Positive Results Announced from SebuDerm Gel Study in Treatment of Seborrheic Dermatitis
The results of a clinical study evaluating the impact of Sonoma Pharmaceuticals, Inc.'s SebuDerm (topical hypochlorous acid) gel in the treatment of mild to moderate facial and scalp seborrheic dermatitis were presented at the 13th Annual Maui Dermatology Conference in Maui, HI.
In a 25-patient study, conducted by Zoe Draelos, MD, president of Dermatology Consulting Services in High Point, NC, two key metrics were utilized in assessing efficacy of SebuDerm; the first being the investigator’s global assessment (IGA) of efficacy improvement in appearance and symptoms from baseline; and secondly, the subject global assessment (SGA) of improvement in itching, burning and stinging. No adverse effects were reported and overall treatment was well tolerated by the subjects.
“Seborrheic dermatitis is a common condition afflicting men and women of all ages that is challenging for dermatologists to treat. While treatment options exist, recurrence is common and few options exist for disease maintenance. A new addition to the dermatologist’s armamentarium will be welcomed," Dr. Draelos said.
The IGA of efficacy improvement from baseline was 33 percent at day 14 and 52 percent at day 28. The SGA of efficacy improvement from baseline was 62 percent through day 28.
The company received a new 510(k) clearance from the FDA for SebuDerm Gel as a prescription product, intended to manage and relieve the burning, itching, erythema, scaling, and pain experienced with seborrhea and seborrheic dermatitis in December 2015.
U.S. commercialization is underway via Sonoma’s dermatology division IntraDerm Pharmaceuticals’ 30-plus-person direct sales team. Sonoma is also in discussions with prospective international distributors and partners to bring this advanced technology to dermatology patients throughout the globe, including Asia, Latin America and the Middle East.
“Our new SebuDerm gel adds a valuable tool to the dermatologist’s bag when it comes to combatting both seborrhea and seborrheic dermatitis,” said Jeffrey Day, president of IntraDerm Pharmaceuticals. “Nearly a quarter of the general population is afflicted with seborrheic dermatitis and we hope to impress our physician customers with our terrific new treatment option in SebuDerm.”