Final Data from a 12-Week Study Shows a Significant Reduction in
Non-Inflammatory Lesions with the Use of CLENZIderm M.D. Serum Gel vs.
Combination Prescription BPO/Clindamycin Product
Today Obagi Medical Products, Inc. (Nasdaq:OMPI), the leader in topical
aesthetic and therapeutic skin health systems, announced the successful
completion of a 12-week study comparing CLENZIderm M.D.TM
Serum Gel to a leading combination prescription benzoyl peroxide
(BPO)/clindamycin product. The announcement was made at the American
Academy of Dermatology’s (AAD) Summer Academy Meeting in Boston, MA. Of
the 65 enrolled patients, 23 received four weeks of treatment (100
percent compliance) and 42 received 12 weeks of treatment (88 percent
compliance). The data of the multicenter, investigator-blind,
randomized, split-face study shows that patients with moderate facial
acne vulgaris experienced significantly greater reductions in
non-inflammatory lesions when using the CLENZIderm M.D. Serum Gel when
compared to the leading topical BPO/clindamycin product.
“The use of CLENZIderm M. D. Serum Gel in this study resulted in faster
onset of results, showing a greater reduction in non-inflammatory
lesions in weeks one through four. In treating a disease like acne that
can cause significant emotional distress, I want to treat my patients
with a product that I know will give them rapid improvement,” says
investigator Leon Kircik, MD, of Physicians Skin Care in Louisville,
Kentucky, and fellow of the American Academy of Dermatology. “Results of
the study also showed continued improvement through week 12 with the use
of CLENZIderm M.D. Serum Gel.”
“The results of this study indicate that Obagi Medical Products’ novel
solubilized BPO technology may improve the treatment options available
for the 17 million acne patients in the U.S.,” says James P. Hartman,
Vice President of Marketing for Obagi Medical Products. “With the
growing issue of antibiotic resistance, creating this technology that
penetrates the follicle and reduces acne flare-ups quickly and
effectively without the need for antibiotics allows OMP to offer an
alternative in the treatment of acne.”
Study Methodology
Participants in the comparison study ranged in age from 11-45 years of
age and exhibited moderate facial acne vulgaris (25-100 non-inflammatory
lesions, 25-100 inflammatory lesions and up to 2 nodulocystic lesions on
the face). Patients applied CLENZIderm M. D. Serum Gel to one facial
side and the BPO/clindamycin product on the contralateral side, twice
daily for the duration of the study. Of the 23 subjects enrolled in the
4-week study, all completed the study. Of the 42 subjects enrolled in
the 12-week study, 37 (88%) completed the study.
During the first four weeks of treatment, reductions in non-inflammatory
lesion count were significantly greater with the CLENZIderm M.D. Serum
Gel regimen than the BPO/clindamycin regimen. The reduction in
inflammatory lesion count was comparable in both groups throughout the
study. At the close of the 12-week study the area treated with
CLENZIderm M.D. Serum Gel showed a 57 percent reduction versus a 46
percent reduction in non-inflammatory lesions on the area treated with
BPO/clindamycin. Levels of patient satisfaction, based on improvement in
their acne, erythema, dryness, peeling, stinging/burning and itching,
were comparable in both groups.
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NON-INFLAMMATORY LESIONS
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TREATMENT
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WEEK 1 REDUCTION
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WEEK 4 REDUCTION
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WEEK 12 REDUCTION
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5% Solubilized BPO serum gel
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26% (P≤ .05)
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42%
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57%
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5% BPO/1% clindamycin
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3%
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28%
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46%
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About Solubilized Benzoyl Peroxide
OMP’s proprietary, solubilized BPO, leveraging 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
Relations Contact:
OMP, Inc.
Preston Romm, Chief Financial
Officer
562-256-1007