Treatment of keloid scars post-shave excision with imiquimod 5% cream: A prospective, double-blind, placebo-controlled pilot study.

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.