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-Ib)

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): 203
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Hot Springs, Arizona, United States, 71913
      • Burke Pharmaceutical Research
  • California
    • San Diego, California, United States, 92117
      • Skin Surgery Medical Group Inc.
  • Georgia
    • Alpharetta, Georgia, United States, 30022
      • Atlanta Dermatology, Vein & Research Center, LLC
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Altman Dermatology Associates
    • Buffalo Grove, Illinois, United States, 60089
      • Glazer Dermatology
  • Indiana
    • Evansville, Indiana, United States, 47713
      • Deaconess Clinic Downtown
    • Indianapolis, Indiana, United States, 46256
      • Dawes Fretzin Clinical Research Group, LLC
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists, PC
  • Nevada
    • Henderson, Nevada, United States, 89002
      • Karl G. Heine Dermatology
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Group Health Associates
  • 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
      • Dermatology Clinical Research Center of San Antonio
    • Tyler, Texas, United States, 75703
      • Dermatology Associates of Tyler
  • 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

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: PEP005 (ingenol mebutate) Gel; PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days	Drug: PEP005 (ingenol mebutate) Gel; two day treatment
Placebo Comparator: Vehicle gel; Vehicle gel once daily for 2 consecutive days	Drug: Vehicle gel; two day treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients With Complete Clearance of Actinic Keratoses (AK) Lesions	Proportion of Patients with Complete Clearance of the treatment field defined as no clinically visible Actinic Keratoses (AK) lesions in the selected treatment area	57 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients With Partial Clearance of Actinic Keratoses (AK) Lesions	Proportion of patients with Partial Clearance defined as ≥ 75 % reduction in the number of Actinic Keratoses (AK) lesions identified at baseline in the treatment area	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

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: July 19, 2009
• First Submitted That Met QC Criteria: July 19, 2009
• First Posted (Estimate): July 21, 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: Actinic keratosis; Peplin; PEP005
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis
• Other Study ID Numbers: PEP005-028