Genetic Susceptibility and Influence of the Microbiomae in Bullous Pemphigoid

Bullous Pemphigoid Clinical Trial

— MICROPB  

Official title:

Genetic Susceptibility and Influence of the Microbiomae in Bullous Pemphigoid

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02874079
• Other study ID #: PO15125
• 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

• Bullous Pemphigoid
• Disease Susceptibility
• Genetic Predisposition to Disease
• Pemphigoid, Bullous

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