Status:
COMPLETED
A Long Term Follow up Study of Patients Who Have Completed the PEP005-016 or PEP005-025 Studies
Lead Sponsor:
Peplin
Collaborating Sponsors:
TKL Research, Inc.
Conditions:
Actinic Keratosis
Eligibility:
All Genders
18+ years
Brief Summary
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 asse...
Detailed Description
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.
Eligibility Criteria
Inclusion
- Patient must have achieved complete clearance of AK lesions (lesion count = 0) at Day 57 in one of the following Peplin AK clinical studies: PEP005-016 or PEP005-025
- Patient has provided informed consent documented by signing the Informed Consent Form (ICF) prior to any study-related procedures
Exclusion
- Concurrent participation in another research study which would involve the selected treatment area (except for any post-study follow-up visits for previous Peplin AK study)
- Early termination from study PEP005-016 or PEP005-025
Key Trial Info
Start Date :
August 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT00953732
Start Date
August 1 2009
End Date
October 1 2010
Last Update
March 26 2015
Active Locations (42)
Enter a location and click search to find clinical trials sorted by distance.
1
Burke Pharmaceutical Research
Hot Springs, Arizona, United States, 71913
2
Center for Dermatology
Fremont, California, United States, 94538
3
Dermatology Research Associates
Los Angeles, California, United States, 90045
4
Dermatology Specialists Inc
Oceanside, California, United States, 92056