JDPA Spring 2016

DPA J

V o l u m e 1 0 • n u m b e r 2 • S P R I N G 2 0 1 6 • www.jdpa.org

Journal of Dermatology for Physician Assistants

Dermatology PA News & Notes SDPA Student Corner 16 __________________________________

CLINIcal dermatology Dermatology Case Report

31

__________________________________

surgical dermatology Surgical Wisdom 34 _________________________________

cosmetic dermatology The Needle is the New Knife 36 __________________________________

professional development Notes from your Office Manager

40

›› Earn CME credit with this issue CME Clinical Research Trials in Dermatology – More Than Skin Deep - Part II

20

Official Journal of the Society of Dermatology Physician Assistants

Volume 10 • number 2 • SPRING 2016

1

80 mg/mL

NOW AVAILABLE. Taltz is the newest interleukin-17A (IL-17A) inhibitor* indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. *The relationship between the mechanism of action and clinical outcomes has not been determined.

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 PASI 90 PASI 100 vs 2 %

vs 1%

Taltz 80 mg every 2 weeks (n=351)

vs 1%

83%

achieved clear skin or minimal psoriasis (sPGA 0,1)

vs 2 %

Placebo (n=168)

ADDITIONAL RESULTS

In Trial 1 (Taltz n=433, placebo n=431) and Trial 3 (Taltz n=385, placebo n=193), Taltz patients achieved similar results (89% and 87% achieved PASI 75 vs 4% and 7% for placebo; 71% and 68% achieved PASI 90 vs 1% and 3% for placebo; 35% and 38% achieved PASI 100 vs 0% and 0% for placebo; 82% and 81% achieved sPGA 0,1 vs 3% and 7% for placebo).

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.

Visit taltz.com to get patients started 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.

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

IX HCP ISI 22MAR2016

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.

Taltz® is a registered trademark of Eli Lilly and Company. PP-IX-US-0154 03/2016 ©2016, LILLY USA, LLC. ALL RIGHTS RESERVED.

Volume 10 • number 2 • SPRING 2016

3

T:7.5”

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

T:7.5”

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

2015-16 SDPA Board of Directors PRESIDENT Matthew Brunner, MHS, PA-C PRESIDENT-ELECT Jennifer Conner, MPAS, PA-C IMMEDIATE PAST PRESIDENT Vicki Roberts, MPAS, PA-C VICE PRESIDENT Jacki Kment, MPAS, PA-C SECRETARY / TREASURER Joleen Volz, MPAS, PA-C DIRECTORS AT LARGE Jane Mast, PA-C Matt Dohlman, PA-C Gina Mangin, MPAS, PA-C Mark Hyde, 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 2, Spring 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.

THIS ISSUE IS SPONSORED BY

6

Journal of Dermatology for Physician Assistants

Editor’s Message

A

s many of us who work in dermatology know, we are often first hand witnesses to the devastating emotional effects that many dermatological conditions can have on our patients. Through out my years working as a PA I have learned to never trivialize even the smallest amounts of affected areas of skin as even they can make someone feel extremely self-conscious, depressed, and/or anxious. When I have seen a case of a more aggressive form of skin disease (e.g., alopecia totalis or universalis), I immediately assume that the patient will need every bit of my emotional support to help him or her through its management. However, there are times when I am fortunate to be able to work with a patient who has been able to maintain emotional control in spite of his or her skin disease. Individuals who are able to do so have always left a lasting impression on me and on pretty much everyone else that they meet. The ability of these patients to show confidence in the face of adversity is a truly admirable quality.

When people meet Courtney Sayre for the first time their immediate impression is admiration and inspiration for her confidence in the face of such adversity. Courtney’s remarkable success in emotionally overcoming her alopecia is highlighted in this issue’s “From the Patient’s Perspective.” Courtney is mature beyond her years and has taken it upon herself to make the most out of every situation. She is interested in pursuing a career in medicine, and I have no doubt that her life experiences and how she has chosen to overcome such an obstacle with grace and poise will be a benefit for her in her future career. As she has done for myself and will do for our readers in this issue, I believe that this remarkable young woman will positively impact how we care for such patients. Courtney is a good reminder for us as health care providers that both a positive outlook and emotional stability are possible in the face of such troubling skin disease. J

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

Volume 10 • number 2 • SPRING 2016

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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.

20

Clinical Research Trials in Dermatology – More Than Skin Deep - Part II

By Sandra Morris, PA-C

›› CME 12 Derm PA News & Notes – part one • Certification Review • Student Corner – Call for SDPA Junior Student Coordinator Applicants • SDPA State Affiliates – The Texas Dermatology Physician Assistants

20 Clinical Dermatology • CME Article –Clinical Research Trials in Dermatology – More Than Skin Deep - Part II • Dermatology Case Report – Phytophotodermatitis – “Lime Burns”

Departments 06 Editorial Board 07 Editor’s Message 11 SDPA News & Current Affairs 12 Dermatology Market Watch 26 From The Patient’s Perspective 28 Clinical Snapshots 34 Surgical Wisdom 38 Cosmetic Pearls 40 Notes from your Office Manager 44 The Difference We Make 51 Camp Discovery 2016 54 Professional Opportunities and Development

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

36 Cosmetic Dermatology • The Needle is the New Knife: Advances in Dermal Fillers

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

44 Derm PA News & Notes – part two

Go Green & Read On the Go 8

Journal of Dermatology for Physician Assistants

• Workplace Excellence • Supervising Physician Corner – An Interview with Alan Rockoff, MD

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 2 • SPRING 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 JULY AAD Summer Meeting July 28 – 31, 2016 Boston, MA 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

Two years ago, the SDPA celebrated its’ 20th anniversary; our organization’s humble beginnings started in 1994 when a group of dermatology PAs met and shared a pizza during the AAD’s annual conference in New Orleans. We have come a long way in these last twenty-two years, but as you and I know, our profession continues to face an uphill battle for recognition from some of our physician colleagues, payers, and even other professional organizations. Just as those PA pioneers helped to start the SDPA, a new opportunity is presenting itself to our generation.

The SDPA has established a role for dermatology PAs in philanthropic endeavors since 2012 through our partnership with the Melanoma Research Foundation and annual Miles for Melanoma events. Recently, the SDPA’s leadership recognized the need for a separate foundation to serve as a supporting organization of the SDPA in order to address some of the unmet needs of our profession and the patients we serve. As a result, the Dermatology PA Foundation (DPAF) was incorporated in May of 2015. The DPAF held its very first Board of Trustees meeting in November 2015 during the SDPA’s 13th Annual Fall Dermatology Conference in Orlando.

This past March, the DPAF was granted tax-exempt status under section 501c(3) of the Internal Revenue Code and was classified as a public charity.

The mission statement of the DPAF reads as follows: ‘The Dermatology PA Foundation seeks to fund and promote education, research, and philanthropy to advance the field of dermatology.’ It is my belief that the mission of this new charity complements the PA profession’s best attributes.

• Education is at the heart of what we do as PAs whether we are educating the patients for whom we care or engaging in our commitment to lifelong learning.

• Research is one of the last frontiers of the PA profession as the potential of our profession here has yet to be actualized. It also correlates well to PAs commitment to practice evidence-based medicine. One of the DPAF’s early goals will be to provide funding for publishable research on how dermatology PAs change access to care and affect patient outcomes.

• Philanthropy is defined as the practice of giving time, talent, and treasure to improve the lives of other people. The SDPA recognizes the intrinsic desire of dermatology PAs to better the lives of the patients for whom we care.

Rarely in a lifetime does an opportunity present itself to be a part of history in the making. Just as those early pioneers of dermatology PAs met in New Orleans in 1994, the dermatology PAs of the future will one day look back on 2016 as a turning point in the dermatology PA profession.

As the SDPA launches the DPAF, we are excited to announce the establishment of a Chairman’s Founder Circle of giving. We are asking for our dermatology PA colleagues, corporate partners, and friends of SDPA to consider making a taxdeductible donation to the DPAF. We know everyone has different life circumstances that will allow giving at different levels and we have designed a donor program that will allow individuals to give monthly or annual payments. All first year donors who contribute to the DPAF at a Chairman’s Circle level will be recognized in the DPAF’s Founder’s Circle and will continue to be recognized as such at DPAF events and in publications as long as they give on an annual basis at a Chairman’s Circle level. We are excited to announce our website is now active so you can learn more about DPAF, read about our Chairman’s Circle, and make a commitment as a donor at www.dermPAfoundation.org.

It is my sincere hope you will take the time today to explore our new website and make a commitment to be a part of this exciting new foundation that will benefit the lives of dermatology patients and expand the reach of the dermatology PA profession. History is ready to be made! J

Matthew Brunner, MHS, PA-C SDPA President, Diplomate

Volume 10 • number 2 • SPRING 2016 11

Dermatology PA news & notes

Dermatology Market Watch Approval for Sernivo™ Dr. Reddy’s has announced that its US subsidiary, Promius PharmaTM, LLC, U.S. has received approval for Sernivo™ (betamethasone dipropionate) Spray, 0.05% from the U.S. Food and Drug Administration (FDA). Sernivo Spray, a prescription topical steroid, is indicated for the treatment of mild to moderate plaque psoriasis in patients eighteen years of age or older.

and efficacy of Sernivo Spray. In both trials, randomized subjects applied Sernivo Spray or vehicle spray to the affected areas twice daily for twenty-eight days. Enrolled subjects had body surface area of involvement between 10% to 20%, and an Investigator Global Assessment (IGA) score of 3 (moderate). Efficacy was assessed as the proportion of subjects who were considered a treatment success (defined as having an IGA score of 0 or 1 [clear or almost clear] and at least a 2-scale reduction from baseline).

