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SEE MORE AAD ANNUAL MEETING NEWS! aadmeetingnews.org
A Publication of the American Academy of Dermatology | Association
SUNDAY. MARCH 3, 2019
INSIDE COMPLEX ALOPECIAS 3 DIVERSE POPULATIONS 4 MORBIDITY, MORTALITY IN PEDIATRICS 12 EXHIBIT HALL MAP 14 EARLY CLUES TO DERMATOLOGIC DIAGNOSIS 20
© Janssen Biotech, Inc. 2019 01/19 cp-74265v1
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2019 AMERICAN ACADEMY OF DERMATOLOGYANNUAL MEETING
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Morbidity and mortality conferences can improve safetyM orbidity and mortality
conferences (MMC) are a staple in anesthesia
and surgery, but rare in dermatology. That difference is dermatology’s loss, said Alice J. Watson, MD, MPH, a dermatologist at Brigham and Women’s Hospital and assistant professor at Harvard Medical School.
“Morbidity and mortality conferences can be a powerful tool to drive safety and quality in your practice. We are not perfect, and the systems we work in are not perfect,” Dr. Watson said. “We all make
mistakes, take shortcuts, and get distracted. There is plenty to work with even if dermatology doesn’t have a lot of mortality.”
Dr. Watson discussed the theory and practice of MMC during Saturday’s “The Revamped Morbidity and Mortality Conference — A Must for All Dermatology Practices” (U035).
She organizes a quarterly dermatology MMC at lunchtime for providers and a breakfast MMC for other staff every six months. Any event that includes food attracts more attendees, she noted, and increased
attendance increases attention and impact.
Near misses are more common than lapses that affect patients and are no less important for lack of immediate patient harm.
“When you reduce near misses, you dramatically reduce the incidence of events that result in harm,” she said. “The more you focus on safety, the more attention people pay to safety. And it is easier to talk about a near miss than the time someone lost a biopsy specimen or misdiagnosed a cancer.”
Regular attention to safety pays off, Dr. Watson added. After more than two years of MMC, Brigham faculty surveys show the percentage of providers from whom they get feedback increased from 7% to 29%. The percentage of providers who believe mistakes will not be held against them jumped from 13% to 60%.
“It doesn’t have to be a disaster to be a useful MMC discussion,” she said. “Safety is about the things that happen every day. It is about raising awareness of safety issues in everything we do.”
Summer in the CityJoin the brightest minds in dermatology for an unforgettable educational experience in New York.
2019 AAD Summer MeetingNew York, New York
July 25–28, 2019NEW YORK HILTON
Alice J. Watson, MD, MPH: “Regular attention to safety pays off.”
Sunday’s Plenary lineup8-11:30 a.m.Ballroom B Paul Nghiem, MD, PhD“Less Toxic, More Effective: A Win-Win for Merkel Cell Carcinoma” Boris D. Lushniak, MD“I Acted and Behold, Service was Joy” Crystal L. Mackall, MD“Engineering T Cells for Cancer Therapy” Robin Farmanfarmaian“Patient Empowerment in the Digital Age” Diane M. Thiboutot, MD“In Search of the Next Isotretinoin” George J. Hruza, MD, MBAPresident-Elect’s Address Suzanne M. Olbricht, MDPresident’s Address
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3DERMATOLOGY WORLD MEETING NEWS • SUNDAY • MARCH 3, 2019
Vol. 30, No 3 March 3, 2019
PresidentSuzanne Olbricht, MD
Physician ReviewerMarta Van Beek, MD, MPH
Executive Director & CEOElaine Weiss, JD
Director, CommunicationsKatie Domanowski
Associate Director, PublishingRichard Nelson, MS
Managing Editor, Special PublicationsDean Monti, MFA
Creative ManagerNicole Torling
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DATE
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THAN A MOISTURIZERAmLactin® gently exfoliatesplus deeply hydrates with beneficial levels of lactic acid
Experience the difference at booth #2925
SUNBURN ALERT: This product contains an alpha-hydroxy acid (AHA) that may increase your skin’s sensitivity to sunburn. Be sun smart: Use sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterward.
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Meet your 2019 slate of candidates
Board of Directors
President-Elect Vice President-Elect
Kenneth J. Tomecki, MD, FAAD
Julie A. Hodge, MD, MPH, FAAD
Robert A. Weiss, MD, FAAD
Neal Bhatia, MD, FAAD
Nominating Committee Member Representatives
Roy G. Geronemus, MD, FAAD
Mark Lebwohl, MD, FAAD
Kathleen Hectorne, MD, FAAD
Murad Alam, MD, MSCI, MBA, FAAD
Hon S. Pak, MD, MBA, FAAD
Naomi Lawrence, MD, FAAD
Amy McMichael, MD, FAAD
Howard B. Pride, MD, FAAD
Jonathan Kantor, MD, MSCE, FAAD
Cheryl M. Burgess, MD, FAAD
Non-transplant alopecia treatments grow in popularity
T hree minimally invasive procedures are gaining traction for the
management of alopecia. As research continues and evidence mounts, experts discussed three key strategies during Saturday’s “Emerging Non-transplant Procedures and Drug Delivery for the Management of Complex Alopecias” (U034).
Platelet-rich plasma (PRP)PRP is the autologous high concentration of platelets in a small volume of plasma. It’s performed in a 10-minute process that’s comprised of five steps: Collect the blood, centrifuge it, remove platelet-poor plasma (PPP), re-suspend and collect PRP, and inject.
PRP treats hair loss by promoting vascularization and angiogenesis, triggering anagen entry, extending anagen duration, reducing inflammation and oxidative stress, and triggering hair stem cell regeneration. Neil S. Sadick, MD, clinical professor of dermatology at Weill Cornell Medical College in New York,
said the first sign that the treatment is working is that the patient will experience decreased shedding. If the patient hasn’t experienced hair growth by the five- to six-month mark, Dr. Sadick will discuss ending treatment.
See related PRP story in Dermatology World: www.aad.org/dw/monthly/ 2018/may/a-new-spin
MicroneedlingMicroneedling is the practice of wounding the skin to mimic embryonic follicle development and to express nascent follicles. By introducing microscopic punctures to the skin, the follicle infundibulum is dilated, and the patient will experience improved transepidermal and transfollicular delivery of hair growth agents.
Nicole Elaine Rogers, MD, a dermatologist with East Jefferson General Hospital in Metairie, Louisiana, said there is evidence that the process of wounding the skin alone can enhance hair growth. “Alone, it is probably not superior to existing alopecia therapies,” she
said. But in combination, she believes it is probably superior.
See related story in Dermatology World on microneedling: www.aad.org/dw/monthly/2018/september/the-many-uses-of-microneedling
Laser-assisted drug deliveryIn addition to microneedling, transdermal drug delivery treatments can include fractionated lasers. These create small channels through the
stratum corneum to the dermis and can include either ablative lasers or non-ablative lasers.
Sisters Ana Carina Junqueira Bertin, MD, and Ana Lucia Ariano Junqueira, MD, from Clinic 462 in São Paulo, Brazil, use fractional non-ablative lasers in their practice. These act as a wounding source, increase blood flow, impact cytokine expression, induce growth factor changes, and enhance penetration of topical agents.
From left to right: Nicole Elaine Rogers, MD, Neil S. Sadick, MD, Ana Lucia Ariano Junqueira, MD, and Maria K. Hordinsky, MD, share minimally invasive procedures for the management of alopecia.
The American Academy of Dermatology has selected its candidates in this year’s election. The Nominating Committee voted to present the following slate of candidates (listed in random order) to the membership for the 2019 Academy election of officers, directors, and Nominating Committee member representatives.
The election is open through Saturday, March 16. Vote online at www.aad.org/aadelection or from the 2019 AAD Meeting Mobile App.
4 DERMATOLOGY WORLD MEETING NEWS • SUNDAY • MARCH 3, 2019
Several Th2 cytokines, including IL-13, are key drivers of atopic dermatitis.1
BECOME ANATOPIC DERMATITIS
DETECTIVE
Reference: 1. Gittler JK, Shemer A, Suárez-Fariñas M, et al. J Allergy Clin Immunol. 2012;130(6):1344-1354.
LEO and the LEO Lion Design are registered trademarks of LEO Pharma A/S.©2019 LEO Pharma Inc. All rights reserved. MAT-22212 January 2019 Printed in USA.
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Meeting unmet needs: Seeing patients as individuals
B etter understanding and representation of the variety of skin colors and
structures are needed in clinical studies and treatments. That was the message of the speakers at Saturday’s “Addressing Unmet Needs in Diverse Populations: Therapeutic, Aesthetic, and Investigational Approaches” (U036).
“Dermatologists can be the primary agents of change” by driving more understanding of these unique patient needs, said Hema Sundaram, MA, MD, a dermatologist in Rockville, Maryland. She said many patients with skin of color are experiencing suboptimal access to high quality medical care, lower rates of treatment, and worse treatment outcomes.
Seemal R. Desai, MD, a dermatologist from Plano, Texas, specifically called out three conditions that lack effective treatment in diverse populations: melasma, vitiligo, and psoriasis. Traditional treatments for melasma include topical retinoids, combination therapy, azelaic acid, hydroquinone, and chemical peels. However, he said tranexamic acid is an interesting option for visibly improving melasma because you can treat
for a shorter period of time and not use hydroquinone. He also encouraged further studies on men of color with melasma.
Dr. Desai pointed to the need to stabilize vitiligo, especially in patients from Southeast Asia and India, because they tend to be ostracized as a result of their condition. As a pearl, he suggested oral mini-pulse therapy and prescribing dexamethasone 4 mg daily on two consecutive days per week for eight weeks to get it under control. He said it is safer than prednisone.
“There is very little data on psoriasis for people of color,” he said. “We need more data, so we can offer biologic and topical treatments for these patients.”
Dr. Sundaram said there’s a growing occurrence of skin cancer and cutaneous malignancies in skin of color.
This is leading to increased morbidity and mortality in these patients because it’s usually found later. “There are atypical presentations when compared to what we see in Caucasians,” she said.
She encouraged the development of skin cancer prevention and screening programs specifically tailored for the African-American, Latin, and Asian populations.
For dermatology in particular, she said there are ethnic ideals of beauty that need to be respected.
“What constitutes beauty for Asian, Caucasian, and African-Americans is different,” she said. She questioned whether in the pursuit of the ideal ethnic face, patients are actually being ‘caucasianized,’ and in so doing, creating facial disharmony and dissatisfaction in patients.
Hema Sundaram, MA, MD
The American Academy of Dermatology Poster Exhibits Workgroup is pleased to announce the recipients of the 2019 Poster Awards.
Award nominees are selected and judged from a pool of the highest scoring abstracts submitted for poster presentation.
