Bullous Pemphigoid
Conditions
Brief summary
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
Interventions
OTHERIGA score
IGA score will be assessed by 2 blinded investigators
OTHERBULLOUS PEMPHIGOID DISEASE AREA INDEX (BPDAI)
BPDAI will be assessed by 2 by 2 blinded investigators
Sponsors
University Hospital, Rouen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of IGA Score between baseline and 6-month follow-up visit | 6 months | IGA score : 0 to 4 |
| BPDAI Score between baseline and 6-month follow-up visit | 6 months | BPDAI : 0 to 120 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of IGA Score between baseline and 1-month follow-up visit | 1 month | IGA score : 0 to 4 |
| Evolution of IGA Score between baseline and 3-weeks follow-up visit | 3 weeks | IGA score : 0 to 4 |
| Evolution of IGA Score between baseline and 2-weeks follow-up visit | 2 weeks | IGA score : 0 to 4 |
| Evolution of IGA Score between baseline and 1-week follow-up visit | 1 week | IGA score : 0 to 4 |
| Evolution of BPDAI Score between baseline and 3-month follow-up visit | 3 months | BPDAI : 0 to 120 |
| Evolution of IGA Score between baseline and 3-month follow-up visit | 3 months | IGA score : 0 to 4 |
| Evolution of BPDAI Score between baseline and 1-month follow-up visit | 1 month | BPDAI : 0 to 120 |
| Evolution of BPDAI Score between baseline and 3 weeks follow-up visit | 3 weeks | BPDAI : 0 to 120 |
| Evolution of BPDAI Score between baseline and 2 weeks follow-up visit | 2 weeks | BPDAI : 0 to 120 |
| Evolution of BPDAI Score between baseline and 1 week follow-up visit | 1 week | BPDAI : 0 to 120 |
| Evolution of BPDAI Score between baseline and 2-month follow-up visit | 2 months | BPDAI : 0 to 120 |
| Evolution of IGA Score between baseline and 2-month follow-up visit | 2 months | IGA score : 0 to 4 |
Countries
France
Contacts
Primary ContactPascal JOLY, Pr
Backup ContactJulien BLOT
Outcome results
None listed