Treatment success was achieved in significantly more subjects using Sernivo than Vehicle at both Day 15 and Day 29 across both studies. At Day 29 in Studies 1 and 2, Sernivo achieved treatment success of 42.7% and 34.5% compared to vehicle success rates of 11.7% and 13.6%, respectively (p<0.001). J

Promius has conducted two successful multi-center, randomized, doubleblind, vehicle-controlled clinical trials in subjects aged eighteen years and older with moderate plaque psoriasis to evaluate the safety

30 Years of Free Skin Cancer Screenings Indoor Tanning Youth Access Laws

WASHINGTON

NEW HAMPSHIRE (U14)

Effective 6/12/2014

MONTANA

IDAHO

IOWA

NEBRASKA

NEVADA UTAH

• Detected 256,329 suspected skin cancer lesions • Detected 28,822 suspected melanomas The AAD is constantly working with state dermatology societies and state legislatures to introduce and support laws and regulations that protect consumers and promote awareness about skin cancer prevention and the dangers of indoor tanning. As a result, 42 states have enacted tanning bed restrictions to potentially reduce the risk of melanoma and other forms of skin cancer.

The map shows states with indoor tanning youth access laws. J 12 Journal of Dermatology for Physician Assistants

ILLINOIS COLORADO

CALIFORNIA

KANSAS

MISSOURI

INDIANA (U16)

NEW MEXICO

OKLAHOMA

7/5/2014

W.VA. (U14) VIRGINIA

R.I. CONN. (U17) NEW JERSEY (U17) DELAWARE (U14) MARYLAND D.C. (U14)

N. CAROLINA (U14) S. CA.

ARKANSAS

MISS.

ALASKA

OHIO

KENTUCKY TENNESSEE

ARIZONA

PENNSYLVANIA (U17) - Effective

Effective 7/1/2014

MAINE (U14) MASS.

NEW YORK (U17)

WISCONSIN (U16)

SOUTH DAKOTA WYOMING

• Conducted 2,572,846 screenings

MICHIGAN

8/1/2014

OREGON

The AAD's free skin cancer screening program (now known as the SPOTme® Skin Cancer Screening Program) is one of the most successful association-led public health programs in U.S. history. Since 1985, dermatology volunteers have:

VERMONT

NORTH DAKOTA MINNESOTA (U14) Effective

ALABAMA (U14) Effective 9/1/2014

GEORGIA (U14)

TEXAS FLA. HAWAII

LOUISIANA Effective 8/1/2014

Under 18 prohibited from indoor tanning

Parental consent and/or accompaniment required for indoor tanning

Under 17, 16 or 14 prohibited from indoor tanning

No indoor tanning restrictions for youth 14-662-DC

#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 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. Tell us what motivates you to make sure your skin is "Looking Good in 2016." #LookingGoodin2016

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 2 • SPRING 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

Certification Review

All Those Things Inside the Skin You Might Have Forgotten

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

EXPLANATION: This patient presents with the classic findings of achalasia. Achalasia presents with long-standing dysphagia to solids and liquids, incomplete relaxation of and elevated resting pressure of the lower esophageal sphincter. Barium swallow reveals a narrowing of the esophagogastric sphincter, the classic “bird’s beak” appearance. Achalasia is the loss of peristalsis in the distal esophagus. The pathophysiologic mechanism consists of

degeneration of neurons in the esophageal wall resulting in failure of lower esophageal sphincter relaxation.

Anatomic disruption of the gastroesophageal junction is associated with a hiatal hernia. Diffuse esophageal spasm is due to impairment of inhibitory innervation, secondary to malfunction in endogenous nitric oxide synthesis, causing premature and rapidly propagated contractions in the distal esophagus. Scleroderma is due to early neural dysfunction, secondary to vascular derangement or collagen deposits. Regional enteritis is secondary to immune-mediated inflammation. J The correct answer is D.

QUESTION: A 45-year-old male presents with a long history of heartburn. The patient states he has dysphagia to solids and occasionally liquids. Patient denies any weight loss. Physical examination is unremarkable. Manometry reveals incomplete relaxation of the lower esophageal sphincter and elevated resting lower esophageal sphincter pressure. Barium swallow shows a narrowing of the esophagogastric junction. Which of the following is the pathophysiologic mechanism of this patient’s most likely diagnosis?

A. Anatomic disruption of gastroesophageal junction B. Malfunction in endogenous nitric oxide synthesis C. Collagen deposits leading to neural dysfunction D. Degeneration of neurons in the esophageal wall E. Immune-mediated inflammation

James A. Van Rhee, MS, PA-C, is the Program Director for the Yale University School of Medicine Physician Associate Program. Mr. Van Rhee has been involved in physician assistant education for 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.

Write for the JDPA! Are you a PA who...

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JDPA Journal of Dermatology for Physician Assistants

Volume 10 • number 2 • SPRING 2016 15

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!

DERmatology pa news & notes

Student Corner Call for SDPA Junior Student Coordinator Applicants Here is your chance to become involved in the PA professional community. The SDPA is currently accepting applications for the Junior Student Coordinator position. The deadline is September 1st, 2016.

This position is a 2-year commitment. The selected applicant will spend his/her first year as Junior Student Coordinator (first year PA-S) and then advance to Senior Student Coordinator (second year PA-S).

Some of the responsibilities of the position include working closely with the student affairs committee chair, responding to emails from SDPA student members or committee chairs, brainstorming ideas on how to improve student membership benefits, updating articles with information pertaining to upcoming conferences or leadership opportunities for students, and continuing to facilitate the student involvement in the SDPA. Considering how busy PA school can be, the Junior Student Coordinator and Senior Student Coordinator will work together to ensure the proper balance of responsibilities.

Applicants interested in the Junior Student Coordinator position must be SDPA student members. Some of the benefits of becoming a SDPA student member include gaining access to the Journal of Dermatology for Physician Assistants (the official and peer reviewed journal of the SDPA), the job listings and resume posting services, as well as opportunities to become more involved in the leadership and direction of your chosen profession as PAs. The SDPA encourages everyone who is interested in dermatology to join as a student member for just $25, to receive all of the wonderful opportunities (join now at www.dermpa.org).

If you are interested in becoming involved in the SDPA as a Junior Student Coordinator please go to www. dermpa.org. From the homepage, hover over the Membership tab, click on “Students”, and under the section titled “How do I get involved in leadership?” select “Read more here” where you will find the application; you may then complete it by September 1st. If you have any questions, please contact Brittney Franley, PA-S, SDPA Student Affairs Committee Junior Student Coordinator at bfranley@dermpa.org. J Sincerely, Brittney Franley, PA-S2 SDPA Student Affairs Committee Junior Student Coordinator Maria Kelly, PA-S2 SDPA Student Affairs Committee Senior Student Coordinator Stephanie Palazzolo, MMS, PA-C SDPA Student Affairs Committee Recent Graduate Advisor 16 Journal of Dermatology for Physician Assistants

INDICATION & USAGE Desonate® (desonide) Gel 0.05% is indicated for the treatment of mild to moderate atopic dermatitis in patients 3 months of age and older.

Patients should be instructed to use Desonate® for the minimum amount of time as necessary to achieve the desired results because of the potential for Desonate® to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Treatment should not exceed 4 consecutive weeks.

Put the

squeeze

on atopic dermatitis.

4

Approved for use in patients with mild to moderate atopic dermatitis 3 months of age and older

4

$0 COPAY with unlimited fills*

4

No AB rated generic equivalent1

*Up to a maximum benefit of $200 per fill. Eligibility rules apply.

Actual product and sample tube shown. According to the Prescribing Information the Desonate® formulation ranges from translucent to opaque. Available by prescription only.

IMPORTANT SAFETY INFORMATION Desonate® is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Topical corticosteroids can produce reversible hypothalamic pituitary adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency, Cushing’s syndrome, hyperglycemia and unmasking of latent diabetes.

Systemic absorption may require periodic evaluation 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. 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 due to their larger skin surface-to-body mass ratios.

Unless directed by a physician, do not use on the underarm or groin area of children. Do not use to treat diaper dermatitis.

Use in children less than 3 months of age is not recommended.

Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include skin 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.

If concomitant skin infections are present or develop during treatment, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Desonate® should be discontinued until the infection is adequately controlled.

If irritation develops, Desonate® should be discontinued and appropriate therapy instituted.

The most common adverse reactions (incidence ≥ 1%) are headache, application site burning and rash.

Desonate® is for topical use only. Not for ophthalmic, oral or intravaginal use. As with other corticosteroids, therapy should be discontinued when control is achieved.

See Brief Summary of full Prescribing Information for Desonate® on next page.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

References: 1. US Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Active ingredient search results from “OB_Rx” table for query on “desonide.” http://www.accessdata.fda.gov/scripts/cder/ob/docs/ tempai.cfm. Accessed March 2015.

© 2015 Bayer HealthCare Pharmaceuticals Inc. Bayer, the Bayer Cross, Desonate and the Desonate logo are registered trademarks of Bayer. All rights reserved. PP-850-US-0166 | April 2015

Volume 10 • number 2 • SPRING 2016 17

DESONATE® (desonide) Gel 0.05% For Topical Use Only Rx Only BRIEF SUMMARY CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE Desonate is indicated for the treatment of mild to moderate atopic dermatitis in patients 3 months of age and older.

Patients should be instructed to use Desonate for the minimum amount of time as necessary to achieve the desired results because of the potential for Desonate to suppress the hypothalamic-pituitary-adrenal (HPA) axis [see Warnings and Precautions (5.1)].

Treatment should not exceed 4 consecutive weeks [see Dosage and Administration (2)].

