Adapalene 0.1% lotion in the treatment of acne vulgaris: results from two placebo-controlled, multicenter, randomized double-blind, clinical studies
Eichenfield, L.F.; Jarratt, M.; Schlessinger, J.; Kempers, S.; Manna, V.; Hwa, J.; Liu, Y.; Graeber, M.; Albrecht, L.; Arthur, E.; Barba, A.; Barber, K.; Bond, M.; Bucko, A.; Clark, S.; Cornelison, R.; Dinehart, S.; Dinulos, J.; Draelos, Z.; Fisher, G.; Glazer, S.; Glenn, M.; Del Rey, M.; Haber, R.; Hamzavi, I.; Harris, H.; Jarratt, M.; Landells, I.; Lee, M.; Leonardi, C.; Loebl, A.; Lynde, C.; Matheson, R.; Moore, A.; Mraz, S.; Papp, K.; Pariser, D.; Rafal, E.; Smith, S.; Stough, D.; Swinehart,
Journal of Drugs in Dermatology Jdd 9(6): 639-646
2010
ISSN/ISBN: 1545-9616 PMID: 20645525 Document Number: 10793
Acne vulgaris is a common chronic skin disease affecting roughly 15 percent of the general population and up to 85 percent of adolescents and young adults. Adapalene, a synthetic naphthoic acid derivative with retinoid activity, has demonstrated good clinical efficacy in the treatment of acne if used with full compliance. 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. 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. 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. Adapalene 0.1% lotion used once a day for 12 weeks is effective and well tolerated in the treatment of acne vulgaris.
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