Efficacy and Tolerability of a Fixed Combination of Clindamycin Phosphate (1.2%) and Benzoyl Peroxide (3.75%) Aqueous Gel in Moderate and Severe Acne Vulgaris Subpopulations.

OBJECTIVE

To evaluate the efficacy, safety, and tolerability of a fixed combination clindamycin phosphate 1.2% and benzoyl peroxide 3.75% (clindamycin-BP 3.75%) aqueous gel in the treatment of moderate and severe acne.

METHODS

Multicenter, double-blind study in 498 patients with moderate or severe acne randomized to clindamycin-BP 3.75% or vehicle, once-daily for 12 weeks. Efficacy evaluations included inflammatory and noninflammatory lesion counts and evaluator's global severity at baseline, and at weeks 4, 8, and 12. Adverse events (AEs) and tolerability were also assessed. This was a post hoc analysis of moderate and severe acne populations.

RESULTS

Clindamycin-BP 3.75% significantly reduced inflammatory and noninflammatory lesions in both moderate and severe acne patients compared with vehicle. More than half of the patients with severe acne (55.1%) had at least a 2-grade reduction in evaluator's global severity score by week 12, and 30.6% of patients assessed their acne as 'clear' or 'almost clear'. Clindamycin-BP 3.75% was well tolerated, with no substantive differences from vehicle; and no patient discontinued due to AEs.

CONCLUSIONS

Clindamycin-BP 3.75% aqueous gel is an effective and well-tolerated once-daily topical treatment for both moderate and severe acne.