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OpenTrials
Completed

NCT Number: NCT00335179

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

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.

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Key information

Conditions

Actinic Keratosis Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Loma Linda University Medical Center

Loma Linda, California, 92350, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aldara (imiquimod 5% cream)

Drug

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

Other names: imiquimod cream

Vehicle cream

Drug

Vehicle cream in 250 mg

Other names: placebo cream

Primary outcomes

  1. Gene expression profiling of treated lesions

    Time frame: weeks 1, 2, and 4, and at 4 weeks post-treatment

Secondary outcomes

  1. Confocal microscopic evaluation before, during and post treatment

    Time frame: weeks 1, 2, 4 and at 4 weeks post-treatment

Sponsors and collaborators

Lead sponsor

Graceway Pharmaceuticals, LLC

Industry

Registry information

Official study 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%

Important dates

Study start
2003
Primary completion
2003
Study completion
2003
First posted
Jun 9, 2006
Registry last updated
Jul 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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