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ABSTRACT: A 2.5% formulation of benzoyl peroxide was compared with its vehicle, and with a 5% and a 10% proprietary benzoyl peroxide gel preparation in three double-blind studies involving 153 patients with mild to moderately severe acne vulgaris. The 2.5% benzoyl peroxide formulation was more effective than its vehicle and equivalent to the 5% and 10% concentrations in reducing the number of inflammatory lesions (papules and pustules). Desquamation, erythema, and symptoms.of burning with the 2.5% gel were less frequent than with the 10% preparation but equivalent to the 5% gel. The 2.5% formulation also significantly reduced Propionibacterium acnes and the percentage of free fatty acids in the surface lipids after 2 weeks of topical application.