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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)

Primary Purpose

Actinic Keratosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
PEP005 (Ingenol Mebutate) gel, 0.015%
Vehicle Gel
Sponsored by
Peplin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

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

Sites / Locations

  • Burke Pharmaceutical Research
  • Center for Dermatology
  • North Florida Dermatology Associates, PA
  • Altman Dermatology Associates
  • Laser Skin Surgery Center of Indiana
  • Deaconess Clinic, Inc
  • The Indiana Clinical Trials Center, PC
  • Skin Specialists, PC
  • Karl G. Heine Dermatology
  • Academic Dermatology Associates
  • Mount Sinai School of Medicine
  • Dermatology Associates of Rochester, PC
  • Dermatology, Laser Vein Specialists of the Carolinas
  • Oregon Medical Research Center, PC
  • DermResearch, Inc.
  • Suzanne Bruce and Associates, PA, The Center for Skin Research
  • Progressive Clinical Research
  • The Education and Research Foundation
  • Premier Clinical Research
  • The Skin Centre
  • South East Dermatology, Belmont Specialist Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PEP005 (Ingenol Mebutate) gel

Vehicle gel

Arm Description

Outcomes

Primary Outcome Measures

Complete Clearance of Actinic Keratoses (AK) Lesions
Complete clearance of the treatment field

Secondary Outcome Measures

Partial Clearance of Actinic Keratoses (AK)
Partial clearance defined as ≥ 75% reduction in the number of AK lesions identified at baseline in the treatment area

Full Information

First Posted
June 4, 2009
Last Updated
February 18, 2015
Sponsor
Peplin
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1. Study Identification

Unique Protocol Identification Number
NCT00915551
Brief Title
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)
Official Title
A Multi-center, Randomized, Parallel Group, Double-blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.015% In Patients With Actinic Keratoses ON the Head (Face or Scalp) (REGION-IIb)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis
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
278 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PEP005 (Ingenol Mebutate) gel
Arm Type
Experimental
Arm Title
Vehicle gel
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PEP005 (Ingenol Mebutate) gel, 0.015%
Intervention Description
once daily for 3 consecutive days
Intervention Type
Drug
Intervention Name(s)
Vehicle Gel
Intervention Description
once daily for 3 consecutive days
Primary Outcome Measure Information:
Title
Complete Clearance of Actinic Keratoses (AK) Lesions
Description
Complete clearance of the treatment field
Time Frame
baseline and 57 days
Secondary Outcome Measure Information:
Title
Partial Clearance of Actinic Keratoses (AK)
Description
Partial clearance defined as ≥ 75% reduction in the number of AK lesions identified at baseline in the 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: 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
Facility Information:
Facility Name
Burke Pharmaceutical Research
City
Hot Springs
State/Province
Arizona
ZIP/Postal Code
71913
Country
United States
Facility Name
Center for Dermatology
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
North Florida Dermatology Associates, PA
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Altman Dermatology Associates
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Laser Skin Surgery Center of Indiana
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
Deaconess Clinic, Inc
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
The Indiana Clinical Trials Center, PC
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Skin Specialists, PC
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Karl G. Heine Dermatology
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89002
Country
United States
Facility Name
Academic Dermatology Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029-6574
Country
United States
Facility Name
Dermatology Associates of Rochester, PC
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Dermatology, Laser Vein Specialists of the Carolinas
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Oregon Medical Research Center, PC
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
DermResearch, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Suzanne Bruce and Associates, PA, The Center for Skin Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
The Education and Research Foundation
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Premier Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
The Skin Centre
City
Benowa
State/Province
Queensland
ZIP/Postal Code
4217
Country
Australia
Facility Name
South East Dermatology, Belmont Specialist Centre
City
Carina Heights
State/Province
Queensland
ZIP/Postal Code
4152
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 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)

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