Meta-Analysis of Randomized Controlled Trials Shows Faster
Improvement in Non-Inflammatory Lesions in Weeks 2 – 4 with 5 Percent
Solubilized BPO vs. Benzoyl Peroxide and Clindamycin Topical Treatments
Today Obagi Medical Products, Inc. (Nasdaq:OMPI), the leader in topical
aesthetic and therapeutic skin health systems, announced the results of
a meta-analysis of 23 randomized controlled clinical trials (RCTs) that
compared the company’s patented solubilized 5 percent BPO (sBPO) against
existing 5 percent BPO, 1-1.2 percent clindamycin (CL) and combination
BPO/CL products in reducing acne lesions. The announcement was made at
the American Academy of Dermatology’s (AAD) Summer Academy Meeting in
Boston, Mass. The data from the meta-analysis, using data adjusted for
each study’s size, shows that this new 5 percent sBPO has an equal to
superior lesion reduction profile when compared to the leading
prescription BPO, combination BPO/CL and topical CL products.
“Our findings indicate that the use of this BPO regimen is as effective
as similar acne treatments on the market today and appears to work
faster in reducing non-inflammatory lesions,” says Alexa Kimball, MD,
MPH, board-certified dermatologist and director of the Clinical Unit for
Research Trials in Skin, Massachusetts General Hospital, and Associate
Professor, Harvard Medical School in Boston, Mass. “These results may be
due to the solubilized BPO formulation’s improved ability to penetrate
the hair follicle.”
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NON-INFLAMMATORY LESION REDUCTION
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TREATMENT
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WEEK 2 -4
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WEEK 10-12
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5% sBPO
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42.7%
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47.7%
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5% BPO
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19.1%
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30.9%
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1-1.2% CL
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10.0%
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32.6%
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BPO/clindamycin
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26.2%
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40.3%
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INFLAMMATORY LESION REDUCTION
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TREATMENT
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WEEK 2 -4
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WEEK 10-12
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5% sBPO
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55.2%
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51.8%
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5% BPO
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33.4%
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43.7%
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1-1.2% CL
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21.5%
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45.9%
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BPO/clindamycin
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40.7%
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55.6%
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“For years, physicians have struggled with providing their acne patients
with a treatment that provides fast results with minimal side effects,”
said Jim Hartman, Vice President of Marketing at Obagi Medical Products.
“Considering the desire to minimize exposure to topical and systemic
antibiotics, we are pleased to see the results of this meta-analysis
that indicate a topical antibiotic may not be needed in the treatment of
acne.”
Study Methodology
A meta-analysis following the Cochrane collaboration guidelines in
accordance with the PRISMA statement was conducted. Data sources
included the PubMed database from 1987 to the present, FDA summaries for
the basis of drug approval, and posters and unpublished statistical
analyses of studies where available. This analysis included randomized
controlled trials (RCTs) that treated subjects with either 5% BPO,
1-1.2% CL or combination BPO/CL. Studies included endpoints of actual
lesion reduction and/or percent lesion reduction of inflammatory and/or
non-inflammatory lesions at 2-4 weeks and/or 10-12 weeks. Search
criteria included 124 potential RCTs. After review, 23 RCTs met all
inclusion and exclusion criteria and were deemed valid to include in the
meta-analysis. Data was grouped by type of topical treatment and
endpoint (at 2-4 weeks, 5% sBPO: n=4 studies, s=210 subjects, 5% BPO:
n=10, s=824, 1-1.2% CL: n=14, s=3143, combination BPO/CL: n=15, s=1923,
placebo: n=9, s=1308). The overall mean percent reduction and actual
reduction in inflammatory and non-inflammatory lesion counts were
calculated at 2-4 and 10-12 weeks.
About Solubilized Benzoyl Peroxide
Obagi Medical’s proprietary, solubilized BPO, known as SoluZyl
Technology, is 1/10,000 the size of any other benzoyl peroxide molecule
available, so it can penetrate deep into the root of the follicle and
treat acne where it starts. Obagi Medical’s solubilized 5% BPO is
clinically proven to kill more P. acnes bacteria faster than the
leading gel BPO/antibiotic combination product.
The solubilized BPO is available in both gel and lotion forms and can be
purchased individually or as part of a CLENZIderm M.D. Acne Therapeutic
System. The Systems come in two formulations, one for normal to oily
skin patients (Gel) and one for normal to dry skin patients (Lotion).
The CLENZIderm M.D. Systems are not available over the counter and can
only be obtained through physician offices.
About Obagi Medical Products, Inc.
Obagi Medical Products develops and commercializes skin health products
for the dermatology, plastic surgery, and related aesthetic markets.
Using its Penetrating Therapeutics™ technologies, Obagi Medical's
products are designed to improve penetration of agents across the skin
barrier for common and visible skin conditions in adult skin including
chloasma, melasma, senile lentigines, acne vulgaris and sun damage. The
history of Obagi's skin care product introductions is as follows: Obagi
Nu-Derm®, 1988; Obagi-C® Rx (the first and only prescription-strength
vitamin C and hydroquinone system), 2004; Obagi® Professional-C (a line
of highly stable vitamin C serums), 2005; Obagi® Condition and Enhance
for use with cosmetic procedures to enhance patient outcomes and
satisfaction, 2006; Obagi ELASTIderm™ eye treatment and Obagi
CLENZIderm® M.D. acne therapeutic systems, 2007; a formulation of Obagi
CLENZIderm® M.D. Systems for normal to dry skin, June 2007; and Obagi
ELASTIderm™ Décolletage System, January 2008, and Obagi Rosaclear™
System in January 2009. Visit www.obagi.com
for information.
Forward Looking Statements
There are forward-looking statements contained herein, which can be
identified by the use of forward-looking terminology such as the words
"believes," "expects," "may," "will," "should," "potential,"
"anticipates," "plans," or "intends" and similar expressions. Such
forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause actual results, events or
developments to be materially different from the future results, events
or developments indicated in such forward-looking statements. Such
factors include, but are not limited to the intense competition our
products face and will face in the future, the level of market
acceptance of our products, the possibility that our products could be
rendered obsolete by technological or medical advances, the possibility
that we may become involved in intellectual property claims and
litigation that could adversely affect the profitability of or our
ability to sell our products, the possibility that our products may
cause undesirable side effects and the fact that our ability to
commercially distribute our products may be significantly harmed if the
regulatory environment governing our products changes. A more detailed
discussion of these and other factors that could affect results is
contained in our filings with the U.S. Securities and Exchange
Commission, including our Form 10-K for the year ended December 31,
2008. These factors should be considered carefully and readers are
cautioned not to place undue reliance on such forward-looking
statements. No assurance can be given that the future results covered by
the forward-looking statements will be achieved. All information in this
press release is as of the date of this press release and Obagi Medical
Products does not intend to update this information.
Press Contact:
Creative Media Marketing
Lori
Tomonari, 212-979-8884
LoriT@cmmpr.com
or
Investor
Contact:
OMP, Inc.
Preston Romm, Chief Financial Officer,
562-256-1007