Therapeutic studies with a new combination benzoyl peroxide/clindamycin topical gel in acne vulgaris.

Abstract Three independent clinical studies were conducted in more than 1250 patients with moderate to moderately severe acne vulgaris to evaluate the efficacy and safety of a new combination gel that stably combines 5% benzoyl peroxide and 1% clindamycin. The results indicated that the benzoyl peroxide/clindamycin combination product was an effective treatment for reducing the inflammatory and noninflammatory lesions of acne vulgaris. In overall improvement as rated by the physicians and patients, the combination gel was superior to clindamycin alone, and in 2 of the 3 studies, to benzoyl peroxide alone. The antimicrobial activity of the combination gel was significantly (each P < .01) superior to that seen with topical application of its individual constituents, 5% benzoyl peroxide or 1% clindamycin, and was numerically better than that found with topical application of a 5% benzoyl peroxide/3% erythromycin combination product. As with benzoyl peroxide, dry skin was the most frequent side effect with use of the combination gel, with isolated incidences of other localized irritation. No other safety or tolerability concerns were identified.