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

This study has been completed.
Sponsor:
Information provided by:
Graceway Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT00335179
First received: June 8, 2006
Last updated: July 22, 2010
Last verified: July 2010
  Purpose

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 Intervention Phase
Actinic Keratosis
Drug: Aldara (imiquimod 5% cream)
Drug: Vehicle cream
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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%

Resource links provided by NLM:


Further study details as provided by Graceway Pharmaceuticals, LLC:

Primary Outcome Measures:
  • Gene expression profiling of treated lesions [ Time Frame: weeks 1, 2, and 4, and at 4 weeks post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Confocal microscopic evaluation before, during and post treatment [ Time Frame: weeks 1, 2, 4 and at 4 weeks post-treatment ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: January 2003
Study Completion Date: July 2003
Primary Completion Date: July 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00335179

Locations
United States, California
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
  More Information

Publications:
Responsible Party: James Lee, MD, Graceway Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00335179     History of Changes
Other Study ID Numbers: 1467-IMIQ
Study First Received: June 8, 2006
Last Updated: July 22, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Graceway Pharmaceuticals, LLC:
Actinic keratosis
AK
imiquimod
confocal microscopy
gene microarray

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Neoplasms
Precancerous Conditions
Skin Diseases
Imiquimod
Adjuvants, Immunologic
Antineoplastic Agents
Immunologic Factors
Interferon Inducers
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014