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

NCT ID: NCT00335179

Last Updated: 2010-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-31
• Study Completion Date: 2003-07-31

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.

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.

Conditions

Actinic Keratosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Imiquimod cream

Imiquimod 5% cream containing 12.5 mg of imiquimod per 250 mg of cream Applied 3 times per week for 4 weeks

Group Type: ACTIVE_COMPARATOR

Aldara (imiquimod 5% cream)

Intervention Type: DRUG

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

Vehicle cream

Vehicle cream 250 mg Applied 3 times per week for 4 weeks

Group Type: PLACEBO_COMPARATOR

Vehicle cream

Intervention Type: DRUG

Vehicle cream in 250 mg

Interventions

Aldara (imiquimod 5% cream)

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

Intervention Type: DRUG

Vehicle cream

Vehicle cream in 250 mg

Intervention Type: DRUG

Other Intervention Names

imiquimod cream; placebo cream

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Graceway Pharmaceuticals, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Graceway Pharmaceuticals

Principal Investigators

TC Meng, MD

Role: STUDY_DIRECTOR

Graceway Pharmaceuticals

Locations

Loma Linda University Medical Center

Loma Linda, California, United States

Countries

United States

References

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. doi: 10.1111/j.1365-2133.2007.08218.x. Epub 2007 Oct 18.

Reference Type: BACKGROUND

PMID: 17944981 (View on PubMed)

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. doi: 10.1186/1479-5876-5-7.

Reference Type: BACKGROUND

PMID: 17257431 (View on PubMed)

Other Identifiers

1467-IMIQ

Identifier Type: -

Identifier Source: org_study_id