Adapalene 0.1% gel compared to tazarotene 0.1% cream in the treatment of acne vulgaris.

A variety of topical retinoids is available for the treatment of acne vulgaris. Selection of the appropriate treatment depends not only on efficacy but also on how well the patient can tolerate different formulations. The goal of this study was to evaluate the efficacy and tolerability of daily adapalene 0.1% gel compared to daily tazarotene 0.1% cream and to demonstrate the noninferiority of adapalene 0.1% gel when compared to tazarotene 0.1% cream in treating acne. This represents 2 arms of a 3-arm study. Subjects 12 to 35 years of age with acne vulgaris (N=202) participated in a 12-week, randomized, evaluator-blinded study of once-daily therapy with adapalene 0.1% gel versus tazarotene 0.1% cream. The primary measure of efficacy was the reduction in total lesion counts posttreatment. Subjects treated with adapalene 0.1% gel achieved similar reductions in total lesion counts at week 12 compared to the subjects treated with the tazarotene cream, which demonstrates the noninferiority of adapalene treatment compared to tazarotene (median difference: -1.18%; lower confidence limit [LCL]: -9.26). At week 2, the number of patients that experienced erythema and scaling with tazarotene 0.1% cream was greater when compared to adapalene 0.1% gel and statistically significant. By week 12, the percentage of subjects reporting cutaneous irritation had returned to or near baseline levels and was similar between treatment arms for all parameters assessed. Adapalene gel was associated with fewer treatment-related adverse events than tazarotene cream (36% versus 58%, respectively), and less than half as many adverse events that were "definitely" related to study treatment than tazarotene cream (20% versus 45%, respectively). Daily therapy with adapalene 0.1% gel was shown to be noninferior to tazarotene 0.1% cream in total acne lesion reductions, and during initial stages of treatment, demonstrated better tolerability with respect to erythema and scaling.

RCT Entities:   Population Interventions Outcomes