4 CONTRAINDICATIONS Desonate is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

5 WARNINGS AND PRECAUTIONS 5.1 Effects on Endocrine System Systemic absorption of topical corticosteroids can produce reversible hypothalamicpituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid.

The effect of Desonate on HPA axis function was investigated in pediatric subjects, 6 months to 6 years old, with atopic dermatitis covering at least 35% of their body, who were treated with Desonate twice daily for 4 weeks. One of 37 subjects (3%) displayed adrenal suppression after 4 weeks of use, based on the cosyntropin stimulation test.

As follow-up evaluation of the subject’s adrenal axis was not performed, it is unknown whether the suppression was reversible [see Use In Specific Populations (8.4) and Clinical Pharmacology (12.2)].

Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of Desonate due to their larger skin surface-to-body mass ratios [see Use In Specific Populations (8.4)].

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 more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure.

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.

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 skin 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 Concomitant Skin Infections If concomitant skin infections are present or develop during treatment, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Desonate should be discontinued until the infection is adequately controlled.

5.4 Skin Irritation If irritation develops, Desonate should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

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

In controlled clinical studies of 425 Desonate-treated subjects and 157 Vehicle-treated subjects, adverse events occurred at the application site in 3% of subjects treated with Desonate and the incidence rate was not higher compared with vehicle-treated subjects.

The most common local adverse events in Desonate treated subjects were application site burning in 1% (4/425) and rash in 1% (3/425) followed by application site pruritus in <1% (2/425).

Adverse events that resulted in premature discontinuation of study drug in Desonate treated subjects were telangiectasia and worsening of atopic dermatitis in one subject each. Additional adverse events observed during clinical trials for patients treated with Desonate included headache in 2% (8/425) compared with 1% (2/157) in those treated with vehicle.

The following additional local adverse reactions have been reported infrequently with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, secondary infection, skin atrophy, striae, and miliaria.

18 Journal of Dermatology for Physician Assistants

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

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

No reproductive studies in animals have been performed with Desonate. Dermal embryofetal development studies were conducted in rats and rabbits with a desonide cream, 0.05% formulation. Topical doses of 0.2, 0.6, and 2.0 g cream/kg/day of a desonide cream, 0.05% formulation or 2.0 g/kg of the cream base were administered topically to pregnant rats (gestational days 6-15) and pregnant rabbits (gestational days 6-18). Maternal body weight loss was noted at all dose levels of the desonide cream, 0.05% formulation in rats and rabbits. Teratogenic effects characteristic of corticosteroids were noted in both species. The desonide cream, 0.05% formulation was teratogenic in rats at topical doses of 0.6 and 2.0 g cream/kg/day and in rabbits at a topical dose of 2.0 g cream/kg/day. No teratogenic effects were noted for the desonide cream, 0.05% formulation at a topical dose of 0.2 g cream/kg/day in rats and 0.6 g cream/kg/day in rabbits. These doses (0.2 g cream/kg/day and 0.6 g cream/kg/day) are similar to the maximum recommended human dose based on body surface area comparisons.

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 human milk. Because many drugs are excreted in human milk, caution should be exercised when Desonate is administered to a nursing woman.

8.4 Pediatric Use Safety and effectiveness of Desonate in pediatric patients less than 3 months of age have not been evaluated, and therefore its use in this age group is not recommended.

The effect of Desonate on HPA axis function was investigated in pediatric subjects, with atopic dermatitis covering at least 35% of their body, who were treated with Desonate twice daily for 4 weeks. One of 37 subjects (3%) displayed adrenal suppression after 4 weeks of use, based on the cosyntropin stimulation test [see Warnings and Precautions (5.1)].

In controlled clinical studies in subjects 3 months to 18 years of age, 425 subjects were treated with Desonate and 157 subjects were treated with vehicle [see Adverse Reactions (6) and Clinical Studies (14)].

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 when they are treated with topical corticosteroids. They are therefore also at greater risk of glucocorticosteroid insufficiency after withdrawal of treatment and of Cushing’s syndrome while on treatment.

Adverse effects, including striae, have been reported with inappropriate use of topical corticosteroids in infants and children. HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

8.5 Geriatric Use Clinical studies of Desonate did not include patients aged 65 and older to determine if they respond differently than younger patients. Treatment of this patient population should reflect the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

17 PATIENT COUNSELING INFORMATION Patients using topical corticosteroids should receive the following information and instructions: • This medication is to be used as directed by the physician. It is for external use only.

Avoid contact with the eyes.

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

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

• Unless directed by a physician, this medication should not be used on the underarm or groin areas of pediatric patients.

• Parents of pediatric patients should be advised not to use Desonate in the treatment of diaper dermatitis. Desonate should not be applied in the diaper area, as diapers or plastic pants may constitute occlusive dressing [see Dosage and Administration (2)].

• Patients should report to their physician any signs of local adverse reactions.

• Other corticosteroid-containing products should not be used with Desonate without first consulting with the physician.

• As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 4 weeks, contact the physician. © 2014, Bayer HealthCare Pharmaceuticals Inc. All rights reserved.

Manufactured for:

Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ 07981 Manufactured in Canada

6706906BS3 Rev. July 2014

SDPA State Affiliates

The Texas Dermatology Physician Assistants

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

RENATA - How many members are you in communication with and do you provide any networking opportunities within your state?

Santos San Antonio has thirteen members, Austin has thirty, and the Dallas area number is growing.

The first two local metropolitan representatives we have so far are from San Antonio and Dallas. Karen Adams is our Dallas TDPA representative and Courtney Aldridge is our San Antonio TDPA representative.

Our goal is to have one TDPA representative from each major city in Texas. We also look to recruit more representatives at the SDPA conferences, especially at the meeting in Austin this summer.

RENATA - What reason do you want a state chapter to get established?

Santos - In order to provide better networking opportunities within our state with the long-term goal of establishing CME for our members in the future.

RENATA - What key points are you planning in order to make your state chapter successful?

Santos - We plan on building a strong core of leaders that can establish and improve communication for dermatology PAs in Texas. I would like to have a main contact in every major city that will serve on our TDPA board.

RENATA - Do you have a Tax ID and are you registered as a not-for-profit organization?

Santos - We do not have a Tax ID yet and are currently not registering as a 501. We plan on

reconsidering these items once our organization is in better communication with each other and we have established goals.

RENATA - Why do you want to become an SDPA State Chapter Affiliate?

Santos - Texas is a large state with amazing opportunities for PAs to practice and excel. It would be great to be able to network and build a community in order to spread awareness and educate the public about our profession and our role working in dermatolgy.

RENATA - How can members contact you if they are interested in joining your State Affiliate chapter?

Do you have annual dues?

Santos – At this time there are no annual dues to join. We can be contacted at TXDermPAs@gmail. com. J The SDPA currently has 18 State Affiliate chapters. 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!

Volume 10 • number 2 • SPRING 2016 19

DERmatology pa news & notes

The SDPA held its Annual Summer Dermatology Conference in Austin, Texas this past June 1st-5th. As Texas was the host state for the event, I thought it would be a great opportunity to interview Selina Santos, PA-C, a member of the Texas Dermatology Physician Assistants (TDPA), to find out more information about this particular SDPA State Affiliate. We hope everyone enjoyed the conference in the “Lone Star State!”

Clinic al Dermatology

Clinical Research Trials in Dermatology – More Than Skin Deep - Part II

By Sandra Morris, PA-C

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

›› CME

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

Approval is valid for 1 year from the issue date of June 2016. Participants may submit the self-assessment 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:

1. Understand the paradigm shift in treating melanoma (and cancer in general) - from treating it directly to enhancing the patient’s immune response to the cancer.

2. Understand the purpose of the checkpoint pathway in T cell regulation and how melanoma cells utilize this pathway to enhance tumor growth.

3. Identify the differences between immunooncology and oncogene-targeted therapies currently available for the treatment of melanoma.

20 Journal of Dermatology for Physician Assistants

Clinical Research Trials in Dermatology – More Than Skin Deep - Part II

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 2 • SPRING 2016 21

Clinical Research Trials in Dermatology â&#x20AC;&#x201C; More Than Skin Deep - Part II

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

Clinical Research Trials in Dermatology – More Than Skin Deep - Part II

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 2 • SPRING 2016 23

Clinical Research Trials in Dermatology â&#x20AC;&#x201C; More Than Skin Deep - Part II

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

Clinical Research Trials in Dermatology – More Than Skin Deep - Part II

SDPA Members Only Content

J

Sandra Morris, PA-C completed her undergraduate degree in Medical Technology at the University of Southern Mississippi, a Master’s of Science degree in Microbiology and Immunology at the University of Tennessee, and a Master’s of Medical Science in Physician Assistant Studies at Emory University. She currently works at Newnan Dermatology. She has been involved in clinical trial research related to the development of systemic medications for psoriasis and psoriatic arthritis in conjunction with one of her supervising physicians, Dr. Mark Ling, who is owner of a dermatologic research company in Newnan, Georgia.

She is currently a member of the American Academy of Physician Assistants, Georgia Association of Physician Assistants, Society of Dermatology Physician Assistants, and Georgia Dermatology Physician Assistants. She has indicated no relationships to disclose relating to the content of this article.

Volume 10 • number 2 • SPRING 2016 25

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.

From The Patient’s Perspective My Life My Way, With or Without Hair

By Courtney Sayre

CLINIC AL Dermatology

Losing my hair helped me find myself - the most open minded, confident, and happy version of myself.

I found the “bald girl with a positive outlook on life” version of myself. This is the most profound self-revelation I have experienced thus far. For that reason I am grateful beyond words for the disease, which made me bald.

I am thankful for my alopecia totalis.