1st Place8059: Safety of 5a-reductase inhibitors and spironolactone in breast cancer patients receiving endocrine therapiesAuthors: Raquel Rozner, MD, Azael Freites-Martinez, MD, Jerry Shapiro, MD, Eliza B. Geer, MD, Shari Goldfarb, MD, Mario Lacouture, MD
2nd Place8555: Retrospective clinical, molecular, and outcome analysis of Spitzoid melanocytic tumors at a large volume academic medical center: A 10-year experienceAuthors: Sophia Zhang BS, Arivarasan Karunamurthy, MD, Jonhan Ho, MD, MS, Laura Ferris, MD, PhD, Jonathan Lee, MD
3rd Place9798: Hidradenitis Suppurativa is Associated with Increased Odds of Stroke, Coronary Artery Disease, Heart Failure, and PAD: A Population-Based Analysis in the United StatesAuthors: Rachael Ward, BS, MPH, Rayan Kaakati, BS, Tarannum Jaleel, BS, MD, Beiyu Liu, MS, PhD, Cindy Green, PhD
4th Place9824: Prevention of Taxane-Induced Alopecia and Nail ToxicityAuthors: Dustin H. Marks, BS, Azam A. Qureshi, BA, Adam Friedman, MD
Honorable Mention9909: Screening for Second Primary Melanoma in High Risk Patients: A Cost-Effectiveness AnalysisAuthors: Divya Seth, MPH, Margaret Krasne, MPH, Lyndon James, MBBS, MPH, Jane Kim, PhD, Jeremy Bordeaux, MD, MPH
”Be nice” and four more rules for young physicians
A rianne Shadi Kourosh, MD, MPH, a dermatologist
at Massachusetts General Hospital, wants to pass on some sage advice to young physicians. In fact, it’s the same advice she received when she was starting out, and some she wished she would have received.
Here are five pearls she presented during Saturday’s “Young Physician Pearls and Pitfalls: A Survival Guide for the First 10 Years” (F057).
1Protect your eyes. On the surface, this suggestion is literal. You
actually need to wear proper eye protection. But it goes beyond that, said Dr. Kourosh. You need to protect yourself and your ability to do your job in the long term. In this same vein, she recommends getting disability insurance while still a resident; this way, you’ll be locked into lower rates.
2Keep a paper trail. Dr. Kourosh said to document encounters
fairly and accurately. Learn accurate and prudent billing and coding procedures. Use neutral language, such as “declined” instead of “refused,” and record all pertinent discussions. It’s important to protect not only yourself, but your entire team.
3Pace yourself. It can be tempting to go after all of your goals at once,
but make sure to prioritize your health along the way. Sleep, exercise, meditate. Practice self-care habits that work for you, pursue your hobbies, and travel if it appeals to you.
4Be nice. Be a good neighbor to your colleagues. Help when
you can; cover for, support, and defend them. But it goes beyond your colleagues — be a good neighbor for those who work for
you as well. Show your entire team respect.
5Get involved. You can’t change the future of dermatology if you don’t
speak up for what you believe in. Run for office. Serve on
committees. Come to the AADA Legislative Conference.
And if you’re feeling stuck and needing help? The AAD is always available for education, advocation, and other resources and programs.
Young physicians chuckle as Arianne Shadi Kourosh, MD, MPH, tells them they “won’t be 21 forever” and other sage advice.
Several Th2 cytokines, including IL-13, are key drivers of atopic dermatitis.1
BECOME ANATOPIC DERMATITIS
DETECTIVE
Reference: 1. Gittler JK, Shemer A, Suárez-Fariñas M, et al. J Allergy Clin Immunol. 2012;130(6):1344-1354.
LEO and the LEO Lion Design are registered trademarks of LEO Pharma A/S.©2019 LEO Pharma Inc. All rights reserved. MAT-22212 January 2019 Printed in USA.
FOR MORE INFORMATION CHECK OUT ADdetective.com
Review the case at
LEO Pharma Booth#3227
6 DERMATOLOGY WORLD MEETING NEWS • SUNDAY • MARCH 3, 2019
Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936-1080 © 2019 Novartis 1/19 COS-1366705
ACTUAL PATIENTLAURALEE
Discover theComplete
Cosentyx ApproachBooth #3021
CYNDIACTUAL PATIENT
Actual COSENTYX patients compensated for their time.
Stay connected
#AAD2019 with the president of #2020 CILAD Madrid
@olzerpa
Blue light and Endothelin are implicated in the pathogenesis of #melasma. That’s just one of the gems from the unmasking facial pigmentation session this morning. Session jam packed! #AAD2019
@MRodriguesMD
Congrats to @DrScottElmanon a great presentation at #AAD2019 on ID-derm related complications related to immunosuppression! Thanks for representing #mgh #dermatology and the #medderm program so well!#dermtwitter
@DrStevenTChen
Exciting session on global dermatology at #AAD2019 with rock stars Toby Maurer @UCSFMedicine Claire Fuller @Fuller9Claire@ILDSDerm Esther Freeman @AADskin@Fogarty_NIH @NIH_NIAMS @GlobalHealthMGH #gloderm
@PeterKilmarx
@juleslipoff Biggest piece of advice for trainees (and myself when stuck)... do everything possible to find, discern etiology and focus treatment to that end (easier said than done). #itch #AAD2019
@DanielButlerMD
Atopic dermatitis is common, even among adults—but childhood disease is likely more persistent than previously thought, Dr. Aaron Drucker said at #AAD2019. @MDEdgeTweets
@jeffbcraven
TODAY’S TOP TWEETS #AAD2019 @AADmember
“Physician burnout is something that you have to fight against. The best way to do it is to develop a sense of gratitude. Every day, I go into the practice being thankful that I have patients who trust me to do a good job.”
Julie Harper, MDBirmingham, Alabama
“Begin with you. You have to think about why you wanted to be a physician. But then you also have to think about what sort of things you want to do for yourself. Make time for yourself, for activities, and broaden your approach to leaving your legacy, not just at work.
Markham Luke, MD, PhDGaithersburg, Maryland
“I think one of the most important things is to be well-rounded and to take time for yourself after work. Stay close to family and friends. Do different things that help you feel more at peace after a long, stressful day, like meditating, working out, and getting proper sleep.
Emily Boes, DOLakewood, Ohio
What have you done to cope with physician burnout?
WATER COOLER
CONNECT FOR TODAY’S TOP POSTS #AAD2019 @AADMember
Share your photos on Instagram to win big at the Annual Meeting!The Instagram Challenge is still on! Submit photos with friends and colleagues and have the chance to win big prizes! Use #AAD2019Challenge to enter.
Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936-1080 © 2019 Novartis 1/19 COS-1366705
ACTUAL PATIENTLAURALEE
Discover theComplete
Cosentyx ApproachBooth #3021
CYNDIACTUAL PATIENT
Actual COSENTYX patients compensated for their time.
8 DERMATOLOGY WORLD MEETING NEWS • SUNDAY • MARCH 3, 2019
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Why are you voting?DW Election Correspondent Terry Cronin Jr., MD, asked Annual Meeting attendees about the top issues in the field — and snuck in a few Boards questions. Watch at www.aad.org/derm-on-the-street.
• Learn about AAD products and services.
• Demo products such as Simulated Patient Encounters, Digital Derm Coding Consult Pro, and Dermatology Patient Education Digital Subscription.
• Check out the Resident Corner to apply for membership or try out Board Prep Plus.
• Discover new tools in the AADA’s Practice Management Center to help with coding challenges, combating burnout, and meeting HIPAA requirements.
• Renew AAD membership. • Receive exclusive Meeting-only
discounts on products. • Explore Preferred Provider
programs.
Explore professional growth resources at AADCareerCompass
Learn about DataDerm™, AAD’s data registry
Hear Dialogues in Dermatology LIVE!’s podcast
Additionally, you can:
AAD Resource CenterThe place to experience, explore, and interact.
HOURS: Sunday-Monday8 a.m.-5 p.m. | Hall D
TARGET AUDIENCEThe educational design of this activity addresses the needs of dermatologists, clinical immunologists, and other clinicians involved in the treatment and management of patients with pustular psoriasis.
EDUCATIONAL OBJECTIVESAfter completing this activity, the participant should be better able to:• Describe the genetic and pathophysiologic
mechanisms that contribute to the development of pustular psoriasis including factors that have informed the development of new therapies
• Comprehensively assess patients with suspected pustular psoriasis based on clinical manifestations, diagnostic criteria, and disease severity
• Describe the mechanistic rationales and clinical evidence for current and emerging biologic therapies for the treatment of generalized pustular psoriasis and palmoplantar pustulosis
• Individualize therapeutic regimens for pustular psoriasis, with a focus on generalized disease subtypes and palmoplantar pustulosis
PROGRAM AGENDA7:00–7:10 Preactivity Questionnaire and
Faculty Introductions 7:10–7:30 Introduction to Pustular Psoriasis
Pathophysiology 7:30–7:50 Evaluating Patients With
Generalized Pustular Psoriasis or Palmoplantar Pustulosis
7:50–8:20 Evolving Therapeutic Approaches for Patients With Pustular Psoriasis
8:20–8:40 Case Study Discussion: Prerecorded Patient Examples
8:40–9:00 Postactivity Questionnaire and Q&A Session
AMERICANS WITH DISABILITIES ACT Event staff will be glad to assist you with any special needs (ie, physical, dietary, etc). Please contact Christa Master prior to the live event at [email protected] program is independent and is not part of the official AAD Annual Meeting, as planned by its Scientific Assembly Committee. This program does not qualify for continuing medical education (CME) credit.
PROGRAM OVERVIEWPustular psoriasis is a relatively rare form of psoriasis and has historically been classified into generalized and localized forms of the disease.1 Generalized pustular psoriasis is characterized by widespread sterile pustules on erythematous skin, recurrent fever, and systemic flushing and malaise.1,2 Palmoplantar pustulosis, a localized form, is characterized by erythema, pruritis, burning, and pain on the palms of the hands and soles of the feet. Recent evidence suggests that IL36RN mutations are the most common genetic aberration linked to pustular psoriasis, with the allelic frequency distinguishing generalized pustular psoriasis from palmoplantar pustulosis; the former shows a 4 to 1 increase versus the latter.3 Whether pustular psoriasis presents as localized or generalized, patients are subject to significant health risks and poor quality of life outcomes due to both skin and systemic manifestations. Patients may be subject to delays in diagnosis, in part because the disease states are relatively rare and there are little solid epidemiologic data.4 Dermatologists are faced with limited guidance on selecting therapies for patients with any of the pustular psoriasis subtypes.1 Biologic agents for pustular psoriasis and palmoplantar pustulosis are being examined in clinical trials. These include some biologics approved for psoriasis as well as agents with novel therapeutic targets, such as an anti-interleukin (IL)-36 receptor antibody.5 This Clinical Issues symposium will use both lecture and faculty discussion among leading dermatology experts to explore many of these issues, with an emphasis on evolving diagnostic and management strategies for generalized pustular psoriasis and palmoplantar pustulosis.
REFERENCES1. Robinson A, Van Voorhees AS, Hsu S, et al. Treatment of pustular
psoriasis: from the Medical Board of the National Psoriasis Foundation. J Am Acad Dermatol. 2012;67(2):279-288.
