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Not yet recruitingNCT05366127IGA scoreUpdated May 9, 2022

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

An observational study in Bullous Pemphigoid, sponsored by University Hospital, Rouen. Not yet recruiting at 11 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-09.

Sponsored by University Hospital, Rouen · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Bullous Pemphigoid

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03

In context

Pemphigoid, Bullous

73 studies on the registry are indexed under Pemphigoid, Bullous; 11 are open to participants now.

This study's planned enrollment of 150 is above the median of 120 across 24 observational studies indexed under Pemphigoid, Bullous.

Browse Pemphigoid, Bullous studies →

Lead sponsor

University Hospital, Rouen is the lead sponsor of 410 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patient with bullous pemphigoid

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

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)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patient with bullous pemphigoid

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

    Other: IGA score · Other: BULLOUS PEMPHIGOID DISEASE AREA INDEX (BPDAI)

Interventions

  • OtherIGA score

    IGA score will be assessed by 2 blinded investigators

  • OtherBULLOUS PEMPHIGOID DISEASE AREA INDEX (BPDAI)

    BPDAI will be assessed by 2 by 2 blinded investigators

06

What researchers measure

Primary outcomes

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

    IGA score : 0 to 4

    Time frame: 6 months

  2. BPDAI Score between baseline and 6-month follow-up visit

    BPDAI : 0 to 120

    Time frame: 6 months

Secondary outcomes

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

    IGA score : 0 to 4

    Time frame: 3 months

  2. Evolution of IGA Score between baseline and 2-month follow-up visit

    IGA score : 0 to 4

    Time frame: 2 months

  3. Evolution of IGA Score between baseline and 1-month follow-up visit

    IGA score : 0 to 4

    Time frame: 1 month

  4. Evolution of IGA Score between baseline and 3-weeks follow-up visit

    IGA score : 0 to 4

    Time frame: 3 weeks

  5. Evolution of IGA Score between baseline and 2-weeks follow-up visit

    IGA score : 0 to 4

    Time frame: 2 weeks

  6. Evolution of IGA Score between baseline and 1-week follow-up visit

    IGA score : 0 to 4

    Time frame: 1 week

  7. Evolution of BPDAI Score between baseline and 3-month follow-up visit

    BPDAI : 0 to 120

    Time frame: 3 months

  8. Evolution of BPDAI Score between baseline and 2-month follow-up visit

    BPDAI : 0 to 120

    Time frame: 2 months

  9. Evolution of BPDAI Score between baseline and 1-month follow-up visit

    BPDAI : 0 to 120

    Time frame: 1 month

  10. Evolution of BPDAI Score between baseline and 3 weeks follow-up visit

    BPDAI : 0 to 120

    Time frame: 3 weeks

  11. Evolution of BPDAI Score between baseline and 2 weeks follow-up visit

    BPDAI : 0 to 120

    Time frame: 2 weeks

  12. Evolution of BPDAI Score between baseline and 1 week follow-up visit

    BPDAI : 0 to 120

    Time frame: 1 week

07

Study locations

11 sites
  • 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
    • Frédéric Caux · Contact
  • Bichat Hospital
    Paris, France
    • Catherine Picard-Dahan · Contact
  • Henri Mondor Hospital
    Paris, France
  • Saint-Louis Hospital
    Paris, France
  • Reims University Hospital
    Reims, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05366127
Lead sponsor
University Hospital, Rouen
Responsible party
Sponsor
First posted
May 9, 2022
Start date
Jul 1, 2022 (estimated)
Primary completion
Jul 30, 2026 (estimated)
Completion
Jul 30, 2026 (estimated)
Last update
May 9, 2022

Study contacts

Pascal JOLY, Pr
Contact
pascal.joly@chu-rouen.fr
+3323288 ext. 8265
Julien BLOT
Contact
julien.blot@chu-rouen.fr
Pascal JOLY
principal investigator · University Hospital, Rouen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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