Back to resultsA 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 Gel
Vehicle gel
Sponsored by
About this trial
This is an interventional treatment trial for Actinic Keratosis focused on measuring Peplin, Actinic keratosis, PEP005
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
Sites / Locations
- Dermatology Research Associates
- Dermatology Specialists Inc
- Skin Surgery Medical Group Inc.
- Conant Medical Group
- University of Miami, Skin Research Camp
- Atlanta Dermatology, Vein & Research Center, LLC
- Medaphase Inc
- Glazer Dermatology
- Dawes Fretein Clinical Research Group, LLC
- Pedia Research LLC
- Hamzavi Dermatology
- Minnesota Clinical Study Center
- Wake Research Associates
- Dermatology Research Associates
- J & S Studies, Inc.
- Dermatology Associates of Tyler
- Center for Clinical Studies
- Dermatology Research Center, Inc.
- Virginia Clinical Research, Inc
- Southderm Pty Ltd
- St George Dematology and Skin Cancer Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
PEP005 gel
Vehicle gel
Arm Description
PEP005 gel, 0.015% applied once daily for three consecutive days
Vehicle gel applied once daily for three consecutive days
Outcomes
Primary Outcome Measures
Patients With Complete Clearance of Actinic Keratosis (AK) Lesions.
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 (AK)
Patients with partial clearance defined as ≥ 75% reduction in the number of actinic keratosis (AK) lesions identified at baseline in the treatment area
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00916006
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-IIa)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
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
269 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PEP005 gel
Arm Type
Experimental
Arm Description
PEP005 gel, 0.015% applied once daily for three consecutive days
Arm Title
Vehicle gel
Arm Type
Placebo Comparator
Arm Description
Vehicle gel applied once daily for three consecutive days
Intervention Type
Drug
Intervention Name(s)
PEP005 Gel
Other Intervention Name(s)
PEP005
Intervention Description
0.015%, three day treatment
Intervention Type
Drug
Intervention Name(s)
Vehicle gel
Other Intervention Name(s)
Placebo
Intervention Description
Vehicle gel, three day treatment
Primary Outcome Measure Information:
Title
Patients With Complete Clearance of Actinic Keratosis (AK) Lesions.
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 (AK)
Description
Patients with partial clearance defined as ≥ 75% reduction in the number of actinic keratosis (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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene Bauer, MD
Organizational Affiliation
Chief Medical Officer
Official's Role
Study Director
Facility Information:
Facility Name
Dermatology Research Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Dermatology Specialists Inc
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
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
Conant Medical Group
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
Facility Name
University of Miami, Skin Research Camp
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
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
Medaphase Inc
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Glazer Dermatology
City
Buffalo Grove
State/Province
Illinois
ZIP/Postal Code
60089
Country
United States
Facility Name
Dawes Fretein Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Pedia Research LLC
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Facility Name
Hamzavi Dermatology
City
Fort Gratiot
State/Province
Michigan
ZIP/Postal Code
48059
Country
United States
Facility Name
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Dermatology Research Associates
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
J & S Studies, Inc.
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Dermatology Associates of Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75703
Country
United States
Facility Name
Center for Clinical Studies
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
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
Virginia Clinical Research, Inc
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Southderm Pty Ltd
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
St George Dematology and Skin Cancer Centre
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
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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