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pediatric dermatology Archives | ODAC Dermatology, Aesthetic and Surgical Conference

Long Term Use of Novel Therapeutic for Topical Treatment of Primary Axillary Hyperhidrosis in Pediatric Subjects

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Source: ODAC Dermatology, Aesthetic & Surgical Conference (ODAC) Discovery in Dermatology Poster Session

At the 17th Annual ODAC Dermatology, Aesthetic, and Surgical Conference (ODAC) held January 17-20 in Orlando, FL, Brandon Kirsch, MD, Janet DuBois, MD, Martin N. Zaiac, MD and Deepak Chadha, MS, MBA, RAC presented scientific research of long term data with a novel therapeutic for topical treatment of primary axillary hyperhidrosis in pediatric subjects.

Discovery in Dermatology
The use of retro-metabolically designed drugs in dermatology is novel and has the potential for providing significant therapeutic benefit to pediatric and adult patients.

Sofpironium bromide is an ester analogue of glycopyrrolate that inhibits muscarinic receptors in sweat glands. It was developed according to the principles of retro-metabolic drug design, in which the goal is to create an active compound that is metabolized in vivo to an inactive moiety in a single, predictable reaction. Retro-metabolically designed drugs are rapidly metabolized in the bloodstream, potentially allowing for optimal therapeutic effect at application sites with minimal systemic side effects.

Brickell Bio Ped Data

Introduction
~2.1% of the US population aged <18 years has primary hyperhidrosis (HH); ~65% have axillary HH. Long-term safety/tolerability and efficacy of topical HH treatments have rarely been studied in pediatric patients. Sofpironium bromide is a retro-metabolically designed analog of glycopyrrolate (anticholinergic) in development for topical treatment of primary axillary HH. Absorbed drug is rapidly metabolized, potentially allowing optimal local therapeutic effect with minimal systemic effects..

Procedures
21 of 25 subjects (age 9-16 yrs) with primary axillary HH of ≥6 months duration, completing a previous 1-week safety and pharmacokinetic (PK) study (BBI-4000-CL-105), were enrolled. Objectives were to assess safety/tolerability and PK, and explore efficacy of sofpironium bromide gel, 15% applied to both axillae for 24 weeks.

Results
Mean age (SD) 13.3 (2.29) years. 16 subjects completed this 24-week study. 7 had treatment emergent adverse events (TEAEs); 4 with AEs related to study drug, including expected systemic anticholinergic AEs (blurred vision, dry mouth, dry eyes, mydriasis) and local events (pain, pruritus, rash, erythema). 2 subjects discontinued due to TEAEs, including dry eye, dry mouth, local pruritus, local rash. The majority (52.4%) of subjects did not have any local symptoms/signs, and none observed were severe in nature. PK did not show evidence of drug/major metabolite accumulation, with most subjects having concentrations not quantifiable. The validated patient-reported outcome, Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax), showed mean (SD) change from baseline (from previous study) to Week 24 of this study of -1.91 (1.038). A -1.00 change shows clinically meaningful improvement.

Conclusion
In this 24-week study in pediatric subjects sofpironium bromide, 15% was safe/well tolerated. Majority of subjects had no TEAE, and there were no severe or serious AEs. There was no evidence of drug accumulation. There was indication of clinically meaningful improvement in axillary HH.

Systemic Therapy Options for Pediatric Skin Diseases are Improving

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Kirkorian Pediatric Systemic Disease ODAC

Source: Dermatology News

The following is an excerpt from Dermatology News Expert Analysis, Conference Coverage from ODAC.  

ORLANDO – Because Food and Drug Administration–approved treatment options for children and adolescents with severe dermatologic diseases are limited, systemic therapies for these patients often require the use of off-label medications. However, this scenario is changing, A. Yasmine Kirkorian, MD, said at the ODAC Dermatology, Aesthetic & Surgical Conference.

