Short-course therapy with imiquimod 5% cream for solar keratoses: a randomized controlled trial.
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.
Chen
Keng
K
St George Hospital, Kogarah, New South Wales, Australia.
Yap
Lee Mei
LM
Marks
Robin
R
Shumack
Stephen
S
D000287:Administration, Topical; D000368:Aged; D000634:Aminoquinolines / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004643:Emollients; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000077271:Imiquimod; D007155:Immunologic Factors / Q000008:administration & dosage*; D007642:Keratosis / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D011336:Probability; D012016:Reference Values; D012720:Severity of Illness Index; D013472:Sunlight / Q000009:adverse effects*; D016896:Treatment Outcome
D000634:Aminoquinolines; D004643:Emollients; D007155:Immunologic Factors; D000077271:Imiquimod