MedWire News: A fixed-dose once-daily combination of clindamycin phosphate 1.2% and a low concentration - 2.5% - of benzoyl peroxide (BPO) is an effective treatment option for acne vulgaris that has a highly favorable tolerability profile, say US researchers.
It is well established that products containing both clindamycin and BPO have superior efficacy to either agent alone, while reducing the potential for Propionibacterium acnes resistance, explain Diane Thiboutot (Pennsylvania State University College of Medicine, Hershey) and colleagues.
"A clindamycin-BPO combination product with a lower concentration of BPO may reduce the potential for irritation and dryness while maintaining superior efficacy," the researchers say.
They therefore investigated the efficacy and tolerability of clindamycin-BPO 2.5% aqueous gel in 2813 patients, aged 12 years or more, with moderate-to-severe acne vulgaris.
Patients were randomly assigned to receive clindamycin-BPO 2.5%, clindamycin alone, BPO 2.5% alone, or vehicle in two identical multicenter, double-blind, 12-week studies.
Relative to baseline, the absolute reductions in inflammatory lesion count, noninflammatory lesion count, and total lesion count, were significantly greater for clindamycin-BPO 2.5% than for the other three treatment groups from week 4 through week 12.
Similarly, treatment success, defined as at least a 2-grade improvement in Evaluator Global Severity Score, was achieved by a significantly greater proportion of patients in the clindamycin-BPO 2.5% group than in any of the other three treatment groups for the same time period.
The overall incidence of adverse events, determined to be possibly, probably, or definitely related to therapy, was low and similar among the clindamycin-BPO 2.5%, clindamycin alone, BPO 2.5% alone, and vehicle groups (5.9%, 4.3%, 5.9%, and 6.1%, respectively).
Application site reactions in patients receiving clindamycin-BPO 2.5% were rare, and no patient in this group experienced application site dryness. Furthermore, no patient treated with clindamycin-BPO 2.5% experienced severe local signs or symptoms or discontinued study medication due to erythema, scaling, itching, burning, or stinging.
Writing in the Journal of the American Academy of Dermatology, the researchers conclude: "[Clindamycin-BPO 2.5%] is an effective, safe, and well-tolerated topical therapy for the treatment of patients with moderate to severe inflammatory and noninflammatory acne vulgaris."
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