Validation of a Simplified Severity Score (Investigator Global Assessment: IGA) in Bullous Pemphigoid
NCT ID: NCT05366127
Last Updated: 2022-05-09
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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NOT_YET_RECRUITING
150 participants
OBSERVATIONAL
2022-07-01
2026-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patient with bullous pemphigoid
IGA score and BPDAI score will be assessed to patient with bullous pemphigoid
IGA score
IGA score will be assessed by 2 blinded investigators
BULLOUS PEMPHIGOID DISEASE AREA INDEX (BPDAI)
BPDAI will be assessed by 2 by 2 blinded investigators
Interventions
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IGA score
IGA score will be assessed by 2 blinded investigators
BULLOUS PEMPHIGOID DISEASE AREA INDEX (BPDAI)
BPDAI will be assessed by 2 by 2 blinded investigators
Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed or relapsing BP
* Clinical features suggestive of classic BP AND suggestive histological features AND deposition of IgG and/ or C3 deposits on the dermal epiderma junction, AND detection of circulating anti-epidermal antibodies labelling the epidermal side of salt-split skin
* Patient having read and understood the information letter and not opposed to participation
* Must be willing and able to adhere to all specified requirements, including but not limited to adherence to the follow-up visits
Exclusion Criteria
* Pemphigoid gestationis
* Linear IgA dermatosis (predominant or exclusive IgA deposits on the DEJ)
* Skin lesions suggesting the diagnosis of epidermolysis bullosa acquisita (skin fragility, atrophy, milia)
18 Years
ALL
No
Sponsors
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University Hospital, Rouen
OTHER
Responsible Party
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Principal Investigators
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Pascal JOLY
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Rouen
Locations
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Bordeaux University Hospital
Bordeaux, , France
Dijon University Hospital
Dijon, , France
Lille University Hospital
Lille, , France
Lyon University Hospital
Lyon, , France
Montpellier University Hospital
Montpellier, , France
Nantes University Hospital
Nantes, , France
Avicennes Hospital
Paris, , France
Bichat Hospital
Paris, , France
Henri Mondor Hospital
Paris, , France
Saint-Louis Hospital
Paris, , France
Reims University Hospital
Reims, , France
Countries
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Central Contacts
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Facility Contacts
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Frédéric Caux
Role: primary
Catherine Picard-Dahan
Role: primary
Other Identifiers
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2022/0017/OB
Identifier Type: -
Identifier Source: org_study_id
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