Sonoma Pharmaceuticals, a specialty pharmaceutical company that develops and markets unique and effective solutions for the treatment of dermatological conditions and advanced tissue care, has announced the results of a clinical study evaluating the impact of SebuDerm (topical hypochlorous acid) gel in the treatment of mild to moderate facial and scalp seborrheic dermatitis.
In a 25-patient study, conducted by Zoe Draelos, managing director; and president of dermatology consulting services in High Point, North Carolina, 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.
Author of the study, Zoe Draelos, managing director, commented, “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.”
The IGA of efficacy improvement from baseline was 33% at day 14 and 52% at day 28. The SGA of efficacy improvement from baseline was 62% through day 28.
Dr. Draelos’ clinical study poster is being presented at 13th Annual Maui Dermatology Conference in Maui, Hawaii on March 20-24, 2017. The company received a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the company’s 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.
US 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.”
Sonoma is a specialty pharmaceutical company that develops and markets unique and effective solutions for the treatment of dermatological conditions and advanced tissue care. The company’s products, which are sold throughout the United States and internationally, have improved outcomes for more than five million patients globally by reducing infections, itch, pain, scarring and harmful inflammatory responses. The company's headquarters are in Petaluma, California, with manufacturing operations in the United States and Latin America. European marketing and sales are headquartered in Roermond, Netherlands.