A Phase 2 interventional study of Aldara (imiquimod 5% cream) and Vehicle cream in Actinic Keratosis, sponsored by Graceway Pharmaceuticals, LLC. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-07-23.
Sponsored by Graceway Pharmaceuticals, LLC · Phase 2, Interventional, and Treatment
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.
364 studies on the registry are indexed under Keratosis, Actinic; 31 are open to participants now.
This study's enrollment of 17 is below the median of 60 across 315 interventional studies indexed under Keratosis, Actinic.
Browse Keratosis, Actinic studies →Graceway Pharmaceuticals, LLC is the lead sponsor of 19 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Imiquimod 5% cream containing 12.5 mg of imiquimod per 250 mg of cream Applied 3 times per week for 4 weeks
Drug: Aldara (imiquimod 5% cream)
Vehicle cream 250 mg Applied 3 times per week for 4 weeks
Drug: Vehicle cream
Imiquimod 5% cream containing 12.5 mg of imiquimod per 250 mg of cream
Also known as: imiquimod cream
Vehicle cream in 250 mg
Also known as: placebo cream
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
This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.
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Graceway Pharmaceuticals, LLC