2. Fujita H, Terui T, Hayama K, et al. Japanese guidelines for the management and treatment of generalized pustular psoriasis: The new pathogenesis and treatment of GPP. J Dermatol. 2018;45(11):1235-1270.
3. Twelves S, Mostafa A, Dand N, et al. Clinical and genetic differences between pustular psoriasis subtypes. J Allergy Clin Immunol. 2018. [Epub ahead of print.]
4. Benjegerdes KE, Hyde K, Kivelevitch D, Mansouri B. Pustular psoriasis: pathophysiology and current treatment perspectives. Psoriasis (Auckl). 2016;6:131-144.
5. Bachelez H, Choon S, Marrakchi S, et al. Efficacy and safety of BI 655130, an anti-interleukin-36 receptor antibody, in patients with acute generalized pustular psoriasis. Abstract D3T01.1E. EADV Congress; September 12-16, 2018; Paris, France.
This activity is jointly provided by Clinical and Patient Educators Association (CPEA) and Integritas Communications.
This activity is supported by an independent educational grant from Boehringer Ingelheim.
There is no registration fee for attending this program; however, seating is limited. Preregistration does not guarantee seating. We recommend arriving at the symposium location early.
Jeffrey J. Crowley, MD, FAADBakersfield Dermatology and Skin Cancer Medical Group
Bakersfield, California
Neil J. Korman, MD, PhDProfessor of Dermatology Department of Dermatology Case Western Reserve University Director, Clinical Trials Unit Clinical DirectorMurdough Family Center for Psoriasis University Hospitals Cleveland Medical Center
Cleveland, Ohio
Abby S. Van Voorhees, MDChair, Department of Dermatology Eastern Virginia Medical School Norfolk, Virginia
Jeffrey J. CrowleyBakersfield Dermatology and Skin Cancer Medical Group
Bakersfield, California
Neil J. KormanProfessor of Dermatology Department of Dermatology Case Western Reserve University
Abby S. Van VoorheesChair, Department of Dermatology Eastern Virginia Medical School Norfolk, Virginia
2019 BI PSORIASIS NewsAd R1.indd 1 1/29/19 3:53 PM
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4C AAD Annual Meeting News Daily
For patients aged 9 years and older with primary axillary hyperhidrosis
Once-daily QBREXZA is the first and only FDA-approved, topical anticholinergic cloth towelette1
©2019 Dermira, Inc. All rights reserved. PM-US-QBR-0349 01/2019
Reference: 1. QBREXZA™ (glycopyrronium) cloth prescribing information, Dermira.
QBREXZA.com/HCP
Discover
Visit Booth #415
March 2, 2019 at 2:45 PM | Industry Experts Theater | Booth #002
Come Join Our Industry Expert Session and Raise the Bar for Your Patients With Primary Axillary Hyperhidrosis
INDICATION QBREXZATM (glycopyrronium) cloth is an anticholinergic indicated for topical treatment of primary axillary hyperhidrosis in adult and pediatric patients 9 years of age and older.
IMPORTANT SAFETY INFORMATION Contraindications: QBREXZA is contraindicated in patients with medical conditions that can be exacerbated by the anticholinergic effect of QBREXZA (e.g., glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, Sjogren’s syndrome).
WARNINGS AND PRECAUTIONSWorsening of Urinary Retention: QBREXZA should be used with caution in patients with a history or presence of documented urinary retention. Prescribers and patients should be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, distended bladder), especially in patients with prostatic hypertrophy or bladder-neck obstruction. Instruct patients to discontinue use immediately and consult a physician should any of these signs or symptoms develop. Patients with a history of urinary retention were not included in the clinical studies.
Control of Body Temperature: In the presence of high ambient temperature, heat illness (hyperpyrexia and heat stroke due to decreased sweating) can occur with the use of anticholinergic drugs such as QBREXZA. Advise patients using QBREXZA to watch for generalized lack of sweating when in hot or very warm environmental temperatures and to avoid use if not sweating under these conditions.
Operating Machinery or an Automobile: Transient blurred vision may occur with use of QBREXZA. If blurred vision occurs, the patient should discontinue use until symptoms resolve. Patients should be warned not to engage in activities that require clear vision such as operating a motor vehicle or other machinery, or performing hazardous work until the symptoms have resolved.
ADVERSE REACTIONSThe most common adverse reactions seen in ≥2% of subjects treated with QBREXZA were dry mouth (24.2%), mydriasis (6.8%), oropharyngeal pain (5.7%), headache (5.0%), urinary hesitation (3.5%), vision blurred (3.5%), nasal dryness (2.6%), dry throat
(2.6%), dry eye (2.4%), dry skin (2.2%) and constipation (2.0%). Local skin reactions, including erythema (17.0%), burning/stinging (14.1%) and pruritus (8.1%) were also common.
DRUG INTERACTIONSAnticholinergics: Coadministration of QBREXZA with anticholinergic medications may result in additive interaction leading to an increase in anticholinergic adverse effects. Avoid coadministration of QBREXZA with other anticholinergic-containing drugs.
INSTRUCTIONS FOR ADMINISTERING QBREXZAInstruct patients to use one cloth to apply QBREXZA to both axillae by wiping the cloth across one underarm, ONE TIME. Using the same cloth, apply the medication to the other underarm, ONE TIME. Inform patients that QBREXZA can cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes.
Instruct patients to wash their hands with soap and water immediately after discarding the used cloth.
USE IN SPECIFIC POPULATIONSPregnancy: There are no available data on QBREXZA use in pregnant women to inform a drug-associated risk for adverse developmental outcomes.
Lactation: There are no data on the presence of glycopyrrolate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for QBREXZA and any potential adverse effects on the breastfed infant from QBREXZA or from the underlying maternal condition.
Renal Impairment: The elimination of glycopyrronium is severely impaired in patients with renal failure.
Please see Brief Summary of Full Prescribing Information on adjacent page.
QBREXZATM (glycopyrronium) cloth, 2.4%, for topical useThe following is a Brief Summary; refer to Full Prescribing Information for complete product information.
1 INDICATIONS AND USAGEQBREXZA is indicated for topical treatment of primary axillary hyperhidrosis in adult and pediatric patients 9 years of age and older.
2 DOSAGE AND ADMINISTRATION
For topical use only.
QBREXZA is for topical use in the underarm area only and not for use in other body areas.
QBREXZA is administered by a single-use pre-moistened cloth packaged in individual pouches. QBREXZA should be applied to clean dry skin on the underarm areas only. QBREXZA should not be used more frequently than once every 24 hours.
Tear open the pouch and pull out the cloth, unfold the cloth, and wipe it across one entire underarm once. Using the same cloth, wipe the other underarm once. A single cloth should be used to apply QBREXZA to both underarms.
Wash hands immediately with soap and water after applying and discarding the QBREXZA cloth. QBREXZA may cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes. Avoid transfer of QBREXZA to the periocular area [see Warnings and Precautions (5.3)].
Do not apply QBREXZA to broken skin. Avoid using QBREXZA with occlusive dressings.
4 CONTRAINDICATIONS
QBREXZA is contraindicated in patients with medical conditions that can be exacerbated by the anticholinergic effect of QBREXZA (e.g, glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, Sjogren’s syndrome).
5 WARNINGS AND PRECAUTIONS5.1 Worsening of Urinary Retention QBREXZA should be used with caution in patients with a history or presence of documented urinary retention. Prescribers and patients should be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, distended bladder), especially in patients with prostatic hyperplasia or bladder-neck obstruction. Instruct patients to discontinue use immediately and consult a physician should any of these signs or symptoms develop.
Patients with a history of urinary retention were not included in the clinical studies.
5.2 Control of Body Temperature In the presence of high ambient temperature, heat illness (hyperpyrexia and heat stroke due to decreased sweating) can occur with the use of anticholinergic drugs such as QBREXZA. Advise patients using QBREXZA to watch for generalized lack of sweating when in hot or very warm environmental temperatures and to avoid use if not sweating under these conditions.
5.3 Operating Machinery or an AutomobileTransient blurred vision may occur with use of QBREXZA. If blurred vision occurs, the patient should discontinue use until symptoms resolve. Patients should be warned not to engage in activities that require clear vision such as operating a motor vehicle or other machinery, or performing hazardous work until the symptoms have resolved.
6 ADVERSE REACTIONS
The following adverse reactions are described in greater detail in other sections • Worsening of Urinary Retention [see Warnings and Precautions (5.1)]
6.1 Clinical Trials ExperienceBecause 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 two double-blind, vehicle-controlled clinical trials (Trial 1 [NCT02530281] and Trial 2 [NCT02530294]) of 459 subjects treated with QBREXZA once daily and 232 treated with vehicle, subjects were 9 to 76 years of age, 47% male, and the percentages of White, Black (including African Americans), and Asian subjects were 82%, 12%, and 1%, respectively.
Table 1 summarizes the most frequent adverse reactions (≥2%) in subjects with primary axillary hyperhidrosis treated with QBREXZA.
Table 1: Adverse Reactions Occurring in ≥2% of Subjects
Adverse ReactionsQBREXZA (N=459)
n (%)
Vehicle (N=232)
n (%)
Dry mouth 111 (24.2%) 13 (5.6%)
Mydriasis 31 (6.8%) 0
Oropharyngeal pain 26 (5.7%) 3 (1.3%)
Headache 23 (5.0%) 5 (2.2%)
Urinary hesitation 16 (3.5%) 0
Vision blurred 16 (3.5%) 0
Nasal dryness 12 (2.6%) 1 (0.4%)
Dry throat 12 (2.6%) 0
Dry eye 11 (2.4%) 1 (0.4%)
Dry skin 10 (2.2%) 0
Constipation 9 (2.0%) 0
Table 2 shows the most frequently reported local skin reactions, which were relatively common in both the QBREXZA and vehicle groups.
Table 2: Local Skin Reactions
Local Skin ReactionsQBREXZA (N=454)a
n (%)
Vehicle (N=231) a
n (%)
Erythema 77 (17.0%) 39 (16.9%)
Burning/stinging 64 (14.1%) 39 (16.9%)
Pruritus 37 (8.1%) 14 (6.1%)
aPatients with a post-baseline local skin reaction assessment
In an open-label safety trial (NCT02553798), 564 subjects were treated for up to an additional 44 weeks after completing Trial 1 or Trial 2. Adverse reactions occurring at a frequency ≥2.0% were: dry mouth (16.9%), vision blurred (6.7%), nasopharyngitis (5.8%), mydriasis (5.3%), urinary hesitation (4.2%), nasal dryness (3.6%), dry eye (2.9%), pharyngitis (2.2%), and application site reactions (pain [6.4%], dermatitis [3.8%], pruritus [3.8%], rash [3.8%], erythema [2.4%]).
7 DRUG INTERACTIONS7.1 AnticholinergicsCoadministration of QBREXZA with anticholinergic medications may result in additive interaction leading to an increase in anticholinergic adverse effects [see Warnings and Precautions (5) and Adverse Reactions (6)]. Avoid coadministration of QBREXZA with other anticholinergic-containing drugs.
