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

March 25, 2015 updated by: Peplin

A 12 Month, Long-term Follow-up Study of Patients With Actinic Keratosis on Non-head Areas (Trunk and Extremities) Who Have Completed Day 57 in Study PEP005-020

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

98

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5006
        • Dematology on Ward
    • Victoria
      • Melbourne, Victoria, Australia, 3141
        • Dermatology Institute of Victoria
    • Western Australia
      • Subiaco, Western Australia, Australia, 6008
        • St John of God Dermatology
  • United States
    • Florida
      • Orange Park, Florida, United States, 32073
        • Park Avenue Dermatology
    • Georgia
      • Newnan, Georgia, United States, 30263
        • Medaphase Inc
      • Snellville, Georgia, United States, 30078-3250
        • Gwinnett Clinical Research Centre
    • Michigan
      • Clinton Twp, Michigan, United States, 48038
        • Michigan Center for Research Corp
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health Systems
    • New York
      • Rochester, New York, United States, 14623
        • Dermatology Associates of Rochester
    • Oregon
      • Portland, Oregon, United States, 97239-4501
        • Oregon Health and Science University
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Dermatology Research Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who have achieved complete clearance of AK lesions (lesion count of 0) at Day 57 in study PEP005-020

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Drug: 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.
Other Names:
  • AK lesion recurrence

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Summarize treatment area recurrence of AK lesions in the selected treatment area
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Summarize long-term safety data (incidence of adverse events in the treatment area)
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peplin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

August 4, 2009

First Submitted That Met QC Criteria

August 4, 2009

First Posted (Estimate)

August 6, 2009

Study Record Updates

Last Update Posted (Estimate)

March 26, 2015

Last Update Submitted That Met QC Criteria

March 25, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEP005-031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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