Background: Acne in skin of color is an increasing problem, presenting unique challenges. Although combination therapy is now standard of care in acne, concerns exist with the increased potential irritation and dryness in skin of color. Although individual medications can be titrated or applied at different times of the day to minimize irritation, this is not always practical or desirable. There is a paucity of clinical studies that evaluate the safety and efficacy of acne medications in skin of color.
Methods: A post-hoc analysis of efficacy and cutaneous tolerability in 797 subjects receiving clindamycin phosphate 1.2% benzoyl peroxide (BPO) 2.5% gel from two 12-week, multi-center, double-blind studies that enrolled 2,813 subjects with moderate to severe acne. Efficacy, tolerability, and subject satisfaction in Fitzpatrick skin types I-III subjects were compared to subjects with Fitzpatrick skin types IV-VI.
Results: Median reductions in inflammatory lesions were comparable between the two groups. There was a small difference in noninflammatory and total lesions in favor of those patients with Fitzpatrick skin types I-III (P=0.013 and P=0.024, respectively). Median reductions in inflammatory, noninflammatory, and total lesions at week 12 were 63%, 50%, and 52.4%, respectively for Fitzpatrick skin types I-III and 65%, 47%, and 51.4%, respectively for Fitzpatrick skin types IV-VI. Treatment success was comparable between the two groups and both groups had a high level of subject satisfaction at week 12. Cutaneous tolerability was excellent, with all mean scores less than or equal to 0.2 at week 12 (where 1=mild). Results in the two groups were comparable, although there was slightly more erythema reported in the Fitzpatrick skin types I-III subjects (0.2 versus 0.1). This could be due to the difficulty in visualizing erythema in subjects with darker skin.
Conclusions: Acne subjects with Fitzpatrick skin types IV-VI were not found to be more susceptible to cutaneous irritation from treatment with clindamycin phosphate 1.2%/BPO 2.5% gel and both efficacy and tolerability was comparable across the two treatment groups.