8 USE IN SPECIFIC POPULATIONS8.1 PregnancyThere are no available data on QBREXZA use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. In pregnant rats, daily oral administration of glycopyrrolate (glycopyrronium bromide) during organogenesis did not result in an increased incidence of gross external or visceral defects. When glycopyrrolate was administered intravenously to pregnant rabbits during organogenesis, no adverse effects on embryo-fetal development were seen. The available data do not support relevant comparisons of systemic glycopyrronium exposures achieved in the animal studies to exposures observed in humans after topical use of QBREXZA.
The estimated background risks 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 LactationThere are no data on the presence of glycopyrrolate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for QBREXZA and any potential adverse effects on the breastfed infant from QBREXZA or from the underlying maternal condition.
8.4 Pediatric UseThe safety, effectiveness and pharmacokinetics of QBREXZA have been established in pediatric patients age 9 years and older for topical treatment of primary axillary hyperhidrosis. Use of QBREXZA in this age group is supported by evidence from two multicenter, randomized, double-blind, parallel-group, vehicle-controlled 4-week trials which included 34 pediatric subjects 9 years and older [see Adverse Reactions (6.1)]. The safety and effectiveness of QBREXZA have not been established in pediatric patients under 9 years of age.
8.5 Geriatric UseClinical trials of QBREXZA did not include sufficient numbers of subjects age 65 years and older to determine whether they respond differently from younger subjects.
8.6 Renal ImpairmentThe elimination of glycopyrronium is severely impaired in patients with renal failure.
10 OVERDOSAGE
Because glycopyrronium is a quaternary amine which does not easily cross the blood-brain barrier, symptoms of glycopyrronium overdosage are generally more peripheral in nature rather than central compared to other anticholinergic agents. Associated signs and symptoms related to excessive anticholinergic activity may include flushing, hyperthermia, tachycardia, ileus, urinary retention, loss of ocular accommodation and light sensitivity due to mydriasis.
In the case of overdose when symptoms are severe or life threatening, therapy may include:
• Managing per standard of care any acute conditions such as hyperthermia, coma, and/or seizures, as applicable, and managing any myoclonic or choreoathetoid movements which may lead to rhabdomyolysis in some cases of anticholinergic overdosage
• Managing severe urinary retention with catheterization if not spontaneously reversed within several hours
• Providing cardiovascular support and/or controlling arrhythmias
• Maintaining an open airway, providing ventilation as necessary
• Administering a quaternary ammonium anticholinesterase such as neostigmine to help alleviate severe and/or life threatening peripheral anticholinergic effects.
Topical overdosing of QBREXZA could result in an increased incidence or severity of local skin reactions. Administration of QBREXZA under occlusive conditions may result in an increase in anticholinergic effects, including dry mouth and urinary hesitation.
16.2 Storage and HandlingStore at room temperature 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature].
QBREXZA is flammable; keep away from heat or flame.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Worsening of Urinary Retention Instruct patients to be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, distended bladder). Instruct patients to discontinue use and consult a physician immediately should any of these signs or symptoms develop.
Control of Body Temperature (Risk of Overheating or Heat Illness) In the presence of high ambient temperature, heat illness due to decreased sweating can occur with the use of anticholinergic drugs such as QBREXZA. Advise patients using QBREXZA to watch for generalized lack of sweating when in hot or very warm environmental temperatures and to avoid use if not sweating under these conditions.
Operating Machinery or an Automobile Transient blurred vision may occur with QBREXZA. If this occurs, instruct patients to contact their healthcare provider, discontinue use of QBREXZA and avoid operating a motor vehicle or other machinery, or performing hazardous work until symptoms resolve.
Instructions for Administering QBREXZA It is important for patients to understand how to correctly apply QBREXZA (see Patient Information).
• Instruct patients to use one cloth to apply QBREXZA to both axillae by wiping the cloth across one underarm, ONE TIME.
• Using the same cloth, apply the medication to the other underarm, ONE TIME.
• Inform patients that QBREXZA can cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes.
• Instruct patients to wash their hands with soap and water immediately after discarding the used cloth.
• Remind patients not to apply QBREXZA to other body areas or to broken skin. Instruct patients to avoid using QBREXZA with occlusive dressings.
• QBREXZA is flammable; avoid use near heat or flame.
Manufactured for:
Dermira, Inc. Menlo Park, CA 94025
Version 1, June 2018
PM-US-QBR-0029
S:20.25”
S:13.5”
T:20.75”
T:14”
B:21”
B:14.25”
F:10.375”
FS:9.875”
F:10.375”
FS:9.875”
11101394_AAD_Ann_Mtg_News_M7.indd 1 2/5/19 4:08 PM
PREPARED BY FCB
Job #: 11101394Releasing as: PDFx1a Production: Debi Post X2844
Colors: 4C AD: [email protected]
Client: Dermira Bleed: 21" x 14.25" AE: Tyler Byrne
Product: Qbrexza Finished Size: 10.375" x 14" Producer: Hakeem Williams
Client Code: PM-US-QBR-0349 Trim/Final: 20.75" x 14" QC: L.Powell
Date: February 5, 2019 4:08 PM Live/Safety: 20.25" x 13.50"h Digital Artist: tp, VA, tp, VA, tp, VA, lp
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Path: PrePress:Dermira:11101394:11101394_AAD_Ann_Mtg_News_M7
4C AAD Annual Meeting News Daily
For patients aged 9 years and older with primary axillary hyperhidrosis
Once-daily QBREXZA is the first and only FDA-approved, topical anticholinergic cloth towelette1
©2019 Dermira, Inc. All rights reserved. PM-US-QBR-0349 01/2019
Reference: 1. QBREXZA™ (glycopyrronium) cloth prescribing information, Dermira.
QBREXZA.com/HCP
Discover
Visit Booth #415
March 2, 2019 at 2:45 PM | Industry Experts Theater | Booth #002
Come Join Our Industry Expert Session and Raise the Bar for Your Patients With Primary Axillary Hyperhidrosis
INDICATION QBREXZATM (glycopyrronium) cloth is an anticholinergic indicated for topical treatment of primary axillary hyperhidrosis in adult and pediatric patients 9 years of age and older.
IMPORTANT SAFETY INFORMATION Contraindications: QBREXZA is contraindicated in patients with medical conditions that can be exacerbated by the anticholinergic effect of QBREXZA (e.g., glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, Sjogren’s syndrome).
WARNINGS AND PRECAUTIONSWorsening of Urinary Retention: QBREXZA should be used with caution in patients with a history or presence of documented urinary retention. Prescribers and patients should be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, distended bladder), especially in patients with prostatic hypertrophy or bladder-neck obstruction. Instruct patients to discontinue use immediately and consult a physician should any of these signs or symptoms develop. Patients with a history of urinary retention were not included in the clinical studies.
Control of Body Temperature: In the presence of high ambient temperature, heat illness (hyperpyrexia and heat stroke due to decreased sweating) can occur with the use of anticholinergic drugs such as QBREXZA. Advise patients using QBREXZA to watch for generalized lack of sweating when in hot or very warm environmental temperatures and to avoid use if not sweating under these conditions.
Operating Machinery or an Automobile: Transient blurred vision may occur with use of QBREXZA. If blurred vision occurs, the patient should discontinue use until symptoms resolve. Patients should be warned not to engage in activities that require clear vision such as operating a motor vehicle or other machinery, or performing hazardous work until the symptoms have resolved.
ADVERSE REACTIONSThe most common adverse reactions seen in ≥2% of subjects treated with QBREXZA were dry mouth (24.2%), mydriasis (6.8%), oropharyngeal pain (5.7%), headache (5.0%), urinary hesitation (3.5%), vision blurred (3.5%), nasal dryness (2.6%), dry throat
(2.6%), dry eye (2.4%), dry skin (2.2%) and constipation (2.0%). Local skin reactions, including erythema (17.0%), burning/stinging (14.1%) and pruritus (8.1%) were also common.
DRUG INTERACTIONSAnticholinergics: Coadministration of QBREXZA with anticholinergic medications may result in additive interaction leading to an increase in anticholinergic adverse effects. Avoid coadministration of QBREXZA with other anticholinergic-containing drugs.
INSTRUCTIONS FOR ADMINISTERING QBREXZAInstruct patients to use one cloth to apply QBREXZA to both axillae by wiping the cloth across one underarm, ONE TIME. Using the same cloth, apply the medication to the other underarm, ONE TIME. Inform patients that QBREXZA can cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes.
Instruct patients to wash their hands with soap and water immediately after discarding the used cloth.
USE IN SPECIFIC POPULATIONSPregnancy: There are no available data on QBREXZA use in pregnant women to inform a drug-associated risk for adverse developmental outcomes.
Lactation: There are no data on the presence of glycopyrrolate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for QBREXZA and any potential adverse effects on the breastfed infant from QBREXZA or from the underlying maternal condition.
Renal Impairment: The elimination of glycopyrronium is severely impaired in patients with renal failure.
Please see Brief Summary of Full Prescribing Information on adjacent page.
QBREXZATM (glycopyrronium) cloth, 2.4%, for topical useThe following is a Brief Summary; refer to Full Prescribing Information for complete product information.
1 INDICATIONS AND USAGEQBREXZA is indicated for topical treatment of primary axillary hyperhidrosis in adult and pediatric patients 9 years of age and older.
2 DOSAGE AND ADMINISTRATION
For topical use only.
QBREXZA is for topical use in the underarm area only and not for use in other body areas.
QBREXZA is administered by a single-use pre-moistened cloth packaged in individual pouches. QBREXZA should be applied to clean dry skin on the underarm areas only. QBREXZA should not be used more frequently than once every 24 hours.
Tear open the pouch and pull out the cloth, unfold the cloth, and wipe it across one entire underarm once. Using the same cloth, wipe the other underarm once. A single cloth should be used to apply QBREXZA to both underarms.
Wash hands immediately with soap and water after applying and discarding the QBREXZA cloth. QBREXZA may cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes. Avoid transfer of QBREXZA to the periocular area [see Warnings and Precautions (5.3)].
Do not apply QBREXZA to broken skin. Avoid using QBREXZA with occlusive dressings.
4 CONTRAINDICATIONS
QBREXZA is contraindicated in patients with medical conditions that can be exacerbated by the anticholinergic effect of QBREXZA (e.g, glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, Sjogren’s syndrome).
5 WARNINGS AND PRECAUTIONS5.1 Worsening of Urinary Retention QBREXZA should be used with caution in patients with a history or presence of documented urinary retention. Prescribers and patients should be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, distended bladder), especially in patients with prostatic hyperplasia or bladder-neck obstruction. Instruct patients to discontinue use immediately and consult a physician should any of these signs or symptoms develop.
Patients with a history of urinary retention were not included in the clinical studies.
