in a thin layer on the affected areas of skin, and it is for external use only. Differin Gel 0.1% should not be used on damaged skin (for example, cuts, abrasions, eczema, or sunburn). People using Differin Gel 0.1% should avoid sunburn and avoid product contact with their eyes, lips and mouth. Differin Gel 0.1% should not be used by people who are allergic to the product. In the first few weeks of use, skin may become irritated (redness, itching, dryness, burning).

Consumers should stop use and ask a health care provider if irritation becomes severe, if there is no improvement in acne after three months of daily use, if symptoms of allergic reaction appear, or if they become pregnant or are planning to become pregnant while using the drug. J

$30,000

Amount Raised $18,000 *as of September 15, 2016

$0

Dermatology PA Foundation News The DPAF is thrilled to have raised over $18,000 to date through the generous support through the SDPA community and partners. We continue to explore options to ensure contributed funds are put towards meaningful programs and causes, which fit the DPAF’s and SDPA’s goals. To date we have contributed, or committed to contributing, over $30,000! Consider making a onetime or continuing tax-deductible donation today to support our efforts.

Volume 10 • number 3 • SUMMER 2016 15

DERmatology pa news & notes

Differin Gel Adapalene 0.1% Acne Treatment

Certification Review

All Those Things Inside the Skin You Might Have Forgotten

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

QUESTION: A two-year-old female presents to the office with her mother. The mother states the little girl has not wanted to move her left arm since she fell on the elbow earlier today. On physical examination the patient denies any pain and vital signs are normal. The child holds the arm close to her body with the elbow flexed and forearm pronated. Passive range of motion is normal, but pain is noted with even slight supination of the forearm.

Which of the following is the most likely diagnosis?

A. Todd’s paralysis B. Ewing’s sarcoma C. Radial head subluxation D. Mid-shaft humeral fracture E. Postnatal brachial neuropathy EXPLANATION: This patient presents with the classic presentation of radial head subluxation, also called nursemaid’s elbow. Radial head subluxation is typically noted in children age two to four. Subluxation occurs when sudden axial traction is applied to a pronated forearm with the elbow in extension. On presentation the child is not using the affected arm, and the arm is held close to the body with elbow flexed and forearm pronated. Mild tenderness is noted on palpation. Todd’s paralysis is focal weakness and noted post seizure. Ewing’s

sarcoma is a malignant tumor of the bone typically noted in adolescents and young adults and presents with intermittent fevers, anemia, and pain at the location of the tumor. Mid-shaft humeral fracture is noted post-trauma, pain is noted at the injury site and an x-ray would reveal a fracture. Postnatal brachial neuropathy is impairment of the brachial plexus and is most often caused by trauma.

Onset of symptoms varies and includes weakness and pain, less commonly sensory loss. Examination may reveal weakness, atrophy, sensory loss, or diminished reflexes. J The correct answer is C.

DERmatology pa news & notes

Are you recertifying soon? Start your board review early. Each issue of the JDPA features one board question accompanied by a brief explanation of the answer along with any pertinent test taking tips. Best of luck!

James A. Van Rhee, MS, PA-C, is the Program Director for the Yale University School of Medicine Physician Assistant Program. Mr. Van Rhee has been involved in physician assistant education for over 20 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 fifteen years he has been course director and presenter of the Physician Assistant Board Review, which is now being produced live online by Kaplan Medical.

Miles for Melanoma Why We Run

This November 5, the recently launched Dermatology PA Foundation (DPAF) will host the SDPA’s 5th Annual Miles for Melanoma 5k Run/Walk during the 14th Annual SDPA Fall Dermatology Conference in Las Vegas. The event is part of a series of events held around the country intended to raise awareness and money for the fastest growing cancer in the world.

Join us to run or walk in Vegas and help us raise money for this great cause, and as an added incentive to help us raise money, the DPAF will match up to $7,500 in donations!

16 Journal of Dermatology for Physician Assistants

Student Corner Preparing PA Students for Practice

By Genét Finnegan, MHS, PA-C

Whether you are a PA student, a recent graduate planning a career in dermatology, or an experienced practicing dermatology PA, we want to hear from you!

If you are interested in working with SDPA leaders to continually improve the resources and tools available to our student members, please contact Genét Finnegan, MHS, PA-C at gfinnegan@dermpa.org. J Genét Finnegan, MHS, PA-C earned her Bachelor of Science in Biology from Loyola College in Maryland and graduated from the Drexel University Hahnemann PA Program in 2009, with a Master of Health Science, earning the Elizabeth Peabody Stolberg Award for clinical and academic excellence. Genét moved to New York following graduation and since that time has been practicing general and cosmetic dermatology in Manhattan. She currently holds a position within the Department of Dermatology at Columbia University Medical Center at New York Presbyterian Hospital, where she specializes in cutaneous oncology. Genét has been a member of the SDPA since 2008. She recalls the significant role the organization played in her successful transition from student to practicing dermatology PA. She joined the SDPA leadership team to help educate and support PA students as they enter the unique and exciting field of dermatology.

What Do You Want To Read About In The JDPA? We’re interested in knowing what kind of articles SDPA members would be interested in reading more about in order to help improve their practice of dermatology.

Share your content ideas today.

Email them to editor@jdpa.org

JDPA Journal of Dermatology for Physician Assistants

Volume 10 • number 3 • SUMMER 2016 17

DERmatology pa news & notes

PA students represent the future of our profession.

Each year PA programs across the nation train an ever-increasing number of PA students to enter the field of medicine, where they go on to work in every practice setting imaginable, continually furthering our overarching mission to improve patient care and increase access to that care.

The PA profession as a whole, and particularly the PA practice of dermatology, is at an exciting, pivotal point in its history. And more than ever, students entering the field need support in their transition from PA school to clinical practice.

The SDPA is here to help. One of the goals of the SDPA is to assist students who have a passion for dermatology in making a successful transition to becoming practicing PAs. The SDPA provides a wealth of dermatology-specific resources, including clinical education materials and information on jobhunting, resume writing, and contract negotiation, all of which can be accessed in the student section on the SDPA website. Maintaining student membership also provides invaluable opportunities to network with practicing dermatology PAs and attend SDPA conferences at a discounted rate.

DAYS

CAT. 1 CME HOURS

PI CME HOURS*

SA CME HOURS

#SDPAfall

Keeping up with your CME can be challenging, especially while juggling family and community responsibilities and a demanding patient schedule. The SDPA offers you the opportunity to earn a tremendous amount of CME credit while learning about the latest dermatological developments and procedures, gaining pearls of wisdom and new tips and tricks — all from industry thought-leaders and experts. Join us in Las Vegas this November for the SDPA 14th Annual Fall Dermatology Conference.

Featured Topics Include: • • • • •

Emerging Trends in Medical Dermatology PA Economics: Contracts and Negotiations Infectious Disease Update (Zika and more) Male Genital Disease Updates on Non-Invasive Cosmetic Procedures

Special Events & Workshop Highlights: • 5th Annual Miles for Melanoma 5k Run/Walk • Dermatology PA Foundation (DPAF) Silent Auction • Viva Las Vegas! Welcome Event • VIP Reception at the Mob Museum • Fundamentals of Dermatologic Surgery

Complete program and registration details at: sdpaconferences.org For complete details on CME credits, visit sdpaconferences.org. *Additional $125 charge for Performance Improvement CME program. Workshop will provide the instructions and materials to complete the CME at a later date.

18 Journal of Dermatology for Physician Assistants

DERMPA.ORG

SDPA State Affiliates

Things To Do in Las Vegas, Nevada While Attending the SDPA 14th Annual Fall Dermatology Conference

By Renata M. Block, MMS, PA-C SDPA Constituent Relations Committee Chair Diplomate SDPA

Blend of Cuisines - Sensi (Italian, Asian, Seafood), Le Cirque (French, European), and Top of the World Buffet – Bacchanal (Caesars Palace), Wicked Spoon (The Cosmopolitan), The Buffet (Wynn), and The Buffet Bellagio

The SDPA is excited to hold the 14th Annual Fall Dermatology Conference in Las Vegas, Nevada again this November. The Constituent Relations Committee has contacted some SDPA members who are Nevada residents in order to identify the “Best of Las Vegas,” which should not be missed. Enjoy!

The “Strip” - The Las Vegas Strip is a stretch of Las Vegas Boulevard South in Clark County, Nevada, internationally known for its concentration of resort hotels and casinos along its route.

Bellagio Conservatory & Botanical Gardens - Be sure to stop and check out the dancing fountains - www. bellagio.com

FOOD

American - Sage, miX, Table 34, and Postrio Bar & Grill French - Twist by Pierre Gagnaire, Picasso, Guy Savoy, Joel Robuchon Restaurant, and Bouchon Greek/Mediterranean – Estiatorio Milos and The Mad Greek Asian - Kumi, Koi, Yellowtail, Ping Pang Pong, Hakkasan, and TAO Steak - SW Steakhouse, CUT, Strip House, Gordon Ramsay Steak, Brand Steakhouse, Morels French Steakhouse & Bistro, and Carnevino Italian Steakhouse Seafood - Michael Mina at Bellagio, Mastro’s Ocean Club, Rick Moonen’s RM Seafood, and Emeril’s New Orleans Fish House Sushi - barMASA, Blue Ribbon Sushi Bar & Grill, Mizumi, and Nobu Barbeque - Mesa Grill, Memphis BBQ, Rollin Smoke, Lucille’s Smokehouse Bar-B-Que, and Buzz BBQ Italian - Bartolotta Ristorante Di Mare, Lupo, Rao’s, Piero’s Italian Cusine, Panevino, Battista’s Hole in the Wall, and Francesco’s

Venetian Gondola Ride - No trip to Venice or The Venetian would be complete without a graceful and romantic glide down the Grand Canal in an authentic Venetian gondola. Float beneath bridges, beside cafes, under balconies and through the vibrant Venetian streetscape as your singing gondolier sweeps you down the Grand Canal for a ride like no other - www.venetian.com/ hotel/attractions/gondola-rides.html The Gallery Featuring Dale Chihuly at CityCenterThe Gallery Featuring Dale Chihuly, located in the Gallery Row Shops at CityCenter, showcases compelling artwork from world-renowned artist Dale Chihuly within its 4,350-square-foot facility. You'll see a diverse representation of Chihuly's sculptures, drawings, editions and prints www.vegas.com/attractions/on-the-strip/citycenter-gallery Fremont Street Experience – The Fremont Street Experience (FSE) is a pedestrian mall and attraction in downtown Las Vegas. The FSE occupies the westernmost five blocks of Fremont Street, including the area known for years as "Glitter Gulch," and portions of some other Volume 10 • number 3 • SUMMER 2016 19

DERmatology pa news & notes

ACTIVITIES

DERmatology pa news & notes

adjacent streets. The attraction is a barrel vault canopy, 90ft high at the peak and four blocks in length. While Las Vegas is known for never turning the outside casino lights off, each show begins by turning off the lights on all of the buildings, including the casinos, under the canopy - www. vegasexperience.com Las Vegas Monorail – Let the Las Vegas Monorail show you the best way to travel on the Strip. The trains provide fun, quick, and convenient Vegas transportation to and from hotels, the convention center, and casinos. With trains arriving every 4 to 9 minutes at seven stations along Las Vegas Boulevard - www.lvmonorail.com Adventuredome Theme Park at the Circus Circus Hotel - Climate-controlled amusement park at Circus Circus featuring rides, arcade, midway & miniature golf www.adventuredome.com The Stratosphere Tower - Head to the top of the Stratosphere Casino, Hotel & Tower. Jutting 1,149ft into the Vegas skyline, the iconic Stratosphere Tower is the tallest freestanding observation tower in the United States and one of the most exciting attractions among Las Vegas resorts - www.stratospherehotel.com/Activities/ThrillRides High Roller Observation Wheel at the LINQ Hotel & Casino - This 550ft tall Ferris wheel with observation cabins offers city views and holds up to 40 people -www. caesars.com/linq/high-roller#.VTfj2pTF8xI

Day Trip to Hoover Dam - Hoover Dam, once known as Boulder Dam, is a concrete arch-gravity dam in the Black Canyon of the Colorado River, on the border between Nevada and Arizona - www.usbr.gov/lc/ hooverdam Day Trip to the Grand Canyon - Grand Canyon National Park is the United States’ 15th oldest national park. Named a UNESCO World Heritage Site in 1979, the park is located in Arizona, a four our drive from Las Vegas - www.nps.gov/grca/index.htm Hiking at Red Rock Canyon – Hikers in Red Rock Canyon explore this natural wonder with red rocks and petroglyphs, which draws those looking to hike, rock climb, or go for a scenic drive - www.redrockcanyonlv.org

20 Journal of Dermatology for Physician Assistants

Auto Collections at the LINQ Hotel - One of the most unusual things to do in Las Vegas is The Auto Collections at The LINQ Hotel & Casino, an attraction that combines the thrills of an exotic car museum with the opportunity to actually buy some of the most unique and eclectic automobiles in the world - www.caesars.com/linq/ things-to-do/the-auto-collections - .VTpPSGY7TBs Exotics Racing - Accessible to all, Exotics Racing School is one of the most exciting attractions in Las Vegas.