When the onset first began, however, my feelings were vastly different. My dermatologist informed me that there were treatment options. However, since alopecia is an autoimmune disorder, none of them were guaranteed to make my hair come back so I needn’t get my hopes up.

Ever willing to try, I began using two different topical medications, which proved to be unsuccessful. In desperation, we tried cortisone steroid shots. These were painful and also unsuccessful, so we discontinued use.

My alopecia was relatively aggressive, causing me to lose nearly all of my hair within a matter of months. I tried my best to remain positive, but the failed medications and decreasing amount of hair on my teenage-girl head were difficult to bear emotionally. Surely there were more treatment options, but something my dermatologist said when he first diagnosed me with alopecia stuck with me. He told me that my best bet was to embrace being bald. At the time, the suggestion was equally terrifying and ridiculous, but as I write this paper today I am contented to say that I have done just that.

Being a bald girl has influenced my life in the most humbling of ways. I am frequently asked if I have cancer, as my lack of hair makes me resemble someone who is receiving chemotherapy. After nearly two years of withstanding these misguided strangers’ questions I have grown to anticipate and accept them. They simply act as

“I am not terminally ill.

I am healthy, and I am happy.

That alone is reason for a peace of mind.”

The National Alopecia Areata Foundation (NAAF) supports research to find a cure or acceptable treatment for alopecia areata, supports those with the disease, and educates the public about alopecia areata.

Contact Information: www.naaf.org 14 Mitchell Boulevard San Rafael, CA 94903 Phone: (415) 472-3780 Fax: (415) 472-5343 E-mail: info@naaf.org 26 Journal of Dermatology for Physician Assistants

a reminder that I do not, in fact, have cancer. I am not terminally ill. I am healthy, and I am happy. That alone is reason for a peace of mind.

This disease has taught me to acknowledge the insignificance of things like hair or other superficial aspects of appearance, which our society has unfortunately placed so much emphasis on. It has challenged me to instead place my focus on the “bigger” things in life. I may not have hair, but I am healthy. I have the ability

I promised my dermatologist and myself that I would sustain a positive mindset no matter what happened because there are people out there who do have cancer or some other terrible illness. There are people struggling to stay alive. When I think about this, I am again made aware that in the grand scheme of things my life is good. I am thankful for the valuable lessons being bald have taught me, and the new perspectives I have gained. My growth is bigger than just my own personal

self-acceptance. It has changed the way I think about others, and has made me more accepting and openminded when considering the world at large. More than anything, however, it has provided me motivation to push myself to keep discovering who I truly am, and to live my life as the most exemplary, moral, and respectful person I possibly can be. I have my whole life ahead of me, and I am excited to see where it takes me, with or without hair. J Courtney Sayre lives in upstate NY with her parents, two sisters, and her cat Katie. She is a senior in High School where she actively participates in Character Education and SADD (Students Against Destructive Decisions). Courtney’s earlier years were spent riding and showing horses, participating in 4-H events, and playing lacrosse. She remains active in 4-H where she is a member of the Senior Advisory Board for her local county. Upon graduation, she intends to pursue a degree in Wellness Management in the Fall of 2016, where she will explore the numerous career paths within the medical field. Courtney is thankful for the accelerated insight on life values her alopecia has provided her and plans to make the most of them in her future, and the futures of those around her.

Take Home Points for Derm PAs:

By Steven K. Shama, MD, MPH, FAAD 1. There is a time and a place for clinicians such as Courtney’s dermatologist, when they are pretty sure that the worst is yet to come with alopecia areata, to say to a patient to “embrace being bald.” Recall that Courtney’s first response to her dermatolgist’s comment was “…terrifying and ridiculous…” However, at some point in a patient’s diagnosis of a chronic disease with little hope for cure, the clinician must be honest with the patient and in as compassionate a way suggest that the patient find the best, most uplifting message in their diagnosis. In fact, as Courtney writes, it was the best words her dermatologist could have told her. The message that Courtney received did not take away her hope, but set a realistic path

that would benefit both Courtney’s care and her life.

2. An unexpected benefit from the honesty of her dermatologist was that Courtney not only accepted her skin condition but set her on a path to deeply explore her own life and its meaning, and to see people with greater acceptance and open mindedness. None of us can ever know the exact “message” a diagnosis of a chronic disease brings to us, but why can’t we, as clinicians, respectfully and in a compassionate way suggest to our patients that their diagnosis may bring something positive into their lives and explore with them what this message might be. J

Volume 10 • number 2 • SPRING 2016 27

CLINIC AL Dermatology

to live my life and accomplish whatever I set my mind to do. I am who I am not because of my appearance, but because of the way I treat others and the way I choose to live my life.

I choose to love myself; I choose happiness.

But what choice is it, really? The way I look at it, I can either be miserable about the fact that I don’t have hair or choose to love both my life and myself unconditionally. For me, the choice is pretty easy.

Clinical snapshots A Solitary Purple Papule On The Arm

By Engin Şenel, BBA, MD and Yasemin Yuyucu Karabulut, 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.

CLINIC AL Dermatology

©Copyright 2014 Şenel et al.

©Copyright 2014 Şenel et al.

©Copyright 2014 Şenel et al.

Engin Şenel, BBA, MD is an assistant professor of dermatology at the Hitit UniversityFacultyofMedicine,DepartmentofDermatology,Çorum,Turkey.

Yasemin Yuyucu Karabulut, MD works at the Mersin University Faculty of Medicine, Department of Pathology, Mersin, Turkey. Both 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 (©2015 Şenel et al.) and source (What is your diagnosis? A solitary papule on the arm. Dermatol Pract Concept. 2014;4(4):13 and 2015;5(1):14) are credited.

28 Journal of Dermatology for Physician Assistants

FOR POWERFUL CONTROL OF

ACNE

• Turn down inflammatory lesion counts*† — Week 12—ITT: –68.7% vs –39.2% for vehicle (P<.001); Severe: –74.4% vs –33.0% for vehicle (P<.001) • Local tolerability scores (erythema, dryness, scaling, stinging/burning) were assessed at each visit — Mean scores peaked at week 1 and decreased thereafter, and were mostly mild to moderate in severity (ITT, n=217) PRESCRIBE EPIDUO FORTE GEL FOR POWERFUL CONTROL OF MODERATE TO SEVERE ACNE Important Safety Information Indication: Epiduo® Forte (adapalene and benzoyl peroxide) Gel, 0.3%/2.5% is indicated for the topical treatment of acne vulgaris. Adverse Events: In the pivotal study, the most commonly reported adverse reactions (≥1%) in patients treated with Epiduo Forte Gel were skin irritation, eczema, atopic dermatitis and skin burning sensation. Warnings/Precautions: Patients using Epiduo Forte Gel should avoid exposure to sunlight and sunlamps and wear sunscreen when sun exposure cannot be avoided. Erythema, scaling, dryness, stinging/burning, irritant and allergic contact dermatitis may occur with use of Epiduo Forte Gel and may necessitate discontinuation. When applying Epiduo Forte Gel, care should be taken to avoid the eyes, lips and mucous membranes.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see brief summary of full Prescribing Information on next page. * A multicenter, randomized, double-blind, parallel-group, active- and vehicle-controlled, 12-week study comparing the efficacy and safety of once-daily adapalene 0.3%/BPO 2.5% fixed-dose combination gel relative to vehicle in subjects with moderate to severe acne vulgaris (N=503). At baseline, subjects had between 20 and 100 inflammatory lesions and 30 to 150 noninflammatory lesions. † Week 12 percentages based on multiple imputation.

ITT=intent to treat.

Power up at www.epiduoforte.com/hcp

Volume 10 • number 2 • SPRING 2016 29

IMPORTANT INFORMATION ABOUT

EPIDUO® FORTE

(adapalene and benzoyl peroxide) GEL, 0.3% / 2.5% BRIEF SUMMARY This summary contains important information about EPIDUO FORTE (Ep-E-Do-Oh For-Tay) Gel. It is not meant to take the place of your doctor’s instructions. Read this information carefully before you start using EPIDUO FORTE Gel. Ask your doctor or pharmacist if you do not understand any of this information or if you want to know more about EPIDUO FORTE Gel. For full Prescribing Information and Patient Information, please see the package insert.

WHAT IS EPIDUO FORTE GEL? EPIDUO FORTE Gel is a prescription medicine used on the skin (topical) to treat acne vulgaris. Acne vulgaris is a condition in which the skin has blackheads, whiteheads and pimples.

WHO IS EPIDUO FORTE GEL FOR? EPIDUO FORTE Gel is for use in people 12 years of age and older. It is not known if EPIDUO FORTE Gel is safe and effective for children younger than 12 years old.

Do not use EPIDUO FORTE Gel for a condition for which it was not prescribed. Do not give EPIDUO FORTE Gel to other people, even if they have the same symptoms you have. It may harm them.

WHAT SHOULD I TELL MY DOCTOR BEFORE USING EPIDUO FORTE GEL? Before you use EPIDUO FORTE Gel, tell your doctor if you: • have other skin problems, including cuts or sunburn.

• have any other medical conditions.

• are pregnant or planning to become pregnant. It is not known if EPIDUO FORTE Gel can harm your unborn baby. Talk to your doctor if you are pregnant or planning to become pregnant.

• are breastfeeding or plan to breastfeed. It is not known if EPIDUO FORTE Gel passes into your breast milk and if it can harm your baby. Talk to your doctor about the best way to feed your baby if you use EPIDUO FORTE Gel. Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Using other topical acne products may increase the irritation of your skin when used with EPIDUO FORTE Gel. WHAT SHOULD I AVOID WHILE USING EPIDUO FORTE GEL? • You should avoid spending time in sunlight or artificial sunlight, such as tanning beds or sunlamps. EPIDUO FORTE Gel can make your skin sensitive to sun and the light from tanning beds and sunlamps. You should use sunscreen and wear a hat and clothes that cover the areas treated with EPIDUO FORTE Gel if you have to be in the sunlight.

