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

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Brief Title

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

Official Title

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

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
    



Study Type

Observational


Primary Outcome

Evolution of IGA Score between baseline and 6-month follow-up visit

Secondary Outcome

 Evolution of IGA Score between baseline and 3-month follow-up visit

Condition

Bullous Pemphigoid

Intervention

IGA score

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

150

Start Date

July 1, 2022

Completion Date

July 30, 2026

Primary Completion Date

July 30, 2026

Eligibility Criteria

        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)
      

Gender

All

Ages

18 Years - N/A


Contacts

Pascal JOLY, +3323288, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT05366127

Organization ID

2022/0017/OB


Responsible Party

Sponsor

Study Sponsor

University Hospital, Rouen


Study Sponsor

Pascal JOLY, Principal Investigator, Rouen University Hospital


Verification Date

May 2022