You will have the opportunity to drive any of the cars in their fleet of Ferrari, Lamborghini, Aston Martin, Porsche, Audi, Mercedes, and Nissan on the Las Vegas Motor Speedway. Take the wheel of these supercars and push the limits of performance with 1-on-1 coaching from their instructors - www.exoticsracing.com Neon Museum - The Neon Museum in Las Vegas features signs from old casinos and other businesses displayed outdoors on over six acres - www.neonmuseum. org Mob Museum- The Mob Museum, officially the National Museum of Organized Crime and Law Enforcement, is a history museum located in downtown Las Vegas - www.themobmuseum.org The Big Elvis Show - Pete Vallee stars as Big Elvis in this classic Las Vegas impersonator show. Watch as he performs all the hits, plus other popular tunes spanning six decades. Big Elvis is one of the best free Las Vegas shows on the Strip. Performing inside The Piano Bar, Big Elvis interacts with his audience, takes song requests and invites them to participate. Vallee is a multi-time Best of Las Vegas winner who performed more than 7,000 performances on the Strip, making this Las Vegas Elvis show an institution - www.caesars.com/harrahs-las-vegas/shows/big-elvis .VTflupTF8xI So there it is SDPA members, right from our sources!

You cannot get any better information than from the locals. For maps, events, restaurants, and everything else about Las Vegas, please visit www.lasvegas-entertainmentguide.com. For more things to do visit www.timeout.com/ las-vegas. Have fun and we’ll see you in Vegas!

Clinic al Dermatology

Update on Management of Hidradenitis Suppurativa

By Caroline Laggis, MD, Allyson Sorensen, PA-C, and Christopher Hull, 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.

›› 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 September 2016. Participants may submit the selfassessment exam at any time during that period.

This program was planned in accordance with AAPA’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:

• Understand the multifactorial etiology of hidradenitis suppurativa (HS).

• Outline how classification of severity of disease can determine best treatment approaches.

• Describe the advantages and disadvantages of various treatment modalities with particular focus on biologic therapy options.

Volume 10 • number 3 • SUMMER 2016 21

Update on Management of Hidradenitis Suppurativa

SDPA Members Only Content

CLINIC AL 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.

22 Journal of Dermatology for Physician Assistants

Update on Management of Hidradenitis Suppurativa

SDPA Members Only Content

CLINIC AL 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.

Volume 10 • number 3 • SUMMER 2016 23

Update on Management of Hidradenitis Suppurativa

SDPA Members Only Content

CLINIC AL 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.

24 Journal of Dermatology for Physician Assistants

Update on Management of Hidradenitis Suppurativa

SDPA Members Only Content

CLINIC AL 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

Volume 10 • number 3 • SUMMER 2016 25

Update on Management of Hidradenitis Suppurativa

SDPA Members Only Content

CLINIC AL 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.

26 Journal of Dermatology for Physician Assistants

Update on Management of Hidradenitis Suppurativa

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.

Allyson Sorensen, PA-C works at the University of Utah School of Medicine Department of Dermatology. She has indicated no relationships to disclose relating to the content of this article.

Christopher Hull, MD is an Associate Professor of Dermatology at the University of Utah School of Medicine.

He has indicated no relationships to disclose relating to the content of this article.

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

JDPA Journal of Dermatology for Physician Assistants

If you know a patient who would like to share his/her story, please contact us at editor@jdpa.org Volume 10 • number 3 • SUMMER 2016 27

CLINIC AL Dermatology

Caroline Laggis, MD graduated from the Medical University of South Carolina in Charleston, SC in May 2016 and is a resident at the University of Utah in the Department of Dermatology. She has indicated no relationships to disclose relating to the content of this article.

From The Patient’s Perspective How To Talk To Your Loved Ones About Your Psoriasis

By Sabrina D Skiles

CLINIC AL Dermatology

The National Psoriasis Foundation (NPF) offers many resources for patients with psoriasis. They offer ways for people newly diagnosed with psoriasis to connect with others who have experienced similar journeys. They have an online patient navigation center and options to connect one on one with NPF mentors. Sabrina Skiles has had psoriasis for fifteen years and is an NPF mentor as well as an online blogger. She shares ideas ranging from living with psoriasis, health, and fashion. She shares with the JDPA readers her experience in talking about her psoriasis with her now husband while they were still dating and offers tips and suggestions on how people dealing with psoriasis can talk with loved ones.

Your friends and family are around you everyday.

They know everything about you, and psoriasis shouldn’t be the exception. You may not know why you have the disease, but you can understand the science behind the disease and share that with your loved ones. Here are a few things I’ve learned that loved ones can express with their partners to help them open up about psoriasis.

Why do we go to concerts by your favorite band? Or loyally buy clothes from your favorite store or designer?

Why do we take our kids to the best cheerleading or

The National Psoriasis Foundation (NPF) is a non-profit organization with a mission to drive efforts to cure psoriatic disease and improve the lives of those affected.

Founded in 1966 from a tiny classified ad in a Portland, OR newspaper, the Psoriasis Foundation has evolved to become the leading patient advocacy group for the 7.5 million Americans living with psoriasis and psoriatic arthritis.

As emerging research continues to demonstrate the serious, systemic effects of these chronic autoimmune diseases, our highest priority is to find a cure.

National Psoriasis Foundation Contact Information: www.psoriasis.org 6600 SW 92nd Ave., Suite 300, Portland, OR 97223 Phone: (800) 723-9166 Email: getinfo@psoriasis.org NPF Blog: www.psoriasis.org/blog NPFBLOG The P is Silent, but We are Not! 28 Journal of Dermatology for Physician Assistants

basketball coaches around? One of the major reasons may be that we confide in and have confidence in those leaders in their respective fields because they are the best at what they do. That being said, we know what we are going to get when we invest in these things. But the same can be said for anyone who has psoriasis or a chronic disease. You too can be an expert in how psoriasis affects you. How exactly can we get there? It’s time to start confiding in those around you. Opening up about having psoriasis can be difficult. But I have come to realize that talking about your condition actually makes opening up so much easier. For me, it didn’t happen at first, it took practice, a lot of practice, as well as truly learning to confide in those around you. But it is possible, and I’m here to help those with psoriasis learn to open up to others as well. The more you know about the disease, the more confident you will feel and will want to tell the world about this chronic disease. When I was first diagnosed over fifteen years ago, I didn’t have all of the resources that there are now. Because of that reason, I was scared to death to talk to my now husband about this chronic disease that didn’t make me feel sexy at all. However, hearing the following phrases from him made all the difference in helping me to learn to confide in him about my skin. “I’m not dating you for what you look like.” I remember to this day exactly where we were. We were standing on a deck at a restaurant in Galveston, Texas.

Despite the muggy weather, I was wearing a quarter length black shirt and jeans to hide my elbows and legs.

My husband and I were talking about what a great night we were having with each other and opening up about a lot of things. Now was time to tell him. I first asked if he knew anything about psoriasis. He said no. I explained to him that it was a chronic autoimmune disease with no cure yet. I told him that it affects the immune system and appears as red/flaky patches on the skin. I showed him my patches. I told him what treatments I was on, and how it affected my quality of life. He was extremely

Loved ones should remember this phrase when showing support to someone with psoriasis. Similarly, those with psoriasis should remember this when opening up to family, friends, coworkers, or significant others.

Loved ones are not there to judge you, but instead care for and accept you for who you are. To further help you on your journey of opening up about having psoriasis, here are some prompts, questions, and psoriasis statistics that can help you when talking to those around you: • “Do you know anything about psoriasis or autoimmune diseases?”

• “Psoriasis affects the immune system and appears as red/flaky patches on the skin.” (Now would be a good time to show your patches) • “It is not contagious.”

• “Psoriasis affects more than 7.5 million Americans and about 25 percent of people have a genetic predisposition to getting psoriasis.”

(You were just one of the lucky ones!)

• “There are different types of treatments out there, but here is what has worked for me....

I’ve also tried (insert what treatments you’ve tried) but they didn’t help, and it really made me feel (explain how it makes you feel).”

• “Psoriasis affects my quality of life because…” (it’s extremely itchy, it can be embarrassing, hard to talk about, etc) • “What questions do you have for me?”

Have you opened up recently with your family or friends? What has helped you? What is stopping you? J

Photo by Todd Spoth Photography.

Sabrina D Skiles is a lifestyle and psoriasis blogger who has had psoriasis for over fifteen years. She is the creator of Homegrown Houston, the online website where she provides inspiration from living with psoriasis to fashion, career, love, family and health (www.homegrownhouston.com). She enjoys being an NPF mentor, Psocial Ambassador, and online influencer to raise awareness for psoriasis

BECAUSE COMING HOME NEVER GOES OUT OF STYLE Everyone needs a little inspiration today whether it be on fashion, career, love, family, or health – which is what Homegrown Houston is all about. Think of this as your 24/7 inspiration source where I share my love for fashion and advice on how to lead a healthy, balanced, and fashionable life while managing psoriasis.

I have a classic, sophisticated yet downto-earth style and I want to bring daily fashion inspirations to you to make living with psoriasis just a little easier! I’m also a health and nutrition consultant with simple tips on how to eat better on a daily basis. I am a volunteer mentor and coach for the National Psoriasis Foundation, living with psoriasis for over fifteen years, providing guidance to those newly diagnosed. I have been with my husband for six years and married for three of those, so I feel like I know what’s important in a marriage and how to make it stronger everyday. I am also a mother to a 9 month-old son so I offer tips and advice on managing psoriasis during pregnancy as well.

I am always open to suggestions on what my next post should be, who to feature, how much you like (or don’t like) my website, and everything in between.

Volume 10 • number 3 • SUMMER 2016 29

CLINIC AL Dermatology

understanding. He could tell that opening up was hard on me but was grateful that I was showing him this side of me. He was also thankful that I was teaching him about something he didn’t know about yet. One thing he said to me that has stayed with me was, “I’m not dating you for what you look like, I’m dating you for who you are.”

Take Home Points for Derm PAs:

By Steven K. Shama, MD, MPH, FAAD

CLINIC AL Dermatology

1. As clinicians we diagnose and treat conditions of the skin.

Sabrina is reminding us that we need to help patients to adjust to chronic diseases, both physically and especially, socially.

Whether we do the counseling ourselves or help our patients connect with someone like Sabrina who is a mentor for the NPF, this referral may very well be as important as the treatment itself since better-adjusted patients are more likely to be compliant with caring for their skin and have better clinical results.

2. Sabrina suggests ways of introducing her condition to others, by asking certain questions. When was the last time you suggested an approach similar to

Hire a DermPA

Sabrina’s for your patients to take, in order to ultimately make lighter their private burden of having psoriasis? Whether we train our patients in specific approaches or not, at the very least we should be asking our patients with any skin disorders, “How does your skin condition affect you socially? Would you like me or someone else to help you in learning how to talk to others about your condition?”

Perhaps many of us have rarely given our patients the gift of caring about them as a whole human being, in addition to caring for them by simply treating their skin condition. In giving this “caring about” gift, we give ourselves a gift too, that of being a complete clinician.

The Perfect Complement to the Modern Dermatologist

Announcing the All New: HireADermPA.com

Empower. Educate. Advance.

Contact Us: 844-DERMPAS 30 Journal of Dermatology for Physician Assistants

Clinical snapshots Keratotic Papules of Palms and Soles

By Vincenzo Maione, MD, Giuseppe Stinco, MD, Maria Orsaria, MD and Enzo Errichetti, MD

SDPA Members Only Content

CLINIC AL 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.

Figure 1: Multiple keratotic crateriform papules over the palms.

©Copyright 2015 Maione et al.

Figure 2: Numerous depressed pits of different sizes on the soles.

©Copyright 2015 Maione et al.

Volume 10 • number 3 • SUMMER 2016 31

CLINIC AL Dermatology

Figure 3: Epidermal depression with hypergranulosis and marked orthokeratotic hyperkeratosis (H&E, magnification 2×).

