Study to Assess the Safety and Efficacy of Imiquimod 5% Cream for the Treatment of Actinic Keratosis on the Arms and Hands

This study has been completed.

Sponsored by:	Graceway Pharmaceuticals, LLC
Information provided by:	Graceway Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:	NCT00115154

Purpose

The purpose of this study is to evaluate the safety and efficacy of imiquimod 5% cream compared to vehicle cream in the treatment of Actinic Keratosis (AK) on the arm and/or hand when the cream is applied once daily 2 days per week for 16 weeks.

Condition	Intervention	Phase
Keratosis	Drug: Aldara (imiquimod) cream, 5%	Phase IV

Drug Information available for: S 26308

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Vehicle-Controlled, Double-Blind Study to Assess the Safety and Efficacy of Imiquimod 5% Cream for the Treatment of Actinic Keratosis on the Upper Extremities

Further study details as provided by Graceway Pharmaceuticals, LLC:

Primary Outcome Measures:

The primary objective of this study is to evaluate the efficacy of imiquimod 5% cream compared to vehicle cream in the treatment of AK on the upper extremities when the cream is applied once daily 2 days per week for 16 weeks.

Secondary Outcome Measures:

The secondary objective is to evaluate the safety of treatment with imiquimod 5% cream in subjects with AK lesions on the upper extremities.

Estimated Enrollment:	270
Study Start Date:	May 2005
Estimated Study Completion Date:	September 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

18 years of age
Have AK on arm or hand
Discontinuation of sun tanning and the use of tanning beds
Discontinuation of the use of moisturizers, body oils, over-the-counter retinol products and products containing alpha or beta hydroxy acid in the treatment and surrounding area
Withholding of the use of sunscreen in the treatment area for 24 hours prior to all study visits and for 8 hours before applying study cream
Postponement of the treatment of non-study AK lesions anywhere on the arm being treated until study participation is complete

Exclusion Criteria:

Subjects must not have any evidence of systemic cancer or immunosuppression or other unstable health conditions
Participation in another clinical study
Have previously received treatment with imiquimod within the treatment area
Have squamous cell carcinoma (SCC), basal cell carcinoma (BCC), or other malignancy in the treatment or surrounding area that requires treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115154

Locations

United States, Arizona

Tucson, Arizona, United States, 85710
United States, California

Vista, California, United States, 92083
United States, Georgia

Newnan, Georgia, United States, 30263

Atlanta, Georgia, United States, 30263
United States, Illinois

Buffalo Grove, Illinois, United States, 60089
United States, Indiana

Evansville, Indiana, United States, 47713
United States, New Jersey

Delran, New Jersey, United States, 08075
United States, New York

Rochester, New York, United States, 14623

New York, New York, United States, 10025
United States, North Carolina

Greenville, North Carolina, United States, 27834
United States, Oregon

Portland, Oregon, United States, 97223
United States, Rhode Island

Providence, Rhode Island, United States, 02903
United States, Tennessee

Knoxville, Tennessee, United States, 37922
United States, Texas

Houston, Texas, United States, 77030

Dallas, Texas, United States, 75246
United States, Virginia

Virginia Beach, Virginia, United States, 23454
United States, Washington

Wenatchee, Washington, United States, 98801
United States, Wisconsin

Milwaukee, Wisconsin, United States, 53209

Sponsors and Collaborators

Graceway Pharmaceuticals, LLC

More Information

Study ID Numbers:	1516-IMIQ
Study First Received:	June 21, 2005
Last Updated:	February 16, 2007
ClinicalTrials.gov Identifier:	NCT00115154
Health Authority:	United States: Food and Drug Administration

Keywords provided by Graceway Pharmaceuticals, LLC:

Actinic Keratosis
AK
3M Pharmaceuticals

Aldara
Imiquimod
Actinic Keratosis (AK)

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