Treatment of Epidermolysis Bullosa Dystrophica by Polyphenon E (Epigallocatechin 3 Gallate)
NCT ID: NCT00951964
Last Updated: 2014-05-07
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
PHASE2
18 participants
INTERVENTIONAL
2010-10-31
2013-07-31
Brief Summary
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These lesions are due to mutation on gene COL7A1 coding for collagen VII. There is no treatment available. Cares are consisting to dress lesions and to protect the skin.
The investigators have recently observed on patients having residual expression of collagen VII that phenotype severity is modulated by activation degree of dermic metalloproteinase. The investigators have also observed that epigallocatechin-3-gallate (Polyphenon E®) could be regulated this activity.
The primary purpose of this study is to assessing the efficacity of Polyphenon E to decrease the number of cutaneous bullosa after four month of treatment.
The primary outcome measure is the rate of patient presenting a decrease of 20% or more of the number of cutaneous bullosa.
Secondary outcomes are: severity of mucosa impairment, affected cutaneous surface, the average duration of cicatrisation and treatment tolerance.
This study foresees the inclusion of 22 patients older than 2 years old in 5 centers.
When patients are included, they will be randomized and receive the treatment (or placebo) for 4 months.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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1
patients receive the treatment in first and placebo in second part of study
Polyphenon E before Placebo
patients receive polyphenon E during 4 months, then 2 months of wash-out and finally 4 months of placebo
2
patients receive placebo in first and treatment in second part of study
placebo before treatment
patients receive 4 months of placebo, then 2 months of wash out et finally 4 months of treatment
Interventions
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Polyphenon E before Placebo
patients receive polyphenon E during 4 months, then 2 months of wash-out and finally 4 months of placebo
placebo before treatment
patients receive 4 months of placebo, then 2 months of wash out et finally 4 months of treatment
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* patient receiving induction treatment,protease inhibitor treatment
* liver failure
2 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nice
OTHER
Responsible Party
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Principal Investigators
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Christine Chiaverini, PhD
Role: PRINCIPAL_INVESTIGATOR
dermatology department, Nice University Hospital
Locations
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Dermatology Department, Bordeaux University Hospital
Bordeaux, , France
Dijon University Hospital, Dermatology Department
Dijon, , France
Dermatology Department, Necker Enfants Malades, APHP
Paris, , France
Dermatology Department, Saint Louis Hospital, APHP
Paris, , France
Toulouse University Hospital, Dermatology Department
Toulouse, , France
Countries
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References
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Chiaverini C, Roger C, Fontas E, Bourrat E, Bourdon-Lanoy E, Labreze C, Mazereeuw J, Vabres P, Bodemer C, Lacour JP. Oral epigallocatechin-3-gallate for treatment of dystrophic epidermolysis bullosa: a multicentre, randomized, crossover, double-blind, placebo-controlled clinical trial. Orphanet J Rare Dis. 2016 Mar 25;11:31. doi: 10.1186/s13023-016-0411-5.
Other Identifiers
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09-APN-01
Identifier Type: -
Identifier Source: org_study_id
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