Bullous Pemphigoid Clinical Trial
— IGA scoreOfficial title:
Validation of a Simplified Severity Score (Investigator Global Assessment: IGA) in Bullous Pemphigoid
The aim of the study is to validate a global and simple score : IGA (Investigator Global Assessment) score for the evaluation of the extent and severity of the disease in patients with bullous pemphigoid
| Status | Not yet recruiting |
| Enrollment | 150 |
| Est. completion date | July 30, 2026 |
| Est. primary completion date | July 30, 2026 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Consecutive adult patients aged = 18 years - 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: - Predominant or exclusive mucosal involvement leading to suspect the diagnosis of mucous membrane pemphigoid - 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) |
| Country | Name | City | State |
|---|---|---|---|
| France | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Rouen |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evolution of IGA Score between baseline and 6-month follow-up visit | IGA score : 0 to 4 | 6 months | |
| Primary | BPDAI Score between baseline and 6-month follow-up visit | BPDAI : 0 to 120 | 6 months | |
| Secondary | Evolution of IGA Score between baseline and 3-month follow-up visit | IGA score : 0 to 4 | 3 months | |
| Secondary | Evolution of IGA Score between baseline and 2-month follow-up visit | IGA score : 0 to 4 | 2 months | |
| Secondary | Evolution of IGA Score between baseline and 1-month follow-up visit | IGA score : 0 to 4 | 1 month | |
| Secondary | Evolution of IGA Score between baseline and 3-weeks follow-up visit | IGA score : 0 to 4 | 3 weeks | |
| Secondary | Evolution of IGA Score between baseline and 2-weeks follow-up visit | IGA score : 0 to 4 | 2 weeks | |
| Secondary | Evolution of IGA Score between baseline and 1-week follow-up visit | IGA score : 0 to 4 | 1 week | |
| Secondary | Evolution of BPDAI Score between baseline and 3-month follow-up visit | BPDAI : 0 to 120 | 3 months | |
| Secondary | Evolution of BPDAI Score between baseline and 2-month follow-up visit | BPDAI : 0 to 120 | 2 months | |
| Secondary | Evolution of BPDAI Score between baseline and 1-month follow-up visit | BPDAI : 0 to 120 | 1 month | |
| Secondary | Evolution of BPDAI Score between baseline and 3 weeks follow-up visit | BPDAI : 0 to 120 | 3 weeks | |
| Secondary | Evolution of BPDAI Score between baseline and 2 weeks follow-up visit | BPDAI : 0 to 120 | 2 weeks | |
| Secondary | Evolution of BPDAI Score between baseline and 1 week follow-up visit | BPDAI : 0 to 120 | 1 week |
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