A Long Term Follow up Study of Patients Who Have Completed the PEP005-016 or PEP005-025 Studies
This study is designed to follow up patients who have achieved complete clearance of AK lesions at the Day 57 visit having completed the PEP005-016 or PEP005-025 studies over a 12 month period to assess both recurrence of Actinic Keratosis (AK) lesions and long term safety in the selected treatment area.
|Study Design:||Time Perspective: Prospective|
|Official Title:||A 12 Month, Long-term Follow-up Study of Patients With Actinic Keratosis on the Head (Face or Scalp) Who Have Completed Day 57 in Studies PEP005-016 or PEP005-025 (REGION IIa and IIb)|
- Summarize treatment area recurrence of AK lesions, in the selected treatment area [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Summarize long-term safety data(incidence of AEs in the treatment area) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2009|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Drug: Lesion count
Lesion count in area treated by study drug in a prior study. No drug will be applied during this long-term follow up study. Drug was applied during the primary study.
Other Name: AK lesion recurrence
A 12 month long-term follow-up study of patients who have achieved complete clearance of AK lesions at the Day 57 in the Phase 3 studies PEP005-016 or PEP005-025.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00953732
Show 42 Study Locations
|Study Director:||Eugene Bauer, MD||Chief Medical Officer|