A Multicenter Efficacy and Tolerability Evaluation of Benzoyl Peroxide in a 10% Urea Vehicle for the Treatment of Acne Vulgaris
May 2006 | Volume 5 | Issue 5 | Original Article | 442 | Copyright © May 2006
Michael H. Gold MD
Objective: To assess the efficacy and tolerability of the treatment of acne vulgaris with multiple strengths of benzoyl peroxide in a 10% urea vehicle gel or cream and cleanser.
Methods: A multicenter, non-randomized, open-label study in which 1,089 patients with acne vulgaris were enrolled at 133 participating physician office sites. Qualifying and consenting patients were prescribed either 4.5% or 8.5% benzoyl peroxide in a 10% urea vehicle cream or gel and cleanser. Additional medications were permitted during the study with the exception of those containing benzoyl peroxide. The physician assessed lesion counts, both inflammatory and non-inflammatory, at baseline and Week 4. Dryness and erythema were rated by the physician on a scale from 0 (none) to 8 (severe or deep) at baseline and Week 4.
Results: Nine hundred sixty-three patients completed the study. The following significant treatment arms were analyzed: patients treated with 4.5%/8.5% benzoyl peroxide in a 10% urea vehicle product only, patients treated with 4.5%/8.5% benzoyl peroxide in a 10% urea vehicle products along with oral doxycycline, and patients treated with 4.5%/8.5% benzoyl peroxide in a 10% urea vehicle products along with oral minocycline. A 44% (n=567) mean reduction in total lesion count was observed after 4 weeks of treatment with 4.5%/8.5% benzoyl peroxide in a 10% urea vehicle products only. Dual therapy using oral doxycycline (n=17) proved to be even more effective with a significant mean reduction in lesion count of 52% after only 4 weeks of treatment. Dual therapy using oral minocycline (n=21) yielded a significant mean reduction in lesion count of 34% after 14 weeks of treatment. The overall tolerability of the treatment illustrated the utility of urea as a moisturizing agent.
Conclusion: Benzoyl peroxide in a 10% urea vehicle gel or cream and cleanser, used once daily for 4 weeks found to be both effective and well tolerated for the treatment of symptoms related to acne vulgaris.