Study to Assess the Safety and Efficacy of Imiquimod 5% Cream for the Treatment of Actinic Keratosis on the Arms and Hands
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
1 other identifier
interventional
270
1 country
18
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2005
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 21, 2005
CompletedFirst Posted
Study publicly available on registry
June 22, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedFebruary 19, 2007
February 1, 2007
June 21, 2005
February 16, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
The secondary objective is to evaluate the safety of treatment with imiquimod 5% cream in subjects with AK lesions on the upper extremities.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Unknown Facility
Tucson, Arizona, 85710, United States
Unknown Facility
Vista, California, 92083, United States
Unknown Facility
Atlanta, Georgia, 30263, United States
Unknown Facility
Newnan, Georgia, 30263, United States
Unknown Facility
Buffalo Grove, Illinois, 60089, United States
Unknown Facility
Evansville, Indiana, 47713, United States
Unknown Facility
Riverside Park, New Jersey, 08075, United States
Unknown Facility
New York, New York, 10025, United States
Unknown Facility
Rochester, New York, 14623, United States
Unknown Facility
Greenville, North Carolina, 27834, United States
Unknown Facility
Portland, Oregon, 97223, United States
Unknown Facility
Providence, Rhode Island, 02903, United States
Unknown Facility
Knoxville, Tennessee, 37922, United States
Unknown Facility
Dallas, Texas, 75246, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
Virginia Beach, Virginia, 23454, United States
Unknown Facility
Wenatchee, Washington, 98801, United States
Unknown Facility
Milwaukee, Wisconsin, 53209, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 21, 2005
First Posted
June 22, 2005
Study Start
May 1, 2005
Study Completion
September 1, 2006
Last Updated
February 19, 2007
Record last verified: 2007-02