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

Not yet recruiting

• Conditions: Bullous Pemphigoid

• 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

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 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 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 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 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

Trial Locations

Locations (11)

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

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