Sonoma Pharmaceuticals Announces Newly Published Results from Study of Hypochlorous Acid in Management of Hypertrophic and Keloid Scars
PETALUMA, Calif., Oct. 25, 2018 (GLOBE NEWSWIRE) -- Sonoma Pharmaceuticals, Inc. (Nasdaq: SNOA), today announced newly published results from a study into the use of the company’s proprietary Performance Stabilized HOClTM (hypochlorous acid) for the management of scars. The newly published data, sponsored by Sonoma Pharmaceuticals, was presented in a lecture/poster by Dr. Mark Steven Nestor, MD, PhD, Director of the Center of Cosmetic Enhancement and Director of the Center for Clinical and Cosmetic Research; both within the Miami Miller School of Medicine in Miami, Florida. Dr. Nestor presented the poster at the Beaver Creek Dermatology Conference in Beaver Creek, Colorado in August 2018.
The original double-blind, multi-center randomized scar study was conducted in 2013 by Alicia D. Bucko, DO, CPI; Zoe Draelos, MD; Janet C. Dubois, MD and Terry Jones, MD. The 40-patient study was conducted at four U.S. investigative sites over 16 weeks, ending March 2013. Qualified scars included linear or widespread hypertrophic or keloid scars. Scars were evaluated using the validated Vancouver Scar Scale (VSS). The investigator and each subject (40 subjects) completed the VSS and symptom evaluators at each of the five evaluation visits. Overall efficacy was assessed with the Investigator Global Assessment (IGA) at baseline and again on day 56 (end of treatment) and on day 112.
The primary objective of the scar study was to compare the results of treating hypertrophic and keloid scars with Sonoma’s proprietary Performance Stabilized HOCl with silicone gel versus ordinary silicone gel. Silicone-based products are currently recommended as the first-line option for preventing and treating excessive scarring after surgery or trauma.
HOCl plus silicone gel and plain silicone gel both improved hypertrophic scar parameters including vascularity, pliability, height, pain and itch. The mean VSS among subjects treated with HOCl plus silicone gel decreased from 6.2 at baseline to 3.5 at day 112. The mean VSS among subjects treated with plain silicone gel decreased from 5.78 at baseline to 3.94 at day 112. The mean VSS among subjects decreased by 43.5% and 31.8% among subjects treated with the HOCl plus silicone gel and silicone gel, respectively. The IGA scores for HOCl plus silicone gel were superior to silicone gel alone at a 95% confidence level at both 84 and 112 days. In summary, HOCl plus silicone gel is more effective for treating hyperthrophic scars and demonstrated superiority over silicone gel as a single agent. Further information on the study and the newly published data can be accessed at http://ir.sonomapharma.com/static-files/71a75ee7-27cb-477a-9a9a-90cd610e6eb0.
“These results are most compelling,” Dr. Mark Steven Nestor said. “We know the vast majority of scars can be effectively managed if treated consistently and with the latest technologies available. These HOCl-based products are a potentially landscape-altering shift in scar treatment moving forward and will likely become a standard of care.”
The Performance Stabilized HOCl-based Celacyn® Rx Scar Management Gel from Sonoma Pharmaceuticals is now available by prescription through leading U.S. dermatologists. For more information or to order visit: http://intraderm.com/celacyn-scar-management-gel/.
Scar Treatment Market
According to a 2003 report by Frost & Sullivan, it is estimated that 62 million scars are formed each year in the United States. There are about 93 million people in the United States suffering from scars, out of which about 169 million scars can be characterized as hypertrophic (raised) and keloid (red colored) scars. The raised and red scars market forms the primary target for the scar therapy products. Annually, about 600,000 visits for burns and more than 2.6 million emergency room visits for cut injuries, this forms the potential market for the scar therapy products. The statistics show that out of 6.2 million reconstructive procedures performed on patients in a year, 250,000 surgeries are related with scar revisions.
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 “managed,” “treated,” and “become,” 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.
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Released October 25, 2018