5.2 Control of Body Temperature In the presence of high ambient temperature, heat illness (hyperpyrexia and heat stroke due to decreased sweating) can occur with the use of anticholinergic drugs such as QBREXZA. Advise patients using QBREXZA to watch for generalized lack of sweating when in hot or very warm environmental temperatures and to avoid use if not sweating under these conditions.
5.3 Operating Machinery or an AutomobileTransient blurred vision may occur with use of QBREXZA. If blurred vision occurs, the patient should discontinue use until symptoms resolve. Patients should be warned not to engage in activities that require clear vision such as operating a motor vehicle or other machinery, or performing hazardous work until the symptoms have resolved.
6 ADVERSE REACTIONS
The following adverse reactions are described in greater detail in other sections • Worsening of Urinary Retention [see Warnings and Precautions (5.1)]
6.1 Clinical Trials ExperienceBecause 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 two double-blind, vehicle-controlled clinical trials (Trial 1 [NCT02530281] and Trial 2 [NCT02530294]) of 459 subjects treated with QBREXZA once daily and 232 treated with vehicle, subjects were 9 to 76 years of age, 47% male, and the percentages of White, Black (including African Americans), and Asian subjects were 82%, 12%, and 1%, respectively.
Table 1 summarizes the most frequent adverse reactions (≥2%) in subjects with primary axillary hyperhidrosis treated with QBREXZA.
Table 1: Adverse Reactions Occurring in ≥2% of Subjects
Adverse ReactionsQBREXZA (N=459)
n (%)
Vehicle (N=232)
n (%)
Dry mouth 111 (24.2%) 13 (5.6%)
Mydriasis 31 (6.8%) 0
Oropharyngeal pain 26 (5.7%) 3 (1.3%)
Headache 23 (5.0%) 5 (2.2%)
Urinary hesitation 16 (3.5%) 0
Vision blurred 16 (3.5%) 0
Nasal dryness 12 (2.6%) 1 (0.4%)
Dry throat 12 (2.6%) 0
Dry eye 11 (2.4%) 1 (0.4%)
Dry skin 10 (2.2%) 0
Constipation 9 (2.0%) 0
Table 2 shows the most frequently reported local skin reactions, which were relatively common in both the QBREXZA and vehicle groups.
Table 2: Local Skin Reactions
Local Skin ReactionsQBREXZA (N=454)a
n (%)
Vehicle (N=231) a
n (%)
Erythema 77 (17.0%) 39 (16.9%)
Burning/stinging 64 (14.1%) 39 (16.9%)
Pruritus 37 (8.1%) 14 (6.1%)
aPatients with a post-baseline local skin reaction assessment
In an open-label safety trial (NCT02553798), 564 subjects were treated for up to an additional 44 weeks after completing Trial 1 or Trial 2. Adverse reactions occurring at a frequency ≥2.0% were: dry mouth (16.9%), vision blurred (6.7%), nasopharyngitis (5.8%), mydriasis (5.3%), urinary hesitation (4.2%), nasal dryness (3.6%), dry eye (2.9%), pharyngitis (2.2%), and application site reactions (pain [6.4%], dermatitis [3.8%], pruritus [3.8%], rash [3.8%], erythema [2.4%]).
7 DRUG INTERACTIONS7.1 AnticholinergicsCoadministration of QBREXZA with anticholinergic medications may result in additive interaction leading to an increase in anticholinergic adverse effects [see Warnings and Precautions (5) and Adverse Reactions (6)]. Avoid coadministration of QBREXZA with other anticholinergic-containing drugs.
8 USE IN SPECIFIC POPULATIONS8.1 PregnancyThere are no available data on QBREXZA use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. In pregnant rats, daily oral administration of glycopyrrolate (glycopyrronium bromide) during organogenesis did not result in an increased incidence of gross external or visceral defects. When glycopyrrolate was administered intravenously to pregnant rabbits during organogenesis, no adverse effects on embryo-fetal development were seen. The available data do not support relevant comparisons of systemic glycopyrronium exposures achieved in the animal studies to exposures observed in humans after topical use of QBREXZA.
The estimated background risks 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 LactationThere are no data on the presence of glycopyrrolate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for QBREXZA and any potential adverse effects on the breastfed infant from QBREXZA or from the underlying maternal condition.
8.4 Pediatric UseThe safety, effectiveness and pharmacokinetics of QBREXZA have been established in pediatric patients age 9 years and older for topical treatment of primary axillary hyperhidrosis. Use of QBREXZA in this age group is supported by evidence from two multicenter, randomized, double-blind, parallel-group, vehicle-controlled 4-week trials which included 34 pediatric subjects 9 years and older [see Adverse Reactions (6.1)]. The safety and effectiveness of QBREXZA have not been established in pediatric patients under 9 years of age.
8.5 Geriatric UseClinical trials of QBREXZA did not include sufficient numbers of subjects age 65 years and older to determine whether they respond differently from younger subjects.
8.6 Renal ImpairmentThe elimination of glycopyrronium is severely impaired in patients with renal failure.
10 OVERDOSAGE
Because glycopyrronium is a quaternary amine which does not easily cross the blood-brain barrier, symptoms of glycopyrronium overdosage are generally more peripheral in nature rather than central compared to other anticholinergic agents. Associated signs and symptoms related to excessive anticholinergic activity may include flushing, hyperthermia, tachycardia, ileus, urinary retention, loss of ocular accommodation and light sensitivity due to mydriasis.
In the case of overdose when symptoms are severe or life threatening, therapy may include:
• Managing per standard of care any acute conditions such as hyperthermia, coma, and/or seizures, as applicable, and managing any myoclonic or choreoathetoid movements which may lead to rhabdomyolysis in some cases of anticholinergic overdosage
• Managing severe urinary retention with catheterization if not spontaneously reversed within several hours
• Providing cardiovascular support and/or controlling arrhythmias
• Maintaining an open airway, providing ventilation as necessary
• Administering a quaternary ammonium anticholinesterase such as neostigmine to help alleviate severe and/or life threatening peripheral anticholinergic effects.
Topical overdosing of QBREXZA could result in an increased incidence or severity of local skin reactions. Administration of QBREXZA under occlusive conditions may result in an increase in anticholinergic effects, including dry mouth and urinary hesitation.
16.2 Storage and HandlingStore at room temperature 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature].
QBREXZA is flammable; keep away from heat or flame.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Worsening of Urinary Retention Instruct patients to be alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, distended bladder). Instruct patients to discontinue use and consult a physician immediately should any of these signs or symptoms develop.
Control of Body Temperature (Risk of Overheating or Heat Illness) In the presence of high ambient temperature, heat illness due to decreased sweating can occur with the use of anticholinergic drugs such as QBREXZA. Advise patients using QBREXZA to watch for generalized lack of sweating when in hot or very warm environmental temperatures and to avoid use if not sweating under these conditions.
Operating Machinery or an Automobile Transient blurred vision may occur with QBREXZA. If this occurs, instruct patients to contact their healthcare provider, discontinue use of QBREXZA and avoid operating a motor vehicle or other machinery, or performing hazardous work until symptoms resolve.
Instructions for Administering QBREXZA It is important for patients to understand how to correctly apply QBREXZA (see Patient Information).
• Instruct patients to use one cloth to apply QBREXZA to both axillae by wiping the cloth across one underarm, ONE TIME.
• Using the same cloth, apply the medication to the other underarm, ONE TIME.
• Inform patients that QBREXZA can cause temporary dilation of the pupils and blurred vision if it comes in contact with the eyes.
• Instruct patients to wash their hands with soap and water immediately after discarding the used cloth.
• Remind patients not to apply QBREXZA to other body areas or to broken skin. Instruct patients to avoid using QBREXZA with occlusive dressings.
• QBREXZA is flammable; avoid use near heat or flame.
Manufactured for:
Dermira, Inc. Menlo Park, CA 94025
Version 1, June 2018
PM-US-QBR-0029
S:20.25”S:13.5”
T:20.75”T:14”
B:21”B:14.25”
F:10.375”
FS:9.875”
F:10.375”
FS:9.875”
11101394_AAD_Ann_Mtg_News_M7.indd 1 2/5/19 4:08 PM
12 DERMATOLOGY WORLD MEETING NEWS • SUNDAY • MARCH 3, 2019
Knocking down morbidity and mortality in pediatric dermatology
A dverse events are part and parcel of the practice of medicine, including
pediatric dermatology. But not all adverse events are created equal. Some are inherent risks of illness and all but impossible to avoid. And some adverse events are the result of errors in diagnosis or treatment, errors that can be avoided.
“There is always room for practice improvement, including in adult, pediatric, surgical, and dermatopathology aspects of dermatology,” said
Carrie C. Coughlin, MD, assistant professor of medicine at Washington University. “The only way we can avoid making the same mistakes or producing the same adverse outcomes is to evaluate events that have happened and use them as teaching points going forward.”
On Friday, Dr. Coughlin moderated “Pediatric Dermatology M&M,” a case-based session that focused on evaluating gaps in communication that can lead to error, learning to distinguish adverse events that are risks of therapy or disease and those that result from error, and discussing strategies for handling and coping with adverse events.
The blameless environmentFour cases explored complications encountered while caring for children in both inpatient and outpatient settings. The key, Dr. Coughlin said, is to create a blameless
environment in which all physicians can learn and improve their own practice. Look for common issues associated with melanocytic lesions in children, infectious complications, and non-accidental trauma, what patients and child safety experts more commonly call child abuse.
The ultimate goal is to improve patient outcomes by improving the care dermatologists deliver in every practice setting.
“These cases are representative of the patients we see both in the outpatient setting and in the hospital,” Dr. Coughlin said. “What is important is exploring how adverse events could be avoided or mitigated. This is information you can use to improve practice quality tomorrow.”
Practical pearlsMelanoma is far less common in children than in adults, but still an important diagnosis to make correctly. Often, the
key is distinguishing between a benign Spitzoid lesion and melanoma. The distinction is not always obvious, especially as melanoma can present differently in children, tweens, and adolescents.
Infectious complications are an everyday occurrence in the inpatient setting. Fungal infections are less common than bacterial infections in most pediatric units, but morbidity and mortality that result from fungal infections can be high without prompt diagnosis and management.
A heightened alertDermatologists are often involved when children are evaluated for non-accidental trauma. It is important to maintain a high index of suspicion when examining children with skin trauma. Even the most plausible tale of accident or denial of any known exposure may turn out to be a case of neglect or intentional harm.
