Status:
COMPLETED
Study to Assess the Safety and Efficacy of Imiquimod 5% Cream for the Treatment of Actinic Keratosis on the Arms and Hands
Lead Sponsor:
Graceway Pharmaceuticals, LLC
Conditions:
Keratosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 app...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
End Date :
September 1 2006
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT00115154
Start Date
May 1 2005
End Date
September 1 2006
Last Update
February 19 2007
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
Tucson, Arizona, United States, 85710
2
Vista, California, United States, 92083
3
Atlanta, Georgia, United States, 30263
4
Newnan, Georgia, United States, 30263