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.

©Copyright 2015 Maione et al.

REFERENCES: 1. Oztas P, Alli N, Polat M, et al. Punctate palmoplantar keratoderma (Brauer-Buschke-Fischer Syndrome) Am J Clin Dermatol. 2007;8(2):113–6.

2. Giehl KA, Eckstein GN, Pasternack SM, et al. Nonsense mutations in AAGAB cause punctate palmoplantar keratoderma type Buschke-Fischer-Brauer. Am J Hum Genet. 2012;91(4):754–9.

3. Zhang XJ, Li M, Gao TW, et al. Identification of a locus for punctate palmoplantar keratodermas at chromosome 8q24.13-8q24.21. J Invest Derm.

2004;122(5):1121–5.

4. Alikhan A, Burns T, Zargari O. Punctate porokeratotic keratoderma. Dermatol Online J. 2010;16(1):13.

5. Meziane M, Senouci K, Ouidane Y, et al. Acrokeratoelastoidosis. Dermatol Online J. 2008;14(9):11.

6. Abulafia J, Vignale RA. Degenerative collagenous plaques of the hands and acrokeratoelastoidosis: pathogenesis and relationship with knuckle pads. Int J Dermatol. 2000;39(6):424–32.

7. Kong MS, Harford R, O’Neill JT. Keratosis punctata palmoplantaris controlled with topical retinoids: a case report and review of the literature. Cutis.

2004;74(3):173–79.

8. Raone B, Raboni, Patrizi A. Alitretinoin: a new treatment option for hereditary punctate palmoplantar keratoderma (Brauer-Buschke-Fischer syndrome) J Am Acad Dermatol. 2014;71(2):e48–9.

Vincenzo Maione, MD works at the Department of Experimental and Clinical Medicine, Institute of Dermatology, at the University of Udine, Italy. Giuseppe Stinco, MD works at the Department of Experimental and Clinical Medicine, Institute of Dermatology, at the University of Udine, Italy. Maria Orsaria, MD works at the Institute of Pathology, University of Udine, Italy. Enzo Errichetti, MD works at the Department of Experimental and Clinical Medicine, Institute of Dermatology, at the University of Udine, Italy. All authors have indicated no conflicts of interest to disclose relating to the content of this article.

This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author (©Copyright 2015 Maione et al.) and source (Keratotic papules of palms and soles. Dermatol Pract Concept 2015;5(2):10) are credited.

32 Journal of Dermatology for Physician Assistants

CLASS 1 STRENGTH WITH A WELL-TOLERATED SPRAY FORMULATION1,2 Topicort® Topical Spray is a topical corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older.

Important Safety Information • Topicort® Topical Spray is a topical corticosteroid that has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis.

• Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid.

• Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression.

• Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local reactions may be irreversible.

• Safety and effectiveness of Topicort® Topical Spray in patients younger than 18 years of age have not been studied; therefore use in pediatric patients is not recommended.

References: 1. National Psoriasis Foundation. Topical Steroids Potency Chart. https://www.psoriasis.org/sublearn03_mild_ potency. Accessed on 9/1/15. 2. Topicort® Topical Spray Prescribing Information. Taro Pharmaceuticals U.S.A., Inc. See brief summary of Prescribing Information on reverse side. © 2016 Taro Pharmaceuticals U.S.A., Inc. TaroPharma® and Topicort® are registered trademarks of Taro Pharmaceuticals U.S.A., Inc. AD1000047M August 2016

Volume 10 • number 3 • SUMMER 2016 33

TOPICORT® (desoximetasone) Topical Spray, 0.25% Rx Only

Table 1. Number (%) of Subjects with Adverse Reactions Occurring in ≥ 1% Topicort® Topical Spray, 0.25% b.i.d. (N = 149)

Vehicle spray b.i.d.

(N = 135)

Number of Subjects with Adverse Reactions

13 (8.7%)

18 (13.3%)

4 CONTRAINDICATIONS None

Application site dryness

4 (2.7%)

7 (5.2%)

Application site irritation

4 (2.7%)

5 (3.7%)

5 WARNINGS AND PRECAUTIONS 5.1 Effect on Endocrine System Topicort® Topical Spray is a topical corticosteroid that has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis.

Application site pruritus

3 (2.0%)

5 (3.7%)

BRIEF SUMMARY 1 INDICATIONS AND USAGE Topicort® Topical Spray is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older.

Systemic absorption of topical corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid.

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Teratogenic Effects: Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Topicort® Topical Spray should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

In a study including 21 evaluable subjects 18 years of age or older with moderate to severe plaque psoriasis, adrenal suppression was identified in 1 out of 12 subjects having involvement of 10-15% of body surface area (BSA) and 2 out of 9 subjects having involvement of >15% of BSA after treatment with Topicort® Topical Spray twice a day for 28 days. [see Clinical Pharmacology (12.2)]

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels.

Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of high potency steroids, larger treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure and young age.

8.3 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 Topicort® Topical Spray is administered to a nursing woman.

An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression.

If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.

Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids.

Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.

Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.

Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure.

Pediatric patients may be more susceptible to systemic toxicity from use of topical corticosteroids. [see Use in Specific Populations (8.4)] 5.2 Local Adverse Reactions with Topical Corticosteroids Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions may be irreversible.

5.3 Allergic Contact Dermatitis with Topical Corticosteroids Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing.

5.4 Concomitant Skin Infections Concomitant skin infections should be treated with an appropriate antimicrobial agent.

If the infection persists, Topicort® Topical Spray should be discontinued until the infection has been adequately treated.

5.5 Flammable Contents Topicort® Topical Spray is flammable; keep away from heat or flame.

ADVERSE REACTIONS 6.1 Clinical Trials Experience 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 randomized, multicenter, prospective vehicle-controlled clinical trials, subjects with moderate to severe plaque psoriasis of the body applied Topicort® Topical Spray or vehicle spray twice daily for 4 weeks. A total of 149 subjects applied Topicort® Topical Spray.

Adverse reactions that occurred in ≥ 1% of subjects treated with Topicort® Topical Spray were application site dryness (2.7%), application site irritation (2.7%) and application site pruritus (2.0%).

Another less common adverse reaction (<1% but >0.1%) was folliculitis.

Desoximetasone has been shown to be teratogenic and embryotoxic in mice, rats, and rabbits when given by subcutaneous or dermal routes of administration at doses 3 to 30 times the human dose of Topicort® Topical Spray based on a body surface area comparison.

If used during lactation, Topicort® Topical Spray should not be applied on the chest to avoid accidental ingestion by the infant.

8.4 Pediatric Use Safety and effectiveness of Topicort® Topical Spray in patients younger than 18 years of age have not been studied; therefore use in pediatric patients is not recommended. 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 at greater risk of adrenal 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. [see Warnings and Precautions (5.1)] 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. [see Warnings and Precautions (5.1)] 8.5 Geriatric Use Clinical studies of Topicort® Topical Spray did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, 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.

10 OVERDOSAGE Topicort® Topical Spray can be absorbed in sufficient amounts to produce systemic effects. [see Warnings and Precautions (5.1)] 17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information and Instructions for Use) Inform patients of the following: • Use this medication as directed by the physician.

• Topicort® Topical Spray is for external use only. Avoid use on the face, axilla or groin.

• Do not use this medication for any disorder other than that for which it was prescribed.

• Do not bandage or otherwise cover or wrap the treated skin so as to be occlusive.

• Report any signs of local or systemic adverse reactions to the physician.

• Do not use other corticosteroid-containing products with Topicort® Topical Spray without first consulting with the physician.

• Discontinue therapy when control is achieved. If no improvement is seen within 4 weeks, contact the physician.

• This medication is flammable; avoid heat, flame, or smoking when applying this product.

• Discard this product 30 days after dispensed by pharmacist.

Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1 Dist. by: TaroPharma® a division of Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 Revised: April 2013 AD100-0030

34 Journal of Dermatology for Physician Assistants

SURGIC AL Dermatology Journal Club: Practice Changing Articles for Dermatology PAs

Comparison of Sterile vs Nonsterile Gloves in Cutaneous Surgery and Common Outpatient Dental Procedures JAMA Dermatol. Published online August 03, 2016. doi:10.1001/jamadermatol.2016.1965 [Epub ahead of print] Brewer JD1, Gonzalez AB2, Baum CL1, Arpey CJ1, Roenigk RK1, Otley CC1, Erwin PJ3 1 Division of Dermatologic Surgery, Mayo Clinic, Rochester, Minnesota 2 Center for Clinical and Translational Science, Mayo Graduate School, Rochester, Minnesota 3 Mayo Medical Library, Mayo Clinic, Rochester, Minnesota

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.

Journal clubs are a great way to review and critically evaluate the most current literature impacting the practice of dermatology. For physician assistants who are new to the practice of dermatology, journal clubs can assist them to become more familiar with advanced medical literature and improve their understanding of current issues within the field. The articles selected for the JDPA Journal Club are meant to be shared and discussed with your colleagues, peers, and supervising physicians. If you have any articles to recommend for the JDPA Journal Club, please email them to editor@jdpa.org

Volume 10 â&#x20AC;˘ number 3 â&#x20AC;˘ SUMMER 2016 35

SURGICAL wisdom Dermcast.tv Blog

Spitz Nevi or Melanoma? Can Reflectance Confocal Microscopy Help?

By Martha L. Sikes, MS, RPh, PA-C

SURGIC AL Dermatology

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.

Image: Wikimedia Commons / National Cancer Institute

Dermcast.tv is the official online media resource of the SDPA. We are very proud that Dermcast is the #1 iTunes Podcast in dermatology. Dermcast.tv is your source for audio podcasts, the most current dermatology news and research, procedural videos, conference highlights, and much, much more. As members of the SDPA, everything on Dermcast.tv is not only tailored precisely for you and your needs, it is available to you FREE! To read more SDPA blogs and/or to follow the next live blog from the next SDPA dermatology conference, please visit the Dermcast.tv website at www.dermcast.tv.

36 Journal of Dermatology for Physician Assistants

COSMETIC Dermatology Journal Club: Practice Changing Articles for Dermatology PAs

Importance of Physical Appearance in Patients with Skin Cancer Dermatol Surg. 2015 Feb;41(2):183-8.

Sobanko JF1, Sarwer DB, Zvargulis Z, Miller CJ 1 Division of Dermatologic Surgery and Cutaneous Oncology, Department of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania

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.

Journal clubs are a great way to review and critically evaluate the most current literature impacting the practice of dermatology. For physician assistants who are new to the practice of dermatology, journal clubs can assist them to become more familiar with advanced medical literature and improve their understanding of current issues within the field. The articles selected for the JDPA Journal Club are meant to be shared and discussed with your colleagues, peers, and supervising physicians. If you have any articles to recommend for the JDPA Journal Club, please email them to editor@jdpa.org.

Volume 10 â&#x20AC;˘ number 3 â&#x20AC;˘ SUMMER 2016 37

Cosmetic pearls Gel manicures: The Good, the Bad, and the UV With Proper Procedures and UV Protection, Gels Can Improve Nail Appearance

COSMETIC Dermatology

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.

38 Journal of Dermatology for Physician Assistants

SDPA Members Only Content

Reprinted with permission from the American Academy of Dermatology

Chris G. Adigun, MD, FAAD is a board certified dermatologist in Chapel Hill, North Carolina.

Prior to opening her practice at the Dermatology & Laser Center of Chapel Hill in 2016, Dr. Adigun worked as an Assistant Professor of Dermatology in the New York University Department of Dermatology in Manhattan.

Dr. Adigun specializes in nail disorders, general dermatology, and cosmetic dermatology. Dr. Adigun has devoted much of her time to increasing public awareness of skin cancer and the harmful effects of UV rays—both medical and cosmetic. She lectures extensively on the importance of diligent skin and nail care, and its effects on general well being.

Volume 10 • number 3 • SUMMER 2016 39

COSMETIC 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.

Professional development

Notes from your Office Manager Communication with Patients The Risk: Communication is the cornerstone of the clinician-patient relationship. Patients’ perceptions of clinician communication skills may impact the potential for allegations of malpractice. The following are some suggestions, which are designed to promote open communication and enhance your ability to reach an accurate diagnosis and develop an appropriate plan of care.

Recommendations: 1. Employ active listening techniques and allow the patient sufficient time to voice their concerns.

2. Sit at the level of the patient and maintain eye contact.

3. Assess the patient’s literacy level. This may be as simple as asking what is the highest grade level the patient attained.

