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

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ClinicalTrials.gov Identifier: NCT05366127
Recruitment Status : Not yet recruiting
First Posted : May 9, 2022
Last Update Posted : May 9, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Study Description
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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

Condition or disease Intervention/treatment
Bullous Pemphigoid Other: IGA score Other: BULLOUS PEMPHIGOID DISEASE AREA INDEX (BPDAI)

Study Design
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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of a Simplified Severity Score (Investigator Global Assessment: IGA) in Bullous Pemphigoid
Estimated Study Start Date : July 1, 2022
Estimated Primary Completion Date : July 30, 2026
Estimated Study Completion Date : July 30, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pemphigus

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Evolution of IGA Score between baseline and 6-month follow-up visit [ Time Frame: 6 months ]
    IGA score : 0 to 4

  2. BPDAI Score between baseline and 6-month follow-up visit [ Time Frame: 6 months ]
    BPDAI : 0 to 120


Secondary Outcome Measures :
  1. Evolution of IGA Score between baseline and 3-month follow-up visit [ Time Frame: 3 months ]
    IGA score : 0 to 4

  2. Evolution of IGA Score between baseline and 2-month follow-up visit [ Time Frame: 2 months ]
    IGA score : 0 to 4

  3. Evolution of IGA Score between baseline and 1-month follow-up visit [ Time Frame: 1 month ]
    IGA score : 0 to 4

  4. Evolution of IGA Score between baseline and 3-weeks follow-up visit [ Time Frame: 3 weeks ]
    IGA score : 0 to 4

  5. Evolution of IGA Score between baseline and 2-weeks follow-up visit [ Time Frame: 2 weeks ]
    IGA score : 0 to 4

  6. Evolution of IGA Score between baseline and 1-week follow-up visit [ Time Frame: 1 week ]
    IGA score : 0 to 4

  7. Evolution of BPDAI Score between baseline and 3-month follow-up visit [ Time Frame: 3 months ]
    BPDAI : 0 to 120

  8. Evolution of BPDAI Score between baseline and 2-month follow-up visit [ Time Frame: 2 months ]
    BPDAI : 0 to 120

  9. Evolution of BPDAI Score between baseline and 1-month follow-up visit [ Time Frame: 1 month ]
    BPDAI : 0 to 120

  10. Evolution of BPDAI Score between baseline and 3 weeks follow-up visit [ Time Frame: 3 weeks ]
    BPDAI : 0 to 120

  11. Evolution of BPDAI Score between baseline and 2 weeks follow-up visit [ Time Frame: 2 weeks ]
    BPDAI : 0 to 120

  12. Evolution of BPDAI Score between baseline and 1 week follow-up visit [ Time Frame: 1 week ]
    BPDAI : 0 to 120


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patient with bullous pemphigoid
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05366127


Contacts
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Contact: Pascal JOLY, Pr +3323288 ext 8265 pascal.joly@chu-rouen.fr
Contact: Julien BLOT julien.blot@chu-rouen.fr

Locations
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France
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
Contact: Frédéric Caux         
Bichat Hospital
Paris, France
Contact: Catherine Picard-Dahan         
Henri Mondor Hospital
Paris, France
Saint-Louis Hospital
Paris, France
Reims University Hospital
Reims, France
Sponsors and Collaborators
University Hospital, Rouen
Investigators
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Principal Investigator: Pascal JOLY Rouen University Hospital
More Information
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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT05366127    
Other Study ID Numbers: 2022/0017/OB
First Posted: May 9, 2022    Key Record Dates
Last Update Posted: May 9, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pemphigoid, Bullous
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases