Efficacy of topical isotretinoin 0.05% gel in acne vulgaris: Results of a multicenter, double-blind investigation

Two hundred sixty-eight patients with mild to moderate acne vulgaris completed a multicenter, double-blind, controlled study comparing isotretinoin 0.05% gel with its vehicle. Patients were treated twice daily for up to 14 weeks. Efficacy was measured by counting facial inflammatory and noninflammatory lesions and by grading acne severity initially and at 2- to 3-week intervals throughout the study. The isotretinoin 0.05% gel proved to be statistically more effective than vehicle in reducing inflammatory lesions after 5 weeks and in reducing noninflammatory lesions and acne severity grade after 8 weeks. Except for two patients who dropped out because of irritation, isotretinoin 0.05% gel was well tolerated.