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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00335179

Enrollment

Registered

2006-06-09

Start date

2003-01-31

Completion date

2003-07-31

Last updated

2010-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Actinic Keratosis

Keywords

Actinic keratosis, AK, imiquimod, confocal microscopy, gene microarray

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.

Interventions

DRUGAldara (imiquimod 5% cream)

Imiquimod 5% cream containing 12.5 mg of imiquimod per 250 mg of cream

DRUGVehicle cream

Vehicle cream in 250 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026