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

Peplin

Status: Completed

Conditions: Actinic Keratosis

Treatments: Drug: Lesion count

Study type: Observational

Funder types: Industry

Identifiers

NCT00953732

PEP005-030

Details and patient eligibility

About

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.

Full 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.

Enrollment: 117 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

117 participants in 1 patient group

1

Treatment:

Drug: Lesion count