Study to Assess the Safety and Efficacy of Imiquimod 5% Cream for the Treatment of Actinic Keratosis on the Arms and Hands
Information source: Graceway Pharmaceuticals, LLC
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Keratosis
Intervention: Aldara (imiquimod) cream, 5% (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Graceway Pharmaceuticals, LLC
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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: The secondary objective is to evaluate the safety of treatment with imiquimod 5% cream in subjects with AK lesions on the upper extremities.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Tucson, Arizona 85710, United States
Vista, California 92083, United States
Newnan, Georgia 30263, United States
Atlanta, Georgia 30263, United States
Buffalo Grove, Illinois 60089, United States
Evansville, Indiana 47713, United States
Delran, New Jersey 08075, United States
Rochester, New York 14623, United States
New York, New York 10025, United States
Greenville, North Carolina 27834, United States
Portland, Oregon 97223, United States
Providence, Rhode Island 02903, United States
Knoxville, Tennessee 37922, United States
Houston, Texas 77030, United States
Dallas, Texas 75246, United States
Virginia Beach, Virginia 23454, United States
Wenatchee, Washington 98801, United States
Milwaukee, Wisconsin 53209, United States
Additional Information
Starting date: May 2005
Ending date: September 2006
Last updated: February 16, 2007
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