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

March 25, 2015 updated by: Peplin

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

117

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
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • Southderm Pty Ltd
      • Kogarah, New South Wales, Australia, 2217
        • St George Dematology and Skin Cancer Centre
    • Queensland
      • Benowa, Queensland, Australia, 4217
        • The Skin Centre
      • Carina Heights, Queensland, Australia, 4152
        • South East Dermatology, Belmont Specialist Centre
  • United States
    • Arizona
      • Hot Springs, Arizona, United States, 71913
        • Burke Pharmaceutical Research
    • California
      • Fremont, California, United States, 94538
        • Center for Dermatology
      • Los Angeles, California, United States, 90045
        • Dermatology Research Associates
      • Oceanside, California, United States, 92056
        • Dermatology Specialists Inc
      • San Diego, California, United States, 92117
        • Skin Surgery Medical Group Inc.
      • San Francisco, California, United States, 94114
        • Conant Medical Group
    • Florida
      • Jacksonville, Florida, United States, 32204
        • North Florida Dermatology Associates, PA
      • Miami, Florida, United States, 33136
        • University of Miami, Skin Research Camp
    • Georgia
      • Alpharetta, Georgia, United States, 30022
        • Atlanta Dermatology, Vein & Research Center, LLC
      • Newnan, Georgia, United States, 30263
        • Medaphase Inc
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Altman Dermatology Associates
      • Buffalo Grove, Illinois, United States, 60089
        • Glazer Dermatology
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Laser Skin Surgery Center of Indiana
      • Evansville, Indiana, United States, 47713
        • Deaconess Clinic, Inc
      • Indianapolis, Indiana, United States, 46256
        • Dawes Fretein Clinical Research Group, LLC
      • Plainfield, Indiana, United States, 46168
        • The Indiana Clinical Trials Center, PC
    • Kentucky
      • Owensboro, Kentucky, United States, 42301
        • Pedia Research LLC
    • Michigan
      • Fort Gratiot, Michigan, United States, 48059
        • Hamzavi Dermatology
    • Minnesota
      • Fridley, Minnesota, United States, 55432
        • Minnesota Clinical Study Center
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Skin Specialists, PC
    • Nevada
      • Henderson, Nevada, United States, 89002
        • Karl G. Heine Dermatology
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Academic Dermatology Associates
    • New York
      • New York, New York, United States, 10029-6574
        • Mount Sinai School of Medicine
      • Rochester, New York, United States, 14623
        • Dermatology Associates of Rochester, PC
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Dermatology, Laser Vein Specialists of the Carolinas
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates
    • Oregon
      • Portland, Oregon, United States, 97223
        • Oregon Medical Research
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Dermatology Research Associates
    • Texas
      • Austin, Texas, United States, 78759
        • Dermresearch, Inc.
      • College Station, Texas, United States, 77845
        • J & S Studies, Inc.
      • Houston, Texas, United States, 77056
        • Suzanne Bruce and Associates, The Center for Skin Research
      • San Antonio, Texas, United States, 78229
        • Progressive Clinical Research
      • Tyler, Texas, United States, 75703
        • Dermatology Associates of Tyler
      • Webster, Texas, United States, 77598
        • Center for Clinical Studies
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Dermatology Research Center, Inc.
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • The Education and Research Foundation
      • Norfolk, Virginia, United States, 23507
        • Virginia Clinical Research, Inc
    • Washington
      • Spokane, Washington, United States, 99204
        • Premier Clinical Research

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

All patients must have achieved complete clearance of AK lesions at Day 57 visit in either study PEP005-016 or PEP005-025 will be offered participation in this study.

Description

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

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. 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 AEs 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

Collaborators

TKL Research, Inc.

Investigators

  • Study Director: Eugene Bauer, MD, Chief Medical Officer

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

August 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 5, 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

  • PEP005-030

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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