• You should avoid weather extremes such as wind and cold as this may cause irritation to your skin.

• You should avoid applying EPIDUO FORTE Gel to cuts, abrasions and sunburned skin.

• You should avoid skin products that may dry or irritate your skin such as medicated or harsh soaps, astringents, cosmetics that have strong skin drying effects and products containing high levels of alcohol, spices or limes.

• You should avoid the use of “waxing” as a hair removal method on skin treated with EPIDUO FORTE Gel. • EPIDUO FORTE Gel may bleach your clothes or hair.

Allow EPIDUO FORTE Gel to dry completely before dressing to prevent bleaching of your clothes.

30 Journal of Dermatology for Physician Assistants

WHAT ARE THE MOST COMMON SIDE EFFECTS OF EPIDUO FORTE GEL? EPIDUO FORTE Gel may cause serious side effects including: • Local skin reactions. Local skin reactions are most likely to happen during the first 4 weeks of treatment and usually lessen with continued use of EPIDUO FORTE Gel. Signs and symptoms of local skin reaction include: • Redness • Dryness • Scaling • Stinging or burning Tell your doctor right away if these side effects continue for longer than 4 weeks or get worse; you may have to stop using EPIDUO FORTE Gel. These are not all of the possible side effects of EPIDUO FORTE Gel. For more information, ask your doctor or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also contact GALDERMA LABORATORIES, L.P. at 1-866-735-4137.

HOW SHOULD I USE EPIDUO FORTE GEL? • Use EPIDUO FORTE Gel exactly as your doctor tells you to use it.

EPIDUO FORTE Gel is for use on the skin only (topical). Do not use EPIDUO FORTE Gel in or on your mouth, eyes or vagina.

• Apply EPIDUO FORTE Gel 1 time a day.

• Do not use more EPIDUO FORTE Gel than you need to cover the treatment area. Using too much EPIDUO FORTE Gel or using it more than 1 time a day may increase your chance of skin irritation.

APPLYING EPIDUO FORTE GEL: • Wash the area where the Gel will be applied with a mild or soapless cleanser and pat dry.

• EPIDUO FORTE Gel comes in a pump. Depress the pump to dispense a small amount (about the size of a pea) of EPIDUO FORTE Gel and spread a thin layer over the affected area.

• Wash your hands after applying the Gel. WHERE SHOULD I GO FOR MORE INFORMATION ABOUT EPIDUO FORTE GEL? • Talk to your doctor or pharmacist.

• Go to www.EPIDUOFORTE.com or call 1-866-735-4137.

All trademarks are the property of their respective owners.

GALDERMA LABORATORIES, L.P., Fort Worth, Texas 76177 USA Revised: July 2015 20089-0415-BS

Reference: 1. Epiduo Forte Clinical Study Report (SRE 18240). Data on file.

Galderma Laboratories, L.P. ©2015 Galderma Laboratories, L.P. Galderma Laboratories, L.P. 14501 N. Freeway Fort Worth, TX 76177 EFO-00031(1) Printed in USA 01/16

www.epiduoforte.com/hcp

Dermatology Case Report Phytophotodermatitis “Lime Burns”

By Ruth Pierre-Louis PA-S and Mary E. Showstark, MS, PA-C

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

Volume 10 • number 2 • SPRING 2016 31

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.

Ruth Pierre-Louis, PA-S completed her undergraduate studies at Hofstra University of New York. She is now in her culminating semester of the Touro College Physician Assistant Program. She has indicated no relationships to disclose relating to the content of this article.

Mary E. Showstark, MS, PA-C completed her undergraduate studies at University of Florida. She went on to complete her PA studies and master's degree at University of Florida in 2004 and has currently been working at Touro College Physician Assistant Program teaching and mentoring students. She has indicated no relationships to disclose relating to the content of this article.

32 Journal of Dermatology for Physician Assistants

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

Atypical (Dysplastic) Nevi: Outcomes of Surgical Excision and Association with Melanoma JAMA Dermatol. 2013 Aug;149(8):928-34.

Reddy KK1, Farber MJ, Bhawan J, Geronemus RG, Rogers GS. Laser & Skin Surgery Center of New York, New York, New York

1

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 2 â&#x20AC;˘ SPRING 2016 33

SURGICAL wisdom Dermcast.tv Blog What to do with Excess Fat Under the Chin?

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.

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.

34 Journal of Dermatology for Physician Assistants

Hire a DermPA

The Perfect Complement to the Modern Dermatologist

Announcing the All New: HireADermPA.com

Empower. Educate. Advance.

Contact Us: 844-DERMPAS

Volume 10 • number 2 • SPRING 2016 35

COSMETIC deRMATOLOGY

The Needle is the New Knife: Advances in Dermal Fillers Developments in Techniques and Materials Improve Results for Patients 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.

36 Journal of Dermatology for Physician Assistants

SDPA Members Only Content

Whitney P. Bowe, MD, FAAD, is a clinical assistant professor of dermatology at the Icahn School of Medicine at Mount Sinai in New York. She earned her medical degree at the University of Pennsylvania School of Medicine in Philadelphia and completed her dermatology residency at SUNY Downstate Medical Center in New York.

Reprinted with permission from the American Academy of Dermatology

SDPA MEMBERSHIP HAVE YOU TAKEN ADVANTAGE OF OUR REFER A MEMBER CAMPAIGN? RECEIVE A $20 AMAZON GIFT CARD For every Fellow, Associate or Affiliate* member you refer to become a member of the SDPA *Effective 10/1/15 - No award will be given for referring Student Members.

Please note: Each referral will be counted only after the new member pays his/her dues and lists the referring member’s name on the application. Referral of supervising physicians and student members will NOT qualify for this campaign, but are certainly encouraged.

Volume 10 • number 2 • SPRING 2016 37

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.

Cosmetic pearls Nickel Allergy: Dermatologists Share Tips to Avoid Exposure and Reduce Symptoms SDPA Members Only Content

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.

Jenny Eileen Murase, MD, FAAD is an assistant clinical professor of dermatology at the University of California, San Francisco. She earned her medical degree and completed her residency at the University of California, Irvine.

Reprinted with permission from the American Academy of Dermatology

38 Journal of Dermatology for Physician Assistants

in 5

Americans

will develop skin cancer in their lifetime.

DON’T BE THE 1.

Prevent. Detect. Live.

It’s easy to prevent and detect skin cancer.

Learn more at SpotSkinCancer.org. © 2015 American Academy of Dermatology. Use of this poster does not imply product or service endorsement by the American Academy of Dermatology.

Volume 10 • number 2 • SPRING 2016 39

Professional development

Notes from your Office Manager The Proper Handling of Patient Complaints The Risk: Patient satisfaction is an integral part of providing healthcare, regardless of the clinical setting. Dissatisfaction with medical care may be a harbinger of medical malpractice litigation. When you receive a complaint about care, how you handle the situation may directly impact the potential for any future litigation. All medical office practices should have a policy or protocol in place to address patient complaints based upon the following recommendations.

Recommendations: 1. One individual should be identified and consistently utilized as the primary person to handle complaints. This is often the office manager.

2. All staff should know to whom complaints should be addressed, as well as what information constitutes a complaint that requires attention or intervention by the appropriately designated person. This should, at minimum, include: a. Either written or verbal complaints regarding medical care; b. Any billing or payment issues that involve concerns about the clinical care; and c. Any letters of complaint from third party payors, IPRO, NYS Department of Health, or other regulatory entities. We recommend that you retain personal counsel for assistance in formulating written responses to such agencies.

3. Effective communication skills are essential when addressing a patient complaint. These should include: a. Expressing concern for the patient’s condition and wellbeing;

b. Being an active listener, and asking questions when appropriate; c. Investigating complaints and following up as indicated; and d. Discussing solutions to patients’ issues and their available options.

4. Convey concern, avoid judgmental comments about patients and their families, staff, physicians and other practitioners, and never be adversarial or defensive.

5. Keep letters of response concise and simple.

A copy of any written response relevant to the patient’s care should be kept in the patient’s medical record.

6. Conversations with patients can, and should, be documented in the medical record. It is appropriate to quote the patient when documenting their concerns.

7. Attorneys’ requests for records may be an indication of a patient’s unhappiness. The patient’s medical record should be reviewed in conjunction with these requests in an effort to assess the potential for medical malpractice litigation.

8. Consider seeking guidance for unusual or difficult situations. Your medical professional liability insurance carrier’s staff is available to assist with handling complaints, forming responses, and determining potential exposure to claims of malpractice.

9. Never document any contact with your medical professional liability insurance company or your attorneys in the medical record. 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

Patricia Ferrer, MPAS, PA-C combined several of her passions into a new business venture when she designed a pair of palm-less, sun-protective gloves to enhance her tennis game (Ms. Ferrer jokes that unfortunately they do not ‘enhance’ her game, but rather give her sun protection so she can continue playing the sport she enjoys the most for hours outside). Ms. Ferrer is an avid tennis player, dermatology physician assistant, medical mission volunteer, JDPA Editorial Board member, past SDPA Committee Chair, and she loves to sew. Playing as much tennis as she does, Ms. Ferrer couldn’t find a pair of gloves currently on the market to meet her needs so she set to work on creating a pair that would. Combining her past work experiences in dermatology and her passion for tennis and sewing, she started her company PalmFree™ SunWear, LLC. Her company sells UPF gloves (with patent pending) that are not only used for sporting activities but by any outdoor enthusiasts or workers. “The most important thing to me is to have people wear the glove and prevent a lot of the heartache in the future of having skin cancer on the back of their hands.” says Ms. Ferrer. The gloves sell for $25 with free shipping and are available at www.palmfreesunwear.com. In her first two months in business she sold more than seventy-five pairs of gloves. The UPF gloves block ninety-eight percent of ultraviolet radiation and are marketed to dermatology patients, tennis and golf players, outdoor enthusiasts, construction workers, and those with photosensitive skin.

