Study of Inflammatory Mechanisms in Epidermolysis Bullosa Simplex- Dowling Meara
NCT ID: NCT01556308
Last Updated: 2014-07-29
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
NA
6 participants
INTERVENTIONAL
2012-03-31
2013-10-31
Brief Summary
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Material and methods: A first retrospective immunohistochemical study will be led on remainder skin biopsies of DM-EBS patients took for the diagnosis. A second clinical multicentric prospective study will be led on 8 patients older than 1 year with severe DM-EBS. After informed written consent, they will answer to a standardized questionnaire. In case of flare of the disease, the liquid and the top of the blisters will be took. Samples will be analyzed in the Pr Nicolas 851 INSERM unit. After centrifugation of the liquid blisters, the repartition of inflammatory cells will be evaluated by Fluorescence Activated Cell Sorting on the pellet. Markers of inflammation will be evaluated on the surnageant with Luminex® technical with a multiplex targeting cytokines and chemokines. An immuno-histochemic analysis in association with a quantitative PCR will be made on the top of the blisters. If unknown, genotypic study will be made.
Perspectives: A better comprehension of physiopathological mechanisms in DM-EBS could offer new therapeutic ways.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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DM-EBS
Taking of liquid and top of blisters
the liquid and the top of blisters will be took.
Interventions
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Taking of liquid and top of blisters
the liquid and the top of blisters will be took.
Eligibility Criteria
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Inclusion Criteria
* older than 1 year-old
* severe Dowling Meara epidermolysis bullosa (more than 2 blisters per day)
* systematic written informed consent
* child consent
* affiliated to french social security
Exclusion Criteria
* no consent
* non affiliated to french social security
* participation to another clinical trial within 3 months ago
* intercurrent disease justifying the withdrawal of the study
* own patient decision to stop the study, withdrawal of informed consent
1 Year
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nice
OTHER
Responsible Party
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Locations
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Hôpital Archet 2
Nice, , France
Countries
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Other Identifiers
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11-AOI-02
Identifier Type: -
Identifier Source: org_study_id
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