A Long Term Follow up Study of Patients Who Have Completed the PEP005-020 Study
- Conditions
- Actinic Keratosis
- Interventions
- Drug: Lesion count
- Registration Number
- NCT00952783
- Lead Sponsor
- Peplin
- Brief Summary
This study is designed to follow up patients, who have achieved complete clearance of AK lesions (lesion count of 0) at Day 57 in the PEP005-020 study, 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 98
Not provided
Not provided
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 adverse events in the treatment area) 12 months
Trial Locations
- Locations (11)
Park Avenue Dermatology
🇺🇸Orange Park, Florida, United States
Gwinnett Clinical Research Centre
🇺🇸Snellville, Georgia, United States
Medaphase Inc
🇺🇸Newnan, Georgia, United States
Michigan Center for Research Corp
🇺🇸Clinton Twp, Michigan, United States
Henry Ford Health Systems
🇺🇸Detroit, Michigan, United States
Dematology on Ward
🇦🇺Adelaide, South Australia, Australia
Dermatology Associates of Rochester
🇺🇸Rochester, New York, United States
Dermatology Research Associates
🇺🇸Nashville, Tennessee, United States
Dermatology Institute of Victoria
🇦🇺Melbourne, Victoria, Australia
St John of God Dermatology
🇦🇺Subiaco, Western Australia, Australia
Oregon Health and Science University
🇺🇸Portland, Oregon, United States