Obagi Medical Products' CLENZIderm M.D. Serum Gel Significantly Reduces Non-Inflammatory Lesions with Visible Results as Early as Week One
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
BOSTON--(BUSINESS WIRE)--Jul 30, 2009 - 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.”
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.
|TREATMENT||WEEK 1 REDUCTION||WEEK 4 REDUCTION||WEEK 12 REDUCTION|
|5% Solubilized BPO serum gel||26% (P‰¤ .05)||42%||57%|
|5% BPO/1% clindamycin||3%||28%||46%|
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.
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Posted: July 2009