Double-Blind, Randomized, Placebo-Controlled, Prospective Study Evaluating the Tolerability and Effectiveness of Imiquimod Applied to Postsurgical Excisions on Scar Cosmesis

Authors


Address correspondence and reprint requests to: Brian Berman, MD, PhD, 1600 NW 10th Avenue, Room 2023A (R250), Miami, FL 33136, or e-mail: bberman@med.miami.edu.

Abstract

Background. It has been reported that topical application of imiquimod 5% cream induces interferon-α, an antifibrotic cytokine.

Objective. To determine the tolerability and effectiveness on the cosmetic outcome of the application of imiquimod to postsurgical excision sites.

Materials and Methods. A prospective, double-blinded, randomized, vehicle-controlled trial was conducted among 20 patients with two skin lesions clinically diagnosed as melanocytic nevi. Imiquimod 5% cream was applied to one of the sutured surgical wounds starting the night of the excision nightly for a period of 4 weeks. The second sutured excision site was treated with vehicle cream. Scar cosmesis, erythema, pigmentary alterations, induration, tenderness, and pain were assessed using a visual analogue scale 2, 4, and 8 weeks after surgery.

Results. Eighteen subjects completed the study, with a total of 36 excision sites; no wound site dehisced, and no signs of infection were noted. Surgical wounds treated with imiquimod had more erythema, pigmentary alterations, and lower cosmesis rated by the investigator compared with wounds treated with placebo, both becoming nonsignificant in further evaluations. For pigmentary alterations, induration, and cosmesis rated by the patients, no statistically significant difference between treatment groups was observed at week 8.

Conclusion. Treatment of surgical excision-site wounds with imiquimod was well tolerated and without serious adverse events. Evaluations for cosmesis of placebo-treated surgical sites were better than imiquimod-treated sites at week 8, becoming nonsignificant later.

DR. BERMAN IS A CONSULTANT AND ON THE SPEAKERS BUREAU FOR 3M PHARMACEUTICALS, WHICH SUPPLIED THE MATERIALS USED IN THIS STUDY. THE UNIVERSITY OF MIAMI-Miller SCHOOL OF MEDICINE RECEIVED STUDY SPONSORSHIP FUNDING FROM 3M PHARMACEUTICALS.

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