Follow-up Study to Evaluate Sustained Clearance Rates of Actinic Keratoses up to One Year
The objective of this study was to obtain long-term sustained clearance rates for subjects previously treated with imiquimod creams in studies GW01-0702, GW01-0703, GW01-0704 and GW01-0705.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Follow-up Study to Evaluate Sustained Clearance Rates of Actinic Keratoses up to One Year After Completion of Studies GW01-0702, GW01-0703, GW01-0704, and GW01-0705|
- Number of Participants With Recurrence of AK Lesions [ Time Frame: Up to one year ] [ Designated as safety issue: No ]The primary efficacy variable in this study was the absence of AK lesions(sustained clearance rate) in the previously treated area.
|Study Start Date:||April 2008|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
This is a Phase 3 longitudinal and observational study. Subjects who previously enrolled in studies GW01-0702, GW01-0703, GW01-0704, and GW01-0705 and were completely cleared of their AK lesions in the selected treatment area at the end-of-study visit will return for follow-up visits at 6 and 12 months after the EOS visit or until a recurrence of AKs.
The NCT numbers for the above mentioned studies are:
NCT00603798 - for Studies GW01-0703 and GW01-0705
NCT00605176 for Studies GW01-0702 and GW01-0704
Please refer to this study by its ClinicalTrials.gov identifier: NCT00668733
|Study Director:||Sharon Levy, MD||Graceway Pharmaceuticals, LLC|