Sonoma Pharmaceuticals Announces Results from Study of Sonoma’s Performance-Stabilized HOCl™ (Hypochlorous Acid) in Manag...
August 28 2018 - 7:05AM
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.
Forward-Looking StatementsExcept 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.
Investor Contact:
Sonoma Pharmaceuticals,
Inc.Bob MillerCFO(925) 787-6218
Sonoma Pharmaceuticals (NASDAQ:SNOA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Sonoma Pharmaceuticals (NASDAQ:SNOA)
Historical Stock Chart
From Apr 2023 to Apr 2024