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

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.

• Authors: Joshua A Zeichner, Dana W K Stern, Annemarie Uliasz, Sarit Itenberg, Mark Lebwohl
• Journal: Journal of the American Academy of Dermatology (J Am Acad Dermatol) Vol. 60 Issue 1 Pg. 59-62 (Jan 2009) ISSN: 1097-6787 [Electronic] United States
• PMID: 18937999 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Adjuvants, Immunologic
• Aminoquinolines
• Pharmaceutical Preparations
• Imiquimod

Topics

• Adjuvants, Immunologic (administration & dosage)
• Aged
• Aminoquinolines (administration & dosage)
• Double-Blind Method
• Drug Administration Schedule
• Female
• Humans
• Imiquimod
• Keratosis, Actinic (drug therapy)
• Male
• Pharmaceutical Preparations
• Pilot Projects
• Time Factors