Actinic Keratosis Clinical Trial
Official title:
A 12 Month, Long-term Follow-up Study of Patients With Actinic Keratosis on Non-head Areas (Trunk and Extremities) Who Have Completed Day 57 in Study PEP005-020
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.
Status | Completed |
Enrollment | 98 |
Est. completion date | October 2010 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion - Patient has provided informed consent documented by signing the Informed Consent Form (ICF) prior to any study-related procedures - Patient achieved complete clearance of AK lesions (lesion count of 0) in the selected treatment area at the Day 57 visit in study PEP005-020 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 PEP005-020 |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Australia | Dematology on Ward | Adelaide | South Australia |
Australia | Dermatology Institute of Victoria | Melbourne | Victoria |
Australia | St John of God Dermatology | Subiaco | Western Australia |
United States | Michigan Center for Research Corp | Clinton Twp | Michigan |
United States | Henry Ford Health Systems | Detroit | Michigan |
United States | Dermatology Research Associates | Nashville | Tennessee |
United States | Medaphase Inc | Newnan | Georgia |
United States | Park Avenue Dermatology | Orange Park | Florida |
United States | Oregon Health and Science University | Portland | Oregon |
United States | Dermatology Associates of Rochester | Rochester | New York |
United States | Gwinnett Clinical Research Centre | Snellville | Georgia |
Lead Sponsor | Collaborator |
---|---|
Peplin |
United States, Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Summarize treatment area recurrence of AK lesions in the selected treatment area | 12 months | No | |
Secondary | Summarize long-term safety data (incidence of adverse events in the treatment area) | 12 months | Yes |
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