Treatment of Keloid Scars Post-Shave ExcisionWith Imiquimod 5% Cream: A Prospective,Double-Blind, Placebo-Controlled Pilot Study

May 2009 | Volume 8 | Issue 5 | Original Article | 455 | Copyright © May 2009

Brian Berman MD PhD, Catherine Harrison-Balestra MD,Oliver A. Perez MD, Martha Viera MD, Adriana Villa MD,Deborah Zell MD, Claudia Ramirez MD


Background: No effective treatment exists for permanent keloid removal. When applied to excised-sites, imiquimod 5% cream reduces keloid recurrence. Case series suggest the tolerability and efficacy of imiquimod 5% application to sites of shaved keloids; however, this has not been verified in placebo-controlled studies.
Objective: To determine the tolerability and compare the efficacy of imiquimod 5% and vehicle cream in lowering keloid recurrence after shaving.
Methods: Twenty randomized, shaved keloids were administered imiquimod 5% or vehicle cream nightly for two weeks, and then given three times a week under occlusion for one month. Pain, tenderness, pruritus and keloid recurrence were evaluated at baseline, week 2, week 6 and 6 months.
Tolerability: Tenderness and pain were significantly (p= 0. 02 and p= 0. 02, respectively) higher at week 2 in the imiquimod group than for those treated with vehicle cream. Pruritus did not attain statistical difference between the groups.
Efficacy: At 6 months, keloid recurrence rates were 37.5% (3/8) in the imiquimod group and 75% (3/4) in the vehicle group, p=0. 54.
Conclusion: Imiquimod was well tolerated. There was not enough statistical power to detect a significant difference in six-month keloid recurrence rates between the two treated groups.