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)

February 18, 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-IIb)

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)

278

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
    • 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
    • Florida
      • Jacksonville, Florida, United States, 32204
        • North Florida Dermatology Associates, PA
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Altman Dermatology Associates
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Laser Skin Surgery Center of Indiana
      • Evansville, Indiana, United States, 47713
        • Deaconess Clinic, Inc
      • Plainfield, Indiana, United States, 46168
        • The Indiana Clinical Trials Center, PC
    • Nebraska
      • Omaha, Nebraska, United States
        • 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
    • Oregon
      • Portland, Oregon, United States, 97223
        • Oregon Medical Research Center, Pc
    • Texas
      • Austin, Texas, United States, 78759
        • Dermresearch, Inc.
      • Houston, Texas, United States, 77056
        • Suzanne Bruce and Associates, PA, The Center for Skin Research
      • San Antonio, Texas, United States, 78229
        • Progressive Clinical Research
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • The Education and Research Foundation
    • 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

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
Placebo Comparator: Vehicle gel
Drug: Vehicle Gel
once daily for 3 consecutive days
Experimental: PEP005 (Ingenol Mebutate) gel
Drug: PEP005 (Ingenol Mebutate) gel, 0.015%
once daily for 3 consecutive days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Clearance of Actinic Keratoses (AK) Lesions
Time Frame: baseline and 57 days
Complete clearance of the treatment field
baseline and 57 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Partial Clearance of Actinic Keratoses (AK)
Time Frame: baseline and 57 days
Partial clearance defined as ≥ 75% reduction in the number of 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

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)

March 6, 2015

Last Update Submitted That Met QC Criteria

February 18, 2015

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEP005-025

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.

Clinical Trials on Actinic Keratosis

Clinical Trials on PEP005 (Ingenol Mebutate) gel, 0.015%

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe