title: Treatment of keloid scars post-shave excision with imiquimod 5% cream: A prospective, double-blind, placebo-controlled pilot study.
abstract: 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.
authors.affiliation: University of Miami, Miller School of Medicine, Department of Dermatology and Cutaneous Surgery, Miami, FL 33136, USA. bberman@med.miami.edu
authors.forename: Brian
authors.initials: B
authors.lastname: Berman
authors.forename: Catherine
authors.initials: C
authors.lastname: Harrison-Balestra
authors.forename: Oliver A
authors.initials: OA
authors.lastname: Perez
authors.forename: Martha
authors.initials: M
authors.lastname: Viera
authors.forename: Adriana
authors.initials: A
authors.lastname: Villa
authors.forename: Deborah
authors.initials: D
authors.lastname: Zell
authors.forename: Claudia
authors.initials: C
authors.lastname: Ramirez
mesh_terms: 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
chemical_list: D000276:Adjuvants, Immunologic; D000634:Aminoquinolines; D000077271:Imiquimod