Adapalene gel 0.1% is effective and well tolerated in acne patients in a dermatology practice setting.

The US Food and Drug Administration has approved adapalene gel 0.1% for use in the treatment of acne vulgaris. The objective of our study was to evaluate the efficacy and tolerability of adapalene gel 0.1% in the treatment of acne vulgaris in a clinical practice. We used a 12-week, multicenter, open-label, noncomparative phase 4 study of adapalene gel 0.1%. The study involved approximately 600 dermatologists in the United States and included 2,545 healthy men and nonpregnant women older than 14 years who had mild or moderate acne vulgaris. Of the patients enrolled, 75% completed the study and most of them (89%) showed an improvement in their acne (clear of acne or marked, definite, or minimal improvement) from baseline. Most patients (69%) were satisfied or very satisfied with adapalene therapy, and most (80%) wished to continue treatment. Only 3.7% of patients enrolled reported treatment-related adverse events (n=94), the most common being skin irritation (2.2%). We conclude from this open-label trial in a dermatology practice setting that adapalene gel 0.1% was effective and well tolerated and had a favorable safety profile. Furthermore, compliance with once-daily application of adapalene was rated as high by 92% of patients who responded to a self-assessment questionnaire.