Genetic Susceptibility and Influence of the Microbiomae in Bullous Pemphigoid

NCT02874079 | Unknown

• 1 other identifier: PO15125
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bullous Pemphigoid

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• micro satellite markers

  Day 1

• SNPs (single nucleotide polymorphisms)

  Day 1

• Skin's Bacteria

  Day 1

Study Arms (2)

bullous pemphigoid

EXPERIMENTAL

patients with bullous pemphigoid

Other: Blood sample and cotton skin swabs

no bullous pemphigoid

ACTIVE COMPARATOR

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

Other: Blood sample and cotton skin swabs

Interventions

Blood sample and cotton skin swabs OTHER

bullous pemphigoid; no bullous pemphigoid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- patients with pemphigoid gestationis

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu de Reims

Reims, France, 51092, France

RECRUITING

MeSH Terms

Conditions

Pemphigoid, Bullous

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Philippe BERNARD

CONTACT

pbernard@chu-reims.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: August 22, 2016
• Study Start: December 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: March 1, 2018
• Last Updated: October 5, 2016

Record last verified: 2016-10

Locations

FR (1)