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
NCT ID: NCT00742391
Last Updated: 2015-03-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
255 participants
INTERVENTIONAL
2008-09-30
2009-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
PEP005 (ingenol mebutate) Gel
PEP005 (ingenol mebutate) Gel
two day treatment
2
Vehicle gel
Vehicle gel
two day treatment
Interventions
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PEP005 (ingenol mebutate) Gel
two day treatment
Vehicle gel
two day treatment
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Peplin
INDUSTRY
Responsible Party
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Locations
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Omni Dermatology Research
Mesa, Arizona, United States
Colorado Medical Research Center
Denver, Colorado, United States
Advanced Dermatology and Cosmetic Research
Kissimmee, Florida, United States
Park Avenue Dermatology
Orange Park, Florida, United States
Advanced Dermatology & Cosmetic Surgery
Ormond Beach, Florida, United States
Medaphase Inc
Newnan, Georgia, United States
Gwinnett Clinical Research Centre
Snellville, Georgia, United States
Dermatology Center of Indiana/Indiana Clinical Trials Center
Plainfield, Indiana, United States
Henry Ford Health Systems
Detroit, Michigan, United States
Karen S. Harkaway, MD. LLC
South Delran, New Jersey, United States
Academic Dermatology Associates
Albuquerque, New Mexico, United States
Dermatology Associates of Rochester
Rochester, New York, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Oregon Medical Research
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Dermatology East
Germantown, Tennessee, United States
Rivergate Dermatology and Skin Care Center
Goodlettsville, Tennessee, United States
J & S Studies, Inc.
College Station, Texas, United States
The Skin Centre
Benowa, Queensland, Australia
Burswood Dermatology
Victoria Park, Western Australia, Australia
Countries
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References
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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.
Related Links
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Food and Drug Authority
Therapeutic Goods Administration
Other Identifiers
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PEP005-014
Identifier Type: -
Identifier Source: org_study_id
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