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)
NCT ID: NCT00915551
Last Updated: 2015-03-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
278 participants
INTERVENTIONAL
2009-06-30
2009-09-30
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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PEP005 (Ingenol Mebutate) gel
PEP005 (Ingenol Mebutate) gel, 0.015%
once daily for 3 consecutive days
Vehicle gel
Vehicle Gel
once daily for 3 consecutive days
Interventions
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PEP005 (Ingenol Mebutate) gel, 0.015%
once daily for 3 consecutive days
Vehicle Gel
once daily for 3 consecutive days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Peplin
INDUSTRY
Responsible Party
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Locations
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Burke Pharmaceutical Research
Hot Springs, Arizona, United States
Center for Dermatology
Fremont, California, United States
North Florida Dermatology Associates, PA
Jacksonville, Florida, United States
Altman Dermatology Associates
Arlington Heights, Illinois, United States
Laser Skin Surgery Center of Indiana
Carmel, Indiana, United States
Deaconess Clinic, Inc
Evansville, Indiana, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, United States
Skin Specialists, PC
Omaha, Nebraska, United States
Karl G. Heine Dermatology
Henderson, Nevada, United States
Academic Dermatology Associates
Albuquerque, New Mexico, United States
Mount Sinai School of Medicine
New York, New York, United States
Dermatology Associates of Rochester, PC
Rochester, New York, United States
Dermatology, Laser Vein Specialists of the Carolinas
Charlotte, North Carolina, United States
Oregon Medical Research Center, PC
Portland, Oregon, United States
DermResearch, Inc.
Austin, Texas, United States
Suzanne Bruce and Associates, PA, The Center for Skin Research
Houston, Texas, United States
Progressive Clinical Research
San Antonio, Texas, United States
The Education and Research Foundation
Lynchburg, Virginia, United States
Premier Clinical Research
Spokane, Washington, United States
The Skin Centre
Benowa, Queensland, Australia
South East Dermatology, Belmont Specialist Centre
Carina Heights, Queensland, 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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PEP005-025
Identifier Type: -
Identifier Source: org_study_id
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