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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

Primary Purpose

Actinic Keratoses

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
PEP005 (ingenol mebutate) Gel
Vehicle gel
Sponsored by
Peplin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratoses focused on measuring Peplin, Actinic keratosis, PEP005

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Omni Dermatology Research
  • Colorado Medical Research Center
  • Advanced Dermatology and Cosmetic Research
  • Park Avenue Dermatology
  • Advanced Dermatology & Cosmetic Surgery
  • Medaphase Inc
  • Gwinnett Clinical Research Centre
  • Dermatology Center of Indiana/Indiana Clinical Trials Center
  • Henry Ford Health Systems
  • Karen S. Harkaway, MD. LLC
  • Academic Dermatology Associates
  • Dermatology Associates of Rochester
  • University Hospitals Case Medical Center
  • Oregon Medical Research
  • Oregon Health and Science University
  • Dermatology East
  • Rivergate Dermatology and Skin Care Center
  • J & S Studies, Inc.
  • The Skin Centre
  • Burswood Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

PEP005 (ingenol mebutate) Gel

Vehicle gel

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 25, 2008
Last Updated
February 18, 2015
Sponsor
Peplin
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1. Study Identification

Unique Protocol Identification Number
NCT00742391
Brief Title
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
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peplin

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratoses
Keywords
Peplin, Actinic keratosis, PEP005

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
255 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
PEP005 (ingenol mebutate) Gel
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Vehicle gel
Intervention Type
Drug
Intervention Name(s)
PEP005 (ingenol mebutate) Gel
Intervention Description
two day treatment
Intervention Type
Drug
Intervention Name(s)
Vehicle gel
Intervention Description
two day treatment
Primary Outcome Measure Information:
Title
Patients With Complete Clearance of Actinic Keratosis (AKs)
Description
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.
Time Frame
57 days
Secondary Outcome Measure Information:
Title
Patients With Partial Clearance of Actinic Keratosis (AKs)
Description
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.
Time Frame
baseline and 57 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Omni Dermatology Research
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Colorado Medical Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Advanced Dermatology and Cosmetic Research
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Park Avenue Dermatology
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
Advanced Dermatology & Cosmetic Surgery
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Medaphase Inc
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Gwinnett Clinical Research Centre
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078-3250
Country
United States
Facility Name
Dermatology Center of Indiana/Indiana Clinical Trials Center
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Henry Ford Health Systems
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Karen S. Harkaway, MD. LLC
City
South Delran
State/Province
New Jersey
ZIP/Postal Code
08075
Country
United States
Facility Name
Academic Dermatology Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Dermatology Associates of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44121
Country
United States
Facility Name
Oregon Medical Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-4501
Country
United States
Facility Name
Dermatology East
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Rivergate Dermatology and Skin Care Center
City
Goodlettsville
State/Province
Tennessee
ZIP/Postal Code
37072
Country
United States
Facility Name
J & S Studies, Inc.
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
The Skin Centre
City
Benowa
State/Province
Queensland
ZIP/Postal Code
4217
Country
Australia
Facility Name
Burswood Dermatology
City
Victoria Park
State/Province
Western Australia
ZIP/Postal Code
6100
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
22417254
Citation
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.
Results Reference
derived
Links:
URL
http://www.fda.gov/
Description
Food and Drug Authority
URL
http://www.tga.gov.au/
Description
Therapeutic Goods Administration

Learn more about this trial

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

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