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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
United States
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

  • Burke Pharmaceutical Research
  • Skin Surgery Medical Group Inc.
  • Atlanta Dermatology, Vein & Research Center, LLC
  • Altman Dermatology Associates
  • Glazer Dermatology
  • Deaconess Clinic Downtown
  • Dawes Fretzin Clinical Research Group, LLC
  • Skin Specialists, PC
  • Karl G. Heine Dermatology
  • Group Health Associates
  • DermResearch, Inc.
  • Suzanne Bruce and Associates, PA, The Center for Skin Research
  • Dermatology Clinical Research Center of San Antonio
  • Dermatology Associates of Tyler
  • Dermatology Research Center, Inc.
  • The Education and Research Foundation
  • Virginia Clinical Research, Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

PEP005 (ingenol mebutate) Gel

Vehicle gel

Arm Description

PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days

Vehicle gel once daily for 2 consecutive days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 19, 2009
Last Updated
February 18, 2015
Sponsor
Peplin
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1. Study Identification

Unique Protocol Identification Number
NCT00942604
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-Ib)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 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
203 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PEP005 (ingenol mebutate) Gel
Arm Type
Active Comparator
Arm Description
PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
Arm Title
Vehicle gel
Arm Type
Placebo Comparator
Arm Description
Vehicle gel once daily for 2 consecutive days
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
Proportion of Patients With Complete Clearance of Actinic Keratoses (AK) Lesions
Description
Proportion of Patients with Complete Clearance of the treatment field defined as no clinically visible Actinic Keratoses (AK) lesions in the selected treatment area
Time Frame
57 days
Secondary Outcome Measure Information:
Title
Proportion of Patients With Partial Clearance of Actinic Keratoses (AK) Lesions
Description
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
Time Frame
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
Burke Pharmaceutical Research
City
Hot Springs
State/Province
Arizona
ZIP/Postal Code
71913
Country
United States
Facility Name
Skin Surgery Medical Group Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92117
Country
United States
Facility Name
Atlanta Dermatology, Vein & Research Center, LLC
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30022
Country
United States
Facility Name
Altman Dermatology Associates
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Glazer Dermatology
City
Buffalo Grove
State/Province
Illinois
ZIP/Postal Code
60089
Country
United States
Facility Name
Deaconess Clinic Downtown
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Skin Specialists, PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Karl G. Heine Dermatology
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89002
Country
United States
Facility Name
Group Health Associates
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
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
Dermatology Clinical Research Center of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Dermatology Associates of Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75703
Country
United States
Facility Name
Dermatology Research Center, Inc.
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
The Education and Research Foundation
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Virginia Clinical Research, Inc
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

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

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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