A Long Term Follow up Study of Patients Who Have Completed the PEP005-020 Study

Peplin

Status: Completed

Conditions: Actinic Keratosis

Treatments: Drug: Lesion count

Study type: Observational

Funder types: Industry

Identifiers

NCT00952783

PEP005-031

Details and patient eligibility

About

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.

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

98 participants in 1 patient group

1

Treatment:

Drug: Lesion count