4. Use lay terminology when communicating with patients and their families.

5. Develop plans for communicating with patients who are hearing impaired, deaf, or have limited English proficiency.

6. Utilize the teach-back method when providing patients with instructions and information. This technique requires that patients repeat the information provided in their own words. The teach-back method is particularly useful in assessing patients’ understanding of:

a) Informed consent discussions. b) Medication instructions including side effects and adverse reactions. c) Test preparation. d) Follow-up instructions.

If the patient is unable to convey the information, it should be restated in simpler terms, perhaps utilizing pictures and/or drawings.

7. Evaluate your educational tools and consent forms to determine the grade level at which they are written. This will allow you to provide written materials that will be understandable to the majority of your patient population. Techniques that determine the readability and comprehension levels of documents are available from numerous sources.

8. At the conclusion of your patient encounter, ask the patient/family if they have any questions or concerns that have not been addressed.

Medical record documentation should reflect all aspects of patient interactions and comprehension. This will demonstrate the effectiveness of your communication skills and promote patient satisfaction, which may reduce your potential exposure to claims of malpractice. J

These Risk Management Tips have been reprinted with permission from: MLMIC Dateline, published by Medical Liability Mutual Insurance Company, 2 Park Avenue, Room 2500, New York, NY 10016. Copyright ©2016 by Medical Liability Mutual Insurance Company. All Rights Reserved. No part of this article may be reproduced or transmitted in any form or by any means, electronic, photocopying, or otherwise, without the written permission of MLMIC.

40 Journal of Dermatology for Physician Assistants

Outside & Inside the 9 to 5...

John Notabartolo, MPAS, PA-C DPAF Chair and SDPA Past President

The Dermatology PA Foundation (DPAF) is exploring many opportunities to share the goodwill of its generous donors. Recently SDPA Past President and DPAF Chair John Notabartolo, MPAS, PA-C made a site visit to the Children’s Skin Disease Foundation’s Camp Wonder located in Livermore, CA. Camp Wonder is a summer camp for children (ages six to sixteen) who have chronic skin disease. Camp Wonder is held for one week, usually at the end of June at the Camp Arroyo site (a year-round location that is run by the Taylor Family Foundation and Trust, which facilitates camps all summer long for children with different chronic medical conditions and provides basic staff, food, and activities for the campers). The site has dormitories, a cafeteria/recreation hall, swimming pool, stables, arts and crafts building, twenty-four hour medical staffing, and a six bed medical facility. The DPAF is excited to explore ways to support Camp Wonder and its campers.

Camp Wonder has been in operation for sixteen years and Mr. Notabartolo met with the director and founder, Francesca Tenconi, as well as her father Don. There were sixty-two campers in attendance whose conditions ranged from chronic eczema to severe epidermolysis bullosa. All facilities at the camp are wheelchair accessible so that the campers who are wheelchair-bound are able to navigate the grounds freely. Many former campers return as adult counselors to mentor the attendees for that week.

Volume 10 • number 3 • SUMMER 2016 41

professional development

DPAF Chair Visits Camp Wonder

professional development

Mr. Notabartolo felt that the most impressive aspect of the camp was the joyful atmosphere and great care provided to all of the campers.

Each of the cabins house four to six campers and two to four staff, depending on the campers’ dermatologic conditions and medical needs. The staff provides the same basic care for the campers that they would receive at home and rarely turn down an applicant. “During my visit, I visited the cabin where campers who have the more severe dermatologic conditions are housed and there were IV poles next to the beds to provide them with the hydration they so sorely needed,” said Mr. Notabartolo. “After a rousing two-hour marathon game of Uno with a group of campers

in the cabin, I took my leave. It was an incredible day full of intense feelings. I look forward to the DPAF working with Camp Wonder and providing continued opportunities to campers to participate.”

Mr. Notabartolo’s discussion with the staff and director centered around how the DPAF can provide Camp Wonder with additional help, both financially and in regards to providing medical volunteers. There was some discussion about the logistics of how PA licensure coverage would extend to such an endeavor and questions as to whether there would be an additional insurance burden placed on the camp by allowing non California resident SDPA members to attend as medical staff. This issue would need to be looked in to further before SDPA members who live outside of the state of California would be able to volunteer their services as a healthcare provider. J

From Left to Right: Tom Fitzgerald, National Sales Manager for Galderma and SDPA Past President and current DPAF Chair John Notabartolo, MPAS, PA-C at Camp Wonder. Galderma has partnered with Camp Wonder and the Children's Skin Diseases Foundation since 2012 and provides a generous grant, employee volunteers, and Cetaphil products both during the camp and throughout the year to help support children's skin health needs.

42 Journal of Dermatology for Physician Assistants

For your patients with corticosteroid-responsive dermatoses...

D A T E H R E P S

Provide relief with Topicort 0.05% 1,2 • • • • • •

Group C molecule3 Low allergenic potential4-6 Available in cream and ointment3,7 Paraben-free1,2 Propylene glycol-free1,2 Fragrance-free

Topicort® (desoximetasone cream USP) 0.05% and Topicort® (desoximetasone ointment USP) 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Topicort® (desoximetasone cream USP) 0.05% and Topicort® (desoximetasone ointment USP) 0.05% are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

IMPORTANT SAFETY INFORMATION 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, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression.

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 to body weight ratio.

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients.

Before prescribing, please see brief Prescribing Information on reverse side.

References: 1. Topicort® Cream 0.05% Prescribing Information. Taro Pharmaceuticals U.S.A., Inc. 2. Topicort® Ointment 0.05% Prescribing Information. Taro Pharmaceuticals U.S.A., Inc. 3. Jacob SE, Steele T. Corticosteroid classes: A quick reference guide including patch test substances and cross-reactivity. J Am Acad Dermatol. 2006;54:723-727. 4. National Psoriasis Foundation.

Topical Steroids Potency Chart. https://www.psoriasis.org/page.aspx?pid=469. Accessed 9/3/15. 5. Baeck M, Chemelle J-A, Rasse C, Terreux R, Goossens A. et al. C16-methyl corticosteroids are far less allergenic than the non-methylated molecules. Contact Dermatitis. 2011;64:305-312. 6. Scheuer E, Warshaw E. Allergy to corticosteroids: Updated and review of epidemiology, clinical characteristics, and structural cross-reactivity. Am J Contact Derm. 2003;14(4):179-187. ©2016 Taro Pharmaceuticals U.S.A., Inc. TaroPharma® and Topicort® are registered trademarks of Taro Pharmaceuticals U.S.A., Inc. AD1000055D August 2016

Volume 10 • number 3 • SUMMER 2016 43

RxRx only only RxRx only only

AsAs with with other other corticosteroids, corticosteroids, therapy therapy should should bebe discontinued discontinued when when control control is is achieved. achieved.

If no If no improvement improvement is seen is seen within within 4 weeks, 4 weeks, contact contact thethe physician. physician.

Brief Brief Summary Summary of Prescribing of Prescribing Information.

Information.

ForFor complete complete prescribing prescribing information information

Laboratory Laboratory Tests Tests The The following following tests tests may may bebe helpful helpful in in evaluating evaluating thethe hypothalamic-pituitaryhypothalamic-pituitaryadrenal adrenal (HPA) (HPA) axis axis suppression: suppression: Urinary Urinary free free cortisol cortisol test test ACTH ACTH stimulation stimulation test test

® ® Topicort Topicort (Desoximetasone (Desoximetasone Cream Cream USP) USP) 0.05% 0.05% ® ® Topicort Topicort (Desoximetasone (Desoximetasone Ointment Ointment USP) USP) 0.05% 0.05%

ForFor topical topical use use only. only.

Not Not forfor oral, oral, ophthalmic, ophthalmic, or or intravaginal intravaginal use. use.

INDICATIONS INDICATIONS AND AND USAGE USAGE ® ® ® ® Topicort Topicort (desoximetasone (desoximetasone cream cream USP) USP) 0.05% 0.05% and and Topicort Topicort (desoximetasone (desoximetasone manifestations manifestations of of corticosteroid-responsive corticosteroid-responsive dermatoses. dermatoses.

CONTRAINDICATIONS CONTRAINDICATIONS Topical Topical corticosteroids corticosteroids areare contraindicated contraindicated in in those those patients patients with with a history a history of of hypersensitivity hypersensitivity to to anyany of of thethe components components of of thethe preparation. preparation.

WARNINGS WARNINGS Keep Keep outout of of reach reach of of children. children.

PRECAUTIONS PRECAUTIONS General General Systemic Systemicabsorption absorptionof oftopical topicalcorticosteroids corticosteroidscan canproduce producereversible reversible hypothalamic-pituitary-adrenal hypothalamic-pituitary-adrenal (HPA) (HPA) axis axis suppression suppression with with thethe potential potential forfor upon upon withdrawal withdrawal of of thethe topical topical corticosteroid. corticosteroid.

Because Because of of thethe potential potential forfor systemic systemic absorption, absorption, useuse of of topical topical corticosteroids corticosteroids may may require require that that patients patients bebe periodically periodically evaluated evaluated forfor HPA HPA axis axis suppression. suppression.

Factors Factors that that predispose predispose a patient a patient using using a topical a topical corticosteroid corticosteroid to to HPA HPA axis axis suppression suppression include include thethe useuse of of more more potent potent steroids, steroids, useuse over over large large surface surface areas, areas, useuse over over prolonged prolonged periods, periods, useuse under under occlusion, occlusion, useuse onon anan altered altered skin skin barrier, barrier, and and useuse in patients in patients with with liver liver failure. failure.

Carcinogenesis, Carcinogenesis, Mutagenesis, Mutagenesis, and and Impairment Impairment of of Fertility Fertility Long-term Long-term animal animal studies studies have have notnot been been performed performed to evaluate to evaluate thethe carcinogenic carcinogenic Desoximetasone Desoximetasone was was nonmutagenic nonmutagenic in the in the Ames Ames test. test.

Corticosteroids Corticosteroids have have been been shown shown to to bebe teratogenic teratogenic in laboratory in laboratory animals animals when when administered systemically relatively dosage levels.

Some corticosteroids administered systemically at at relatively lowlow dosage levels.

Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. have been shown to be teratogenic after dermal application in laboratory animals.

Desoximetasone been shown teratogenic and embryotoxic in mice, Desoximetasone hashas been shown to to bebe teratogenic and embryotoxic in mice, rats, and rabbits when given subcutaneous or dermal routes of administration rats, and rabbits when given byby subcutaneous or dermal routes of administration ® ® in doses 150 times human dose Topicort(desoximetasone in doses 1515 to to 150 times thethe human dose of of Topicort (desoximetasone cream cream ® ® USP) 0.05%, Topicort USP) 0.05%, or or Topicort (desoximetasone (desoximetasone ointment ointment USP) USP) 0.05%.

0.05%.

There There areare nono adequate adequate and and well-controlled well-controlled studies studies in in pregnant pregnant women women onon ®

®

® ® (desoximetasone (desoximetasone cream cream USP) USP) 0.05% 0.05% or or Topicort Topicort (desoximetasone (desoximetasone ointment ointment

thethe potential potential riskrisk to the to the fetus. fetus.

Drugs Drugs of this of this class class should should notnot bebe used used extensively extensively onon pregnant patients, in large amounts, or or forfor prolonged periods of time. pregnant patients, in large amounts, prolonged periods of time.

Nursing Mothers Nursing Mothers It isIt not known whether topical administration of of corticosteroids could result in in is not known whether topical administration corticosteroids could result

AnAn ACTH ACTH stimulation stimulation test test may may bebe helpful helpful in in evaluating evaluating patients patients forfor HPA HPA axis axis suppression. suppression.

If HPA If HPA axis axis suppression suppression is is documented, documented, anan attempt attempt should should bebe made made to to gradually gradually withdraw withdraw thethe drug, drug, to to reduce reduce thethe frequency frequency of of application, application, or or

Systemically Systemically administered administered corticosteroids corticosteroids areare secreted secreted intointo breast breast milk milk in quantities in quantities

require require supplemental supplemental systemic systemic corticosteroids. corticosteroids.

Recovery Recovery of HPA of HPA axis axis function function is is generally generally prompt prompt and and complete complete upon upon discontinuation discontinuation of of topical topical corticosteroids. corticosteroids.

Pediatric Pediatric Use Use Pediatric Pediatricpatients patientsmay maydemonstrate demonstrategreater greatersusceptibility susceptibilityto totopical topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than corticosteroid-induced HPA axis suppression and Cushing’s syndrome than mature patients because a larger skin surface area body weight ratio. mature patients because of of a larger skin surface area to to body weight ratio.

