NCT00953732CompletedNot Applicable
A 12 Month, Long-term Follow-up Study of Patients With Actinic Keratosis on the Head (Face or Scalp) Who Have Completed Day 57 in Studies PEP005-016 or PEP005-025 (REGION IIa and IIb)
Peplin41 sites in 2 countries117 target enrollmentStarted: August 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 117
- Locations
- 41
- Primary Endpoint
- Summarize treatment area recurrence of AK lesions, in the selected treatment area
Study Overview
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.
Study Design
- Study Type
- Observational
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
1
Intervention: Lesion count (Drug)
Outcomes
Primary Outcomes
Summarize treatment area recurrence of AK lesions, in the selected treatment area
Time Frame: 12 months
Secondary Outcomes
- Summarize long-term safety data(incidence of AEs in the treatment area)(12 months)
Investigators
Study Sites (41)
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