Adapalene 0.1% lotion in the treatment of acne vulgaris: results from two placebo-controlled, multicenter, randomized double-blind, clinical studies.

Abstract

BACKGROUND:

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.

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.

• Authors: Lawrence F Eichenfield, Michael Jarratt, Joel Schlessinger, Steven Kempers, Vasant Manna, Joyce Hwa, Yin Liu, Michael Graeber, Adapalene Lotion Study Group
• Journal: Journal of drugs in dermatology : JDD (J Drugs Dermatol) Vol. 9 Issue 6 Pg. 639-46 (Jun 2010) ISSN: 1545-9616 [Print] United States
• PMID: 20645525 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Dermatologic Agents
• Naphthalenes
• Adapalene

Topics

• Acne Vulgaris (drug therapy)
• Adapalene
• Adolescent
• Adult
• Dermatologic Agents (administration & dosage)
• Double-Blind Method
• Female
• Humans
• Male
• Naphthalenes (administration & dosage, adverse effects)