Efficacy and tolerability of a fixed combination of clindamycin phosphate (1.2%) and benzoyl peroxide (3.75%) aqueous gel in moderate or severe adolescent acne vulgaris.

BACKGROUND

Acne is commonplace in adolescents and can be difficult to manage. Providing an effective and well-tolerated treatment may lead to improved adherence, increased patient satisfaction, and improved clinical outcomes.

METHODS

A post hoc analysis of efficacy and cutaneous tolerability in 289 adolescents (age range, 12 to <18 years) with moderate-to-severe acne who had been enrolled in a multicenter study and were randomized to receive either clindamycin phosphate 1.2%/benzoyl peroxide 3.75% gel or vehicle once daily for 12 weeks.

RESULTS

Significantly superior reductions in lesion counts were observed in the clindamycin phosphate 1.2%/benzoyl peroxide 3.75% gel group compared to vehicle from Week 4, with mean percent reductions in inflammatory and noninflammatory lesions from baseline of 59.9 percent and 50.5 percent, respectively (both P<0.001 versus vehicle). One-third of patients treated with clindamycin phosphate 1.2%/benzoyl peroxide 3.75% gel achieved ≥2-grade improvement from baseline in their Evaluator's Global Severity Score (compared to 8.5% with vehicle, P<0.001) and 35 percent of patients reported clear or almost clear skin at Week 12 (compared to 12.8% with vehicle, P<0.001). Cutaneous tolerability was excellent with all mean scores ≤0.2 at Week 12 (where 1=mild).

CONCLUSIONS

Clindamycin phosphate 1.2%/benzoyl peroxide 3.75% gel is an effective, safe, well-tolerated treatment for adolescents with moderate-to-severe acne.