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

Graceway Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Actinic Keratosis

Treatments: Drug: Aldara (imiquimod 5% cream); Drug: Vehicle cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT00335179

1467-IMIQ

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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17 participants in 2 patient groups, including a placebo group

Imiquimod cream

Active Comparator group

Description:

Imiquimod 5% cream containing 12.5 mg of imiquimod per 250 mg of cream Applied 3 times per week for 4 weeks

Treatment:

Drug: Aldara (imiquimod 5% cream)

Vehicle cream

Placebo Comparator group

Description:

Vehicle cream 250 mg Applied 3 times per week for 4 weeks

Treatment:

Drug: Vehicle cream