A Long Term Follow up Study of Patients Who Have Completed the PEP005-016 or PEP005-025 Studies

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peplin
• Collaborator: TKL Research, Inc.

Criteria

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