A Long Term Follow up Study of Patients Who Have Completed the PEP005-016 or PEP005-025 Studies
- Conditions
- Actinic Keratosis
- Interventions
- Drug: Lesion count
- Registration Number
- NCT00953732
- Lead Sponsor
- Peplin
- 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 assess both recurrence of Actinic Keratosis (AK) lesions and long term safety in the selected treatment area.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 117
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 Lesion count -
- Primary Outcome Measures
Name Time Method Summarize treatment area recurrence of AK lesions, in the selected treatment area 12 months
- Secondary Outcome Measures
Name Time Method Summarize long-term safety data(incidence of AEs in the treatment area) 12 months
Trial Locations
- Locations (41)
Burke Pharmaceutical Research
🇺🇸Hot Springs, Arizona, United States
Center for Dermatology
🇺🇸Fremont, California, United States
Dermatology Research Associates
🇺🇸Nashville, Tennessee, United States
Dermatology Specialists Inc
🇺🇸Oceanside, California, United States
Skin Surgery Medical Group Inc.
🇺🇸San Diego, California, United States
Conant Medical Group
🇺🇸San Francisco, California, United States
North Florida Dermatology Associates, PA
🇺🇸Jacksonville, Florida, United States
University of Miami, Skin Research Camp
🇺🇸Miami, Florida, United States
Atlanta Dermatology, Vein & Research Center, LLC
🇺🇸Alpharetta, Georgia, United States
Medaphase Inc
🇺🇸Newnan, Georgia, United States
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