Actinic Keratosis
Conditions
Keywords
Peplin, Actinic keratosis, PEP005
Brief summary
This study is designed to follow up patients, who have participated in the PEP005-028 study and observed complete clearance of their Actinic Keratosis (AK) lesions, over a 12 month period to assess both recurrence of 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. 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 the following Peplin AK clinical Study: PEP005-028 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 PEP005-028
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Summarize treatment area recurrence of AK lesions, in the selected treatment area during a 12 month follow-up period for patients with complete clearance, who have completed Day 57 in Study PEP005-028. | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Summarize long-term safety data, in the selected treatment area over a 12 month follow-up period for patients with complete clearance, who have completed Day 57 in Study PEP005-028. | 12 months |
Countries
United States
Outcome results
None listed