Efficacy and Tolerability of a Fixed Combination of Clindamycin Phosphate (1.2%) and Low Concentration Benzoyl Peroxide (2.5%) Aqueous Gel in Moderate orSevere Acne Subpopulations
August 2009 | Volume 8 | Issue 8 | Original Article | 736 | Copyright © August 2009
Guy Webster MD PhD, Phoebe Rich MD, Michael H. Gold MD, Serena Mraz MD, Barry Calvarese MS, Diana Chen MD
Objective: To evaluate the efficacy and safety of a fixed combination clindamycin phosphate 1.2% and benzoyl peroxide 2.5% (clindamycin-BP 2.5%) aqueous gel in the treatment of moderate or severe acne subpopulations.
Methods: Two multicenter, double-blind studies randomized 2,813 subjects with moderate or severe acne to clindamycin-BP 2.5% gel, each active ingredient, or vehicle gel, once daily for 12 weeks. Efficacy evaluations included inflammatory and non-inflammatory lesion counts and evaluator’s global severity score at baseline and weeks 4, 8 and 12. Adverse events and subjects’ evaluations of product tolerability were also monitored. Subpopulation efficacy and safety analyses by baseline acne severity were performed for the combined data from the two phase 3 studies.
Results: Clindamycin-BP 2.5% gel significantly reduced inflammatory, non-inflammatory and total lesions compared with each active ingredient and vehicle in subjects with moderate acne and compared with vehicle in severe acne subjects at week 12. Significant improvements in evaluator’s global severity score were evident for subjects with moderate acne in the clindamycin-BP 2.5% group compared with each active ingredient and vehicle and compared with vehicle in subjects with severe acne at week 12. Rates of adverse events were low and similar between treatment groups and baseline acne severity.
Conclusion: Clindamycin-BP 2.5% aqueous gel is an effective and safe once-daily treatment for moderate or severe acne.