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

A 12 Month, Long-term Follow-up Study of Patients With Actinic Keratosis on the Head (Face or Scalp) Who Have Completed Day 57 in Studies PEP005-016 or PEP005-025 (REGION IIa and IIb)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00953732

Enrollment

117

Registered

2009-08-06

Start date

2009-08-31

Completion date

2010-10-31

Last updated

2015-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Actinic Keratosis

Keywords

Peplin, Actinic keratosis, PEP005

Brief 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.

Detailed 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.

Interventions

DRUGLesion count

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

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Summarize treatment area recurrence of AK lesions, in the selected treatment area	12 months

Secondary

Measure	Time frame
Summarize long-term safety data(incidence of AEs in the treatment area)	12 months

Countries

Australia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026