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.
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Authors | Keng Chen, Lee Mei Yap, Robin Marks, Stephen Shumack |
Journal | The Australasian journal of dermatology
(Australas J Dermatol)
Vol. 44
Issue 4
Pg. 250-5
(Nov 2003)
ISSN: 0004-8380 [Print] Australia |
PMID | 14616490
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Aminoquinolines
- Emollients
- Immunologic Factors
- Imiquimod
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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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