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

Primary Purpose

Actinic Keratosis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Aldara (imiquimod 5% cream)

Vehicle cream

About this trial

This is an interventional treatment trial for Actinic Keratosis focused on measuring Actinic keratosis, AK, imiquimod, confocal microscopy, gene microarray

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Loma Linda University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Imiquimod cream

Vehicle cream

Arm Description

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

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

Outcomes

Primary Outcome Measures

Gene expression profiling of treated lesions

Secondary Outcome Measures

Confocal microscopic evaluation before, during and post treatment

Full Information

NCT ID

NCT00335179

First Posted

June 8, 2006

Last Updated

July 22, 2010

Sponsor

Graceway Pharmaceuticals, LLC

1. Study Identification

Unique Protocol Identification Number

NCT00335179

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

July 2010

Overall Recruitment Status

Completed

Study Start Date

January 2003 (undefined)

Primary Completion Date

July 2003 (Actual)

Study Completion Date

July 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Graceway Pharmaceuticals, LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Actinic Keratosis

Keywords

Actinic keratosis, AK, imiquimod, confocal microscopy, gene microarray

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Imiquimod cream

Arm Type

Active Comparator

Arm Description

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

Arm Title

Vehicle cream

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Aldara (imiquimod 5% cream)

Other Intervention Name(s)

imiquimod cream

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Vehicle cream

Other Intervention Name(s)

placebo cream

Intervention Description

Vehicle cream in 250 mg

Primary Outcome Measure Information:

Title

Gene expression profiling of treated lesions

Time Frame

weeks 1, 2, and 4, and at 4 weeks post-treatment

Secondary Outcome Measure Information:

Title

Confocal microscopic evaluation before, during and post treatment

Time Frame

weeks 1, 2, 4 and at 4 weeks post-treatment

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

TC Meng, MD

Organizational Affiliation

Graceway Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Loma Linda University Medical Center

City

Loma Linda

State/Province

California

ZIP/Postal Code

92350

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

17944981

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

Results Reference

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PubMed Identifier

17257431

Citation

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.

Results Reference

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

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