Back to resultsA Multi-center Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on Non-head Locations (Trunk and Extremities)
Primary Purpose
Actinic Keratosis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
PEP005 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 patient must be of either:
- Non-childbearing potential, post-menopausal, or there is a confirmed clinical history of sterility (e.g., the patient is without a uterus)
- Childbearing potential, provided there are negative urine pregnancy test results prior to study treatment, to rule out pregnancy
Exclusion Criteria
- Cosmetic or therapeutic procedures within two weeks and within 2 cm of the selected treatment area.
- Treatment with immunomodulators, 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
- Park Avenue Dermatology
- Medaphase Inc
- Gwinnett Clinical Research Centre
- Michigan Center for Research Corp
- Henry Ford Health Systems
- Dermatology Associates of Rochester
- Oregon Health and Science University
- Dermatology Research Associates
- Dematology on Ward
- Dermatology Institute of Victoria
- St John of God Dermatology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PEP005 gel
Arm Description
PEP005 gel, 0.05% administered once daily for 2 consecutive days
Outcomes
Primary Outcome Measures
Safety (Incidence of treatment related AEs, local skin reactions and pigmentation and scarring)
Secondary Outcome Measures
Efficacy (complete and partial clearance of AK lesions)
Full Information
NCT ID
NCT00917306
First Posted
June 8, 2009
Last Updated
March 25, 2015
Sponsor
Peplin
Collaborators
TKL Research, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00917306
Brief Title
A Multi-center Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on Non-head Locations (Trunk and Extremities)
Official Title
A Multi-center, Open-label Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.05% in Patients With Actinic Keratoses on Non-head Locations (Trunk and Extremities)
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
Collaborators
TKL Research, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The open label study is designed to assess the safety and efficacy of 0.05% PEP005 Gel when applied to an area of skin containing 4-8 AK lesions on non-head locations.
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PEP005 gel
Arm Type
Experimental
Arm Description
PEP005 gel, 0.05% administered once daily for 2 consecutive days
Intervention Type
Drug
Intervention Name(s)
PEP005 Gel
Other Intervention Name(s)
PEP005
Intervention Description
0.05% two day treatment
Primary Outcome Measure Information:
Title
Safety (Incidence of treatment related AEs, local skin reactions and pigmentation and scarring)
Time Frame
57 days
Secondary Outcome Measure Information:
Title
Efficacy (complete and partial clearance of AK lesions)
Time Frame
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 patient must be of either:
Non-childbearing potential, post-menopausal, or there is a confirmed clinical history of sterility (e.g., the patient is without a uterus)
Childbearing potential, provided there are negative urine pregnancy test results prior to study treatment, to rule out pregnancy
Exclusion Criteria
Cosmetic or therapeutic procedures within two weeks and within 2 cm of the selected treatment area.
Treatment with immunomodulators, 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
Park Avenue Dermatology
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
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
Michigan Center for Research Corp
City
Clinton Twp
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Facility Name
Henry Ford Health Systems
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Dermatology Associates of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
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 Research Associates
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Dematology on Ward
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5006
Country
Australia
Facility Name
Dermatology Institute of Victoria
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3141
Country
Australia
Facility Name
St John of God Dermatology
City
Subiaco
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
12. IPD Sharing Statement
Links:
URL
http://www.fda.gov
Description
Food and Drug Authority
URL
http://tga.gov.au
Description
Therapeutic Goods Administration
Learn more about this trial
A Multi-center Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on Non-head Locations (Trunk and Extremities)
We'll reach out to this number within 24 hrs