Healthcare Industry News: Clindamycin
News Release - February 1, 2008
Obagi Medical Products' Solubilized Benzoyl Peroxide Provides Clinically Significant Lesion Reduction for Mild to Moderately Severe AcneData from four studies show significant acne lesion reduction and patient satisfaction with the use of CLENZIderm M.D. Acne Therapeutic Systems on all skin types
SAN ANTONIO, Feb. 1 (HSMN NewsFeed) -- Obagi Medical Products, Inc. (Nasdaq: OMPI ), a leader in topical aesthetic and therapeutic skin health systems, announced the results of four studies of the CLENZIderm M.D.(TM) Acne Therapeutic Systems' two proprietary 3-step acne treatments, today at the 66th Annual Meeting of the American Academy of Dermatology in San Antonio. The data show that patients of all skin types with mild-to-moderately severe acne saw significant improvement in inflammatory and non-inflammatory lesions and reported high levels of patient satisfaction, lower levels of dryness and greater comfort when using the innovative formulation of solubilized 5% benzoyl peroxide (BPO) in the CLENZIderm M.D.(TM) Systems.
Key findings of the studies:
Two Studies of the Solubilized 5% BPO Serum Gel for Normal-to-Oily Skin
-- The first study showed that when compared to twice-daily treatment with a leading BPO/Clindamycin combination product, the twice-daily monotherapy with the solubilized 5% BPO serum gel (CLENZIderm M.D.) resulted in a greater and more rapid reduction in the number of non- inflammatory and inflammatory lesions (42% vs. 28% and 70% vs. 61%, respectively, at week 4).
-- The second study showed that the 3-step CLENZIderm M.D. System demonstrated a moderate or greater overall improvement compared with previously used treatments and high patient satisfaction. A majority (up to 77%) of patients who participated in this multicenter observation study considered the CLENZIderm M.D. acne system more effective than prescription and over-the-counter acne medications they had used previously.
Two Studies of the Solubilized 5% BPO Lotion for Normal-to-Dry Skin
-- In the first study, the investigator found that compared to a leading BPO/Clindamycin combination product, the once-daily use of CLENZIderm M.D. System for normal-to-dry skin provided comparable improvements by reducing the non-inflammatory count by a mean of 38% and reducing the inflammatory lesion count by a mean of 63% (versus 48% and 66%, respectively, with BPO/Clindamycin).
-- Patient ratings also showed that the 3-step solubilized 5% BPO Lotion system was as effective as the BPO/Clindamycin combination product and, on a scale of 0(poor) - 4(excellent), achieved a relatively greater improvement in mean score for:
-- Effectiveness of treatment between baseline and week 4 (from 2.5 to 3.4 with the acne system versus 2.5 to 2.9 with BPO/Clindamycin)
-- Reduction of acne (from 1.6 to 3.1 with the acne system versus 1.8 to 2.6 with BPO/Clindamycin)
-- In the second study comparing the CLENZIderm M.D. System for normal-to- dry skin to a BPO/Clindamycin combination product for patient tolerability, the 3-step system demonstrated lower levels of dryness (P less than or equal to .05) after 2 weeks.
"The data show that CLENZIderm M.D. System is not only effective in treating acne, but also well tolerated by all skin types, which is often a reason patients cite for non-compliance with other acne treatments," said James Leyden, MD, University of Pennsylvania Health Systems and KGL, Inc., and lead investigator of the study comparing facial tolerability of the 3-step acne system to the BPO/Clindamycin combination product on normal-to-dry skin. "The solubilized BPO in both the gel and lotion forms is a significant advancement in benzoyl peroxide technology, enhancing delivery to the target site of acne therapy without the excessive drying, flaking and peeling that may occur with other treatments."
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, some of which are too large to enter the follicles and treat acne issues at their source.
"With the solubilized BPO in the CLENZIderm M.D. Systems, we have been able to improve upon the treatment of acne," said Steven Carlson, Chief Executive Officer of Obagi Medical Products. "By offering a product that penetrates the pores and reduces acne flare-ups quickly and effectively, without the need for antibiotics, Obagi is at the forefront of dermatological advancements."
About the CLENZIderm M.D. Systems
The CLENZIderm M.D. System, which uses proprietary ingredients, has two formulations based on skin type. The CLENZIderm 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.
Use of benzoyl peroxide-containing products, including CLENZIderm M.D. Serum Gel and Therapeutic Lotion can cause transient stinging and burning in some patients. However, in clinical trials, this transient stinging and burning did not affect patient satisfaction and continued compliance. Side effects tend to subside within two weeks of use.
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, 2006. 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.
Source: Obagi Medical Products
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