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, and intracranial hypertension have been reported in pediatric patients receiving and intracranial hypertension have been reported in pediatric patients receiving topicalcorticosteroids. corticosteroids.Manifestations Manifestationsof ofadrenal adrenalsuppression suppressionin inpediatric pediatric topical patients include linear growth retardation, delayed weight gain, plasma patients include linear growth retardation, delayed weight gain, lowlow plasma cortisol levels, and absence of response ACTH stimulation.

Manifestations cortisol levels, and absence of response to to ACTH stimulation.

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

Administration topical corticosteroids pediatric patients should limited Administration of of topical corticosteroids to to pediatric patients should bebe limited

Cushing’s Cushing’s syndrome, syndrome, hyperglycemia, hyperglycemia, and and unmasking unmasking of latent of latent diabetes diabetes mellitus mellitus can can also also result result from from systemic systemic absorption absorption of of topical topical corticosteroids. corticosteroids.

Use Use of of more more than than one one corticosteroid-containing corticosteroid-containing product product at at thethe same same time time may may increase increase thethe total total systemic systemic corticosteroid corticosteroid exposure. exposure.

Pediatric Pediatric patients patients may may bebe more more susceptible susceptible to to systemic systemic toxicity toxicity from from useuse of of topical topical corticosteroids. corticosteroids.

Local Local Adverse Adverse Reactions Reactions with with Topical Topical Corticosteroids Corticosteroids Local Local adverse adverse reactions reactions may may bebe more more likely likely to occur to occur with with occlusive occlusive use, use, prolonged prolonged useuse or use or use of higher of higher potency potency corticosteroids. corticosteroids.

Reactions Reactions may may include include atrophy, atrophy, striae, striae, telangiectasias, telangiectasias, burning, burning, itching, itching, irritation, irritation, dryness, dryness, folliculitis, folliculitis, acneiform acneiform eruptions, eruptions, hypopigmentation, hypopigmentation,perioral perioraldermatitis, dermatitis,allergic allergiccontact contactdermatitis, dermatitis,secondary secondary infection, infection, and and miliaria. miliaria.

Some Some local local adverse adverse reactions reactions may may bebe irreversible. irreversible.

Allergic Allergic Contact Contact Dermatitis Dermatitis with with Topical Topical Corticosteroids Corticosteroids Allergic Allergic contact contact dermatitis dermatitis to to anyany component component of of topical topical corticosteroids corticosteroids is is usually usually diagnosed diagnosed byby a failure a failure to to heal heal rather rather than than a clinical a clinical exacerbation. exacerbation.

Clinical Clinical Concomitant Concomitant Skin Skin Infections Infections Concomitant Concomitant skin skin infections infections should should bebe treated treated with with anan appropriate appropriate antimicrobial antimicrobial ® ® agent. agent.

If the If the infection infection persists, persists, Topicort Topicort (desoximetasone (desoximetasone cream cream USP) USP) 0.05% 0.05% ® ® or or Topicort Topicort(desoximetasone (desoximetasone ointment ointment USP) USP) 0.05% 0.05% should should bebe discontinued discontinued until until thethe infection infection hashas been been adequately adequately treated. treated.

Information Information forfor thethe Patient Patient Patients Patients using using topical topical corticosteroids corticosteroids should should receive receive thethe following following information information and and instructions: instructions: 1. 1.

This This medication medication is to is to bebe used used as as directed directed byby thethe physician. physician.

It isIt for is for external external useuse only. only.

Avoid Avoid contact contact with with thethe eyes. eyes.

2. 2.

Patients Patients should should bebe advised advised notnot to to useuse thisthis medication medication forfor anyany disorder disorder other other than than forfor which which it was it was prescribed. prescribed.

3. 3.

The The treated treated skin skin area area should should notnot bebe bandaged bandaged or or otherwise otherwise covered covered or or wrapped wrapped as as to to bebe occlusive occlusive unless unless directed directed byby thethe physician. physician.

4. 4.

Patients Patients should should report report anyany signs signs of of local local adverse adverse reactions, reactions, especially especially under under occlusive occlusive dressings. dressings. ® ® 5. 5.

Other Other corticosteroid-containing corticosteroid-containing products products should should notnot bebe used used with with Topicort Topicort ® ® (desoximetasone (desoximetasone cream cream USP) USP) 0.05% 0.05% or Topicort or Topicort (desoximetasone (desoximetasone ointment ointment Issued: Issued: April April 2014 2014

44 Journal of Dermatology for Physician Assistants

bebe exercised exercised when when topical topical corticosteroids corticosteroids areare administered administered to a tonursing a nursing woman. woman.

corticosteroid corticosteroid therapy therapy may may interfere interfere with with thethe growth growth and and development development of of pediatric patients. pediatric patients.

ADVERSE REACTIONS ADVERSE REACTIONS The following local adverse reactions reported infrequently with topical The following local adverse reactions areare reported infrequently with topical corticosteroids, may occur more frequently with occlusive corticosteroids, butbut may occur more frequently with thethe useuse of of occlusive dressings.

These reactions listed approximate decreasing order dressings.

These reactions areare listed in in anan approximate decreasing order of of occurrence: occurrence: Burning,itching, itching,irritation, irritation,dryness, dryness,folliculitis, folliculitis,hypertrichosis, hypertrichosis,acneiform acneiform Burning, eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration skin, secondary infection, skin atrophy, striae, and miliaria. maceration of of thethe skin, secondary infection, skin atrophy, striae, and miliaria.

In controlled clinical studies incidence adverse reactions were 0.8% In controlled clinical studies thethe incidence of of adverse reactions were lowlow 0.8% ® ® Topicort forfor Topicort (desoximetasone (desoximetasone cream cream USP) USP) 0.05% 0.05% and and included included pruritus, pruritus, erythema, vesiculation, and burning sensation.The The incidence erythema, vesiculation, and burning sensation. incidence adverse of of adverse ® ® reactions was lowlow (0.2%) forfor Topicort reactions was (0.2%) Topicort (desoximetasone (desoximetasone ointment ointment USP) USP) 0.05% 0.05% and included mild burning sensation application. and included mild burning sensation at at thethe sitesite of of application.

OVERDOSAGE OVERDOSAGE PRECAUTIONS).

PRECAUTIONS).

Mfd. Mfd. by:by: Taro Taro Pharmaceuticals Pharmaceuticals Inc., Inc., Brampton, Brampton, Ontario, Ontario, Canada Canada L6T L6T 1C1 1C1 Dist.

Dist. by:by: TaroPharma TaroPharma a division a division of of Taro Taro Pharmaceuticals Pharmaceuticals U.S.A., U.S.A., Inc., Inc., Hawthorne, Hawthorne, 10532 NYNY 10532 ® ® ® ® Topicort Topicort and and TaroPharma TaroPharma areare registered registered trademarks trademarks of of Taro Taro Pharmaceuticals Pharmaceuticals

FDA. FDA. Visit Visit www.fda.gove/Safery/MedWatch/default.htm, www.fda.gove/Safery/MedWatch/default.htm, or call or call 1-800-FDA-1088.

1-800-FDA-1088.

Dermatology PA news & notes

Listening to Patients Having Reactions to Reactions

By Alan Rockoff, MD

My hobby is listening to patients. For one thing, you learn more by listening than by talking.

Besides, practitioners do a better job of helping people when both parties understand each other.

Sometimes patients use familiar words to mean something different from what medical personnel have in mind when they use them, for example, “Reactions.” Medicine divides reactions into two kinds: 1) allergy: the body mounts an immune response to something taken by mouth or applied to the skin; and 2) intolerance, a medicine produces discomfort unrelated to immunity. An example of the first is a penicillin allergy. Even a tiny amount in an allergic individual can produce hives or a widespread itchy rash. An example of the second is severe heartburn from doxycycline-induced esophagitis. The same patient may tolerate doxycycline, even in full dose, if taken with food or if a less irritating form is prescribed.

When patients say they had “a reaction” to some treatment, they don’t necessarily mean either one of these. However, they will still be reluctant to use what we suggest or just refuse. There are, for instance, patients who call two days after I prescribe clindamycin lotion to complain that, “It dried me out completely.” Countering this kind of complaint is often hard. If you say, “I’ve never heard of that,” they are likely to respond, “Well my body is sensitive, so I get strange reactions.”

Like most practitioners, I use negotiating tactics when I’m pretty sure there really was no reaction (in my sense of the word). For instance, I may say, “Stop the cream for three days; then try it on one spot in front of your left ear. Let’s see what happens.” Some patients agree to try. Often nothing happens. They use the medication, and we never do figure out what happened the first time. Sometimes though, the patient is too afraid even to try what they think caused a problem, and we try something else. We may run through successive options, each of which produces a “reaction.”

In cosmetic stores or pharmacies, if a customer returns a skincare cream because it gave him or her “a reaction,” the store takes it back, no questions asked.

This is not just a matter of good business practice; in that context the people on both sides of the transaction are laypeople who use the word “reaction” the way laymen do, not the way clinicians do.

As the years have passed, I have gotten better at appreciating the broad range of true reactions to medications. Still, the list of perplexing things patients complain about gets longer all the time. ◆ The woman who used low-strength tretinoin cream twice stopped two weeks ago and insisted that, “My face is still all dried out.” I assured her that two days of tretinoin cannot damage the skin forever, but she remains unconvinced. ◆ The man who says that putting tretinoin on his nose, “Made me dry out all over.” ◆ The mother who said her daughter stopped putting a steroid cream on her neck because, “Every time we used it, her tongue broke out in blisters.” ◆ The middle-aged woman who said, “I can’t take minocycline because it changed the color of my teeth.” This drug only affects the color of visible teeth under age of eight. ◆ The young woman who puts clindamycin pads only on her right cheek, where she still has pimples, but not on the left, “Because it makes the pimples go away on the cheek that has them, but on the other side it makes pimples come out.”

When I hear complaints like these, I just sigh and make a lateral move. However, sometimes I run out of lateral moves. The other month a woman told me that doxycycline made her “tired.” We tried minocycline, but that made her “irritable.” “My body Volume 10 • number 3 • SUMMER 2016 45

DERmatology pa news & notes

is prone to strange reactions that no one else gets,” she explained. Then she asked for a third option. “I honestly don’t know what to suggest,” I apologized.

“Since you react in ways that other people don’t, I can’t predict what a new treatment will do to you, even if it doesn’t do it to anyone else.” She was unhappy and asked for her records to get another opinion.

“Reactions” that are hard to make sense of are not limited to patient reports. There are, for instance, some of those listed on e-scribing programs: ● Hydrocortisone valerate has been associated with Warts (Capitalized) ● Hydrocortisone valerate has been associated with tinea cruris I honestly don’t know who writes this stuff. I’ve tried to find out too, but they won’t tell me.

The bottom line is that when patients complain of a “reaction,” listen carefully and do your best to figure out whether what happened was a true allergy or intolerance. Even if you’re convinced it was neither, negotiate as best you can. No matter how sure you are that what you prescribed is safe, a patient who is worried that it is not probably will not use it. J

46 Journal of Dermatology for Physician Assistants

Alan Rockoff, MD practices dermatology in Boston, MA. He graduated with his medical degree in 1972 from the Albert Einstein College of Medicine in New York and then completed a pediatric internship and residency at Bronx Municipal Hospital Center.

Continuing his education, Dr. Rockoff completed a dermatology residency program at the combined program at Boston University and Tufts University. Dr. Rockoff is a Clinical Assistant Professor of Dermatology at Tufts University School of Medicine. He has taught senior medical students and other trainees for over thirtyfive years.

Dr. Rockoff has been named one of Boston’s Top Doctors by Boston Magazine for five years. Dr. Rockoff is board certified by the American Board of Pediatrics and the American Board of Dermatology. Dr. Rockoff is a Fellow of the American Academy of Dermatology and a member of the Massachusetts Medical Society and the Massachusetts Academy of Dermatology.

Dr. Rockoff’s publications have appeared in a number of journals.

He writes a monthly column for his dermatologic colleagues in Dermatology News as well as a blog for the magazine Psychology Today. His first book, “Under My Skin: A Dermatologist Looks at His Profession and His Patients” is currently available on Amazon and is his second book, “Act Like a Doctor, Think Like a Patient: Teaching Patient-focused Medicine” will be available on Amazon later this year.

