A Three-Step Acne System Containing Solubilized Benzoyl Peroxide versus Benzoyl Peroxide/Clindamycin in Pediatric Patients with Acne.

Objective. To evaluate the clinical benefit in adolescents of a three-step acne system containing solubilized benzoyl peroxide. Design. Patients in this multicenter, investigator-blind trial were randomly assigned to receive 10 weeks of treatment with either the three-step acne system for normal-to-oily skin (proprietary 2% salicylic acid cleanser twice daily + proprietary 2% salicylic acid toner once daily + solubilized 5% benzoyl peroxide gel twice daily) or with control cleanser + 5% benzoyl peroxide/1% clindamycin gel twice daily. Setting. Patients seeking acne treatment from a dermatologist. Pediatric subgroup analysis from a larger trial. Participants. Eighty-two adolescents with mild-to-moderate facial acne vulgaris. Measurements. Noninflammatory and inflammatory lesion counts, erythema, dryness, peeling, burning/stinging, and itching. Results. The three-step acne system was significantly more effective than benzoyl peroxide/clindamycin in reducing the noninflammatory lesion count at Weeks 2 and 4. The antibiotic-free acne system was also comparably effective to benzoyl peroxide/clindamycin in reducing the inflammatory lesion count at all timepoints. Both regimens were generally well tolerated with mean levels of erythema, dryness, peeling, burning/stinging, and itching less than mild in both groups at all timepoints. Conclusions. The three-step acne system is an effective antibiotic-free acne treatment. Relative to benzoyl peroxide/clindamycin, its ability to achieve comparable reductions in inflammatory lesions, and significantly greater reductions in noninflammatory lesions in the early weeks of treatment is likely attributable to the solubilization of the benzoyl peroxide enhancing the bioavailability and intrafollicular penetration of the benzoyl peroxide.

RCT Entities:   Population Interventions Outcomes