Vehicle-controlled, double-blind, randomized study of imiquimod 5% cream applied 3 days per week in one or two courses of treatment for actinic keratoses on the head.

Author(s): Jorizzo J, Dinehart S, Matheson R, Moore JK, Ling M, Fox TL, McRae S, Fielder S, Lee JH

Affiliation(s): Wake Forest University School of Medicine, Department of Dermatology, Medical Center Blvd, Winston-Salem, NC 27157, USA. jjorizzo@wfubmc.edu

Publication date & source: 2007-08, J Am Acad Dermatol., 57(2):265-8. Epub 2007 May 18.

Publication type: Randomized Controlled Trial; Research Support, Non-U.S. Gov't

BACKGROUND: A shorter dosing regimen of imiquimod for the treatment of actinic keratosis may be effective, with long-term clinical benefits. OBJECTIVE: Imiquimod in one or two shorter courses of treatment was evaluated. METHODS: Patients with actinic keratosis lesions on the head applied imiquimod or vehicle cream 3x/wk for 4 weeks (course 1). Patients with remaining lesions received another course of treatment. Complete and partial clearance rates were evaluated after course 1, after course 2 (overall), and 1 year later. RESULTS: Complete clearance rates were 26.8% (course 1) and 53.7% (overall). Partial clearance rates were 36.6% (course 1) and 61.0% (overall). One-year follow-up recurrence rates were 39% (imiquimod) and 57% (vehicle). LIMITATIONS: Blinded investigators may have been biased toward patients treated with imiquimod identified by treatment site reactions. CONCLUSION: Imiquimod 3x/wk in one or two courses of treatment appears to be effective for the treatment of actinic keratoses on the head, providing long-term clinical benefits. Some recurrences do occur, so long-term follow-up is recommended.