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| |  Combination Adapalene Ointment Improves Acne Better Than Monotherapy: Presented at AAD By Perrie Susman MIAMI BEACH, Fla -- March 10, 2010 -- Treatment of acne with a fixed-dose combination of adapalene .01% and benzoyl peroxide 2.5% appears to help reduce lesions better than either component alone or placebo, researchers said here at the 68th Annual Meeting of the American Academy of Dermatology (AAD). “The adapalene combination get is superior to the adapalene and benzoyl peroxide monotherapies and the corresponding vehicle,” said Linda Stein Gold, MD, Henry Ford Hospital, Detroit, Michigan, during a poster presentation on March 8. She said the combination product “provides an early onset of efficacy starting from week 1 and has a good tolerability and safety profile. It provides the prescribing physician with a unique antibiotic-free fixed-dose combination for the treatment of acne vulgaris.” Dr. Stein Gold and colleagues randomly assigned 1,668 patients aged 12 years and older to receive a fixed-dose combination of adapalene .01% and benzoyl peroxide 2.5%; adapalene .01% monotherapy; benzoyl peroxide 2.5% monotherapy; or placebo. All patients had facial acne vulgaris rated moderate on the Investigator’s Global Assessment of acne severity scale (score of 3, on a scale of 0 = clear to 4 = severe). The patients all had 20 to 50 inflammatory lesions, and 30 to 100 noninflammatory lesions. They did not have any cysts and no more than 1 nodule was permitted. Patients applied the study treatments to the face and trunk, once daily in the evening, for 12 weeks. If a patient had dry skin, use of a moisturiser, daily throughout the study was allowed. In the pivotal trial, Dr. Gold said the primary endpoint -- a clear rating (0) on the Investigator’s Global Assessment of acne severity scale -- was achieved by 30.1% of the patients using the combination product, compared with 19.8% of the patients on adapalene alone, 22.2% of the patients on benzoyl peroxide alone, and 11.3% of the patients on the placebo gel (P = .006). “The fixed-dose adapalene combination showed a greater mean reduction of inflammatory lesions and noninflammatory lesions compared with the 3 other treatment arms,” she reported. “A significant early treatment effect of the combination compared with the vehicle was observed as early as week 1 [P < .001] for all lesion counts and week 4 [P = .004] for success rate, and was sustained until the end of the study,” she said. Dr. Gold also observed that the percent reductions from baseline in inflammatory lesions, noninflammatory lesions, and total lesions were significantly greater in the combination treatment when compared to the 3 other arms (P = .042). There appeared to be greater signs and symptoms among those taking the combination product, the researchers said. “However, these were transient and mostly mild or moderate in severity,” Dr. Gold said. “The number of patients with a report of at least 1 adverse event was similar across the all treatment groups.” Funding for this study was provided by Galderma Laboratories. [Presentation title: A Pivotal Study Comparing the Efficacy and Safety of the Adapalene-Benzoyl Peroxide Fixed-Dose Combination Gel With Each Component and the Vehicle in 1668 Patients With Acne Vulgaris. Abstract P711]
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