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.
Sponsor:
Information provided by:
Graceway Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT00115154
First received: June 21, 2005
Last updated: February 16, 2007
Last verified: February 2007
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Atlanta, Georgia, United States, 30263
Newnan, 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
New York, New York, United States, 10025
Rochester, New York, United States, 14623
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
Dallas, Texas, United States, 75246
Houston, Texas, United States, 77030
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

No publications provided

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

Keywords provided by Graceway Pharmaceuticals, LLC:
Actinic Keratosis
AK
3M Pharmaceuticals
Aldara
Imiquimod
Actinic Keratosis (AK)

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Ichthyosis
Keratoacanthoma
Skin Diseases
Precancerous Conditions
Neoplasms
Skin Abnormalities
Congenital Abnormalities
Infant, Newborn, Diseases
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers

ClinicalTrials.gov processed this record on April 16, 2014