Clincosm LogoSign in Get a demo

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

Sponsor
Graceway Pharmaceuticals, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00335179
Collaborator
(none)
17
Enrollment
1
Location
2
Arms
5.9
Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Aldara (imiquimod 5% cream)
  • Drug: Vehicle cream
 Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Double-Blind, Vehicle-Controlled Study to Evaluate Cellular and Molecular Events During Four Weeks of Treatment for Actinic Keratosis With Aldara (Imiquimod) Cream, 5%
Study Start Date :
Jan 1, 2003
Actual Primary Completion Date :
Jul 1, 2003
Actual Study Completion Date :
Jul 1, 2003

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Imiquimod cream

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)
Imiquimod 5% cream containing 12.5 mg of imiquimod per 250 mg of cream
Other Names:
  • imiquimod cream

    		•
    Placebo Comparator: Vehicle cream

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

    Drug: Vehicle cream
    Vehicle cream in 250 mg
    Other Names:
  • placebo cream

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Gene expression profiling of treated lesions [weeks 1, 2, and 4, and at 4 weeks post-treatment]

    Secondary Outcome Measures

    1. Confocal microscopic evaluation before, during and post treatment [weeks 1, 2, 4 and at 4 weeks post-treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Loma Linda University Medical Center Loma Linda California United States 92350

    Sponsors and Collaborators

    • Graceway Pharmaceuticals, LLC

    Investigators

    • Study Director: TC Meng, MD, Graceway Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00335179
    Other Study ID Numbers:
    • 1467-IMIQ
    First Posted:
    Jun 9, 2006
    Last Update Posted:
    Jul 23, 2010
    Last Verified:
    Jul 1, 2010
    Keywords provided by , ,
    Actinic keratosis
    AK
    imiquimod
    confocal microscopy
    gene microarray
    Additional relevant MeSH terms:
    Keratosis, Actinic
    Keratosis
    Imiquimod

    Study Results

    No Results Posted as of Jul 23, 2010