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Trial record 2 of 4 for:    epidermolysis bullosa acquisita

Genetic Susceptibility and Influence of the Microbiomae in Bullous Pemphigoid (MICROPB)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by CHU de Reims
Sponsor:
Information provided by (Responsible Party):
CHU de Reims
ClinicalTrials.gov Identifier:
NCT02874079
First received: August 11, 2016
Last updated: October 4, 2016
Last verified: October 2016
  Purpose

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.


Condition Intervention
Bullous Pemphigoid
Other: Blood sample and cotton skin swabs

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Genetic Susceptibility and Influence of the Microbiomae in Bullous Pemphigoid

Resource links provided by NLM:


Further study details as provided by CHU de Reims:

Primary Outcome Measures:
  • HLA haplotype [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    the genetic susceptibility in patients bullous pemphigoid were studied by the search of an association between bullous pemphigoid and a particular HLA haplotype


Secondary Outcome Measures:
  • micro satellite markers [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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)

  • SNPs (single nucleotide polymorphisms) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    the genetic susceptibility in patients bullous pemphigoid were studied by the search of an association between bullous pemphigoid and SNPs (single nucleotide polymorphisms)

  • Skin's Bacteria [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Analysis of skin microbiome (type and number of bacteria) of patients with bullous pemphigoid, compared with patients without bullous pemphigoid


Estimated Enrollment: 100
Study Start Date: December 2015
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bullous pemphigoid
patients with bullous pemphigoid
Other: Blood sample and cotton skin swabs
Active Comparator: no bullous pemphigoid
patients with basal cell carcinoma or squamous cell carcinoma and without inflammatory skin disease
Other: Blood sample and cotton skin swabs

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02874079

Contacts
Contact: Philippe BERNARD pbernard@chu-reims.fr

Locations
France
Chu de Reims Recruiting
Reims, France, 51092
Contact: Philippe BERNARD       pbernard@chu-reims.fr   
Sponsors and Collaborators
CHU de Reims
  More Information

Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT02874079     History of Changes
Other Study ID Numbers: PO15125 
Study First Received: August 11, 2016
Last Updated: October 4, 2016
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Disease Susceptibility
Pemphigoid, Bullous
Genetic Predisposition to Disease
Disease Attributes
Pathologic Processes
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on December 06, 2016