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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Bullous Pemphigoid
• Intervention / Treatment: Other: IGA score; Other: BULLOUS PEMPHIGOID DISEASE AREA INDEX (BPDAI)

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Pascal JOLY, Pr; Phone Number: 8265 +3323288; Email: pascal.joly@chu-rouen.fr

Study Locations

• France
  • Bordeaux, France
    • Bordeaux University Hospital
  • Dijon, France
    • Dijon University Hospital
  • Lille, France
    • Lille University Hospital
  • Lyon, France
    • Lyon university hospital
  • Montpellier, France
    • Montpellier University Hospital
  • Nantes, France
    • Nantes University Hospital
  • Paris, France
    • Henri Mondor Hospital
  • Paris, France
    • Bichat Hospital
    • Contact: Catherine Picard-Dahan
  • Paris, France
    • Avicennes Hospital
    • Contact: Frédéric Caux
  • Paris, France
    • Saint-Louis Hospital
  • Reims, France
    • Reims university Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient with bullous pemphigoid

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient with bullous pemphigoid; IGA score and BPDAI score will be assessed to patient with bullous pemphigoid	Other: IGA score; IGA score will be assessed by 2 blinded investigators; Other: BULLOUS PEMPHIGOID DISEASE AREA INDEX (BPDAI); BPDAI will be assessed by 2 by 2 blinded investigators

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Pascal JOLY, Rouen University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): July 30, 2026
• Study Completion (Anticipated): July 30, 2026

Study Registration Dates

• First Submitted: May 4, 2022
• First Submitted That Met QC Criteria: May 4, 2022
• First Posted (Actual): May 9, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Autoimmune Diseases; Skin Diseases, Vesiculobullous; Pemphigoid, Bullous
• Other Study ID Numbers: 2022/0017/OB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No