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

July 22, 2010 updated by: Graceway Pharmaceuticals, LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92350
        • Loma Linda University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Graceway Pharmaceuticals, LLC

Investigators

  • Study Director: TC Meng, MD, Graceway Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

July 1, 2003

Study Completion (Actual)

July 1, 2003

Study Registration Dates

First Submitted

June 8, 2006

First Submitted That Met QC Criteria

June 8, 2006

First Posted (Estimate)

June 9, 2006

Study Record Updates

Last Update Posted (Estimate)

July 23, 2010

Last Update Submitted That Met QC Criteria

July 22, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1467-IMIQ

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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