Get your copy of the 2019 Onsite Meeting Guide to find vital meeting information such as:• Key elements• Daily highlights• AAD honors and
awards• Education
information
• Social media platforms
• Exhibit Hall floor plan and exhibitor lists
• Convention center maps
Carrie C. Coughlin, MD
Available in racks throughout the Walter E. Washington Convention Center
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14 DERMATOLOGY WORLD MEETING NEWS • SUNDAY • MARCH 3, 2019
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IndustryExpertsTheater
AAD Food Court
002
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#
3Gen, Inc./DermLite ................................... 1701
5CC (5-Continent-Congress) .......................... 615
A
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Abacosm LTD ............................................. 4347
AbbVie ...............2101, 2111, 5626, 5628, 5630, 5726, 5728, 5730, 5830
Accurate Manufacturing Inc .......................... 428
AccuTec Blades ........................................... 2355
AccuVein .................................................... 1047
Aclaris Therapeutics, Inc ............................... 601
Acuderm..................................................... 2337
AD Surgical ................................................ 4005
Adult & Pediatric Dermatology, PC .............. 4437
Advalight ...................................................... 710
Advanced Dermatology & Cosmetic Surgery ................................ 3919
Advanced MD, Inc. ..................................... 2350
Aerolase ...................................................... 1917
Aesthetics Biomedical ................................. 4206
Allergan .................................. 1909, 2401, 5030
Alma Lasers ................................................ 2009
ALMIRALL ................................................. 4211
Alphaeon Corporation ................................. 2255
AMA-Meditime ........................................... 2257
American Academy of Dermatology ............ 4055
American Board of Dermatology ................. 2319
American Society for Dermatologic Surgery ........................ 1908
American Society for Mohs Surgery ............. 3346
Amgen, Inc. ................................................ 3637
AMP Medical Products, LLC.......................... 715
Amryt Pharma ............................................ 4422
Anne Arundel Dermatology, P.A. ................. 4225
Anthony Products/Gio Pelle ........................ 1100
Aptar Pharma ............................................. 4103
Aquavit Pharmaceuticals, Inc. ..................... 1003
Ascentium Capital LLC ............................... 1222
Asclepion Laser Technologies ...................... 1709
Aurora Diagnostics ....................................... 425
Australasian College of Dermatologists ......... 938
B
Baitella AG ................................................. 2253
Bank of America Practice Solutions ............. 2047
Beiersdorf, Inc. ........................................... 2737
Beijing Sincoheren S&T Development Co., LTD ................................................. 1138
Beijing Syntech Laser Co., Ltd. ...................... 736
Bellaire Industry/Mesopen .......................... 1005
Benev Company Inc. ......................... 1109, 1204
Berkshire Health Systems ............................. 936
Biodermis ................................................... 1319
Biofrontera, Inc. ............................................ 209
Biopelle, Inc ............................................... 3237
BioPharmX ................................................... 502
Biorasi ........................................................ 2455
bioskin GmbH ............................................ 3450
BirdEye ......................................................... 406
Blaine Labs, Inc. ......................................... 3457
BLUECORE COMPANY CO., LTD ................ 301
Boehringer Ingelheim Pharmaceuticals, Inc ..................... 4327, 5128
Boiron ........................................................ 3155
Bovie Medical ............................................. 4009
brandMD Skin Care ...................................... 937
Brazilian Society for Dermatological Surgery ................................................... 2445
Brymill Cryogenic Systems .......................... 2400
BTL ............................................................ 1009
C
Cabana Life ................................................... 814
Caliber Imaging & Diagnostics .................... 2019
Candela ...................................................... 2137
Canfield Scientific ....................................... 1923
Cantabria Labs ............................................ 3261
Capillus, LLC ................................................ 943
CareCredit .................................................. 1509
Cartessa Aesthetics, LLC ............................... 741
Castle Biosciences, Inc. ............................... 3654
Celgene Corporation ......................... 3421, 5928
Certain Dri ................................................. 4412
Chase Merchant Services ............................... 212
CheckedUP................................................. 4423
Chemistry Rx .............................................. 2959
Chemotechnique Diagnostics/ Dormer Laboratories ............................... 2955
Cherry Imaging .......................................... 1813
CLASSYS ...................................................... 201
Cleure ........................................................ 4313
Clinical Resolution Lab, Inc. ........................ 1240
CLN Skin Care (TopMD Skin Care) ............. 4221
CNH Pillow, Inc. ......................................... 1910
Coalition of Skin Diseases ........................... 3913
Cobalt Medical Supply, Inc. ......................... 3451
cocoon medical ............................................. 307
CoLabs Intl Corp ......................................... 2247
Collagen P.I.N. ............................................ 2153
Compulink Healthcare Solutions ................. 4018
COOLA Suncare ......................................... 3260
Coolibar, Sun Protection You Wear .............. 3054
Corrona LLC ............................................... 3356
Cortex Technology Aps ................................ 1136
CRC Press - Taylor & Francis ....................... 1811
Crown Laboratories, Inc. ............................. 3315
Crystal Clear Digital Marketing ................... 2963
CureMD Healthcare ...................................... 825
Cutanea Life Sciences, Inc ..................... 223, 313
Cutera ........................................................ 1501
Cutis & Cosmetic Dermatology ................... 1723
Cutis Diagnostics ........................................ 4011
Cynosure .................................................... 1801
D
Daavlin ....................................................... 3837
Dartmouth-Hitchcock ................................... 746
DefenAge ..................................................... 508
DEKA Medical ............................................ 1609
Delasco ....................................................... 2627
Derma Faith, LLC ....................................... 3160
DermaSculpt -CosmoFrance ........................ 4111
Dermasensa Laboratories, Inc. .................... 4343
DermaSweep .............................................. 1119
Dermatologic Cosmetic Laboratories ........... 2645
Dermatologist, The ..................................... 3911
Dermatology Advisor .................................. 2251
Dermatology Foundation ............................ 2001
Dermatology News ...................................... 1721
Dermatology Times ...................................... 303
Dermira, Inc. ...................................... 415, 5926
DermoScan Inc. .......................................... 4155
Dermpath Diagnostics ................................ 3625
Dermpath Lab of Central States ................... 1818
▼To Hall D
(shown at right)Map sponsored by AbbVie
Exhibit Hall HoursSUNDAY: 10 a.m.-3 p.m.Unoppossed hours: 12-1 p.m.
Data current as of Jan. 10, 2019.
15DERMATOLOGY WORLD MEETING NEWS • SUNDAY • MARCH 3, 2019
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Hall C Entrance
IndustryExpertsTheater
AAD Food Court
002
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INDUSTRY EXPERTS THEATERThese unique sessions provide exhibiting companies the opportunity to present new research findings on products; conduct demonstrations, detail products, and highlight new products. These sessions are solely promotional and are not eligible for continuing medical education credit.
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IndustryExpertsTheater
AAD Food Court
002
Hall B Entrance Hall A Entrance
Hall D
▼TO AAD CONNECTION(Poster Exhibits, Resource Center, Networking Lounge)
DermTec, Inc. ............................................. 2861
Dermwise ................................................... 1142
Designs for Vision, Inc. ................................. 500
Dino-Lite Scopes (BigC) .............................. 3255
Doctor Multimedia ....................................... 200
Doctor.com ................................................. 4405
Dow Development Laboratories ................... 3558
DRE Medical Inc ......................................... 3917
Dubai Business Events .................................. 744
E
eClinicalWorks.............................................. 801
Eclipse .......................................................... 925
Eclipse Loupes and Products ......................... 405
eclipserx ..................................................... 4326
Elite Research Network, LLC ......................... 202
Ellis Instruments ........................................ 2301
ELON Hair, Nails & Skin ............................. 1819
Elsevier ....................................................... 3309
EltaMD SkinCare ........................................ 1325
eMIRAmed USA......................................... 2458
EndyMed Medical Inc ................................. 1209
Envy Medical .............................................. 2943
Epionce ...................................................... 1343
Epiphany Dermatology ................................ 1001
Epocrates, an athenahealth service ............... 4163
eRelevance Corp ......................................... 2357
Espada Dermatology subsidiary of Mission Pharmacal ................................. 1845
EunSung Global Corp ................................... 919
European Academy of Dermatology and Venereology ....................................... 100
Evolus, Inc. ................................................. 2147
Excimer Therapies Inc. ............................... 4319
ExoCoBio Inc. ............................................. 4152
EZDerm, LLC ............................................. 3845
F
FDA Center for Drug Evaluation and Research ............................................ 711
Ferndale Healthcare, Inc. ............................ 3301
FibroTx LLC ................................................ 4108
FineMec Co, Ltd ............................................ 409
Foamix Pharmaceuticals ............................. 4301
Focus Medical ............................................. 1218
Forefront Dermatology .................................. 719
FORMATK Systems Ltd .............................. 2159
Fotofinder Systems, Inc ............................... 2719
Fotona Lasers .............................................. 2545
G
Galderma Laboratories, LP ...... 2601, 5026, 5028
Genentech, a Member of the Roche Group ..................................................... 2725
GliSODin Skin Nutrients ............................ 3357
GluStitch Inc. ............................................... 407
Gold Bond Ultimate ...................................... 519
Grand Aespio Inc. ....................................... 4053
GreenSky Patient Solutions, LLC ................. 4436
Guangzhou Huafei Tongda Technology Co., Ltd ..................................................... 713
H
Haircheck ................................................... 3951
HairMax-Lexington International................. 1815
Hansderma ................................................. 4210
Hayden Medical Instruments ........................ 901
Heine USA Ltd ........................................... 3720
Henkel Consumer Goods ............................ 2637
Henry Schein .............................................. 1103
Hidrex USA ................................................ 4014
Hill Laboratories Co. ................................... 3055
Hill Top Research ....................................... 2451
Hironic Co., LTD .......................................... 507
Huons Global ............................................... 745
HydroPeptide ............................................. 2555
I
Iagnosis Inc./DermatologistOnCall ............. 2457
Ibero Latin American Collage of Dermatology/CILAD ................................. 401
ILOODA Co., Ltd .......................................... 400
To Hall D (shown at right)
Exhibit Hall Hours
Please go to aad.org/meetings or the
AAD Meeting Mobile App for the most
up-to-date exhibitor list.
Brought to you by
©2019 AbbVie Inc. North Chicago, IL 60064 US-RISN-180097 March 2019 Printed in U.S.A.
Brought to you by
©2019 AbbVie Inc. North Chicago, IL 60064 US-RISN-180097 March 2019 Printed in U.S.A.©2019 AbbVie Inc. North Chicago, IL 60064 US-RISN-180097 March 2019 Printed in U.S.A.
