Long-Term Safety and Efficacy of a Unique Fixed-Dose Combination Gel of Adapalene 0.1% and Benzoyl Peroxide 2.5% for the Treatment of Acne Vulgaris
September 2007 | Volume 6 | Issue 9 | Original Article | 899 | Copyright © September 2007
David M. Pariser MD, Patricia Westmoreland MD, Amy Morris MD, Michael H. Gold MD, Yin Liu PhD, Michael Graeber MD
Background: A unique, once-daily, fixed-dose combination gel with adapalene 0.1% and benzoyl peroxide (BP) 2.5%
has been developed for the treatment of acne vulgaris.
Objective: To evaluate the long-term (up to 12 months) safety and efficacy of the adapalene 0.1%/BP 2.5% fixed-dose
combination gel for the treatment of acne vulgaris.
Methods: A total of 452 subjects were enrolled in this 12-month study and received adapalene/BP once daily. Evaluations
included lesion count reduction, subject’s assessment of acne, adverse events, and cutaneous tolerability.
Results: Adverse events were mild to moderate, occurred early in the study, and decreased thereafter. Discontinuations
due to adverse events were low (2.0%) and no subjects discontinued due to lack of efficacy. Early and sustained reductions
in inflammatory and noninflammatory lesions were observed, with clinically significant lesion reductions as early
as week 1.
Conclusions: These findings are consistent with previous clinical findings and support the use of a once-daily adapalene/BP
fixed-dose combination as a safe and effective treatment in the long-term management of acne.