An Open-Label 18-Month Safety Study of Fluorouracil Cream 0.5% for the Treatment of Actinic Keratoses
This study is being undertaken to: 1. assess the safety of fluorouracil cream for the treatment of actinic keratoses ("AKs") on other common skin surface areas (e.g., posterior scalp, ears, neck, lips, arms and hands); 2. collect additional post-treatment safety data on fluorouracil cream applied to the face (including anterior scalp, if applicable); 3. assess the incidence of recurrence of AKs on the face; and 4. assess the need for re-treatment with fluorouracil cream to the face.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
- The reduction in Actinic Keratosis lesion counts on other body sites from pretreatment to post-treatment and AK clearance of other body site lesions for Treatment Cycle 1.
- The reduction in Actinic Keratosis lesion counts of the face (including anterior scalp, if applicable) from pretreatment to post-treatment and AK clearance of facial lesions for each Treatment Cycle
- The recurrence of facial lesions at 12 and 18 months post initial treatment, and the need for re-treatment.
|Study Start Date:||November 2003|
|Estimated Study Completion Date:||October 2005|