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

Not yet recruiting

• Conditions: Bullous Pemphigoid
• Interventions: Other: IGA score; Other: BULLOUS PEMPHIGOID DISEASE AREA INDEX (BPDAI)

• Registration Number: NCT05366127
• Lead Sponsor: University Hospital, Rouen

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-04
• Study First Submitted QC: 2022-05-04
• Last Update Submitted: 2022-05-04
• Study First Posted: 2022-05-09
• Last Update Posted: 2022-05-09
• Study Start: 2022-07-01
• Primary Completion: 2026-07-30
• Study Completion: 2026-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient with bullous pemphigoid	BULLOUS PEMPHIGOID DISEASE AREA INDEX (BPDAI)	IGA score and BPDAI score will be assessed to patient with bullous pemphigoid
Patient with bullous pemphigoid	IGA score	IGA score and BPDAI score will be assessed to patient with bullous pemphigoid

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Evolution of BPDAI Score between baseline and 3-month follow-up visit	3 months	BPDAI : 0 to 120
Evolution of BPDAI Score between baseline and 2-month follow-up visit	2 months	BPDAI : 0 to 120
Evolution of BPDAI Score between baseline and 1-month follow-up visit	1 month	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 IGA Score between baseline and 2-month follow-up visit	2 months	IGA score : 0 to 4
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 BPDAI Score between baseline and 3 weeks follow-up visit	3 weeks	BPDAI : 0 to 120
Evolution of IGA Score between baseline and 2-weeks follow-up visit	2 weeks	IGA score : 0 to 4
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 IGA Score between baseline and 1-week follow-up visit	1 week	IGA score : 0 to 4

Trial Locations

Locations (11)

Dijon University Hospital; 🇫🇷 Dijon, France

Bordeaux University Hospital; 🇫🇷 Bordeaux, 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

Reims University Hospital; 🇫🇷 Reims, France

Bichat Hospital; 🇫🇷 Paris, France

Henri Mondor Hospital; 🇫🇷 Paris, France

Saint-Louis Hospital; 🇫🇷 Paris, France