A Long Term Follow up Study of Patients Who Have Complete Clearance of Their Actinic Keratosis (AK) Lesions at the Day 57 Visit in the PEP005-028 Study

Peplin

Status: Completed

Conditions: Actinic Keratosis

Treatments: Drug: Lesion count

Study type: Observational

Funder types: Industry

Identifiers

NCT00989313

PEP005-032

Details and patient eligibility

About

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.

Enrollment: 43 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 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

Trial design

43 participants in 1 patient group

1

Treatment:

Drug: Lesion count