EXPERIENCE THE SKY AT BOOTH #2111
16 DERMATOLOGY WORLD MEETING NEWS • SUNDAY • MARCH 3, 2019
Image Skincare ......................................... 2655
INDIBA, S.A. .............................................. 204
Infinity Massage Chairs ............................... 924
Inform Diagnostics ................................... 2819
Inga Ellzey Billing Companies ................... 3957
Innovaderm Research ................................ 2454
Innovative Optics Laser Eye Protection ....... 2104
Integrated Dermatology Group .................. 3015
International Society of Dermatology ......... 4013
Invitrx Therapeutics .................................. 4438
ISDIN ............................................. 1545, 1645
J
JAMA Network, The .................................. 2305
Jan Marini Skin Research .......................... 3819
Janssen Biotech, Inc. ....................... 3801, 5126
Johnson & Johnson Consumer Inc .....................................3401, 5826, 5828
Journal of Clinical and Aesthetic Dermatology ......................................... 4101
Journey Medical Corporation ..................... 4016
K
Kaiser Permanente .................................... 1916
Kamedis ................................................... 4223
Kao USA Inc. (Bio-Oil) .............................. 2660
Kao-Curel ................................................. 2037
Karger Publishers ...................................... 1401
KCD Medical ............................................. 4328
Kernel Medical ............................................ 905
Kyowa Kirin .............................................. 1043
L
L’Oreal ...................................................... 3345
la parfait cosmetics .................................... 4429
Laboratorio Genove ................................... 3561
Laseroptek Co., LTD. ................................. 2461
Laservision ................................................ 4100
LC Cell...................................................... 2354
LearnSkin ................................................... 739
LEO Pharma Inc. 3227, 3825, 5130, 5226, 5230
LIFTLAB Skin Regeneration ...................... 1041
Light Age, Inc. .......................................... 1419
LightStim .................................................... 318
Lilly USA, LLC .......................................... 2751
Lipotec USA, Inc ....................................... 3955
Locks of Love, Inc. ..................................... 2453
Luma Therapeutics, Inc ............................. 2347
Lumenis ................................................... 1837
LUTRONIC ............................................... 1301
M
M.A. Dermaceuticals ................................. 4322
MartiDerm ................................................ 2261
Mastocytosis Society, Inc., The ................... 1141
Mayne Pharma .......................................... 3855
McGraw-Hill Education ............................. 1822
MCV Physicians-VCU Health ....................... 903
MD Charts, Inc. .......................................... 222
MD Cosmetica .......................................... 4161
Med-Aesthetic Solutions Inc. ...................... 3961
MedCo Data ................................................ 837
Medesthetics Magazine................................ 829
Medicol USA ............................................. 3621
Medjet ...................................................... 3945
Medline Industries, Inc. ............................ 3163
Meridian Clinical Research ........................ 4156
Merz ......................................................... 2937
Mesoestetic SL .......................................... 2258
MetaOptima Technology Inc. ..................... 4320
Microsurgery Instruments, Inc. ................. 3820
Midmark Corporation................................ 2901
Millennium Medical Technologies ............... 218
MiraDry, Inc. .............................................. 911
MJ Products Association LLC ....................... 403
Modernizing Medicine, Inc. ....................... 1237
MolluscumRx. ........................................... 3555
MotherToBaby Pregnancy Studies ................ 220
MTI, Inc. .................................................. 2919
MyDermRecruiter/MyMDRecruiter ........... 4315
Myriad Genetic Laboratories, Inc ............... 1002
N
NAOS/Laboratoire Bioderma ........... 3361, 3459
National Biological Corp. ........................... 2025
National Psoriasis Foundation ..................... 408
Nelly De Vuyst Derme & Co ....................... 4119
NeoStrata Company, Inc. ........................... 3411
Neutrogena ............................................... 3600
New Medical Technology, Inc. .................... 1217
NewBeauty ................................................ 4052
NEWPONG CO., LTD ................................ 4407
Nextech..................................................... 1823
NIA24 ...................................................... 1418
NIAMS ..................................................... 1809
NoIR LaserShield ...................................... 1504
NOURITRESS HAIR PRODUCTS ............. 3161
NovaCutis, Inc. ........................................... 708
Novartis Pharmaceuticals Corporation ....... 3021
Novella Clinical ......................................... 1200
Nutrafol .................................................... 4054
O
Obagi Medical Products ............................. 4125
Oculo-Plastik Inc. ...................................... 1000
OCuSOFT Skin Care ................................... 836
Officite ...................................................... 2345
Omni Bioceutical Innovations .................... 2554
Omnilux ................................................... 4104
Ontos, Inc. ................................................ 1004
Ortho Dermatologics ................................. 3001
Otto Trading Inc ............................. 2146, 3254
Oxygenetix Institute Inc. ............................ 3454
P
Palmer’s .................................................... 4309
PCA Skin .................................................. 3661
Peninsula Medical ....................................... 327
PerfAction Technologies ............................ 3761
Perigee ....................................................... 808
Perimed Inc. ............................................. 4105
Perrigo...................................................... 4050
Person & Covey ......................................... 2406
Pfizer Inc. .........1537, 5426, 5428, 5430, 5526, ................................................... 5528, 5530
Pharma Cosmetics, Inc. ............................. 2325
PharmaDerm a division of Fougera Pharmaceuticals .................................... 2925
Philips Respironics.................................... 3256
PhytoCeuticals, Inc. ................................... 1123
Pierre Fabre USA ...................................... 2423
Pinnacle.................................................... 4341
Practical Dermatology ............................... 2346
Practice Flow Solutions ............................. 4317
PracticeLink ................................................ 840
Precision Medical Devices, LLC.................. 4447
ProCell Therapies ...................................... 4012
Procter & Gamble ..................................... 3037
Proinnovera GmbH ................................... 1118
Promius Pharma ....................................... 3351
ProPath Dermatopathology ........................ 1737
Prostemics Co, LTD .................................. 3947
Providence - Provider Solutions + Development ........................................ 210
PSI/Vanicream Skin Care .......................... 1224
Q
Quanta System SPA................................... 1311
Quantificare .............................................. 2550
Quintessence Skin Science ........................ 1137
R
Ra Medical Systems, Inc. ........................... 2307
Red Spot Interactive .................................. 2163
Refine USA ................................................. 841
Regen Lab ................................................... 619
Regeneron/ Sanofi Genzyme .......3645, 5326, 5328, 5330
Restoration Robotics ................................... 625
Revision Skincare ...................................... 3219
Revitalash ................................................. 2444
Robbins Instruments................................. 1500
Rohrer Aesthetics, LLC ................................ 609
Root of Skin MD by AIVITA Biomedical, Inc. ....................................................... 4420
Rose Micro Solutions....................... 1129, 4229
RoyalZ ...................................................... 2262
S
Saalmann medical GmbH & Co, KG .......... 1021
Sanford Health ............................................ 742
SanovaWorks (including JDD) ................... 4010
Sawgio, LLC .............................................. 4227
Scar Heal .................................................. 1127
Schweiger Dermatology Group .................. 4337
SciBase ..................................................... 4110
SCIENTIST SKINLAB LTD. ......................... 426
Sciton ....................................................... 2100
Sebela Pharmaceuticals Inc. ...................... 3257
Sensus Healthcare ..................................... 4201
Sesderma .......................................... 819, 2619
SESHA Skin Therapy ................................ 3058
Shanghai Wonderful Opto-Electrics Tech. Co., Ltd ........................................ 1140
Shantel Medical Supply ............................. 2418
shenb Co., Ltd ............................................. 506
SILAB ....................................................... 3953
Skagit Regional Health ................................ 214
Skin & Cancer Associates/Advanced Dermatology Mgmt ............................... 1236
Skin Cancer Foundation, The .................... 4001
Skin Disease Education Foundation ........... 1719
SkinCeuticals ............................................ 3337
SkinGen International Inc. ........................ 4107
SkinIO ...................................................... 3662
SkylineDX ................................................... 940
SmartPractice ........................................... 2005
SNJ Co., Ltd ................................................ 219
Society of Dermatology Physician Assistants .............................................. 1912
Solumbra by Sun Precautions .................... 1337
Solvital ...................................................... 3159
Speclipse, Inc. ............................................. 208
Springer ................................................... 3910
STRATA Skin Sciences .............................. 1223
Summit Health ......................................... 4044
Sun Pharma .............................................. 4037
Sun Protection Zone ................................. 2118
SurgiTel/General Scientific Corp. ................. 928
Sutter Health .............................................. 740
Symbio LLC .............................................. 3556
Synergy MedSales ....................................... 221
Synteract ................................................... 2909
Syris Scientific .......................................... 1101
T
taberna pro medicum ................................ 3247
Teoxane Laboratories ................................. 2761
Tergus Pharma, LLC .................................. 4208
The HydraFacial Company......................... 4017
Thermi ....................................................... 501
Tiemann-Bernsco ...................................... 3321
Tizo by Fallene, Ltd ................................... 1437
TKL Research ............................................ 1403
Tooti Enterprise Inc. .................................. 3157
Topix Pharmaceuticals, Inc. ....................... 1515
Toskani SL. ............................................... 4061
Total Clinical Trial Management ................ 3061
Tulip Medical Products .............................. 3563
U
U.S. Dermatology Partners ........................ 3557
UCB, Inc. .................................................... 807
Ultra V CO., Ltd .......................................... 216
Under Skin ............................................... 1945
Unilever ................................................... 2437
UV Skinz, Inc. .......................................... 3154
UVBIOTEK ............................................... 1316
V
Vector Surgical .......................................... 1019
Venus Concept USA Inc. ........................... 1201
VERRICA ................................................. 4046
VI Aesthetics ..................................... 737, 5228
Viscot Medical LLC .................................... 1105
VisualDx ................................................... 3721
Vivacare .................................................... 4159
Viviscal Professional .................................. 4321
Vydence Medical ......................................... 712
W
Wallaroo Hat Company ............................. 1037
Water’s Edge Dermatology ......................... 4324
WCD 2019 Milan ........................................ 226
Wells Fargo Practice Finance ..................... 1144
West-TeleVox Solutions .............................. 1727
Wiley ........................................................ 4408
Wolters Kluwer ......................................... 3811
WON TECH Co, Ltd .................................... 227
X
Xstrahl, Inc. .............................................. 2561
Y
Young Pharmaceuticals, Inc. ...................... 4023
Z
Zero Gravity ...................................... 709, 4200
Zhuhai Yasha Bio Technology Company ..... 1045
Zimmer Medizin Systems ......................... 1409
ZO Skin Health, Inc. ................................. 2201
Data current as of Jan. 10, 2019. Please go to aad.org/meetings or the AAD Meeting Mobile App for the most up-to-date exhibitor list.
11106200_AAD_Daily_News_Full_Pg_M2.indd 1 1/25/19 12:50 PM
11106200_AAD_Daily_News_Full_Pg_M2.indd 1 1/25/19 12:50 PM
© 2019 Allergan. All rights reserved. All trademarks are the property of their respective owners.Allergan.com SkinMedica.com 190396 AGE120684 01/19
These SkinMedica® products are intended to meet the FDA’s defi nition of a cosmetic product, an article applied to the human body to cleanse, beautify, promote attractiveness, and alter appearances. These SkinMedica® products are not intended to be drug products that diagnose, treat, cure, or prevent any disease or condition. These products have not been approved by the FDA, and the statements have not been evaluated by the FDA.
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Otezla® is a registered trademark of Celgene Corporation.© 2019 Celgene Corporation 1/19 US-OTZ-19-0021
© 2019 Allergan. All rights reserved. All trademarks are the property of their respective owners.Allergan.com SkinMedica.com 190396 AGE120684 01/19
These SkinMedica® products are intended to meet the FDA’s defi nition of a cosmetic product, an article applied to the human body to cleanse, beautify, promote attractiveness, and alter appearances. These SkinMedica® products are not intended to be drug products that diagnose, treat, cure, or prevent any disease or condition. These products have not been approved by the FDA, and the statements have not been evaluated by the FDA.
