Healthcare Industry News: basal cell carcinoma
News Release - October 23, 2007
New Data Show Obagi Medical Products' Nu-Derm Improves Scar Cosmesis Following Removal of Basal Cell Carcinoma versus Standard TreatmentPhotographic Assessment of Hydroquinone/Retinoid Regimen Presented at the Fall Clinical Dermatology Conference
LONG BEACH, Calif.--(HSMN NewsFeed)--Obagi Medical Products, Inc. (Nasdaq:OMPI ), a leader in topical aesthetic and therapeutic skin health systems, today announced results from a multi-center, randomized, controlled investigator-blinded study evaluating the use of Nu-Derm, a hydroquinone-based skin care system, to help improve the scar cosmesis following electrodesiccation and curettage (EDC) in patients with superficial truncal basal cell carcinoma (BCC). Results from this study found the use of the hydroquinone/retinoid regimen improved the appearance of scarring after the procedure compared to the current standard treatment of cleanser and healing ointment. EDC is a procedure commonly used to treat specific types of skin cancer, but often results in poor scar outcome.
Lead investigator David Pariser, MD, President-elect of the American Academy of Dermatology, Eastern Virginia Medical School, presented photographic assessments that demonstrated that the use of this hydroquinone/retinoid regimen before and after EDC resulted in superior aesthetic outcomes. The study’s primary endpoint, the proportion of lesions that achieved treatment success according to the Investigator’s Global Assessment of Wound Appearance, resulted in 72 percent of the lesions achieving treatment success with the hydroquinone/retinoid regimen vs. 63 percent of the lesions achieving treatment success with standard therapy. In addition, photographs from all treated lesions were reviewed by a panel of six independent blinded dermatologists and plastic surgeons. Results from this panel showed that 61% of lesions treated with the hydroquinone/retinoid regimen achieved treatment success vs. 29% of the lesions achieving treatment success with standard treatment. These differences were statistically significant (P=.020). All lesions (100%) treated with the hydroquinone/retinoid regimen exhibited no or mild wound contraction compared to 93% with standard treatment. Both treatment regimens were similarly well tolerated.
“The photographic evidence from this study, coupled with the global scores from the investigators and a panel of blinded reviewers suggest that pre- and post-treatment with the Nu-Derm System improves the cosmetic appearance of scars following EDC of truncal superficial basal cell carcinoma,” said Dr. Pariser. “Additional studies looking at scar cosmesis outcomes for excisional and incisional procedures will help support these preliminary observations.”
The study evaluated a total of 51 patients with a total of 59 superficial BCC lesions on the trunk. The mean age of patients was 56. All patients were Caucasian with Fitzpatrick skin type I (31 percent), II (35 percent), III (27 percent) or IV (27 percent). Patients were evaluated for three weeks prior to EDC to monitor pre-treatment effect, and for three weeks following 75% re-epithelialization of the wound(s) to monitor post-treatment effect. Patients’ final assessments occurred after a total of six weeks of treatment with the hydroquinone/retinoid therapy or standard therapy.
“Our Nu-Derm study, evaluating a pre- and post-treatment regimen in patients undergoing EDC for superficial basal cell carcinoma is a demonstration of Obagi Medical Products’ commitment to conducting well-controlled, evidence-based clinical programs,” said Lisa D. Parr, Pharm.D., RAC, Vice President Clinical Affairs, Obagi Medical Products. “We will continue to conduct rigorously designed studies to support the science of our penetrating therapeutics technology and clinical efficacy of our existing and new products.”
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, 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 Nu-Derm Condition and Enhance for use with cosmetic procedures to enhance patient outcomes and satisfaction, 2006; Obagi ELASTIderm eye skin care and Obagi CLENZIderm M.D. acne therapeutic systems, 2007; and a formulation of CLENZIderm for normal to dry skin, June 2007. 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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