A Long Term Follow up Study of Patients Who Have Completed the PEP005-016 or PEP005-025 Studies
NCT ID: NCT00953732
Last Updated: 2015-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
117 participants
OBSERVATIONAL
2009-08-31
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PROSPECTIVE
Study Groups
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1
Lesion count
Lesion count in area treated by study drug in a prior study. No drug will be applied during this long-term follow up study. Drug was applied during the primary study.
Interventions
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Lesion count
Lesion count in area treated by study drug in a prior study. No drug will be applied during this long-term follow up study. Drug was applied during the primary study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient has provided informed consent documented by signing the Informed Consent Form (ICF) prior to any study-related procedures
Exclusion Criteria
* Early termination from study PEP005-016 or PEP005-025
18 Years
ALL
No
Sponsors
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TKL Research, Inc.
INDUSTRY
Peplin
INDUSTRY
Responsible Party
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Principal Investigators
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Eugene Bauer, MD
Role: STUDY_DIRECTOR
Chief Medical Officer
Locations
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Burke Pharmaceutical Research
Hot Springs, Arizona, United States
Center for Dermatology
Fremont, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Dermatology Specialists Inc
Oceanside, California, United States
Skin Surgery Medical Group Inc.
San Diego, California, United States
Conant Medical Group
San Francisco, California, United States
North Florida Dermatology Associates, PA
Jacksonville, Florida, United States
University of Miami, Skin Research Camp
Miami, Florida, United States
Atlanta Dermatology, Vein & Research Center, LLC
Alpharetta, Georgia, United States
Medaphase Inc
Newnan, Georgia, United States
Altman Dermatology Associates
Arlington Heights, Illinois, United States
Glazer Dermatology
Buffalo Grove, Illinois, United States
Laser Skin Surgery Center of Indiana
Carmel, Indiana, United States
Deaconess Clinic, Inc
Evansville, Indiana, United States
Dawes Fretein Clinical Research Group, LLC
Indianapolis, Indiana, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, United States
Pedia Research LLC
Owensboro, Kentucky, United States
Hamzavi Dermatology
Fort Gratiot, Michigan, United States
Minnesota Clinical Study Center
Fridley, Minnesota, 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
Wake Research Associates
Raleigh, North Carolina, United States
Oregon Medical Research
Portland, Oregon, United States
Dermatology Research Associates
Nashville, Tennessee, United States
DermResearch, Inc.
Austin, Texas, United States
J & S Studies, Inc.
College Station, Texas, United States
Suzanne Bruce and Associates, The Center for Skin Research
Houston, Texas, United States
Progressive Clinical Research
San Antonio, Texas, United States
Dermatology Associates of Tyler
Tyler, Texas, United States
Center for Clinical Studies
Webster, 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
Premier Clinical Research
Spokane, Washington, United States
Southderm Pty Ltd
Kogarah, New South Wales, Australia
St George Dematology and Skin Cancer Centre
Kogarah, New South Wales, Australia
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, Shumack S, Stein Gold L, Melgaard A, Larsson T, Tyring SK. Long-term follow-up study of ingenol mebutate gel for the treatment of actinic keratoses. JAMA Dermatol. 2013 Jun;149(6):666-70. doi: 10.1001/jamadermatol.2013.2766.
Related Links
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Food and Drug Authority
Therapeutic Goods Administration
Other Identifiers
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PEP005-030
Identifier Type: -
Identifier Source: org_study_id
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