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

Phase 2

Completed

• Conditions: Actinic Keratosis
• Interventions: Drug: Aldara (imiquimod 5% cream); Drug: Vehicle cream

• Registration Number: NCT00335179
• Lead Sponsor: Graceway Pharmaceuticals, LLC

Brief Summary

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

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 Timeline

• Study Start: 2003-01
• Primary Completion: 2003-07
• Study Completion: 2003-07
• Study First Submitted: 2006-06-08
• Study First Submitted QC: 2006-06-08
• Study First Posted: 2006-06-09
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-22
• Last Update Posted: 2010-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Imiquimod cream	Aldara (imiquimod 5% cream)	Imiquimod 5% cream containing 12.5 mg of imiquimod per 250 mg of cream Applied 3 times per week for 4 weeks
Vehicle cream	Vehicle cream	Vehicle cream 250 mg Applied 3 times per week for 4 weeks

Primary Outcome Measures

Name	Time	Method
Gene expression profiling of treated lesions	weeks 1, 2, and 4, and at 4 weeks post-treatment

Secondary Outcome Measures

Name	Time	Method
Confocal microscopic evaluation before, during and post treatment	weeks 1, 2, 4 and at 4 weeks post-treatment

Trial Locations

Locations (1)

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States