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.


RESULTS
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.


RESULTS
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.


CONCLUSIONS
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.
Berman
Brian
B
University of Miami, Miller School of Medicine, Department of Dermatology and Cutaneous Surgery, Miami, FL 33136, USA. bberman@med.miami.edu
Harrison-Balestra
Catherine
C
Perez
Oliver A
OA
Viera
Martha
M
Villa
Adriana
A
Zell
Deborah
D
Ramirez
Claudia
C
D000276:Adjuvants, Immunologic / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000634:Aminoquinolines / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D006801:Humans; D000077271:Imiquimod; D007627:Keloid / Q000188:drug therapy* / Q000517:prevention & control* / Q000601:surgery; D008875:Middle Aged; D010865:Pilot Projects; D011183:Postoperative Complications / Q000517:prevention & control; D011446:Prospective Studies; D012008:Recurrence; D016896:Treatment Outcome
D000276:Adjuvants, Immunologic; D000634:Aminoquinolines; D000077271:Imiquimod