title: Evaluation of the efficacy and safety of topical imiquimod 5% for plaque-type morphea: a multicenter, prospective, vehicle-controlled trial.
abstract: BACKGROUND
  There is currently a lack of evidence-based therapies that are safe and effective for plaque-type morphea. We aimed to evaluate the therapeutic potential and safety profile of imiquimod 5% cream in plaque-type morphea.
  
  
  METHODS
  We enrolled 25 adult patients from two Canadian centers with histologically confirmed plaque-type morphea. Imiquimod 5% was applied to a representative plaque, and vehicle was applied to a control plaque for 9 months. Treatment efficacy was assessed with the Dyspigmentation, Induration, Erythema, and Telangiectasias (DIET) score, histology, and ultrasound evaluation.
  
  
  CONCLUSIONS
  Twenty-two patients completed the entire length of the study. Imiquimod 5% was superior to vehicle in reducing DIET scores at 3, 6, 9, and 12 months (p < .05). Induration demonstrated the greatest response. Histologic evaluation showed significant improvement or resolution of disease. However, no ultrasonographic differences were found in dermal and hypodermal thicknesses between the treatment and vehicle groups (p > .05). Adverse effects were minimal and well tolerated.
authors.affiliation: Divisions of Dermatology and Cutaneous Sciences and Pediatric Dermatology and Department of Radiology and Diagnostic Imaging, University of Alberta, Edmonton, ABDivision of Anatomical Pathology, University of British Columbia, Victoria, BC.
authors.forename: Marlene
authors.initials: M
authors.lastname: Dytoc
authors.affiliation: Divisions of Dermatology and Cutaneous Sciences and Pediatric Dermatology and Department of Radiology and Diagnostic Imaging, University of Alberta, Edmonton, ABDivision of Anatomical Pathology, University of British Columbia, Victoria, BC.
authors.forename: Heidi
authors.initials: H
authors.lastname: Wat
authors.affiliation: Divisions of Dermatology and Cutaneous Sciences and Pediatric Dermatology and Department of Radiology and Diagnostic Imaging, University of Alberta, Edmonton, ABDivision of Anatomical Pathology, University of British Columbia, Victoria, BC.
authors.forename: Melody
authors.initials: M
authors.lastname: Cheung-Lee
authors.affiliation: Divisions of Dermatology and Cutaneous Sciences and Pediatric Dermatology and Department of Radiology and Diagnostic Imaging, University of Alberta, Edmonton, ABDivision of Anatomical Pathology, University of British Columbia, Victoria, BC.
authors.forename: Douglas
authors.initials: D
authors.lastname: Sawyer
authors.affiliation: Divisions of Dermatology and Cutaneous Sciences and Pediatric Dermatology and Department of Radiology and Diagnostic Imaging, University of Alberta, Edmonton, ABDivision of Anatomical Pathology, University of British Columbia, Victoria, BC.
authors.forename: Thomas
authors.initials: T
authors.lastname: Ackerman
authors.affiliation: Divisions of Dermatology and Cutaneous Sciences and Pediatric Dermatology and Department of Radiology and Diagnostic Imaging, University of Alberta, Edmonton, ABDivision of Anatomical Pathology, University of British Columbia, Victoria, BC.
authors.forename: Loretta
authors.initials: L
authors.lastname: Fiorillo
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage; D000279:Administration, Cutaneous; D000287:Administration, Topical; D000328:Adult; D000634:Aminoquinolines / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000077271:Imiquimod; D008297:Male; D011446:Prospective Studies; D012594:Scleroderma, Localized / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000473:pathology; D013997:Time Factors; D016896:Treatment Outcome; D014463:Ultrasonography
chemical_list: D000276:Adjuvants, Immunologic; D000634:Aminoquinolines; D000077271:Imiquimod