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: NCT00942604
Last Updated: 2015-03-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
203 participants
INTERVENTIONAL
2009-07-31
2009-10-31
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 0.05% once daily for 2 consecutive days
PEP005 (ingenol mebutate) Gel
two day treatment
Vehicle gel
Vehicle gel once daily for 2 consecutive days
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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Burke Pharmaceutical Research
Hot Springs, Arizona, United States
Skin Surgery Medical Group Inc.
San Diego, California, United States
Atlanta Dermatology, Vein & Research Center, LLC
Alpharetta, Georgia, United States
Altman Dermatology Associates
Arlington Heights, Illinois, United States
Glazer Dermatology
Buffalo Grove, Illinois, United States
Deaconess Clinic Downtown
Evansville, Indiana, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Skin Specialists, PC
Omaha, Nebraska, United States
Karl G. Heine Dermatology
Henderson, Nevada, United States
Group Health Associates
Cincinnati, Ohio, United States
DermResearch, Inc.
Austin, Texas, United States
Suzanne Bruce and Associates, PA, The Center for Skin Research
Houston, Texas, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States
Dermatology Associates of Tyler
Tyler, Texas, United States
Dermatology Research Center, Inc.
Salt Lake City, Utah, United States
The Education and Research Foundation
Lynchburg, Virginia, United States
Virginia Clinical Research, Inc
Norfolk, Virginia, United States
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
Other Identifiers
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PEP005-028
Identifier Type: -
Identifier Source: org_study_id
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