A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations

A Multi-center, Randomized, Parallel Group, Double-blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.05% In Patients With Actinic Keratoses ON Non-head Locations (REGION-I)

The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.

Study Overview

• Status: Completed
• Conditions: Actinic Keratoses
• Intervention / Treatment: Drug: PEP005 (ingenol mebutate) Gel; Drug: Vehicle gel

• Study Type: Interventional
• Enrollment (Actual): 255
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Benowa, Queensland, Australia, 4217
      • The Skin Centre
  • Western Australia
    • Victoria Park, Western Australia, Australia, 6100
      • Burswood Dermatology
• United States
  • Arizona
    • Mesa, Arizona, United States, 85206
      • Omni Dermatology Research
  • Colorado
    • Denver, Colorado, United States, 80210
      • Colorado Medical Research Center
  • Florida
    • Kissimmee, Florida, United States, 34741
      • Advanced Dermatology and Cosmetic Research
    • Orange Park, Florida, United States, 32073
      • Park Avenue Dermatology
    • Ormond Beach, Florida, United States, 32174
      • Advanced Dermatology & Cosmetic Surgery
  • Georgia
    • Newnan, Georgia, United States, 30263
      • Medaphase Inc
    • Snellville, Georgia, United States, 30078-3250
      • Gwinnett Clinical Research Centre
  • Indiana
    • Plainfield, Indiana, United States, 46168
      • Dermatology Center of Indiana/Indiana Clinical Trials Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health Systems
  • New Jersey
    • South Delran, New Jersey, United States, 08075
      • Karen S. Harkaway, MD. LLC
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Academic Dermatology Associates
  • New York
    • Rochester, New York, United States, 14623
      • Dermatology Associates of Rochester
  • Ohio
    • Cleveland, Ohio, United States, 44121
      • University Hospitals Case Medical Center
  • Oregon
    • Portland, Oregon, United States, 97223
      • Oregon Medical Research
    • Portland, Oregon, United States, 97239-4501
      • Oregon Health and Science University
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Dermatology East
    • Goodlettsville, Tennessee, United States, 37072
      • Rivergate Dermatology and Skin Care Center
  • Texas
    • College Station, Texas, United States, 77845
      • J & S Studies, Inc.

Participation Criteria

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:

• Must be male or female and at least 18 years of age.
• Female patients must be of:
• Non-childbearing potential;
• Childbearing potential, provided negative serum and urine pregnancy test and using effective contraception.
• 4 to 8 AK lesions on non-head locations.

Exclusion Criteria:

• Cosmetic or therapeutic procedures within 2 weeks and within 2 cm 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 treatment area

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; PEP005 (ingenol mebutate) Gel	Drug: PEP005 (ingenol mebutate) Gel; two day treatment
Placebo Comparator: 2; Vehicle gel	Drug: Vehicle gel; two day treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients With Complete Clearance of Actinic Keratosis (AKs)	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 (AKs)	Partial clearance rate of AK lesions defined as the proportion of patients with a 75% or greater reduction in the number of actinic keratosis (AK) lesions identified at baseline in the selected treatment area.	baseline and 57 days

Collaborators and Investigators

• Sponsor: Peplin

Publications and helpful links

General Publications

• Lebwohl M, Swanson N, Anderson LL, Melgaard A, Xu Z, Berman B. Ingenol mebutate gel for actinic keratosis. N Engl J Med. 2012 Mar 15;366(11):1010-9. doi: 10.1056/NEJMoa1111170.

Helpful Links

• Food and Drug Authority
• Therapeutic Goods Administration

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: August 25, 2008
• First Submitted That Met QC Criteria: August 26, 2008
• First Posted (Estimate): August 27, 2008

Study Record Updates

• Last Update Posted (Estimate): March 6, 2015
• Last Update Submitted That Met QC Criteria: February 18, 2015
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Actinic keratosis; Peplin; PEP005
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis
• Other Study ID Numbers: PEP005-014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No