Treatment of actinic keratosis with imiquimod cream is expected to cause changes in the genes that are turned on, and turned off, by skin cells. Some of the drug induced changes in skin cells should also be visible using a special microscope. This study examines both types of changes.
The primary objective of this study was to assess apoptosis by examining the gene expression profiles of actinic keratosis (AK) lesions that were treated with imiquimod 5% cream or vehicle cream once daily 3 times per week for 4 weeks. Secondary objectives were to assess the utility of confocal microscopy (CM) to visually track cellular response to treatment with study cream compared with clinical and histological evaluations, and to evaluate the safety of treatment with imiquimod in subjects with AK on the balding scalp.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
17
Imiquimod 5% cream containing 12.5 mg of imiquimod per 250 mg of cream
Vehicle cream in 250 mg
Loma Linda University Medical Center
Loma Linda, California, United States
Gene expression profiling of treated lesions
Time frame: weeks 1, 2, and 4, and at 4 weeks post-treatment
Confocal microscopic evaluation before, during and post treatment
Time frame: weeks 1, 2, 4 and at 4 weeks post-treatment
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