Workplace Excellence Rediscovering The Adversity Advantage

By Matthew Davidson, PhD

I returned recently to a book from which I have

drawn deeply over the years: The Adversity Advantage,

by Paul Stoltz and Erik Weihenmayer. It’s a powerful resource that takes a somewhat counterintuitive look at adversity and hardship by arguing that while we often spend our lives trying to prevent adversity, suffering, and hardship, in fact the most powerful, impactful, and defining moments of our lives come from these very experiences. They aren’t arguing that we should seek out adversity (even though many people do including myself when I purposely take on a marathon, a killer bike ride, or mountain to climb). Rather, adversity and suffering simply are an inevitable part of the human experience. Thus, we do well to have an intentional approach regarding how to make sense of and get the most positive results from the adversity we experience.

Far too many individuals with whom we work are what I might describe as adversity-adverse, that is they truly operate with an opposition to anything difficult, anything that requires sacrifice, anything that is not well matched to their learning styles, their timetables, or their beliefs about how the world should work.

This is certainly true of many of the youth we work with in K-16 education, sport settings, and ultimately workplace environments including healthcare settings.

Unfortunately, in my opinion, these young people are adversity-adverse because they’ve been wrapped in bubble-wrap by parents, teachers, and coaches who see their jobs as removing adversity and promoting self-esteem. Far too many parents, especially in the most affluent communities we serve, operate as either helicopters or bulldozers, hovering to protect

or removing any obstacle to their child’s success.

They engineer every setting to be the easiest, the best, the most successful. They shield kids from any disappointments, failures, or any situation where they won’t get a trophy, an award, or praise. And yet, for the workplace environments we serve, the most soughtafter qualities are toughness, grit, perseverance, and an optimistic, can-do attitude - the attributes that come from the experience of adversity.

One of the other major culprits in the creation of the adversity-adverse are our colleges and universities, which have created a utopia that is most unlike the “real world.” Colleges and universities realize that students (most often the parents of students) are the customers who are paying the bills, and they are big ones! So the job of the colleges and universities seemingly has become to keep the customers happy.

If the student gets a bad or even an average grade, gets locked out of a class, doesn’t get the part in the play or on the team, or doesn’t have the best food and exercise facilities, then he or she is out of there! Many colleges have gone away from early morning classes or from having any classes on Friday. Why? The customers don’t like getting up early on Friday after a late night of partying on Thursday. I get it; college costs a lot of money, and there are lots of options. Keeping the customer happy is important. However, most of life is about doing what you don’t want to do, when you don’t want to do it. No wonder employers struggle to recruit and retain college graduates who won’t bolt for a new gig as soon as things are difficult, aren’t fun, or aren’t customized to fit the needs of the employee.

Volume 10 • number 3 • SUMMER 2016 47

DERmatology pa news & notes

In my work as President of the Institute for Excellence & Ethics (IEE) I have had the opportunity to work with diverse individuals and organizations in their quest to achieve excellence. This column dedicated to workplace excellence explores the organizational, interpersonal, and ethical issues that contribute to (or detract from) individual or organizational excellence within the physician assistant profession. If you have any workplace topics you would like to see covered in the JDPA please feel free to share them with us. Email editor@ jdpa.org with any topic ideas or questions concerning the workplace.

DERmatology pa news & notes

Like any broad characterization, my portrayal of “parents,” “students,” and “colleges/universities” is broad and doesn’t represent all, for sure. However, we at IEE see enough adversity-adverse people at every level of education and in every sector of the workplace that we believe this attribute is a significant barrier to optimal performance. Perhaps this helps explain why half of all students who get into college don’t graduate and why half of all marriages end in divorce. When the literal or figurative honeymoon is over and the hardships and hard work emerge, many bail out in search of an easier pathway.

The bottom line is that adversity is part of life; those who embrace and master it thrive; while those who don’t struggle - if not in the short-term, certainly in the long-term. Pain, suffering, and adversity are a core part of every major philosophy and religion and the main subject of literature and history. As the saying goes, “You can’t get out of it, so you better get into it.” In our work to promote optimal performance, we try to help those we serve understand what optimal performance indicators are and what best practices are when facing adversity. This book is a great resource for pursuing optimal performance around the inevitable hardships

48 Journal of Dermatology for Physician Assistants

and adversities that we will encounter. I especially recommend the chapter on “suffering well.” As Helen Keller famously said, “Character cannot be developed in ease and quiet. Only through experience of trial and suffering can the soul be strengthened, vision cleared, ambition inspired, and success achieved.” J Matthew L. Davidson, Ph.D. is the Founder, President, and Director of Education for the Institute for Excellence & Ethics (IEE), a 501(c)3 nonprofit corporation dedicated to helping individuals and organizations achieve excellence. He is a National Spokesperson for the Business Bureau National Center for Character Ethics.

The IEE specializes in the development and dissemination of research-based tools for developing the culture and competencies of excellence and ethics in schools, athletics, the workplace, and the home; this is done through professional development workshops & academies, teaching & learning resources, assessment, and consulting services. He is a frequent national presenter and is available for keynote lectures, professional development, retreats, and organizational consulting. He has indicated no relationships to disclose relating to the content of this article. For additional information or to contact the IEE, please visit www.excellenceandethics.org.

Now Showing on Dermcast.tv The Official Online Media Resource of the SDPA

Dermcast.tv is the official online media resource of the SDPA. We are very proud that Dermcast is the #1 iTunes Podcast in dermatology. Dermcast.tv is your source for audio podcasts, the most current dermatology news and research, procedural videos, conference highlights, and much, much more.

As members of the SDPA, everything on Dermcast.tv is not only tailored precisely for you and your needs, it is available to you FREE!

Link: http://bit.ly/1XezcKp Image: Pixabay / Pexels

Compulsive Skin-Picking Disorder: Is There Any Hope?

Results of a double-blind study showed that N-acetylcysteine was more effective than a placebo in reducing the urge to pick. "... Previous research on trichotillomania showed that N-acetylcysteine, a well-tolerated amino acid available without prescription, may increase extracellular levels of glutamate in the nucleus accumbens. Restoring the extracellular glutamate concentration in the nucleus accumbens is thought to then block the need for compulsive behavior..."

Is Oral Fluconazole To Blame for Miscarriages? FDA Issues a Safety Alert The FDA has issued a safety briefing that advises cautious prescribing of oral fluconazole in pregnancy until the results of a Danish study and additional data can be evaluated.

Link: http://bit.ly/1q3wCd4

"... a recent nationwide cohort study conducted in Denmark found that women who took oral fluconazole had a significantly increased risk of miscarriage..."

Unwanted Hair: Patient vs. Clinician Perception Image: Wikimedia Commons / Charles Eisenmann

Link: http://bit.ly/1YcxM3K

A recent study published in JAMA Dermatology sought to determine whether patients’ quality of life may be a more relevant factor in determining treatment plans than the degree or clinical severity of hirsutism. The study looked at the correspondence between clinician ratings and self-ratings of degree of hirsutism, and evaluated the extent to which degree of hirsutism is associated with hirsutism-related quality of life and risk for depression. "... previous studies have shown that patient self-ratings of hirsutism were generally higher than clinician ratings, thus the degree of hirsutism appears to depend on whether a clinician or the patient measures it...."

Image: WikiMedia Commons / Patrick Fitzgerald

Using Mirconeedles and Lasers to Treat Stretch Marks A combination of FMR and CO2 lasers produced a clinical improvement that was better than either treatment alone.

Link: http://bit.ly/1PvoJnk

"... in a Korean study of patients with skin type IV, a combination of FMR and fractionated CO2 lasers produced a clinical improvement that was better than either treatment alone..." J Volume 10 • number 3 • SUMMER 2016 49

DERmatology pa news & notes

Image: Wikipedia

From the Desk of...

Renata M. Block, MMS, PA-C SDPA Constituent Relations Committee Chair Diplomate SDPA

DERmatology pa news & notes

The SDPA 14th Annual Fall Dermatology Conference It is time for the SDPA to visit Las Vegas, Nevada this year where, "What happens in Vegas, stays in Vegas" will be put to rest again November 3rd - 6th.

I thought I could share some insights with you in regards to the dermatology PAs who practice in Nevada and encourage more participation in this SDPA State Affiliate.

Nevada does have an SDPA State Affiliate and we would love for one of you to represent your state at the conference. For those of you who are attending the Fall conference and would like to be involved, please reach out to me at rblock@dermpa. org for more information and details. In 2015 there were twenty dermatology PAs practicing within the state of Nevada who are SDPA members, and the number now is at forty-four! That is an amazing amount of growth and I know the number of members will continue to rise as the demand for dermatology PAs grows even more. The SDPA encourages PAs in all states to establish an SDPA State Affiliate chapter or to become an SDPA State Liaison. For the dermatology PAs working in Nevada, the benefits of participating in the Nevada SDPA State Affiliate include influencing the passage of appropriate state laws concerning PA practice, the chance to be members of a strong networking body, and the opportunity to have a strong voice for their profession within their state.

The AAPA does have a Nevada State Affiliate and encourages Nevada dermatology PAs to be active in and network with the Nevada Academy of Physician Assistants (NAPA). Last year, the NAPA was aggressively lobbying to protect the PA profession in Carson City to fight against a recently 50 Journal of Dermatology for Physician Assistants

proposed NV SB116 BDR 54-260 (Bill Draft Request) submitted in this city to restrict PA practice by revising provisions governing PAs. This bill failed to pass, did not progress to legislature, and died in committee due to the hard work of PAs within the state. It is important that dermatology PAs play an integral part in these significant legislative decisions, and this is why we need you!

The SDPA Constituent Relations Committee is encouraging PAs in Nevada and other states to keep your SDPA State Affiliate active, start an SDPA State Affiliate, or become an SDPA State Liaison.

There will be a meeting at the SDPA 14th Annual Fall Dermatology Conference for those interested in reactivating or forming an SDPA State Affiliate or becoming an SDPA State Liaison. If you are not able to make the meeting please contact me at rblock@ dermpa.org with any questions. For PAs in Nevada, please visit the NAPA website at www.nevadapa. com to show your support and learn more about what you can do to make a difference. J The SDPA currently has 17 State Affiliate chapters and 3 State Liaisons. We continue to grow and would love to have all 50 states participating! It takes teamwork and a strong commitment. For anyone who is interested in starting an SDPA State Affiliate chapter or if you have a state chapter and need some advice about becoming affiliated with the SDPA, please contact me at rblock@dermpa. org. I am here to help you!

Supervising Physician CORNER Choosing Wisely The American Academy of Dermatology Helps to Create List of Ten Things Dermatology Providers and Patients Should Question

Additionally, baseline blood tests and radiographic studies (e.g., chest radiographs, CT scans, and PET scans) are not the most accurate tests for the detection of cancer that is spreading as they have high false-positive rates.

These tests have only shown benefit when performed as indicated for suspicious signs and symptoms based on the patient’s history and physical exam.3-5 The American Board of Internal Medicine (ABIM) Foundation's Choosing Wisely® campaign is focused on encouraging clinicians and patients to talk about medical tests and procedures that may be unnecessary, and, in some instances, can cause harm. To join, a medical society must provide expert guidance on five medical tests or treatments commonly used in its field.

The American Academy of Dermatology (AAD) has identified ten recommendations that can support conversations between patients and dermatology providers about treatments, tests, and procedures that may not be needed.

1. Don’t prescribe oral antifungal therapy for suspected nail fungus without confirmation of fungal infection. Approximately half of nails with suspected fungus do not have a fungal infection. As other nail conditions, such as nail dystrophies, may look similar in appearance, it is important to ensure accurate diagnosis of nail disease before beginning treatment.

By confirming a fungal infection, patients are not inappropriately at risk for the side effects of antifungal therapy, and nail disease is correctly treated.1,2 2. Don’t perform sentinel lymph node biopsy or other diagnostic tests for the evaluation of early, thin melanoma because they do not improve survival.

Patients with early, thin melanoma, such as melanoma in situ, T1a melanoma or T1b melanoma ≤ 0.5mm,

3. Don’t treat uncomplicated, nonmelanoma skin cancer less than 1 centimeter in size on the trunk and extremities with Mohs micrographic surgery.

In healthy individuals, the use of Mohs micrographic surgery for low-risk small (< 1cm), superficial or nonaggressive (based on appearance under a microscope) squamous cell carcinomas and basal cell carcinomas is inappropriate for skin cancers on the trunk and extremities. In these areas of the body, the clinical benefits of this specialized surgical procedure do not exceed the potential risks. It is important to note that Mohs micrographic surgery may be considered for skin cancers appearing on the hands, feet, ankles, shins, nipples or genitals, as they have been shown to have a higher risk for recurrence or require additional surgical considerations.6,7 4. Don’t use oral antibiotics for treatment of atopic dermatitis unless there is clinical evidence of infection. The presence of high numbers of the Staphylococcus aureus (Staph) bacteria on the skin of children and adults with atopic dermatitis (AD) is quite common. While it is widely believed that Staph bacteria may play a role in causing skin inflammation, the routine use of oral antibiotic therapy to decrease the amount of bacteria on the skin has not been definitively shown to reduce the signs, symptoms (e.g., redness, itch) or severity of atopic dermatitis. In addition, if oral antibiotics are used when there is not an infection, it may lead to the development of antibiotic resistance.