Her new venture weaves many threads from her life together, including her work and volunteer experiences in dermatology and her passion to provide medical care to the underserved. “I have been so fulfilled by being able to work in healthcare,” Ms. Ferrer says, “It feeds your soul to take care of others.” Ms. Ferrer states that her personal experiences of medical volunteering in Chiapas, Mexico (the country’s poorest state) since 2008 has opened her eyes, heart, and pocket book to the needs of others less fortunate than us in the U.S.. She intends to donate all profits of PalmFree™ SunWear products to healthcare related charities, mainly Yok Chij Asociacion Civil in San Cristobal de las Casas, Chiapas, Mexico.

The JDPA recently had the opportunity to interview Ms. Ferrer and learn more about what inspired her to start her own business, what her future goals are for her company, and her plans to continue to weave her many passions into one mission.

JDPA: What inspired you to create PalmFree™ SunWear, LLC? Ms. Ferrer: After realizing a palmless UPF sun protective glove could benefit many people and testing the gloves on friends, fellow tennis players, and family members, I realized I had a marketable product. This idea simmered during one of my medical missions in Chiapas, Mexico. Then slowly the thought emerged, “the profits will go to health related charities I’m involved with.”

JDPA: How many prototypes did you make before you arrived at the final product?

Ms. Ferrer: Prior to finalizing the pattern, I created about twenty-five prototypes. I then met with a professional pattern maker that refined the pattern for production.

JDPA: Share what the process was like sewing and actually creating the gloves?

Ms. Ferrer: It was a slow process to find the right design and fit and to sew the complex pattern piece. Sewing with knit fabric is quite different than sewing with regular woven fabric. There were a lot of mistakes and kinks to work out.

JDPA: What qualities were you looking for?

Ms. Ferrer: I wanted something comfortable to cover the back of the hand, provide protection from the sun, and allow the majority of the palm to remain uncovered. The palm needs to sweat, release heat naturally, and to maintain its sensitivity, tactility, and natural grip. I wanted a product that was easy to put on and take off.

JDPA: How many samples did you make before you were satisfied with the product?

Ms. Ferrer: Probably about forty-five samples were created and tested before production. Once we started production, we found a few other glitches that were easily resolved, and production was further refined.

JDPA: What type of activities is this product best suited for?

Ms. Ferrer: Any outdoor activity in which the dorsal side of the hand is sun exposed for long periods. I wear them when driving and playing tennis. Any outdoor enthusiast can benefit and reduce his/her risk of photo damage and photo aging by wearing the gloves. Tennis players, golfers,

Volume 10 • number 2 • SPRING 2016 41

professional development

Outside & Inside the 9 to 5...

professional development

wound and burn care. As they hikers, boaters, fisherman, runners, progress through medical school, cyclists, birdwatchers, nature they continue to volunteer. Don photographers, and any outdoor Sergio, as he is affectionately workers needing the back of their called, is seventy-five years old, hands protected would benefit and I’m not sure how much from wearing the gloves. Archery longer he can continue at this hunters and glider pilots also use pace. I would like the profits the gloves and have let me know from PalmFree™ SunWear to help how much they love them. support him, pay his clinic rent, JDPA: Any plans to expand the and buy medical supplies for his product line? work. Once the medical students Ms. Ferrer: I have created the have completed their training and PalmFree™HalfSleeves; these have we have enough steady income, I the same open-palm component would like to create a salary base but extend to below the elbow, so they can continue to provide which is great for drivers and burn and wound care in the San motorcyclists. Currently, I’m Patricia Ferrer, MPAS, PA-C and Sergio Cristóbal region. This would create working on a full sleeve and hope Castro Martinez, humanitarian local personnel sustainability to launch it by mid summer. and founder of Yok Chij Asociacion and PalmFree™SunWear would JDPA: What kind of feedback Civil in San Cristóbal de las Casas, facilitate the base funding. have you received about the Chiapas.

JDPA: Any additional information product so far? you wish to share?

Ms. Ferrer: The feedback has been very Ms. Ferrer: The creation of the PalmFree positive. Dermatologists recommend the gloves to SunGlove happened serendipitously and has their patients, friends refer friends, and tennis pros continued to grow organically. I never thought I and players love the protection. Golfers use these as would be the one to create that elusive palm-less well on their “ungloved” hand. Our sales provide the glove that I’ve desired for so long. To date, we have best statement; we’ve sold over twelve hundred sold over twelve hundred pairs (90% online and pairs.

10% retail) and the gloves are in tennis pro-shops JDPA: Where are the gloves produced? and dermatology offices in five different states.

Ms. Ferrer: Green Valley, Arizona. I prefer to The majority of non-melanoma skin cancers keep production in the USA. occur on the head, neck, arms, and hands.

JDPA: What are your goals for the company?

Dermatology clinics in the sunny states of California, Arizona, Texas, and Florida see a high percentage Ms. Ferrer: My goal is to create comfortable, of skin cancers. By protecting dorsal hands, photo practical, and affordable sun protective clothing damage and aging can be reduced. Several accessories to protect those at risk for skin cancer, dermatologists have contacted me applauding my photo damage, and photo aging. I would like to gloves and have even ordered a pair for themselves. generate enough sustainable income to support the burn and wound clinic I volunteer at in Chiapas, I’m so proud to have created a sun protective Mexico on a regular basis. product that helps reduce the risk of skin cancers on the back of hands and to direct profits to help JDPA: If this happens, you will consider your venture those suffering from horrible burns who do not a success? have adequate and easily available wound care. J Ms. Ferrer: Yes. However, maintaining the product and creating more sun protective Patricia Ferrer, MPAS, PA-C, accessories is desirable. founder of PalmFree™ SunWear, LLC JDPA: Please share with the JDPA audience what and is currently employed part-time you plan to do with the profits from your business. at Dyson Dermatology in Tucson and Green Valley, Arizona.

Ms. Ferrer: The humanitarian I work with in Chiapas, Sergio Castro is basically a one-man wound care clinic. Over the last few years, local medical students have volunteered with him learning basic 42 Journal of Dermatology for Physician Assistants

For Hand Dermatitis Protect The Skin Like a Glove Tetrix Cream is Specifically Formulated for Treating Hand Eczema with Barrier Protection

®

Tetrix Cream is indicated to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic dermatitis, ® allergic contact dermatitis and irritant contact dermatitis. Tetrix Cream helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.1

®

Tetrix® Cream is contraindicated in persons with a known hypersensitivity to any of the components of the formulation.

Rx Only Topical Use Only Do Not Use in Eyes For Topical Dermatologic Use Only Product Description Tetrix® Cream is a non-sterile cream formulation intended for prescription use only.

Indications and Usage Tetrix® Cream is indicated to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and irritant contact dermatitis. Tetrix® Cream helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

Directions for Use Apply a thin layer to affected areas 2-3 times per day or as directed by a physician.

1. Data on file.

Ingredients Tetrix® is a nonsteroidal cream comprised of aluminum magnesium hydroxide stearate, cetyl dimethicone copolyol, cyclomethicone, dimethicone, hexyl laurate, polyglyceryl-4-isostearate, purified water, and sodium chloride. Contains phenoxyethanol and propylparaben as preservatives.

Contraindications Tetrix® Cream is contraindicated in persons with a known hypersensitivity to any of the components of the formulation.

Precautions For external use only. Avoid contact with eyes and other mucous membranes. Do not use the product if the packaging is damaged or after the expiration date. If your condition does not improve within 10-14 days, consult your physician. The safety and efficacy of Tetrix® Cream has not been determined in pediatric patients.

Keep out of the reach of children.

Tetrix® Cream contains no dyes or fragrances and is well tolerated and safe.

How Supplied Tetrix® Cream is available in a 2-oz. tube.

Store at controlled room temperature: 15°C to 30°C (59°F to 86°F).

Do not freeze.

Distributed by: Encore Dermatology, Inc. 5 Great Valley Parkway Malvern, PA 19355 Manufactured by: DPT Laboratories, Ltd. San Antonio, TX 78215

www.encorederm.com

1-844-848-6543

No. 5,482,714 HRI 8569-000002 TX1101 6/16 Volume 10 •Patent number 2 • SPRING 2016 43

Dermatology PA news & notes

The Difference We Make A Place Called Home…Part 2 How To Run An Exceptional Office

By Steven K. Shama, MD, MPH, FAAD In the Spring 2014 issue of the JPDA I wrote an article that I simply titled “A Place Called Home.” I wrote about making your office spiritually and physically similar to your childhood home or another place during your childhood that brought you peace and a feeling of security. I re-read the article recently and want to expand on what I wrote because the subject is so important and I feel that there is more to be said. Here are my updated thoughts with some minimal repetition needed for clarity and with fresh but seasoned ideas to share.

I was never conscious of how I ran my office, the people I hired, the way I decorated, the colors of the walls, the pictures I hung on the walls, the food I served, the entire atmosphere I created, until one day, years after I first opened my practice, one of my patients commented, "Your entire office is so lovely, so peaceful, so inviting. I've never seen an office quite like this. I feel safe. I feel taken care of." I thanked the person, smiled, and realized for the first time ever that I had recreated the home I lived in when I was a little boy.

