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.

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.