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
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)
1 other identifier
interventional
255
2 countries
20
Brief Summary
The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2008
Shorter than P25 for phase_3
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2008
CompletedFirst Posted
Study publicly available on registry
August 27, 2008
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedResults Posted
Study results publicly available
March 21, 2012
CompletedMarch 6, 2015
March 1, 2012
5 months
August 25, 2008
February 21, 2012
February 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
57 days
Secondary Outcomes (1)
Patients With Partial Clearance of Actinic Keratosis (AKs)
baseline and 57 days
Study Arms (2)
1
ACTIVE COMPARATORPEP005 (ingenol mebutate) Gel
2
PLACEBO COMPARATORVehicle gel
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- to 8 AK lesions on non-head locations.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peplinlead
Study Sites (20)
Omni Dermatology Research
Mesa, Arizona, 85206, United States
Colorado Medical Research Center
Denver, Colorado, 80210, United States
Advanced Dermatology and Cosmetic Research
Kissimmee, Florida, 34741, United States
Park Avenue Dermatology
Orange Park, Florida, 32073, United States
Advanced Dermatology & Cosmetic Surgery
Ormond Beach, Florida, 32174, United States
Medaphase Inc
Newnan, Georgia, 30263, United States
Gwinnett Clinical Research Centre
Snellville, Georgia, 30078-3250, United States
Dermatology Center of Indiana/Indiana Clinical Trials Center
Plainfield, Indiana, 46168, United States
Henry Ford Health Systems
Detroit, Michigan, 48202, United States
Karen S. Harkaway, MD. LLC
South Delran, New Jersey, 08075, United States
Academic Dermatology Associates
Albuquerque, New Mexico, 87106, United States
Dermatology Associates of Rochester
Rochester, New York, 14623, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44121, United States
Oregon Medical Research
Portland, Oregon, 97223, United States
Oregon Health and Science University
Portland, Oregon, 97239-4501, United States
Dermatology East
Germantown, Tennessee, 38138, United States
Rivergate Dermatology and Skin Care Center
Goodlettsville, Tennessee, 37072, United States
J & S Studies, Inc.
College Station, Texas, 77845, United States
The Skin Centre
Benowa, Queensland, 4217, Australia
Burswood Dermatology
Victoria Park, Western Australia, 6100, Australia
Related Publications (1)
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.
PMID: 22417254DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Torsten Skov
- Organization
- LEO Pharma
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2008
First Posted
August 27, 2008
Study Start
September 1, 2008
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
March 6, 2015
Results First Posted
March 21, 2012
Record last verified: 2012-03