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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

98 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Actinic Keratosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Lesion count

Intervention Type DRUG

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.

Interventions

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Lesion count

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.

Intervention Type DRUG

Other Intervention Names

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AK lesion recurrence

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No