Safety and tolerability in the MORE trial.

Adverse events and a high potential for cutaneous irritation may have a negative effect on patient adherence to acne treatments, the primary factor contributing to optimal outcomes. In addition to effectiveness and subject satisfaction, the Measuring Acne Outcomes in a Real-World Experience (MORE) trial evaluated adverse events and cutaneous tolerability of adapalene gel 0.1% in 1396 subjects who received initial combination therapy with adapalene gel 0.1% and 468 subjects who added adapalene gel 0.1% to their existing regimen (safety population). Adverse events were uncommon (reported by 5.8% of subjects) and generally mild, the most frequent being skin and subcutaneous tissue disorders (2.7%). Overall, investigators rated cutaneous tolerability as high. Adherence to therapy also was high with both the initial combination and add-on therapies. The MORE trial confirms that adapalene gel 0.1% is safe and well tolerated and therefore likely to enhance adherence to treatment and the likelihood of optimal treatment outcomes for patients with moderate to moderately severe acne.