Imiquimod 2.5% and 3.75% for the treatment of actinic keratoses: Results of two placebo-controlled studies of daily application to the face and balding scalp for two 3-week cycles - 24/04/13
Abstract |
Background |
Imiquimod 5% cream is approved as a 16-week regimen for the treatment of actinic keratoses involving a 25-cm2 area of skin.
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.
Le texte complet de cet article est disponible en PDF.Key words : actinic keratosis, clinical trial, dose optimization, imiquimod
Abbreviations used : AE, AK, EOS, IGIP, LSR
Plan
Supported by Graceway Pharmaceuticals LLC. |
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Disclosure: Drs Hanke and Beer were investigators and consultants for Graceway and received compensation for services. Drs Stockfleth and Rosen were consultants for Graceway and received compensation for services. Drs Wu and Levy are employees of Graceway. |
Vol 62 - N° 4
P. 573-581 - avril 2010 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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