Cosmetic Dermatology Publishes Data Highlighting the Benefits of CLENZIderm M.D. Systems for Acne
LONG BEACH, Calif.--(BUSINESS WIRE)--Apr 28, 2008 - Obagi Medical Products, Inc. (Nasdaq:OMPI), a leader in topical aesthetic and therapeutic skin health systems, announced today the publication of a study of CLENZIderm M.D.(TM) Acne Therapeutic System in the April 2008 issue of Cosmetic Dermatology. The study included three clinical trials of patients with mild-to-moderate acne. According to the publication, the 3-step CLENZIderm M.D.(TM) Acne Therapeutic System and modified regimens of the system that included the solubilized serum gel appear to be more effective than the combination BPO and clindamycin gel (jar gel formulation) in reducing non-inflammatory lesions, and at least as effective as the BPO and clindamycin gel in reducing inflammatory lesions.The novel solubilized BPO gel, used alone or as part of the 3-step acne-treatment system, offers an effective and well-tolerated approach to treating acne vulgaris. Compared to other BPOs, the solubilized formulation better penetrates the skin follicles, which initiates greater and more rapid reduction of acne lesions. High levels of patient satisfaction with solubilized BPO gel regimens were also observed in these clinical trials.
"These data show that the solubilized benzoyl peroxide incorporated in the CLENZIderm MD System is very effective for treating acne," said investigator James Q. Del Rosso, DO, FAOCD, Clinical Assistant Professor in the Department of Dermatology at the University of Nevada School of Medicine. "Importantly, this formulation demonstrates the ability to reduce both inflamed and non-inflamed acne lesions."
The Obagi Medical Products 3-step acne system, branded CLENZIderm M.D. Systems, contain 5% solubilized BPO, which helps aid in the follicular penetration of BPO. Traditional BPO formulations are poorly soluble, existing primarily as macrocrystals, many of which may be too large to enter the follicles and eliminate the bacteria that causes acne.
"The CLENZIderm MD technology has allowed us to improve overall treatment of acne without the need or risk of antibiotics," said Steven Carlson, Chief Executive Officer of Obagi Medical Products. "The solubilized BPO penetrates pores quickly and effectively. We're proud that Obagi continues to be at the forefront of such dermatological advancements."
Data and Methodology
Data were pooled from 111 patients who participated in 1 of 3 randomized investigator-blinded trials evaluating the use of the following products. Depending on the trial, each treatment was applied once or twice daily for 2 to 4 weeks. Patients were randomized to receive:
-- Solubilized 5% BPO gel alone,
-- Solubilized 5% BPO gel along with 2% salicylic acid toner and/or 2% salicylic acid cleanser (3-step acne-treatment system), or
-- A combination BPO and clindamycin gel product.
Non-inflammatory Lesions
The mean percent reduction in noninflammatory lesion count was greater with the solubilized 5% BPO regimens than with BPO and clindamycin gel at both week 2 and week 4. -0-
TREATMENT WEEK 2 REDUCTION WEEK 4 REDUCTION ---------------------------------------------------------------------- 3-step acne-system 37% 51% ---------------------------------------------------------------------- Solubilized BPO gel alone 29% 42% ---------------------------------------------------------------------- BPO and clindamycin gel 16% 28% ----------------------------------------------------------------------
Inflammatory Lesions
The mean reduction in inflammatory lesion count was comparable across all 3 regimens at week 2, exhibiting a range of 48% to 52%. At week 4, the mean reduction in inflammatory lesions was 65% with the 3-step acne-treatment system, 70% with solubilized BPO gel, and 61% with BPO and clindamycin gel. -0-
TREATMENT WEEK 2 REDUCTION WEEK 4 REDUCTION ---------------------------------------------------------------------- 3-step acne-system 48% 65% ---------------------------------------------------------------------- Solubilized BPO gel alone 52% 70% ---------------------------------------------------------------------- BPO and clindamycin gel 48% 61% ----------------------------------------------------------------------
About the CLENZIderm M.D. Systems
The CLENZIderm M.D. Systems, which use proprietary ingredients, have two formulations based on skin type. The CLENZIderm(TM) System for normal-to-oily skin includes salicylic acid cleanser, toner and the 5% solubilized BPO gel. The CLENZIderm M.D. System for normal-to-dry skin includes a gentle cream cleanser, a therapeutic lotion containing solubilized 5% BPO and a therapeutic moisturizer with 20% glycerin.
The CLENZIderm M.D. Systems are not available over the counter and can only be obtained through the physician office.
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(TM) 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(TM), 1988; Obagi-C Rx(TM) (the first and only prescription-strength vitamin C and hydroquinone system), 2004; Obagi Professional-C(TM) (a line of highly stable vitamin C serums), 2005; Obagi Nu-Derm(TM) Condition and Enhance for use with cosmetic procedures to enhance patient outcomes and satisfaction, 2006; Obagi ELASTIderm(TM) eye treatment and Obagi CLENZIderm M.D.(TM) acne therapeutic systems, 2007; a formulation of CLENZIderm M.D.(TM) Systems for normal to dry skin, June 2007; and ELASTIderm(TM) Decolletage System, January 2008. Obagi's products are only available through physicians. 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, 2007. 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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