“I really would like to emphasize that children with severe disease need to be treated,” added Dr. Kirkorian, a pediatric dermatologist at George Washington University, Washington, and Children’s National Health System, where she is interim chief of the division of dermatology.

Current on-label systemic therapies for pediatric skin disease include etanercept for psoriasis (4 years and older), ustekinumab for psoriasis (12 years and older), adalimumab for hidradenitis suppurativa (12 years and older), and omalizumab for chronic idiopathic urticaria (12 years and older). A new addition to the list is dupilumab, which was approved for children and adolescents with atopic dermatitis (AD) aged 12 years and older in 2019, she noted.

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FDA Approval: Corticosteroid-Sparing Topical for Eczema

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Dr. Friedman Presenting at the ODAC Dermatology Conference

Source: Dermatology Times

The FDA announced it has approved Eucrisa (Anacor Pharmaceuticals, crisaborole) ointment to treat mild to moderate eczema in patients two-years-of-age and older.

Applied twice daily, Eucrisa is a phosphodiesterase 4 (PDE-4) inhibitor. Its precise mechanism of action in atopic dermatitis, however, isn’t known, according to an FDA press release.

“We welcome this corticosteroid-sparing topical option,” says Elaine C. Siegfried, M.D., professor of pediatrics and dermatology at Saint Louis University, Cardinal Glennon Children’s Hospital, St. Louis, Mo. “The other two alternatives (pimecrolimus cream and tacrolimus ointment) carry black box warnings and labelled limitation on duration of use. Although most pediatric dermatologists prescribe these medications in infants and children without long-term safety concerns, prescribing Eucrisa is not hampered by this medicolegal burden. However, cost and access could be a limitation.”

Adam Friedman, M.D., associate professor of dermatology and director of translational research in dermatology at George Washington School of Medicine and Health Sciences, tells Dermatology Times that this most recent approval represents the exciting first of hopefully many new approved therapies for an exceedingly common disease state, which until recently was largely ignored.

“I envision crisaborole being used in a similar manner to calcineurin inhibitors, both as proactive treatment for affected delicate areas like the eyelids, face, body folds, groin or mild disease elsewhere. But, more importantly, [I envision it] as preventative maintenance therapy for disease areas that recur frequently after topical steroid use has been discontinued (though without the baggage of a black box warning and possible substance P induced burning at the onset of use),” he says.

Dr. Friedman, who is presenting on the topic of eczema at the January 16 to 19, 2017 Orlando Derm Aesthetic and Clinical conference in Miami, Fla., says this approval, however, should not overshadow the basic and requisite elements for properly managing this often chronic condition. These basics are: clear patient education on a broad range of topics, including realistic expectations; proper soap, moisturizer and treatment use; and myths about treatment safety, in order to gain the patient’s confidence, which in turn, increases the likelihood of regimen compliance, according to Dr. Friedman.

Taming Atopic Dermatitis and Managing Expectations

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Adam Friedman, MD faculty headshot

Source: Dermatology News

Tactics for managing patients with atopic dermatitis can go a long way to educate patients, set realistic expectations, and devise strategies for existing therapies, even as clinicians await some promising agents expected on the market soon.

“The good news is this is the Age of Eczema. In the last couple of years we’ve seen an explosion in the literature,” Adam Friedman, MD, of the department of dermatology, George Washington University, Washington, D.C., said at the Orlando Dermatology Aesthetic and Clinical Conference. Some of this research is spurring new therapeutics. a phosphodiesterase 4 inhibitor.

Crisaborole ointment, 2% (Eucrisa), a phosphodiesterase 4 inhibitor, was approved by the Food and Drug Administration in December 2016 for treating patients aged 2 years and older with mild to moderate AD, for example. It is a novel, nonsteroidal anti-inflammatory and the first prescription agent approved in the United States for atopic dermatitis in more than 10 years.

Dr. Friedman has no personal experience with crisaborole, which just became available. “But the data look encouraging. From what I’ve seen this may be a nonburning alternative to calcineurin inhibitors. It will be interesting to see how this will fit in our practices.”

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