Placebo-controlled, double-blind, randomized pilot study of imiquimod 5% cream applied once per week for 6 months for the treatment of actinic keratoses - 08/08/11

Doi : 10.1016/j.jaad.2008.08.039

Joshua A. Zeichner, MD, Dana W.K. Stern, MD, Annemarie Uliasz, MD, Sarit Itenberg, BA, Mark Lebwohl, MD ^⁎
Mount Sinai Medical Center, New York, New York

Reprint requests: Mark Lebwohl, MD, Mount Sinai Medical Center, Department of Dermatology, 5 E 98 St, 5th Floor, Box 1047, New York, NY 10029.

Abstract

Background

Imiquimod 5% cream applied twice weekly for 16 weeks is effective for treating actinic keratoses but may be limited by local side effects.

Objective

We sought to explore the efficacy and safety of a once weekly for 24 weeks dosing regimen using a left versus right side of head design.

Results

Twenty patients were enrolled; 15 completed and 5 discontinued for reasons unrelated to adverse events. At the posttreatment visit (week 28), 7 (46.7%) of 15 patients had marked improvement or better on the imiquimod side versus one (6.7%) of 15 on the placebo side. The average investigator assessment scale score change was +2.20 for imiquimod compared with –0.27 for placebo (P = .0002, Wilcoxon signed rank test). Skin reactions were minimal or nonexistent in most patients.

Limitations

Limitations of the study include a small sample size and a lack of objective measure of local side effects.

Conclusion

Imiquimod 5% cream applied once weekly for 24 weeks was convenient for patients and resulted in improvement of actinic keratoses with minimal side effects.

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Plan

Methods

Results

Discussion

	Supported by 3M Pharmaceuticals.
	Disclosure: Dr Lebwohl has served as a consultant for Sanofi-Aventis, as a consultant and speaker for Graceway Pharmaceuticals, and as a consultant for PharmaDerm. Dr Zeichner has served as an investigator and an advisory committee member for Graceway Pharmaceuticals. Drs Stern and Uliasz have served as investigators for Graceway Pharmaceuticals. Ms Itenberg has no conflicts of interest to declare.
	Presented as a poster at the Annual American Academy of Dermatology Meeting, Washington, DC, February 2-6, 2007.