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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00951964 |
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Date of registration:
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03/08/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Treatment of Epidermolysis Bullosa Dystrophica by Polyphenon E (Epigallocatechin 3 Gallate)
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Scientific title:
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Treatment of Epidermolysis Bullosa Dystrophica by Polyphenon E (Epigallocatechin 3 Gallate) |
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Date of first enrolment:
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October 2010 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00951964 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Christine Chiaverini, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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dermatology department, Nice University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- known mutation of COL7A1
Exclusion Criteria:
- tea drinkers
- patient receiving induction treatment,protease inhibitor treatment
- liver failure
Age minimum:
2 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Epidermolysis Bullosa Dystrophica
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Intervention(s)
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Drug: placebo before treatment
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Drug: Polyphenon E before Placebo
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Primary Outcome(s)
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decrease of number of cutaneous bullosa
[Time Frame: after 4 months of treatment]
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Secondary Outcome(s)
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efficacity of treatment
[Time Frame: at 4 , 6, 7 10 months after beginnig of treatment and at year 1]
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tolerance tio treatment
[Time Frame: at 1, 4, 6, 7, 10 and 12 months after beginnig the treatment]
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Secondary ID(s)
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09-APN-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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