NCT05366127

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
3mo left

Started Jul 2022

Longer than P75 for all trials

Geographic Reach
1 country

11 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jul 2022Jul 2026

First Submitted

Initial submission to the registry

May 4, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 9, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Last Updated

May 9, 2022

Status Verified

May 1, 2022

Enrollment Period

4.1 years

First QC Date

May 4, 2022

Last Update Submit

May 4, 2022

Conditions

Bullous Pemphigoid

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (12)

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

    3 months

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

    2 months

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

    1 month

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

    3 weeks

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

    2 weeks

  • +7 more secondary outcomes

Study Arms (1)

Patient with bullous pemphigoid

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

Other: IGA scoreOther: BULLOUS PEMPHIGOID DISEASE AREA INDEX (BPDAI)

Interventions

IGA scoreOTHER

IGA score will be assessed by 2 blinded investigators

Patient with bullous pemphigoid
BULLOUS PEMPHIGOID DISEASE AREA INDEX (BPDAI)OTHER

BPDAI will be assessed by 2 by 2 blinded investigators

Patient with bullous pemphigoid

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with bullous pemphigoid

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Bordeaux University Hospital

Bordeaux, France

Location

Dijon University Hospital

Dijon, France

Location

Lille University Hospital

Lille, France

Location

Lyon University Hospital

Lyon, France

Location

Montpellier University Hospital

Montpellier, France

Location

Nantes University Hospital

Nantes, France

Location

Avicennes Hospital

Paris, France

Location

Bichat Hospital

Paris, France

Location

Henri Mondor Hospital

Paris, France

Location

Saint-Louis Hospital

Paris, France

Location

Reims University Hospital

Reims, France

Location

MeSH Terms

Conditions

Pemphigoid, Bullous

Condition Hierarchy (Ancestors)

Skin Diseases, VesiculobullousSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Pascal JOLY

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pascal JOLY, Pr

CONTACT

+3323288pascal.joly@chu-rouen.fr

Julien BLOT

CONTACT

julien.blot@chu-rouen.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2022

First Posted

May 9, 2022

Study Start

July 1, 2022

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

July 30, 2026

Last Updated

May 9, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(11)