Moderate to severe acne in adolescents with skin of color: benefits of a fixed combination clindamycin phosphate 1.2% and benzoyl peroxide 2.5% aqueous gel.

OBJECTIVE

Acne is common in adolescents and especially difficult to manage in people with color. A fixed combination of clindamycin phosphate and benzoyl peroxide (BPO) (clindamycin phosphate 1.2%/BPO 2.5% gel) was evaluated to determine its utility in treating moderate to severe acne in adolescents with skin of color.

METHODS

Three hundred thirty-seven adolescent acne subjects (aged 12 to <18 years) with skin of color were evaluated from 2 multicenter, double-blind studies. Subjects were randomized to receive clindamycin phosphate 1.2%/BPO 2.5% gel or vehicle, once daily for 12 weeks. Efficacy and tolerability were evaluated. Data were compared with an adolescent (A) and skin of color (B) cohort from the same pivotal study enrolling 2,813 subjects.

RESULTS

Superior mean percent reductions in inflammatory, noninflammatory, and total lesion counts were observed in subjects receiving clindamycin phosphate 1.2%/BPO 2.5% gel compared to vehicle. At week 12, clindamycin phosphate 1.2%/BPO 2.5% gel showed similar lesion reduction compared to groups A and B (P<0.001). Treatment success with clindamycin phosphate 1.2%/BPO 2.5% gel, assessed by investigator and subject, was superior to vehicle and comparable to that seen in groups A and B (P<0.001). Clindamycin phosphate 1.2%/ BPO 2.5% gel was associated with a low incidence of treatment-related AEs and a favorable cutaneous tolerability profile.

CONCLUSIONS

Clindamycin phosphate 1.2%/BPO 2.5% gel has been shown to be effective, safe, and well tolerated in moderate to severe acne in adolescents with skin of color.