A Multi-center Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on the Head (Face or Scalp)

March 13, 2015 updated by: Peplin

A Multi-center, Randomized, Parallel Group, Double-blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.015% In Patients With Actinic Keratoses ON the Head (Face or Scalp) (REGION-IIa)

This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when applied to an area of skin containing 4-8 AK lesions on the face or scalp.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

269

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
    • 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
  • United States
    • California
      • 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
      • 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
      • Buffalo Grove, Illinois, United States, 60089
        • Glazer Dermatology
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Dawes Fretein Clinical Research Group, LLC
    • 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
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Dermatology Research Associates
    • Texas
      • College Station, Texas, United States, 77845
        • J & S Studies, Inc.
      • 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
      • Norfolk, Virginia, United States, 23507
        • Virginia Clinical Research, Inc

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 patients must be of either:

    • Non-childbearing potential, post-menopausal
    • Childbearing potential, provided there are negative serum and urine pregnancy test results prior to study treatment, to rule out pregnancy

Exclusion Criteria:

  • Cosmetic or therapeutic procedures within 2 weeks and 2cm of the selected treatment area
  • Treatment with immunomodulators, or 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PEP005 gel
PEP005 gel, 0.015% applied once daily for three consecutive days
Drug: PEP005 Gel
0.015%, three day treatment
Other Names:
  • PEP005
Placebo Comparator: Vehicle gel
Vehicle gel applied once daily for three consecutive days
Drug: Vehicle gel
Vehicle gel, three day treatment
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients With Complete Clearance of Actinic Keratosis (AK) Lesions.
Time Frame: 57 days
Complete clearance rate of actinic keratosis (AK) lesions, defined as the proportion of patients with no clinically visible AK lesions in the selected treatment area.
57 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients With Partial Clearance of Actinic Keratosis (AK)
Time Frame: baseline and 57 days
Patients with partial clearance defined as ≥ 75% reduction in the number of actinic keratosis (AK) lesions identified at baseline in the treatment area
baseline and 57 days

Collaborators and Investigators

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

Sponsor

Peplin

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

June 1, 2009

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

June 4, 2009

First Submitted That Met QC Criteria

June 5, 2009

First Posted (Estimate)

June 8, 2009

Study Record Updates

Last Update Posted (Estimate)

April 2, 2015

Last Update Submitted That Met QC Criteria

March 13, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEP005-016

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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