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

Peplin98 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Actinic Keratosis

Interventions

Lesion countDRUG

Lesion count in area treated by study drug in a prior study over a 12 month period No drug will be applied during this long-term follow up study. Drug was applied during the primary study.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

Park Avenue Dermatology

Orange Park, Florida, United States

Medaphase Inc

Newnan, Georgia, United States

Gwinnett Clinical Research Centre

Snellville, Georgia, United States

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 adverse events in the treatment area)

Time frame: 12 months

Data from ClinicalTrials.gov

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