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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00335179
Recruitment Status : Completed
First Posted : June 9, 2006
Last Update Posted : July 23, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Actinic Keratosis 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.

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Study Type : Interventional  (Clinical Trial)
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 : January 2003
Actual Primary Completion Date : July 2003
Actual Study Completion Date : July 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Imiquimod

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 Name: 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 Name: placebo cream

Primary Outcome Measures :
  1. Gene expression profiling of treated lesions [ Time Frame: weeks 1, 2, and 4, and at 4 weeks post-treatment ]

Secondary Outcome Measures :
  1. Confocal microscopic evaluation before, during and post treatment [ Time Frame: weeks 1, 2, 4 and at 4 weeks post-treatment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00335179

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United States, California
Loma Linda University Medical Center
Loma Linda, California, United States, 92350
Sponsors and Collaborators
Graceway Pharmaceuticals, LLC
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Study Director: TC Meng, MD Graceway Pharmaceuticals
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Responsible Party: James Lee, MD, Graceway Pharmaceuticals Identifier: NCT00335179    
Other Study ID Numbers: 1467-IMIQ
First Posted: June 9, 2006    Key Record Dates
Last Update Posted: July 23, 2010
Last Verified: July 2010
Keywords provided by Graceway Pharmaceuticals, LLC:
Actinic keratosis
confocal microscopy
gene microarray
Additional relevant MeSH terms:
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Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers