A Long Term Follow up Study of Patients Who Have Complete Clearance of Their Actinic Keratosis (AK) Lesions at the Day 57 Visit in the PEP005-028 Study
NCT ID: NCT00989313
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
43 participants
OBSERVATIONAL
2009-09-30
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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CASE_ONLY
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 achieved complete clearance of AK lesions (lesion count of 0) in the selected treatment area at the Day 57 visit in the following Peplin AK clinical Study: PEP005-028
Exclusion
* Concurrent participation in another research study which would involve the selected treatment area (except for any post-study follow-up visits for previous Peplin AK study)
* Early termination from study PEP005-028
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 Centre
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, 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
Other Identifiers
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PEP005-032
Identifier Type: -
Identifier Source: org_study_id
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