FDA approves adapalene lotion for acne

Fort Worth, Texas - The Food and Drug Administration (FDA) has approved the lotion formulation of adapalene (Differin 0.1 percent, Galderma) for the topical treatment of acne in patients age 12 and older, Medscape Today reports.

FDA approval was based on data from two 12-week, multicenter clinical trials of 2,141 patients with 20 to 50 inflammatory and 30 to 100 noninflammatory acne lesions at baseline. Results showed that use of adapalene 0.1 percent lotion yielded significant reductions in the total number of lesions, inflammatory lesions and noninflammatory lesions compared with the vehicle alone.

Dry skin of mild to moderate severity was the most frequently reported adverse event, occurring primarily during the first two weeks of treatment and decreasing with continued use. Other treatment-related effects included erythema, scaling, dryness and stinging or burning.

Adapalene previously was available in 0.1 percent gel, cream and topical-solution formulations, and as a combination gel with benzoyl peroxide.