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

University Hospital, Rouen

Status: Not yet enrolling

Conditions: Bullous Pemphigoid

Treatments: Other: BULLOUS PEMPHIGOID DISEASE AREA INDEX (BPDAI); Other: IGA score

Study type: Observational

Funder types: Other

Identifiers

NCT05366127

2022/0017/OB

Details and patient eligibility

About

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

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

150 participants in 1 patient group

Patient with bullous pemphigoid

Description:

IGA score and BPDAI score will be assessed to patient with bullous pemphigoid

Treatment:

Other: BULLOUS PEMPHIGOID DISEASE AREA INDEX (BPDAI)

Other: IGA score