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

Actinic Keratosis Clinical Trial

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%

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00335179
• Other study ID #: 1467-IMIQ
• Status: Completed
• Phase: Phase 2
• First received: June 8, 2006
• Last updated: July 22, 2010
• Start date: January 2003
• Est. completion date: July 2003

Study information

• Verified date: July 2010
• Source: Graceway Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 2003
• Est. primary completion date: July 2003
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• Aldara (imiquimod 5% cream)
Imiquimod 5% cream containing 12.5 mg of imiquimod per 250 mg of cream
• Vehicle cream
Vehicle cream in 250 mg

Locations

Country	Name	City	State
United States	Loma Linda University Medical Center	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Graceway Pharmaceuticals, LLC

Country where clinical trial is conducted

United States, 

References & Publications (2)

Torres A, Storey L, Anders M, Miller RL, Bulbulian BJ, Jin J, Raghavan S, Lee J, Slade HB, Birmachu W. Immune-mediated changes in actinic keratosis following topical treatment with imiquimod 5% cream. J Transl Med. 2007 Jan 26;5:7. — View Citation

Torres A, Storey L, Anders M, Miller RL, Bulbulian BJ, Jin J, Raghavan S, Lee J, Slade HB, Birmachu W. Microarray analysis of aberrant gene expression in actinic keratosis: effect of the Toll-like receptor-7 agonist imiquimod. Br J Dermatol. 2007 Dec;157(6):1132-47. Epub 2007 Oct 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gene expression profiling of treated lesions		weeks 1, 2, and 4, and at 4 weeks post-treatment	No
Secondary	Confocal microscopic evaluation before, during and post treatment		weeks 1, 2, 4 and at 4 weeks post-treatment	No