Cellular and Molecular Events During Treatment of Actinic Keratosis With Imiquimod 5% Cream

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Double-Blind, Vehicle-Controlled Study to Evaluate Cellular and Molecular Events During Four Weeks of Treatment for Actinic Keratosis With Aldara (Imiquimod) Cream, 5%

Conditions
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Actinic Keratosis

Intervention / Treatment
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* Drug: Aldara (imiquimod 5% cream)
* Drug: Vehicle cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have actinic keratoses on balding scalp Discontinuation of tanning bed use Discontinuation of moisturizers Avoidance of retinol products Exclusion Criteria: Uncontrolled, clinically significant medical condition Dermatologic disease other than actinic keratosis in treatment area

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Imiquimod cream<br>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)<br>* Imiquimod 5% cream containing 12.5 mg of imiquimod per 250 mg of cream<br>* Other names: imiquimod cream;|
| Placebo Comparator: Vehicle cream<br>Vehicle cream 250 mg Applied 3 times per week for 4 weeks | Drug: Vehicle cream<br>* Vehicle cream in 250 mg<br>* Other names: placebo cream;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene expression profiling of treated lesions |  | weeks 1, 2, and 4, and at 4 weeks post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confocal microscopic evaluation before, during and post treatment |  | weeks 1, 2, 4 and at 4 weeks post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Actinic keratosis, AK, imiquimod, confocal microscopy, gene microarray