Twice-daily applications of benzoyl peroxide 5%/clindamycin 1% gel versus vehicle in the treatment of pseudofolliculitis barbae.

Pseudofolliculitis barbae (PFB) is an inflammatory disorder characterized by the formation of papules, pustules, and hyperpigmentation as a result of ingrown hairs. It is estimated that PFB affects 45% to 83% of black men who shave regularly. In this multicenter, double-blind pilot study, men with 16 to 100 combined papules and pustules on the face and neck were randomized to receive twice-daily benzoyl peroxide 5%/ clindamycin 1% (BP/C) gel (BenzaClin)(n = 47) or vehicle (n = 41) for 10 weeks. Sixty-eight (77.3%) of the participants were black. All patients were required to shave at least twice a week and to use a standardized shaving regimen throughout the study. Clinical evaluations were performed at 2-week intervals. The primary efficacy parameter was the percentage change from baseline in lesion counts. At weeks 2, 4, and 6, mean percentage reductions from baseline in combined papule and pustule counts were significantly greater with BP/C gel compared with vehicle (P < or = .029). Treatment differences in favor of active therapy were more pronounced in the subpopulations of black patients, with least squares mean percentage reductions in papule and pustule counts ranging from 38.2% at week 2 to 63.9% at week 10. Study medication was well tolerated. These positive findings warrant further investigation of BP/C gel in the treatment of patients with PFB.