Volume 10 • number 3 • SUMMER 2016 51

DERmatology pa news & notes

have a very low risk of the cancer spreading to the lymph nodes or other parts in the body. Further, patients with early, thin melanoma have a 97 percent five-year survival rate, which also indicates a low risk of the cancer spreading to other parts of the body. As such, the performance of sentinel lymph node biopsy is unnecessary.3-5

DERmatology pa news & notes

The use of oral antibiotics also can cause side effects, including hypersensitivity reactions (exaggerated immune responses, such as allergic reactions). Although it can be difficult to determine the presence of a skin infection in atopic dermatitis patients, oral antibiotics should only be used to treat patients with evidence of bacterial infection in conjunction with other standard and appropriate treatments for atopic dermatitis.8 5. Don’t routinely use topical antibiotics on a surgical wound. The use of topical antibiotics on clean surgical wounds has not been shown to reduce the rate of infection compared to the use of nonantibiotic ointment or no ointment. Topical antibiotics can aggravate open wounds, hindering the normal wound healing process.

When topical antibiotics are used in this setting, there is a significant risk of developing contact dermatitis, a condition in which the skin becomes red, sore, or inflamed after direct contact with a substance, along with the potential for developing antibiotic resistance.

Only wounds that show symptoms of infection should receive appropriate antibiotic treatment.9,10 6. Don’t use systemic (oral or injected) corticosteroids as a long-term treatment for dermatitis. The potential complications of long-term treatment with oral or injected corticosteroids outweigh the potential benefits.

Although the short-term use of systemic corticosteroids is sometimes appropriate to provide relief of severe symptoms, long-term treatment could cause serious short- and long-term adverse effects in both children and adults. In extreme cases that have failed to respond to other appropriate treatments, the benefits of systemic corticosteroids must be weighed against these potentially serious risks.11-14 7. Don’t use skin prick tests or blood tests such as the radioallergosorbent test (RAST) for the routine evaluation of eczema. Skin prick tests or blood tests may help identify the causes of allergic reactions, including hives or sneezing after exposure to dust or pollen. However, these tests are not useful for diagnosing dermatitis or eczema. When testing for suspected allergies is deemed necessary in patients with these rashes, it is better to conduct patch testing with ingredients of products that come in contact with the patient’s skin.15,16 8. Don’t routinely use microbiologic testing in the evaluation and management of acne. Bacteria are only one of several factors that contribute to acne. Microbiologic testing, used to determine the type of bacteria present in an acne lesion, is generally unnecessary because it does not affect the management of typical acne patients. Microbiologic testing should be considered only when acne has failed to respond to conventional treatments, particularly in patients who have already been treated with oral antibiotics.17-22 52 Journal of Dermatology for Physician Assistants

9. Don’t routinely use antibiotics to treat bilateral swelling and redness of the lower leg unless there is clear evidence of infection. Research has suggested that bilateral lower leg cellulitis is very rare. Patients with swelling and redness of both legs most likely have another condition, such as dermatitis resulting from leg swelling, varicose veins or contact allergies. To ensure appropriate treatment, doctors must consider the likelihood of diagnoses other than cellulitis when evaluating swelling and redness of the lower legs.

Misdiagnosis of bilateral cellulitis can lead to overuse of antibiotics and subject patients to potentially unnecessary hospital stays.23-30 10. Don’t routinely prescribe antibiotics for inflamed epidermal cysts. The overwhelming majority of red and swollen epidermal cysts (ECs) are inflamed but not infected. It is important to confirm infection before treating these cysts with antibiotics. Appropriate treatments for inflamed ECs include incision and drainage or an injection of corticosteroid directly into the cyst.31,32 To date, nearly 100 national and state medical specialty societies, regional health collaboratives, and consumer partners have joined the conversations about appropriate care. With the release of these lists, the campaign will have covered more than 400 tests and procedures that the specialty society partners say are overused and inappropriate, and that clinicians and patients should discuss. For more information on the campaign, visit www.

ChoosingWisely.org.

The AAD’s Choosing Wisely® list was selected by the AAD’s Choosing Wisely® workgroup, who identified areas with the greatest potential for overuse/misuse, a need for quality improvement, and the availability of strong evidence-based research to support the recommendation. The final list was reviewed and approved by the AAD’s Council on Science and Research and the AAD’s Board of Directors. Released October 29, 2013 (1-5) and August 19, 2015 (6-10).

Choosing Wisely recommendations should not be used to establish coverage decisions or exclusions. Rather, they are meant to spur conversation about what is appropriate and necessary treatment. As each patient situation is unique, providers and patients should use the recommendations as guidelines to determine an appropriate treatment plan together. These items are provided solely for informational purposes and are not intended as a substitute for consultation with a medical professional. Patients with any specific questions about the items on this list or their individual situation should consult their physician.

C, Kraft M, Levy BD, Lieberman P, Luccioli S, McCall KM, Schneider LC, Simon RA, Simons FE, Teach SJ, Yawn BP, Schwaninger JM. Guidelines for the diagnosis and management of food allergy in the United States: report of the NIAID-sponsored expert panel. J Allergy Clin Immunol. 2010 Dec;126(6 Suppl):S1-58.

17. Strauss JS, Krowchuk DP, Leyden JJ, Lucky AW, Shalita AR, Siegfried EC, Thiboutot DM, Van Voorhees AS, Beutner KA, Sieck CK, Bhushan R; American Academy of Dermatology/American Academy of Dermatology Association. Guidelines of care for acne vulgaris management. J Am Acad Dermatol. 2007 Apr;56(4):651-63.

18. Zaenglein AL, et al. Guidelines of care for acne vulgaris management. J Am Acad Dermatol;(in press).

19. Cove JH, Cunliffe WJ, Holland KT. Acne vulgaris: is the bacterial population size significant? Br J Dermatol. 1980 Mar;102(3):277-80.

20. Shaheen B, Gonzalez M. A microbial aetiology of acne: what is the evidence? Br J Dermatol. 2011 Sep;165(3):474-85.

21. Miura Y, Ishige I, Soejima N, Suzuki Y, Uchida K, Kawana S, Eishi Y. Quantitative PCR of Propionibacterium acnes DNA in samples aspirated from sebaceous follicles on the normal skin of subjects with or without acne. J Med Dent Sci. 2010 Mar;57(1):65-74.

22. Tochio T, Tanaka H, Nakata S, Ikeno H. Accumulation of lipid peroxide in the content of comedones may be involved in the progression of comedogenesis and inflammatory changes in comedones. J Cosmet Dermatol. 2009 Jun;8(2):152-8.

23. Arakaki RY, Strazzula L, Woo E, Kroshinsky D. The impact of dermatology consultation on diagnostic accuracy and antibiotic use among patients with suspected cellulitis seen at outpatient internal medicine offices: a randomized clinical trial. JAMA Dermatol. 2014 Oct;150(10):1056-61.

24. Hughey LC. The impact dermatologists can have on misdiagnosis of cellulitis and overuse of antibiotics: closing the gap. JAMA Dermatol. 2014 Oct;150(10):1061-2.

25. Hepburn MJ, Dooley DP, Ellis MW. Alternative diagnoses that often mimic cellulitis.

Am Fam Physician. 2003 Jun 15;67(12):2471.

26. David CV, Chira S, Eells SJ, Ladrigan M, Papier A, Miller LG, Craft N. Diagnostic accuracy in patients admitted to hospitals with cellulitis. Dermatol Online J. 2011 Mar 15;17(3):1.

27. Levell NJ, Wingfield CG, Garioch JJ. Severe lower limb cellulitis is best diagnosed by dermatologists and managed with shared care between primary and secondary care. Br J Dermatol. 2011 Jun;164(6):1326-8.

28. Kroshinsky D, Grossman ME, Fox LP. Approach to the patient with presumed cellulitis. Semin Cutan Med Surg. 2007 Sep;26(3):168-78.

29. Hirschmann JV, Raugi GJ. Lower limb cellulitis and its mimics: part I. Lower limb cellulitis. J Am Acad Dermatol. 2012 Aug;67(2):163.e1-12; quiz 175-6.

30. Hirschmann JV, Raugi GJ. Lower limb cellulitis and its mimics: part II. Conditions that simulate lower limb cellulitis. J Am Acad Dermatol. 2012 Aug;67(2):177.e1-9; quiz 185-6.

31. Liu C, Bayer A, Cosgrove SE, Daum RS, Fridkin SK, Gorwitz RJ, Kaplan SL, Karchmer AW, Levine DP, Murray BE, J Rybak M, Talan DA, Chambers HF; Infectious Diseases Society of America. Clinical practice guidelines by the Infectious Diseases Society of America for the treatment of methicillin-resistant Staphylococcus aureus infections in adults and children. Clin Infect Dis. 2011 Feb 1;52(3):e18-55.

32. Diven DG, Dozier SE, Meyer DJ, Smith EB. Bacteriology of inflamed and uninflamed epidermal inclusion cysts. Arch Dermatol. 1998 Jan;134(1):49-51.

Volume 10 • number 3 • SUMMER 2016 53

DERmatology pa news & notes

REFERENCES: 1. Ameen M, Lear JT, Madan V, Mohd Mustapa MF, Richardson M. British Association of Dermatologists’ guidelines for the management of onychomycosis 2014. Br J Dermatol. 2014 Nov;171:937-58.

2. Mehregan DR, Gee SL. The cost effectiveness of testing for onychomycosis versus empiric treatment of onychodystrophies with oral antifungal agents. Cutis. 1999 Dec;64(6):407–10.

3. Bichakjian CK, Halpern AC, Johnson TM, Foote Hood A, Grichnik JM, Swetter SM, Tsao H, Barbosa VH, Chuang TY, Duvic M, Ho VC, Sober AJ, Beutner KR, Bhushan R, Smith Begolka W; American Academy of Dermatology. Guidelines of care for the management of primary cutaneous melanoma. American Academy of Dermatology. J Am Acad Dermatol. 2011 Nov;65(5):1032–47.

4. American Joint Committee on Cancer. AJCC cancer staging manual. 7th ed. New York: Springer; 2010.

5. National Comprehensive Cancer Network. National Comprehensive Cancer Network clinical practice guidelines in oncology (NCCN Guidelines®): melanoma. (Version 3.2015).

6. Connolly SM, Baker DR, Coldiron BM, Fazio MJ, Storrs PA, Vidimos AT, Zalla MJ, Brewer JD, Smith Begolka W; Ratings Panel, Berger TG, Bigby M, Bolognia JL, Brodland DG, Collins S, Cronin TA Jr, Dahl MV, Grant-Kels JM, Hanke CW, Hruza GJ, James WD, Lober CW, McBurney EI, Norton SA, Roenigk RK, Wheeland RG, Wisco OJ. AAD/ACMS/ASDSA/ASMS 2012 appropriate use criteria for Mohs micrographic surgery: a report of the American Academy of Dermatology, American College of Mohs Surgery, American Society for Dermatologic Surgery Association, and the American Society for Mohs Surgery. J Am Acad Dermatol. 2012 67(4):531–50.

7. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Basal cell and Squamous Cell Skin Cancers. (Version 1.2015).

8. Bath-Hextall JF, Birnie AJ, Ravenscroft JC, Williams JC. Interventions to reduce Staphylococcus aureus in the management of atopic eczema: an updated Cochrane review. Br J Dermatol. 2010; 163:12–26.

9. Sheth VM, Weitzul S. Postoperative topical antimicrobial use. Dermatitis. 2008 JulAug;19(4):181-9.

10. Saco M, Howe N, Nathoo R, Cherpelis B. Topical antibiotic prophylaxis for prevention of surgical wound infections from dermatologic procedures: a systematic review and meta-analysis. J Dermatolog Treat. 2014 Apr 8:1-8.