My home had comfortable furniture, personal photos and artwork, lots of colorful plants, warm conversations, and of course delicious food served practically twenty-four hours a day. I truly believe my parents created all of this, not so much for my own family’s comfort, but for visiting relatives and friends.

That was the way my parents lived their lives.

So I ask you this question. Why can't all offices be like a warm, loving home as was my childhood home?

Don't all of us need this kind of world when we visit a medical office? Don’t most patients have some apprehension when they visit you? Don't we all need a place of warmth, where we as individuals will be treated with kindness, compassion, and where our feelings will be valued and understood in a nonjudgmental way, just like in a loving home? Wouldn't it be wonderful if this place were filled with colorful, uplifting artwork and if all of this were wrapped around friendly conversation and good food?

I truly believe that we all have within us this place that we call home, but I hasten to say that not every one of us grew up in a physical home that had all these qualities. Some of our childhood memories may reflect a dysfunctional family home. Hopefully most of us had 44 Journal of Dermatology for Physician Assistants

an aunt or uncle, a grandfather or grandmother, a close friend, a member of the clergy, a teacher, or a trusted individual who made us feel good about ourselves and “at home?” Even if we did not have any of these people in our lives, can't we imagine what it would be like to have had such a place?

Why not look around your office as it is now and think about those memories and/or dreams of your home. Is your office a place with the qualities your patients would want when they are fearful, anxious, and feeling devalued and vulnerable as many patients feel when they are visiting our offices? So why not create an environment that supports and embraces positive feelings, the calm, soothing, and nourishing place that all of us desire during medical visits?

There is a way. I truly believe that one of the most important aspects of an office is the creation of an atmosphere of kindness. It all starts with hiring for kindness. This is my bottom-line. I can train almost anyone to do any task, but kindness is that very special, precious quality in a person that is very difficult to develop. So when choosing to hire a new staff member, I would choose the kinder person even if another candidate has slightly better academic qualifications. I equate kindness and empathy as ends of a very short continuum, and while I am not aware of questionnaires that can be given to potential new hires to elicit kindness, there clearly are ways of scientifically determining the level of someone's empathy. My first suggestion is to hire for kindness.

In addition to the critical aspect of hiring the right people, the physical environment is the next most important since it refreshes the kind soul. I’m thinking about the hallways and the reception areas as well as the

Consider adding live plants, especially ones that have colorful flowers throughout the year. As a soothing touch, create the sounds of flowing water by adding many small recirculating fountains and by placing them wherever people sit, especially in your exam rooms. Don't forget fountains for your staff. Regarding art work, in addition to those you may have bought, choose pieces that either you or members of your staff have made, especially if the art expresses the joyfulness and the innocence of the artist. I avoided having large educational signs in my reception area, especially those showing skin cancers. I preferred to educate patients with small brochures that are tastefully displayed in the reception area or that are handed out by my staff to patients in the exam rooms. I wanted my office to reflect all that is whole with the world and with my patients. I recognized that at some point during the office visit, my patients would be educated on how to stay or become healthy.

One final thought regarding how one creates a warm and inviting office. If I could have fed my patients a full meal, I would have. It's the way I grew up and the way we entertained any visitor to our home; however, my patients had to settle for coffee, tea, or

hot chocolate and the occasional pastry brought in by myself, my office staff, or a happy patient who wanted to share in this positive office experience.

Often patients would visit my office, smile, and ask, “Why the pink walls?” (Yes, the main color of my office for over twenty of my thirty years in practice was pink). The answer was, “It makes the doctor happy!”

When asked why we had the sayings on the walls, the artwork, and the colorful plants and fountains, our reply was, “It makes the doctor happy, and he thought you might enjoy it.”

The bottom line in my practice of over thirty years was providing up-to-date good care in a professional manner and with safety being our top priority. All of this was always wrapped around good caring, in a warm loving “home” that kept my patients and me smiling throughout my years in practice. I truly believe all of us need that “Place Called Home,” whether it is where we live, where we work, or where we visit. Look around your office and make it your home, both for yourself, for your staff, and for your very special patients who come to visit. J Dr. Steve Shama was practicing general dermatology for 30 years in Boston, Massachusetts until last year. He retired at that time but continues in a 20 year career as a professional speaker and enjoys speaking on topics such as, “Dealing With Difficult People and Looking Forward To It!” and “Rediscovering The Joys of Medicine and of Life.” He gives these talks at medical meetings, in private practices, and to general audiences and youth throughout the country. You can reach Dr. Shama at www.steveshama.com.

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 2 • SPRING 2016 45

DERmatology pa news & notes

exam rooms. Many of our offices have been designed by decorators who tell you the “best” colors for your walls and recommend the most trendy furniture. May I suggest that you select the colors and furniture that make you happy, that make you smile. It is your smile that your patients will see and be attracted to.

Workplace Excellence

Forget Perfect; Find Optimal

By Matthew Davidson, PhD

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.

I recently heard from a friend/colleague who

works at a prestigious high school, which boasts some of the best and brightest students. He shared that they were suffering as a community from the recent loss of a female student who had committed suicide. There are not too many things sadder than when a young person takes their own life -especially when they have extraordinary talents, abilities, and opportunities.

When it comes to something like suicide we are rarely able to say, “This was the cause.” That’s certainly true in this particular case. However, my colleague is pretty convinced that one significant contributing factor was this young women’s perfectionism. It just seemed that nothing was good enough for her; no matter how much she achieved or accomplished, no matter how high she ranked or performed relative to others, she simply did not rank or perform high enough or well enough to meet her own standards.

Compassion means “to suffer with.” As a father of four young children, as a teacher and coach, and as someone who works with high school and college students, I’m suffering with my colleague and this community over their loss. I’m also able to feel compassion for this young women, who aspired for excellence and fell prey to the trap of perfectionism.

When your life and life’s work is dedicated to excellence and ethics, perfectionism is an all-to-common personal and professional hazard. Many of the most accomplished performers are also the least happy, the least satisfied, and unfortunately, the most plagued by their own self-rejection and self-loathing. At times I have most certainly let my best instincts for excellence morph into perfectionism (I am grateful to a friend who put me on to the work related to perfectionism; it has helped me and those we serve).

46 Journal of Dermatology for Physician Assistants

A resource that I have found very helpful, which I recommended to my colleague is the book, The Pursuit of Perfect, by Tal Ben-Shahar. Not surprisingly, his course on happiness and perfectionism is one of the most popular at Harvard. I also have enjoyed his books on happiness as well.

For any individual, any teacher, parent, coach, healthcare provider (especially those providing cosmetic services) who is passionate about excellence, you simply must be informed about the dangers of perfectionism and this resource is as good as they come. It presents solid but accessible theory, trustworthy science, some practical tools, and strategies. I draw upon it significantly in my own life, and for those we consult in healthcare, school, sport, and workplace settings.

I recommend it for healthcare providers (especially those who provide cosmetic services and work closely with adolescent patients), parents, coaches, teachers, and those in youth ministry - especially those working with or in high-performing schools and competitive settings.

It is important to remember as you think about the topic that perfectionism is always bad, always disordered. “Optimalists” is the term Tal Ben-Sharar describes as the ideal. This is closely aligned with our work at IEE where we talk about Optimal Performance - optimal is the middle between too much and too little. Optimal Performance is optimal for 1) the circumstance or situation, 2) the goal or expectation, and 3) the persons abilities and sensibilities. Finding optimal isn’t easy, it is an art as much as science. If you desire personal best you must be able to self-correct quickly or risk letting perfectionism ruin you.

The Pursuit of Perfect provides numerous practical examples of signs and symptoms of perfectionism, like:

2. Fear of failure - This isn’t just your normal preperformance nerves (this is the right cosmetic procedure to make me perfect, big game, or challenge and I’m nervous and excited). This is debilitating, panic attack anxiety, which believes that my identity and self-worth is on the line. If I lose or fail, all is lost.

3. An all or nothing mindset - You either took first or you lost. You either got an “A” or you failed. There is no recognition of growth and improvement. There is no satisfaction in the journey or the thrill of good competition and what it brought out of you.

4. Focus exclusively on destination - The quote says, “The journey is the reward.” This is not true for perfectionists. It’s all about arriving, perfecting how they look, getting that “A,” winning that championship, getting that scholarship, or new house, etc. All of the joys along the way, the growth, the relationships, and the journey are devalued (unfortunately, they get very little joy when they arrive either, since they’re usually so quickly on to the next thing).

5. Procrastination - It takes lots of energy to succeed in making their face/body/skin look flawlessly perfect, write the perfect essay (or email), create the perfect project, do the best most impressive thing you’ve ever done. So there’s no good time to start, and so we procrastinate. Perfectionists lose site of just getting something done, and what happens when you find good enough. As they say in the Done Manifesto, “Done is the engine of more.” You can improve something, innovate off of or from something. If we’re procrastinating, it’s often a sign of perfectionism.

Tal Ben-Shahar outlines many other signs and symptoms, and some very helpful character strengths and habits to develop the capacity to help individuals find optimal, including: 1. Developing an attitude of gratitude - which helps one to see everything as a gift, including our challenges and setbacks. Moment to moment mindfulness and gratitude begins to draw attention to the good things that are happening in our lives, even if they aren’t easy.

2. Developing a growth mindset - which values improvement and growth and sees challenges and failure as opportunities to grow, not as the end of the world.

3. Embracing adversity - We don’t have to seek out adversity; we do need to learn to embrace it. It will happen and often it’s from our adversity that we grow, learn the most, and find our deepest and best selves.

