Abstract | BACKGROUND: OBJECTIVE: We sought to evaluate imiquimod 2.5% and 3.75% creams for short-course treatment of the entire face and scalp. METHODS: In two identical studies, adults with 5 to 20 lesions were randomized to placebo, or imiquimod 2.5% or 3.75% cream (1:1:1). Up to two packets (250 mg each) were applied per dose once daily for two 3-week treatment cycles, with a 3-week, no-treatment interval. Efficacy was assessed at 8 weeks posttreatment. RESULTS: In all, 490 subjects were randomized to placebo, or imiquimod 2.5% or 3.75% cream. Median baseline lesion counts for the treatment groups were 9 to 10. Complete and partial clearance rates were 5.5% and 12.8% for placebo, 25.0% and 42.7% for imiquimod 2.5%, and 34.0% and 53.7% for imiquimod 3.75% (P < .001, each imiquimod vs placebo; P = .034, 3.75% vs 2.5% for partial clearance). Median reductions from baseline in lesion count were 23.6%, 66.7%, and 80.0% for the placebo, imiquimod 2.5%, and imiquimod 3.75% groups, respectively (P < .001 each imiquimod vs placebo). There were few treatment-related discontinuations. Temporary treatment interruption (rest) rates were 0%, 17.1%, and 27.2% for the placebo, imiquimod 2.5%, and imiquimod 3.75%, respectively. LIMITATIONS: Local effects of imiquimod, including erythema, may have led to investigator and subject bias. CONCLUSIONS: Both imiquimod 2.5% and 3.75% creams were more effective than placebo and had an acceptable safety profile when administered daily as a 3-week on/off/on regimen.
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Authors | C William Hanke, Kenneth R Beer, Eggert Stockfleth, Jason Wu, Theodore Rosen, Sharon Levy |
Journal | Journal of the American Academy of Dermatology
(J Am Acad Dermatol)
Vol. 62
Issue 4
Pg. 573-81
(Apr 2010)
ISSN: 1097-6787 [Electronic] United States |
PMID | 20133012
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright 2009 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved. |
Chemical References |
- Adjuvants, Immunologic
- Aminoquinolines
- Dosage Forms
- Imiquimod
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Topics |
- Adjuvants, Immunologic
(administration & dosage)
- Administration, Topical
- Adult
- Aged
- Aged, 80 and over
- Aminoquinolines
(administration & dosage)
- Dosage Forms
- Double-Blind Method
- Drug Administration Schedule
- Face
- Female
- Humans
- Imiquimod
- Keratosis, Actinic
(drug therapy)
- Male
- Middle Aged
- Scalp
- Time Factors
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