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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02874079
Other study ID # PO15125
Secondary ID
Status Recruiting
Phase N/A
First received August 11, 2016
Last updated October 4, 2016
Start date December 2015
Est. completion date March 2018

Study information

Verified date October 2016
Source CHU de Reims
Contact Philippe BERNARD
Email pbernard@chu-reims.fr
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial Summary

Autoimmune bullous dermatoses include pemphigus, bullous pemphigoid, pemphigoid gestationis, linear IgA dermatosis, mucous membrane pemphigoid, lichen planus pemphigoid, anti-p200 pemphigoid, epidermolysis bullosa acquisita and dermatitis herpetiformis. Autoimmune bullous dermatoses are rare and have an incidence of 20-60 new cases per 1 million person- year in Europe. The incidence of the individual entities is slight significantly different within Europe, but strongly also in comparison to other countries such as Kuwait, Singapore, USA and South America. The most common of these disorders is the bullous pemphigoid.

A considerable progress has been made in the last years to elucidate the pathogenic role of autoantibodies in these diseases. To this end, various in vitro and animal experiments have been used to understand some basic pathophysiological mechanisms in these diseases. Further studies are currently being carried out to explain a precise elucidation of the disease process and to be able to treat the patients targeted later.

At present, however, no data are available to explain why certain individuals develop the autoimmune disease and others do not. Epidemiological studies showed some triggers to the development of autoimmune dysregulation, e.g. drugs.

Furthermore, it has been shown that genetic factors play a role in the pathogenesis of the disease. A clear association with certain HLA regions have been shown in patients with pemphigus, e.g. about 95% of pemphigus patients from the group of Ashkenazi Jews have the HLA-DRB1*0402 haplotype. Recently, the first non-HLA gene associated with pemphigus was described. For other conditions such as bullous pemphigoid, pemphigoid gestationis or linear IgA dermatosis the association with HLA antigens is less pronounced. Another indication of the importance of the genetic background in these diseases can be elucidated from the observation of autoantibodies at a low concentration in healthy relatives of pemphigus patients.


Description:

Study genetic and microbiologic predisposition of patients developing a bullous pemphigoid from peripheral blood and skin flora.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date March 2018
Est. primary completion date October 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients with bullous pemphigoid in active phase

- patients with basal cell carcinoma or squamous cell carcinoma and without inflammatory skin disease

- patient consenting to participate to the study

- patient enrolled in the national healthcare insurance program

- patient older than 18 years

Exclusion Criteria:

- patients with pemphigoid gestationis

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Other:
Blood sample and cotton skin swabs


Locations

Country Name City State
France Chu de Reims Reims

Sponsors (1)

Lead Sponsor Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary HLA haplotype the genetic susceptibility in patients bullous pemphigoid were studied by the search of an association between bullous pemphigoid and a particular HLA haplotype Day 1 No
Secondary micro satellite markers the genetic susceptibility in patients bullous pemphigoid were studied by the search of an association between bullous pemphigoid and micro satellite markers, or SNPs (single nucleotide polymorphisms) Day 1 No
Secondary SNPs (single nucleotide polymorphisms) the genetic susceptibility in patients bullous pemphigoid were studied by the search of an association between bullous pemphigoid and SNPs (single nucleotide polymorphisms) Day 1 No
Secondary Skin's Bacteria Analysis of skin microbiome (type and number of bacteria) of patients with bullous pemphigoid, compared with patients without bullous pemphigoid Day 1 No
See also
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Recruiting NCT05284929 - Human Leukocyte Antigen Class II (DRB1 and DQB1) Alleles and Haplotypes Frequencies in Patients With Pemphigus Vulgaris Among the Russian Population
Terminated NCT04612790 - A Study to Investigate the Use of Benralizumab in Patients With Bullous Pemphigoid. Phase 3
Recruiting NCT05681481 - A Phase 3 Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid Phase 3
Completed NCT00286325 - Rituximab in the Treatment of Patients With Bullous Pemphigoid Phase 1/Phase 2
Completed NCT04728854 - Telederm and Bullous Pemphigoid