4. Striving for optimal - There is arguably nothing more important and beautiful than finding optimal. When asked how he carved his beautiful Angel, Michelangelo famously said, “I carved away everything that wasn’t angel.” It’s what all great artists do, be they sculptors, musicians, or chefs. They carve away the excess. For every circumstance, for every person, for every goal or pursuit we simply must seek to find the optimal or ideal response. Not too much, not too little, just right. Simple, not easy.

Suicide is a tragedy and represents an extreme response to the forces of perfectionism. But depression, anxiety, and unhappiness are very common results from perfectionism. The lack of joy, lack of happiness, lack of gratitude, lack of mindfulness living are especially prevalent among those who hold high expectations for themselves, and those who are held to high expectations by well-intended parents, teachers, coaches, and spiritual/religious mentors.

High expectations are not the problem; our mindset for pursuing them is the problem. Forget perfect. Find optimal. Developing and sharing this mindset and approach to life may bring peace and joy to ourselves, those we work with, and those we serve. 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.

Volume 10 • number 2 • SPRING 2016 47

DERmatology pa news & notes

1. An expectation of a perfect journey - Everybody else experiences loss, setbacks, problems, or unforeseen challenges, but not the perfectionist.

They expect things to go perfectly, and when they inevitably don’t, anxiety, self-rejection, and a host of other toxic emotions result.

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!

DERmatology pa news & notes

Image: Pixabay / Witizia

Can Subclinical Inflammation Predict Risk of Psoriatic Arthritis?

Prevalence of subclinical inflammatory lesions is high in patients with cutaneous psoriasis. Arthralgia in conjunction with MRI synovitis constitutes a high-risk constellation for the development of PsA.

Link: http://bit.ly/1MD1hbX

Image: StockSnap.io / Ryan Tauss

“... The fact that psoriatic skin disease has a higher prevalence than arthritis raises the question whether patients with psoriasis without PsA are indeed spared from joint inflammation or whether mild changes, which escape physical examination, can be found in some patients....”

Is There a Link Between Male Pattern Baldness and Prostate Cancer?

Based on the National Health and Nutrition Examination Survey (NHANES I) Epidemiologic Follow-up Study (NHEFS), researchers found that compared with no balding, any baldness was significantly associated with a higher risk of fatal prostate cancer and that moderate balding specifically was associated with the highest risk.

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

Image: Ultra HD Wallpapers / Jonny Lindner

“... While prior studies of male pattern baldness in relation to prostate cancer risks have been inconsistent in the methods used and the conclusions drawn, clinical observations and laboratory studies support a link between the two...”

Patient-Reported Outcome Scales: Is a Reliable and Valid Scale Available?

The FACE-Q scale provides the research community and physicians with a PRO instrument they can use to include patients in the assessment of outcomes.

Link: http://bit.ly/1MtUeCg 48 Journal of Dermatology for Physician Assistants

“... The FACE-Q instrument includes more than 40 scales and checklists designed to measure appearance, adverse effects, health-related quality of life, and experience of health care...” J

Volume 10 • number 2 • SPRING 2016 49

A BASE TAN

IS NOT

A SAFE TAN DON’T GET BURNED BY TANNING MYTHS # Ta n M y t h There is a common misconception that a tan acts as the body’s natural protection against sunburn.

# B u r n i n g Tr u t h A tan is the body’s response to injury from UV rays, showing that damage has been done. A “base tan” only provides a sun protection factor (SPF) of about 3 or less, which does little to protect you from future UV exposure.

@cdc_cancer * www.cdc.gov/cancer/skin/burningtruth/ * #burningtruth

National Center for Chronic Disease Prevention and Health Promotion Division of Cancer Prevention and Control

50 Journal of Dermatology for Physician Assistants

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August 13 – 19, Camp Horizon in Millville, Pennsylvania (ages 8 – 13) Dates TBD, Camp Liberty in Andover, Connecticut (ages 8 – 16) ●

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Camp Discovery was founded in 1993 and offers a summer camp experience like no other. Every summer, the American Academy of Dermatology sponsors six weeks of camp in five locations where everyone can experience activities such as fishing, swimming, archery, horseback riding, nature trails, and just plain fun!

Under the expert care of dermatologists and dermatology healthcare professionals, Camp Discovery offers campers the opportunity to spend a week among other young people who have similar skin conditions. Many of the counselors have chronic skin conditions as well, and can provide support and advice to campers.

There is no fee for camp. All costs, including transportation, are provided by the American Academy of Dermatology through generous donations from its members, individuals, and other organizations such as the Dermatology PA Foundation who will be sponsoring two campers for Camp Discovery this year. The American Academy of Dermatology is proud to offer this experience to about 380 children each year. J

LV

For more information about attending or volunteering please visit the Camp Discovery website at www.campdiscovery.org or contact Janine Mueller at (847) 240-1737 or jmueller@aad.org.

Volume 10 • number 2 • SPRING 2016 51

DERmatology pa news & notes

Camp Discovery 2016

Supervising Physician CORNER An Interview with Alan Rockoff, MD

By J. Margaret Casey

DERmatology pa news & notes

Dr. Alan Rockoff has a strong passion for teaching. He has been a medical educator for over thirty-five years and has authored numerous articles, blogs, and books. He reminds his medical and PA students that to act like doctors and healthcare providers they must first learn to think like patients. We had an opportunity to interview Dr. Rockoff and learn more about his experiences as an author. His most recent book is titled “Act Like a Doctor, Think Like a Patient: Teaching Patient-focused Medicine.” According to Dr. Rockoff, “Practicing medicine is not about just fixing bodies but also easing minds. Providers who know what is physically wrong but who don’t take into account what patients themselves think about their medical issues (how it got that way and what to do now) may fail to enlist patients in their own journey towards health.”

JDPA: How long have you been writing?

Dr. Rockoff: I started sending in freelance article submissions to various periodicals about thirty years ago. In 1997 I was invited to write a monthly column for practicing dermatologists in what was then called Skin & Allergy News, recently renamed Dermatology News. About two years ago I started a blog for the magazine Psychology Today, to share some of the same insights with the public at large.

JDPA: Could you share with us the role you think writing has in educating healthcare providers?

Dr. Rockoff: There is of course a long tradition of physicians writing about their profession. Though much of what they write is technical, doctors also write about the experience of taking care of sick people and its effect on both patients and the doctors themselves. Most of my own writing has been directed at other practitioners and discusses not only the various disease states but also interactions with the people who have them.

JDPA: What inspired you to write a book?

Dr. Rockoff: My first book, Under my Skin: A Dermatologist Looks at his Profession and his Patients, was a collection of my columns from Skin & Allergy News.

I have been gratified that not only practitioners but also patients seem to enjoy it.

My latest book is titled, Act Like a Doctor, Think Like a Patient: Teaching Patient-focused Medicine, is in effect the summary of what I have been teaching medical and 52 Journal of Dermatology for Physician Assistants

PA student for the past thirty-five years.

It is structured as a discussion between myself and my students as we walk from room to room, examine patients, and then sit down to discuss the cases afterwards.

I actually got the idea for the book several years ago when I was sitting across from a young student who was only in my office for two weeks instead of the usual four. I was mulling over how to get this all down on paper when he asked a really good question about what I was up to, and I thought, "Hey, that's it; why not just write it up the way it comes out?" I've actually stayed in touch with him, and plan on sending him a copy of the book.

JDPA: What do you hope people gain from reading your writings?

Dr. Rockoff: The practice of every profession is different from what they tell you to expect in school.

Basically, medicine is taught as a technique to learn about diseases and figure out how to fix them. While that is obviously an important part of what doctors and healthcare professionals do, it leaves a lot out. My writings and books elaborate on some of what I believe is missing in medical education today.

JDPA: We look forward to having you contribute articles to the JDPA. What do you think PAs will get out of your writings?

Dr. Rockoff: PAs should get the same benefits as other clinicians get. Ever since I started working with

JDPA: Do you have a favorite author you enjoy reading? Anyone you gain inspiration from?

Dr. Rockoff: I enjoy reading books by authors that I personally know, sometimes friends and sometimes patients. I find it more enjoyable, and it gives me deeper insights into these individuals.

As for inspiration, other people in general inspire me. I never get enough of learning all the ways people manage to muddle through life. Sometimes people are amazing, sometimes appalling, but finding out about them never stops being interesting.

JDPA: Any words of advice for dermatology PAs? Dr. Rockoff: Just keep watching, listening, and paying attention. Is what you do helpful? If not, try to do better next time. J

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 thirty-five years.

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 his second book, “Act Like a Doctor, Think Like a Patient: Teaching Patient-focused Medicine” is set to be released in June 2016.

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.

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 2 • SPRING 2016 53

DERmatology pa news & notes

PAs fifteen years ago, I've been struck that, to a person, they come with no encumbrances about professional identity. The attitude of every PA I've met is, "Let's roll up our sleeves and see patients. When do I start?"

Since everything I write has to do with making the practitioner–patient relationship more satisfying and productive, I assume that healthcare providers with the same attitude toward clinical medicine that I've observed in PAs might find my suggestions of some use.

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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] 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 DM/ONX/14/0031(1)

Volume 10 • number 2 • SPRING 2016 55

HELP YOUR PATIENTS

FIGHT

Acne

– with –

Once-daily treatment of comedonal & inflammatory acne lesions Visit ONEXTON.com to help patients save with a $0 copay* *Offer valid for commercially insured patients only. See savings card for full eligibility Terms and Conditions.

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 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.

Please see Brief Summary of Prescribing Information on the following page. /TMs are trademarks of Valeant Pharmaceuticals International, Inc. or its affiliates. Any other product or brand names and logos are the property of their respective owners. © 2015 Valeant Pharmaceuticals North America LLC. DM/ONX/15/0036(1)

®

56 Journal of Dermatology for Physician Assistants