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
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
Observational Model: Cohort, Time Perspective: Prospective
Number of Participants With Recurrence of AK Lesions
The primary efficacy variable in this study was the absence of AK lesions(sustained clearance rate) in the previously treated area.
Up to one year
Sharon Levy, MD
Graceway Pharmaceuticals, LLC
United States: Food and Drug Administration