Genetic Susceptibility and Influence of the Microbiomae in Bullous Pemphigoid (MICROPB)
Primary Purpose
Bullous Pemphigoid
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample and cotton skin swabs
Sponsored by
About this trial
This is an interventional basic science trial for Bullous Pemphigoid
Eligibility 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
Sites / Locations
- Chu de ReimsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
bullous pemphigoid
no bullous pemphigoid
Arm Description
patients with bullous pemphigoid
patients with basal cell carcinoma or squamous cell carcinoma and without inflammatory skin disease
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
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)
Skin's Bacteria
Analysis of skin microbiome (type and number of bacteria) of patients with bullous pemphigoid, compared with patients without bullous pemphigoid
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02874079
Brief Title
Genetic Susceptibility and Influence of the Microbiomae in Bullous Pemphigoid
Acronym
MICROPB
Official Title
Genetic Susceptibility and Influence of the Microbiomae in Bullous Pemphigoid
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
March 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
5. Study Description
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.
Detailed Description
Study genetic and microbiologic predisposition of patients developing a bullous pemphigoid from peripheral blood and skin flora.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bullous Pemphigoid
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
bullous pemphigoid
Arm Type
Experimental
Arm Description
patients with bullous pemphigoid
Arm Title
no bullous pemphigoid
Arm Type
Active Comparator
Arm Description
patients with basal cell carcinoma or squamous cell carcinoma and without inflammatory skin disease
Intervention Type
Other
Intervention Name(s)
Blood sample and cotton skin swabs
Primary Outcome Measure Information:
Title
HLA haplotype
Description
the genetic susceptibility in patients bullous pemphigoid were studied by the search of an association between bullous pemphigoid and a particular HLA haplotype
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
micro satellite markers
Description
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)
Time Frame
Day 1
Title
SNPs (single nucleotide polymorphisms)
Description
the genetic susceptibility in patients bullous pemphigoid were studied by the search of an association between bullous pemphigoid and SNPs (single nucleotide polymorphisms)
Time Frame
Day 1
Title
Skin's Bacteria
Description
Analysis of skin microbiome (type and number of bacteria) of patients with bullous pemphigoid, compared with patients without bullous pemphigoid
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe BERNARD
Email
pbernard@chu-reims.fr
Facility Information:
Facility Name
Chu de Reims
City
Reims
ZIP/Postal Code
51092
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe BERNARD
Email
pbernard@chu-reims.fr
12. IPD Sharing Statement
Learn more about this trial
Genetic Susceptibility and Influence of the Microbiomae in Bullous Pemphigoid
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