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

This study has been completed.

Sponsored by:	Graceway Pharmaceuticals, LLC
Information provided by:	Graceway Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:	NCT00335179

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)	Phase II

Drug Information available for: S 26308

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Pharmacodynamics Study
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%

Further study details as provided by Graceway Pharmaceuticals, LLC:

Primary Outcome Measures:

Gene expression profiling of treated lesions

Secondary Outcome Measures:

Confocal microscopic evaluation before, during and post treatment

Estimated Enrollment:	16
Study Start Date:	January 2003
Estimated Study Completion Date:	August 2004

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

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

Locations

United States, California

Loma Linda, California, United States, 92350

Sponsors and Collaborators

Graceway Pharmaceuticals, LLC

More Information

Study ID Numbers:	1467-IMIQ
Study First Received:	June 8, 2006
Last Updated:	February 16, 2007
ClinicalTrials.gov Identifier:	NCT00335179
Health Authority:	United States: Food and Drug Administration

Keywords provided by Graceway Pharmaceuticals, LLC:

Actinic keratosis
AK
imiquimod
confocal microscopy
gene microarray

Study placed in the following topic categories:

Keratosis
Skin Diseases
Interferons
Imiquimod
Tylosis

Additional relevant MeSH terms:

Interferon Inducers
Immunologic Factors
Antineoplastic Agents
Therapeutic Uses

Physiological Effects of Drugs
Adjuvants, Immunologic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009