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Search / Trial NCT05366127

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

Launched by UNIVERSITY HOSPITAL, ROUEN · May 4, 2022

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is designed to test a new scoring system called the Investigator Global Assessment (IGA) to help doctors better evaluate the severity of bullous pemphigoid, a skin condition that causes painful blisters. The goal is to make it easier for healthcare providers to assess how serious the disease is in patients and track changes over time.

To be eligible for this trial, participants need to be adults aged 18 or older who have recently been diagnosed with bullous pemphigoid or are experiencing a relapse of the condition. They should have specific signs of the disease that can be confirmed through skin tests. Participants will need to understand the study requirements and agree to attend follow-up visits. It's important to note that individuals with certain other skin conditions or specific types of involvement, such as only mucosal (moist tissue) areas, won't be included in this study. If you choose to participate, you will help contribute to a better understanding of bullous pemphigoid and how to assess its severity.

Gender

ALL

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)

About University Hospital, Rouen

The University Hospital of Rouen is a leading medical institution dedicated to advancing healthcare through innovative research and clinical trials. As a prominent academic hospital, it integrates cutting-edge medical education with patient care, fostering an environment where clinical research is paramount. With a multidisciplinary team of expert clinicians and researchers, the hospital focuses on a wide range of therapeutic areas, aiming to improve patient outcomes and contribute to the global medical community. The University Hospital of Rouen is committed to ethical standards and rigorous scientific methodologies, ensuring the highest quality of care and research integrity in all its clinical trials.

Locations

Montpellier, , France

Nantes, , France

Paris, , France

Lille, , France

Bordeaux, , France

Dijon, , France

Lyon, , France

Reims, , France

Paris, , France

Paris, , France

Paris, , France

Patients applied

0 patients applied

Trial Officials

Pascal JOLY

Principal Investigator

University Hospital, Rouen

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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