Adapalene 0.1% Lotion in the Treatment of Acne Vulgaris: Results From Two Placebo-controlled, Multicenter, Randomized Double-blind, Clinical Studies
June 2010 | Volume 9 | Issue 6 | Original Article | 639 | Copyright © June 2010
Lawrence F. Eichenfield MD,a Michael Jarratt MD,b Joel Schlessinger MD,c Steven Kempers MDd, Vasant Manna MDe, Joyce Hwa RN BSNe, Yin Liu PhDe, Michael Graeber MDe, on Behalf of the Adapalene Lotion Study Group
aUniversity of California, San Diego and Rady Children’s Hospital, San Diego, CA bDermResearch Incorporated, Austin, TX cAdvance Skin Research Center, Omaha, NE dMinnesota Clinical Study Center, Fridley, MN eGalderma Research and Development, Cranbury, NJ
Objectives: To evaluate the efficacy and assess safety of a new adapalene formulation, adapalene 0.1% lotion, versus the lotion vehicle in subjects with acne vulgaris.
Methods: Subjects were randomized to receive either adapalene 0.1% lotion or its vehicle once daily for 12 weeks in two multicenter, randomized, vehicle-controlled, double-blind, parallel group studies. Efficacy was evaluated using two co-primary endpoints: Investigator Global Assessment (IGA) of success rate (defined as the proportion of subjects who achieved at least a two point reduction, on a 5-point scale, from baseline to week 12 in IGA score); and the absolute change from baseline to week 12 in total, inflammatory and non-inflammatory lesions. Signs of local skin irritation and routine clinical safety parameters were evaluated throughout both studies.
Results: In total, 2,141 subjects were included in the two studies: 1,068 patients received adapalene 0.1 percent lotion and 1073 received the vehicle. In both studies, adapalene 0.1% lotion was shown to be significantly more effective than its vehicle in improvement in the IGA success rate. Adapalene 0.1% lotion was also significantly superior to its vehicle in all three lesion reduction measures: total, inflammatory and non-inflammatory. Reports of application site skin irritation in the adapalene 0.1% lotion treatment group were transient and mild or moderate in severity, with only a few being severe. Additionally, according to patient surveys, the lotion formulation was found to be easily spreadable, easily absorbed and pleasant to use.
Conclusion: Adapalene 0.1% lotion used once a day for 12 weeks is effective and well tolerated in the treatment of acne vulgaris.