A Multi-center Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on Non-head Locations (Trunk and Extremities)

March 25, 2015 updated by: Peplin

A Multi-center, Open-label Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.05% in Patients With Actinic Keratoses on Non-head Locations (Trunk and Extremities)

The open label study is designed to assess the safety and efficacy of 0.05% PEP005 Gel when applied to an area of skin containing 4-8 AK lesions on non-head locations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 3

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

Description

Inclusion Criteria:

  • Patient is male or female and at least 18 years of age.

  • Female patient must be of either:

    • Non-childbearing potential, post-menopausal, or there is a confirmed clinical history of sterility (e.g., the patient is without a uterus)
    • Childbearing potential, provided there are negative urine pregnancy test results prior to study treatment, to rule out pregnancy

Exclusion Criteria

  • Cosmetic or therapeutic procedures within two weeks and within 2 cm of the selected treatment area.
  • Treatment with immunomodulators, interferon/ interferon inducers or systemic medications that suppress the immune system within 4 weeks.
  • Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy: within 8 weeks and 2 cm of the selected treatment area.

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PEP005 gel
PEP005 gel, 0.05% administered once daily for 2 consecutive days
Drug: PEP005 Gel
0.05% two day treatment
Other Names:
  • PEP005

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety (Incidence of treatment related AEs, local skin reactions and pigmentation and scarring)
Time Frame: 57 days
57 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy (complete and partial clearance of AK lesions)
Time Frame: 57 days
57 days

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.

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

June 1, 2009

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

June 8, 2009

First Submitted That Met QC Criteria

June 8, 2009

First Posted (Estimate)

June 10, 2009

Study Record Updates

Last Update Posted (Estimate)

April 15, 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

  • PEP005-020

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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