Back to resultsStudy to Assess the Safety and Efficacy of Imiquimod 5% Cream for the Treatment of Actinic Keratosis on the Arms and Hands
Primary Purpose
Keratosis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Aldara (imiquimod) cream, 5%
Sponsored by
About this trial
This is an interventional treatment trial for Keratosis focused on measuring Actinic Keratosis, AK, 3M Pharmaceuticals, Aldara, Imiquimod, Actinic Keratosis (AK)
Eligibility 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
Sites / Locations
Outcomes
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.
Full Information
NCT ID
NCT00115154
First Posted
June 21, 2005
Last Updated
February 16, 2007
Sponsor
Graceway Pharmaceuticals, LLC
1. Study Identification
Unique Protocol Identification Number
NCT00115154
Brief Title
Study to Assess the Safety and Efficacy of Imiquimod 5% Cream for the Treatment of Actinic Keratosis on the Arms and Hands
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 Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Graceway Pharmaceuticals, LLC
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratosis
Keywords
Actinic Keratosis, AK, 3M Pharmaceuticals, Aldara, Imiquimod, Actinic Keratosis (AK)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
270 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Aldara (imiquimod) cream, 5%
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
The secondary objective is to evaluate the safety of treatment with imiquimod 5% cream in subjects with AK lesions on the upper extremities.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
City
Vista
State/Province
California
ZIP/Postal Code
92083
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
City
Buffalo Grove
State/Province
Illinois
ZIP/Postal Code
60089
Country
United States
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
City
Delran
State/Province
New Jersey
ZIP/Postal Code
08075
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study to Assess the Safety and Efficacy of Imiquimod 5% Cream for the Treatment of Actinic Keratosis on the Arms and Hands
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