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
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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| Supported by 3M Pharmaceuticals. |
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| 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. |
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| Presented as a poster at the Annual American Academy of Dermatology Meeting, Washington, DC, February 2-6, 2007. |
Vol 60 - N° 1
P. 59-62 - gennaio 2009 Ritorno al numero
Benvenuto su EM|consulte, il riferimento dei professionisti della salute.
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