Actinic Keratosis
Conditions
Keywords
Peplin, Actinic keratosis, PEP005
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.
Interventions
DRUGLesion count
Lesion count in area treated by study drug in a prior study over a 12 month period No drug will be applied during this long-term follow up study. Drug was applied during the primary study.
Sponsors
Peplin
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Summarize treatment area recurrence of AK lesions in the selected treatment area | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Summarize long-term safety data (incidence of adverse events in the treatment area) | 12 months |
Countries
Australia, United States
Outcome results
None listed