Lead Researcher Mark Steven Nestor, M.D., Ph.D. Presented the Results of the Study at the Practical Symposium Dermatology Conference August 9-12, 2018
PETALUMA, Calif., Aug. 28, 2018 (GLOBE NEWSWIRE) -- Sonoma Pharmaceuticals, Inc. (Nasdaq: SNOA), today announced that results from a study into the use of the company’s proprietary high-strength Performance-Stabilized HOClTM in the management of acne vulgaris were presented at the Practical Symposium Dermatology Conference in Colorado. (http://intradermeu.com/downloads/IntraDerm_AcnePoster_v3_08-02-18.pdf ) and https://www.ncbi.nlm.nih.gov/pubmed/19459079). 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.
“This study truly demonstrates that both of these new HOCl products show significant efficacy in the treatment of mild-to-moderate acne,” said Dr. Nestor. “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. (Tirado-Sanchez A, Ponce-Olivera: “Efficacy and Tolerance of Superoxidized Solution in the Treatment of Mild to Moderate Inflammatory Acne. A Double-Blinded, Placebo-Controlled, Parallel-Group, Randomized, Clinical Trial.” J Derm Treatment 20, (5) 289-292, 2009 and 2) Draelos A. “The Efficacy and Tolerability of a Novel Acne Treatment.” Sonoma Study Report, October 2016).
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.
Mark S. Nestor, M.D., Ph.D.
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.
About Sonoma Pharmaceuticals, Inc.
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. More information can be found at www.sonomapharma.com.
Except for historical information herein, matters set forth in this press release are forward-looking within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including statements about the commercial and technology progress and future financial performance of Sonoma Pharmaceuticals, Inc. and its subsidiaries (the “Company”). These forward-looking statements are identified by the use of words such as “demonstrates,” “recommending,” and “envision,” among others. Forward-looking statements in this press release are subject to certain risks and uncertainties inherent in the Company’s business that could cause actual results to vary, including such risks that regulatory clinical and guideline developments may change, scientific data may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, protection offered by the Company’s patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Company’s products will not be as large as expected, the Company’s products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to meet the Company’s cash needs, fund further development and clinical studies, as well as uncertainties relative to varying product formulations and a multitude of diverse regulatory and marketing requirements in different countries and municipalities, and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission. The Company disclaims any obligation to update these forward-looking statements, except as required by law.
Sonoma Pharmaceuticals™ and Performance-Stabilized HOClTM are trademarks or registered trademarks of Sonoma Pharmaceuticals, Inc. All other trademarks and service marks are the property of their respective owners.
Sonoma Pharmaceuticals, Inc.