Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

University Hospital, Rouen

Conditions:

Bullous Pemphigoid

Eligibility:

All Genders

18+ years

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 pemphig...

Eligibility Criteria

Inclusion

  • 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

  • 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)

Key Trial Info

Start Date :

July 1 2022

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

July 30 2026

Estimated Enrollment :

150 Patients enrolled

Trial Details

Trial ID

NCT05366127

Start Date

July 1 2022

End Date

July 30 2026

Last Update

May 9 2022

Active Locations (11)

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Page 1 of 3 (11 locations)

1

Bordeaux University Hospital

Bordeaux, France

2

Dijon University Hospital

Dijon, France

3

Lille University Hospital

Lille, France

4

Lyon University Hospital

Lyon, France