The study results, as well as the results of Sonoma’s previous HOCl acne studies (total of 127 patients), were presented by the principal investigator, Mark Steven Nestor, M.D., Ph.D., who is Director of the Center for Clinical and Cosmetic Research, Aventura Florida and Voluntary Associate Professor in the Departments of Dermatology and Cutaneous Surgery and the Division of Plastic Surgery at the University of Miami Miller School of Medicine in Miami, Florida.
Dr. Nestor said: “This study truly demonstrates that both of these new HOCl products show significant efficacy in the treatment of mild-to-moderate acne.
“And in doing so, both the gel and the solution were extremely well tolerated. Additionally, based on the safety profile of HOCl, I have no problem recommending HOCl topical treatment to young children or women who are pregnant or trying to get pregnant.
“ I can envision a time in the very near future when this will become a standard protocol in the treatment of acne vulgaris either alone or in combination with other treatments.”
The primary objective of the acne vulgaris pilot study was to evaluate the activity of Sonoma’s high-strength Performance-Stabilized HOClTM (both solution and gel) as effective topical products for mild-to-moderate acne vulgaris.
Twenty patients with mild-to-moderate acne vulgaris were treated for 12 weeks with either solution or gel. The use of HOCl solution resulted in a statistically significant decrease in inflammatory (66%: p=0.0002) and non-inflammatory lesions (43%: p=0.002). Sonoma’s HOCl gel also produced a statistically significant decrease in inflammatory (64%: p=0.003) and non-inflammatory lesions (43%: p=0.005).
In terms of product tolerability, both subjective and objective local skin reactions were minimal to non-existent. No adverse events were reported.
This current study confirmed the results of the two prior studies, (n=127 patients), which included comparisons of Sonoma’s HOCl solution to placebo and benzoyl peroxide and showed a similar improvement in the reduction of lesions in both mild-to-moderate and moderate-to-severe acne.
Sonoma plans to initiate in the near term a new double-blind placebo-controlled trial with a larger patient group, investigating the efficacy of Performance-Stabilized HOCl on moderate to severe acne vulgaris.
Sonoma’s Performance-Stabilized HOCl as part of an acne management regimen will become available in the United States in the winter of 2018.
Dr. Nestor serves as Director of the Center for Clinical and Cosmetic Research™ and the Center for Cosmetic Enhancement®, Aventura, Florida. He is a Voluntary Associate Professor in the Department of Dermatology and Cutaneous Surgery and the Department of Surgery, Division of Plastic Surgery at the University of Miami, Miller School of Medicine.
Dr. Nestor is recognized as a world expert in clinical research in most areas of clinical Dermatology and aesthetics including acne, psoriasis, atopic dermatitis, skin cancer, light therapies, cutaneous laser surgery, photodynamic and radiation therapy, lasers and the use of fillers and toxins. As Director for CCCR he has conducted more than 150 clinical trials.
He has authored over 100 articles and book chapters, has delivered over 900 major presentations around the world and is viewed as an internationally acclaimed lecturer and instructor of clinical and cosmetic dermatology. Dr. Nestor has also directed over 100 meetings and symposia on various topics in the field of cosmetic dermatology, laser surgery and practice management.
Dr. Nestor also serves as a consultant to numerous pharmaceutical and device companies assisting them in the development of new medications, devices and cosmeceuticals.
Source: Company Press Release