Validation of a Simplified Severity Score (Investigator Global Assessment: IGA) in Bullous Pemphigoid

Study Overview
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Brief Summary
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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

Official Title
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Validation of a Simplified Severity Score (Investigator Global Assessment: IGA) in Bullous Pemphigoid

Conditions
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Bullous Pemphigoid

Intervention / Treatment
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* Other: IGA score
* Other: BULLOUS PEMPHIGOID DISEASE AREA INDEX (BPDAI)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient with bullous pemphigoid<br>IGA score and BPDAI score will be assessed to patient with bullous pemphigoid | Other: IGA score<br>* IGA score will be assessed by 2 blinded investigators<br>Other: BULLOUS PEMPHIGOID DISEASE AREA INDEX (BPDAI)<br>* BPDAI will be assessed by 2 by 2 blinded investigators<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of IGA Score between baseline and 6-month follow-up visit | IGA score : 0 to 4 | 6 months | 
| BPDAI Score between baseline and 6-month follow-up visit | BPDAI : 0 to 120 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of IGA Score between baseline and 3-month follow-up visit | IGA score : 0 to 4 | 3 months | 
| Evolution of IGA Score between baseline and 2-month follow-up visit | IGA score : 0 to 4 | 2 months | 
| Evolution of IGA Score between baseline and 1-month follow-up visit | IGA score : 0 to 4 | 1 month | 
| Evolution of IGA Score between baseline and 3-weeks follow-up visit | IGA score : 0 to 4 | 3 weeks | 
| Evolution of IGA Score between baseline and 2-weeks follow-up visit | IGA score : 0 to 4 | 2 weeks | 
| Evolution of IGA Score between baseline and 1-week follow-up visit | IGA score : 0 to 4 | 1 week | 
| Evolution of BPDAI Score between baseline and 3-month follow-up visit | BPDAI : 0 to 120 | 3 months | 
| Evolution of BPDAI Score between baseline and 2-month follow-up visit | BPDAI : 0 to 120 | 2 months | 
| Evolution of BPDAI Score between baseline and 1-month follow-up visit | BPDAI : 0 to 120 | 1 month | 
| Evolution of BPDAI Score between baseline and 3 weeks follow-up visit | BPDAI : 0 to 120 | 3 weeks | 
| Evolution of BPDAI Score between baseline and 2 weeks follow-up visit | BPDAI : 0 to 120 | 2 weeks | 
| Evolution of BPDAI Score between baseline and 1 week follow-up visit | BPDAI : 0 to 120 | 1 week |