11. Sidbury R, Davis DM, Cohen DE, Cordoro KM, Berger TG, Bergman JN, Chamlin SL, Cooper KD, Feldman SR, Hanifin JM, Krol A, Margolis DJ, Paller AS, Schwarzenberger K, Silverman RA, Simpson EL, Tom WL, Williams HC, Elmets CA, Block J, Harrod CG, Begolka WS, Eichenfield LF; American Academy of Dermatology. Guidelines of care for the management of atopic dermatitis: section 3. Management and treatment with phototherapy and systemic agents. J Am Acad Dermatol. 2014 Aug;71(2):327-49.

12. Diepgen TL, Andersen KE, Chosidow O, Coenraads PJ, Elsner P, English J, Fartasch M, Gimenez-Arnau A, Nixon R, Sasseville D, Agner T. Guidelines for diagnosis, prevention and treatment of hand eczema. J Dtsch Dermatol Ges. 2015 Jan;13(1):e1-22.

13. Usatine RP, Riojas M. Diagnosis and management of contact dermatitis. Am Fam Physician. 2010 Aug 1;82(3):249-55.

14. Krejci-Manwaring J, McCarty MA, Camacho F, Manuel J, Hartle J, Fleischer A Jr, Feldman SR. Topical tacrolimus 0.1% improves symptoms of hand dermatitis in patients treated with a prednisone taper. J Drugs Dermatol. 2008 Jul;7(7):643-6.

15. Sidbury R, Tom WL, Bergman JN, Cooper KD, Silverman RA, Berger TG, Chamlin SL, Cohen DE, Cordoro KM, Davis DM, Feldman SR, Hanifin JM, Krol A, Margolis DJ, Paller AS, Schwarzenberger K, Simpson EL, Williams HC, Elmets CA, Block J, Harrod CG, Smith Begolka W, Eichenfield LF. Guidelines of care for the management of atopic dermatitis: Section 4. Prevention of disease flares and use of adjunctive therapies and approaches. J Am Acad Dermatol. 2014 Dec;71(6):1218-33.

16. NIAID-Sponsored Expert Panel, Boyce JA, Assa’ad A, Burks AW, Jones SM, Sampson HA, Wood RA, Plaut M, Cooper SF, Fenton MJ, Arshad SH, Bahna SL, Beck LA, Byrd-Bredbenner C, Camargo CA Jr, Eichenfield L, Furuta GT, Hanifin JM, Jones

Professional Opportunities and Development

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DEFENSE

Prevent. Detect. Live.

Skin cancer is the most diagnosed cancer in the United States. Your best defense is to prevent skin cancer by seeking shade, covering up, and wearing sunscreen.

www.SpotSkinCancer.org © 2012 American Academy of Dermatology. Use of this poster does not imply product or service endorsement by the American Academy of Dermatology.

54 Journal of Dermatology for Physician Assistants

BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION

Neuromuscular Blocking Agents

This Brief Summary does not include all the information needed to use ONEXTON Gel safely and effectively. See full prescribing information for ONEXTON Gel.

Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. ONEXTON Gel should be used with caution in patients receiving such agents.

ONEXTON™ (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/3.75%, for topical use Initial U.S. Approval: 2000 CONTRAINDICATIONS Hypersensitivity ONEXTON Gel is contraindicated in those individuals who have shown hypersensitivity to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin.

Anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in postmarketing use with ONEXTON Gel [see Adverse Reactions] Colitis/Enteritis ONEXTON Gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis [see Warnings and Precautions] WARNINGS AND PRECAUTIONS Colitis/Enteritis Systemic absorption of clindamycin has been demonstrated following topical use of clindamycin. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin. If significant diarrhea occurs, ONEXTON Gel should be discontinued.

Severe colitis has occurred following oral and parenteral administration of clindamycin with an onset of up to several weeks following cessation of therapy.

Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen severe colitis. Severe colitis may result in death.

Studies indicate toxin(s) produced by Clostridia is one primary cause of antibiotic-associated colitis. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus. Stool cultures for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically.

Ultraviolet Light and Environmental Exposure Minimize sun exposure (including use of tanning beds or sun lamps) following drug application [see Nonclinical Toxicology].

ADVERSE REACTIONS The following adverse reaction is described in more detail in the Warnings and Precautions section of the label: Colitis [see Warnings and Precautions].

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

These adverse reactions occurred in less than 0.5% of subjects treated with ONEXTON Gel: burning sensation (0.4%); contact dermatitis (0.4%); pruritus (0.4%); and rash (0.4%).

During the clinical trial, subjects were assessed for local cutaneous signs and symptoms of erythema, scaling, itching, burning and stinging. Most local skin reactions either were the same as baseline or increased and peaked around week 4 and were near or improved from baseline levels by week 12. The percentage of subjects that had symptoms present before treatment (at baseline), during treatment, and the percent with symptoms present at week 12 are shown in Table 1.

Table 1: Local Skin Reactions - Percent of Subjects with Symptoms Present.

Results from the Phase 3 Trial of ONEXTON Gel 1.2%/3.75% (N = 243) Before Treatment (Baseline)

Maximum During Treatment

End of Treatment (Week 12)

Mild Mod.* Severe

Mild Mod.* Severe

Mild Mod.* Severe

Erythema

20

6

0

28

5

<1

15

2

0

Scaling

10

1

0

19

3

0

10

<1

0

Itching

14

3

<1

15

3

0

7

2

0

Burning

5

<1

<1

7

1

<1

3

<1

0

Stinging

5

<1

0

7

0

<1

3

0

<1

*Mod. = Moderate

Postmarketing Experience Because postmarketing adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Anaphylaxis, as well as allergic reactions leading to hospitalizations, has been reported in postmarketing use of products containing clindamycin phosphate/benzoyl peroxide.

DRUG INTERACTIONS Erythromycin Avoid using ONEXTON Gel in combination with topical or oral erythromycincontaining products due to its clindamycin component. In vitro studies have shown antagonism between erythromycin and clindamycin. The clinical significance of this in vitro antagonism is not known.

Concomitant Topical Medications Concomitant topical acne therapy should be used with caution since a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. If irritancy or dermatitis occurs, reduce frequency of application or temporarily interrupt treatment and resume once the irritation subsides. Treatment should be discontinued if the irritation persists.

USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women treated with ONEXTON Gel. ONEXTON Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Animal reproductive/developmental toxicity studies have not been conducted with ONEXTON Gel or benzoyl peroxide. Developmental toxicity studies of clindamycin performed in rats and mice using oral doses of up to 600 mg/kg/day (240 and 120 times amount of clindamycin in the highest recommended adult human dose based on mg/m2, respectively) or subcutaneous doses of up to 200 mg/kg/day (80 and 40 times the amount of clindamycin in the highest recommended adult human dose based on mg/m2, respectively) revealed no evidence of teratogenicity.

Nursing Mothers It is not known whether clindamycin is excreted in human milk after topical application of ONEXTON Gel. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to use ONEXTON Gel while nursing, taking into account the importance of the drug to the mother.

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

Geriatric Use Clinical trials of ONEXTON Gel did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects.

NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity, mutagenicity and impairment of fertility testing of ONEXTON Gel have not been performed.

Benzoyl peroxide has been shown to be a tumor promoter and progression agent in a number of animal studies. Benzoyl peroxide in acetone at doses of 5 and 10 mg administered topically twice per week for 20 weeks induced skin tumors in transgenic Tg.AC mice. The clinical significance of this is unknown.

Carcinogenicity studies have been conducted with a gel formulation containing 1% clindamycin and 5% benzoyl peroxide. In a 2-year dermal carcinogenicity study in mice, treatment with the gel formulation at doses of 900, 2700, and 15000 mg/kg/day (1.8, 5.4, and 30 times amount of clindamycin and 2.4, 7.2, and 40 times amount of benzoyl peroxide in the highest recommended adult human dose of 2.5 g ONEXTON Gel based on mg/m2, respectively) did not cause any increase in tumors. However, topical treatment with a different gel formulation containing 1% clindamycin and 5% benzoyl peroxide at doses of 100, 500, and 2000 mg/kg/day caused a dose-dependent increase in the incidence of keratoacanthoma at the treated skin site of male rats in a 2-year dermal carcinogenicity study in rats. In an oral (gavage) carcinogenicity study in rats, treatment with the gel formulation at doses of 300, 900 and 3000 mg/kg/day (1.2, 3.6, and 12 times amount of clindamycin and 1.6, 4.8, and 16 times amount of benzoyl peroxide in the highest recommended adult human dose of 2.5 g ONEXTON Gel based on mg/ m2, respectively) for up to 97 weeks did not cause any increase in tumors. In a 52-week dermal photocarcinogenicity study in hairless mice, (40 weeks of treatment followed by 12 weeks of observation), the median time to onset of skin tumor formation decreased and the number of tumors per mouse increased relative to controls following chronic concurrent topical administration of the higher concentration benzoyl peroxide formulation (5000 and 10000 mg/kg/day, 5 days/week) and exposure to ultraviolet radiation.

Clindamycin phosphate was not genotoxic in the human lymphocyte chromosome aberration assay. Benzoyl peroxide has been found to cause DNA strand breaks in a variety of mammalian cell types, to be mutagenic in S. typhimurium tests by some but not all investigators, and to cause sister chromatid exchanges in Chinese hamster ovary cells.

Fertility studies have not been performed with ONEXTON Gel or benzoyl peroxide, but fertility and mating ability have been studied with clindamycin. Fertility studies in rats treated orally with up to 300 mg/kg/day of clindamycin (approximately 120 times the amount of clindamycin in the highest recommended adult human dose of 2.5 g ONEXTON Gel, based on mg/m2) revealed no effects on fertility or mating ability.

PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information).

Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 Manufactured by: Contract Pharmaceuticals Limited Mississauga, Ontario, Canada L5N 6L6 U.S. Patents 5,733,886 and 8,288,434 Issued 11/2014 9389300 ONX.0088.USA.16

Volume 10 • number 3 • SUMMER 2016 55

l e G N e” O T X c E a F N r O ou GE Y w “Sho ALLEN t of CH men y reat mator t y l i -da flam Once onal & in ons ed lesi e n com c a

INSTANT SAVINGS OFFER*

INDICATION

ONEXTON (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/3.75% is indicated for the topical treatment of acne vulgaris in patients 12 years of age or older.

IMPORTANT SAFETY INFORMATION

• ONEXTON Gel is contraindicated in patients with a known hypersensitivity to clindamycin, benzoyl peroxide, any component of the formulation, or lincomycin.

• ONEXTON Gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.

• Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin.

ONEXTON Gel should be discontinued if significant diarrhea occurs.

• Orally and parenterally administered clindamycin has been associated with severe colitis, which may result in death.

• Anaphylaxis, as well as other allergic reactions leading to hospitalizations, has been reported in postmarketing use of products containing

•

• •

• •

Visit Onexton.com for savings offers

clindamycin/benzoyl peroxide. If a patient develops symptoms of an allergic reaction such as swelling and shortness of breath, they should be instructed to discontinue use and contact a physician immediately.

The most common local adverse reactions experienced by patients in clinical trials were mild and moderate erythema, scaling, itching, burning and stinging.

ONEXTON Gel should not be used in combination with erythromycin-containing products because of its clindamycin component.

ONEXTON Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. A decision should be made whether to use ONEXTON Gel while nursing, taking into account the importance of the drug to the mother.

Patients should be advised to avoid contact with the eyes or mucous membranes.

Patients should minimize exposure to natural and avoid artificial sunlight (tanning beds or UVA/B treatment) while using ONEXTON Gel. To minimize exposure to sunlight, protective clothing should be worn and a sunscreen with SPF 15 rating or higher should be used.

*This offer is only valid for patients with commercial insurance. Eligible uninsured patients will pay more. This offer is not valid for any person eligible for reimbursement of prescriptions, in whole or in part, by any federal, state, or other governmental programs, including, but not limited to, Medicare (including Medicare Advantage and Part A, B, and D plans), Medicaid, TRICARE, Veterans Administration or Department of Defense health coverage, CHAMPUS, the Puerto Rico Government Health Insurance Plan, or any other federal or state health care programs. This offer is good only in the U.S. at retail pharmacies owned and operated by Walgreen Co. (or its affiliates) or other participating independent retail pharmacies. This offer is not valid in Massachusetts or Minnesota or where otherwise prohibited, taxed or otherwise restricted. Visit www.valeantaccessprogram.com for full terms and conditions.

Please see Brief Summary of full Prescribing Information on the following page. ® /TMs are trademarks of Valeant Pharmaceuticals International, Inc. or its affiliates. All other product or brand names are trademarks of their respective owners. © 2016 Valeant Pharmaceuticals North America LLC. ONX.0075.USA.16 Printed in USA.

56 Journal of Dermatology for Physician Assistants