BLUE LIGHT EXPOSUREIS HERE TO STAYBUT WITH THE LUMIVIVE™ SYSTEM, SKIN DAMAGE DOESN’T HAVE TO
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OTEZLA®
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Otezla® is a registered trademark of Celgene Corporation.© 2019 Celgene Corporation 1/19 US-OTZ-19-0021
20 DERMATOLOGY WORLD MEETING NEWS • SUNDAY • MARCH 3, 2019
PEARLS FROM MEMBERSSylvia Hsu, MDProfessor and Chair, Department of Dermatology, Temple University Lewis Katz School of Medicine
Potential for medical error
There are no particular conditions that have the
highest potential for medical errors. Rather, based on over two decades of my medical dermatology referral practice, there is one particular type of medical error that does stand out, which I call ‘answer key bias.’ However, the term in the literature is ‘blind obedience.’ This is a type of medical error that occurs when the practitioner places undue reliance on test results. I call it answer key bias because all too often the dermatologist treats the biopsy report as the answer key, rather than examining the patient and asking oneself if the histopathological diagnosis makes sense.”
“Eat, meet, and network at the AAD Food Court11 a.m. -2:30 p.m. Sunday.AAD Exhibit Floor located at the back of Hall C
International food stands offering a variety of healthy and delicious options. Ample seating available. Cash or credit accepted.
Dr. Wolf draws attention to two mystery skin disorders that Sherlock Holmes diagnosed in two of his short stories.
Can the classic detective Sherlock Holmes teach dermatologists a thing or two? The
answer is yes, according to John E. Wolf Jr., MD, MA, professor and chairman of the
department of dermatology at Baylor College of Medicine. Dr. Wolf led the Friday session
“The Game’s Afoot: Sherlock Holmes & The Art of Dermatologic Diagnosis.”
“The Adventure of the Blanched Soldier:” This scaly, white skin condition observed by Sherlock Holmes could be:• Tinea versicolor• Vitiligo• Leprosy• Pityriasis Alba
“The Adventure of the Lion’s Mane:” This condition observed in Sherlock Holmes’ story could be:• A deadly
encounter with a jellyfish (Cyanea capilata, the largest jellyfish in the world found in the deep, cold waters of the North Sea and the English Channel. Death is rare in healthy victims).
• An encounter with a Portuguese man o’ war.
“The temptation to form premature theories upon insufficient data is the bane of our profession.”
Sherlock Holmes, “The Adventure of the
Dying Detective”
T he literary chronicles of Holmes’ adventures hold many references
to dermatologic disorders and even more insights into the crucial art of observation and detection. The session looked at both Holmes’ literature and science, including specific diseases. Dr. Wolf offered clues in this audience participation session. Two of Holmes’ classic short stories, “The Adventure of the Blanched Soldier” and “The Adventure of the Lion’s Mane,” were a focus of Dr. Wolf ’s lessons in the Sherlockian principles of detection and applying these principles to the diagnosis of a wide variety of skin disorders.
“The world is full of observations. Yet, sometimes we look at something and don’t really know what’s there,” Dr. Wolf said. “We look at it, not for it. That’s an important lesson.”
Early clues to dermatologic diagnosis
Download the new AAD Meeting Mobile App
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Find the most up-to-date information at the AAD Meeting Mobile App. The app’s real-time functionality is easy to navigate and includes countless features, including the following:
Download the AAD Meeting Mobile App now in the App Store or on Google Play by searching for “AAD Meetings.” For more information on the app, visit www.aad.org/mobile. For anyone using a platform other than iOS or Android, there will also be a mobile website with limited functionality. Mobile App assistance is available at the Walter E. Washington Convention Center in the Connection, Hall D
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2019 AAD Annual MeetingWashington, D.C. • March 1–5, 2019
Additionally, you can:
EXPERIENCE • EXPLORE • INTERACTat the
AAD Resource Center in Hall D
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• FREE professional headshots taken courtesy of AADCareerCompass. Plus, come take your #AAD2019 selfie!
• Don’t forget our expert staff and Preferred Providers will be on-hand to assist you.
• Receive personalized demos on products such as Dermatology Patient Education Digital subscription, Digital Derm Coding Consult Pro, Board Prep Plus, and Simulated Patient Encounters.
• 10% off select AAD products.
• 20% off one AAD product, see coupon below.
SHOP & SAVEWHAT’S NEW
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* Offer only valid at the AAD Resource Center 3/1/19 – 3/4/19. Present this coupon at time of purchase. Coupon may only be used once and cannot be used on already discounted or previously purchased items. Discount excludes taxes, shipping and handling, meeting registration, membership dues, packs and bundles, JAAD subscription and third-party products. AMRC19
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BOOTH38012019 AMERICAN ACADEMY OFDERMATOLOGY ANNUAL MEETING
March 1 to 5, 2019
Washington, DC
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EXPERIENCE • EXPLORE • INTERACTat the
AAD Resource Center in Hall D
✓ ✓
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✓✓
• Learn about dermatology’s premier clinical data registry, AAD’s DataDerm™.
• AADA’s Practice Management Center has new tools for 2019! Access content to help with coding challenges, combating burnout, and meeting HIPAA requirements.
• FREE professional headshots taken courtesy of AADCareerCompass. Plus, come take your #AAD2019 selfie!
• Don’t forget our expert staff and Preferred Providers will be on-hand to assist you.
• Receive personalized demos on products such as Dermatology Patient Education Digital subscription, Digital Derm Coding Consult Pro, Board Prep Plus, and Simulated Patient Encounters.
• 10% off select AAD products.
• 20% off one AAD product, see coupon below.
SHOP & SAVEWHAT’S NEW
SAVE AT THE AAD RESOURCE CENTER
20% OFFONE AAD PRODUCT*
* Offer only valid at the AAD Resource Center 3/1/19 – 3/4/19. Present this coupon at time of purchase. Coupon may only be used once and cannot be used on already discounted or previously purchased items. Discount excludes taxes, shipping and handling, meeting registration, membership dues, packs and bundles, JAAD subscription and third-party products. AMRC19
Present this coupon and get
Friday, March 1 – Monday, March 48 a.m. – 5 p.m. daily
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BOOTH38012019 AMERICAN ACADEMY OFDERMATOLOGY ANNUAL MEETING
March 1 to 5, 2019
Washington, DC
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24 DERMATOLOGY WORLD MEETING NEWS • SUNDAY • MARCH 3, 2019
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This just in – latest of the late-breaking research
Highlights from “Late-breaking Research: Clinical Trials” (S034) During her late-breaking presentation, Dedee Murrell, MD, head of dermatology at The St. George Hospital Clinical School and the University of New South Wales in Sydney, Australia, shared her research in treating patients with pemphigus and avoiding adverse events associated with the prolonged use of corticosteroids.
“Pemphigus patients want to quickly control the disease with minimal or no corticosteroids or their associated toxicities,” Dr. Murrell said. “Principia’s oral BTK inhibitor, acting as an immune modulator, demonstrated positive phase I and II clinical results.”
Elena Peeva, MD, MSc, FACR, from Pfizer presented research on oral Janus Kinase inhibitors PF-06700841 and PF-06651600. Her work studied the clinically evident therapeutic effect in patients with alopecia areata at four and six weeks and the greater efficacy in patients with a shorter duration of their current alopecia episode over 24 weeks.
“In alopecia areata, oral JAK3 and TYK2/JAK1 inhibitors (PF-06651600 and PF-06700841, respectively) demonstrated onset of effect by six weeks. In a disease-episode shorter than 3.5 years, it was associated with greater 24-week response,” Dr. Peeva said.
In presenting his research of a phase IIb study of bimekizumab in providing “lasting relief” for patients with psoriasis, Andrew Blauvelt, MD, MBA, president of Research Excellence & Personalized Patient Care in Portland, Oregon, said results of his 60-week study yielded positive results.
“This demonstrates the value of the unique dual neutralization of IL-17F, along with IL-17A, and its potential to provide meaningful and lasting skin clearance for psoriasis and other inflammatory diseases,” he said.
In another study of psoriasis, Joel Gelfand, MD, MSCE, a dermatologist with Penn Medicine in Philadelphia, presented his findings on the safety of IL-17A inhibition in reducing the risk of cardiovascular disease.
Psoriasis increases the risk of cardiovascular inflammation and cardiovascular events. Specifically, his results showed that secukinumab has a neutral impact on aortic vascular inflammation and CV biomarkers.
Alice Gottlieb, MD, PhD, a dermatologist at New York Medical College, released the findings of her phase II study for novel therapy bermekimab in patients with hidradenitis suppurativa.
“Bermekimab findings in moderate-to-severe hidradenitis suppurativa show treatment is effective even in patients failing current approved biological therapy, and provides unprecedented reduction in severe pain associated with the disease,” Dr. Gottlieb said.
Similarly, Ted Lain, MD, a dermatologist in Pflugerville, Texas, shared two phase III studies of KX2-391 ointment with short five-day self-treatment for actinic keratosis.
His research yielded excellent efficacy and safety results. KX2-391 may be a valuable alternative treatment for AK patients, if approved, Dr. Lain said.
Highlights from Late-breaking Research: Clinical Studies/Pediatric” (F078)
John Barbieri, MD, a dermatologist in Mason, Ohio, was among the speakers to showcase his research in the Saturday afternoon session. His research, spanning 2008 to 2016, studied the use of antibiotics in dermatology surgery.
“We found that antibiotic use associated with dermatologic procedures is increasing, and there is significant geographic variation, suggesting there may be opportunities to improve use of prophylactic antibiotics associated with procedures,” Dr. Barbieri said.
Lawrence F. Eichenfield, MD, a professor and dermatologist with the University of California, San Diego School of Medicine and Rady Children’s Hospital in San Diego, presented his research on molluscum contagiosum, a common and highly contagious skin infection for which there are no FDA-approved treatments. Current unapproved methods of treatment have significant limitations, including pain, scarring, and unproven efficacy. Many are unsuitable for use in children.
“Verrica has formulated VP-102, a consistent, stable cantharadin product, and has now completed two parallel vehicle-controlled studies that show the efficacy and good tolerability,” Dr. Eichenfield said. “Having an FDA-approved therapy that can minimize molluscum infection would be very helpful for our patients and families.”
Two Saturday afternoon late-breaking sessions put a spotlight on the latest groundbreaking observations in clinical trial research and pediatric clinical studies. These unpublished results offer critical data and information in recent investigations and clinical practice.
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REFERENCES: 1. Takikawa M, Inoue S, Horio F, Tsuda T. Dietary anthocyanin-rich bilberry extract ameliorates hyperglycemia and insulin sensitivity via activation of AMP-activated protein kinase in diabetic mice. J Nutr. 2010;140(3):527-533. 2. Morgan N. What you need to know about xerosis in patients with diabetic feet. Wound Care Advisor. https://woundcareadvisor.com/what-you-need-to-know-about-xerosis-in-patients-with-diabetic-feet_vol2-no4/. Accessed June 25, 2018.
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