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Short-course therapy with imiquimod 5% cream for solar keratoses: a randomized controlled trial.

Abstract
A dual-centre, randomized, double-blind, vehicle-controlled study was conducted to evaluate the safety and efficacy of short courses of therapy with imiquimod 5% cream in clearing >/=75% of baseline solar keratoses (SK) within a field of treatment. Subjects with 5-15 baseline SK within one treatment area (scalp, forehead and temples, or both cheeks) were randomized to apply imiquimod or vehicle cream to the entire treatment area three times a week for 3 weeks. Subjects were assessed 4 weeks after completing the first course for clearance of lesions. Subjects with <75% clearance were commenced on a second 3-week course of study cream. Subjects with >/=75% clearance were followed up until study completion without further therapy. All subjects were evaluated at the study endpoint of 14 weeks after initiating therapy for assessment of the primary outcome (>/=75% clearance of baseline solar keratoses). Twenty-one out of 29 (72%) imiquimod-treated subjects cleared >/=75% of baseline lesions compared with 3/10 (30%) subjects using the vehicle cream (Fisher's exact test, P = 0.027). Imiquimod was well tolerated. The present study has a short follow-up endpoint, but suggests that imiquimod is a potential therapeutic alternative in patients with SK.
AuthorsKeng Chen, Lee Mei Yap, Robin Marks, Stephen Shumack
JournalThe Australasian journal of dermatology (Australas J Dermatol) Vol. 44 Issue 4 Pg. 250-5 (Nov 2003) ISSN: 0004-8380 [Print] Australia
PMID14616490 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Aminoquinolines
  • Emollients
  • Immunologic Factors
  • Imiquimod
Topics
  • Administration, Topical
  • Aged
  • Aminoquinolines (administration & dosage)
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Administration Schedule
  • Emollients
  • Female
  • Follow-Up Studies
  • Humans
  • Imiquimod
  • Immunologic Factors (administration & dosage)
  • Keratosis (drug therapy, etiology)
  • Male
  • Middle Aged
  • Probability
  • Reference Values
  • Severity of Illness Index
  • Sunlight (adverse effects)
  • Treatment Outcome

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