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Register of Autoimmune Bullous Dermatoses (REGIBUL)

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ClinicalTrials.gov Identifier: NCT02899923
Recruitment Status : Completed
First Posted : September 14, 2016
Last Update Posted : November 22, 2017
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Brief Summary:

Autoimmune bullous dermatoses are a group of diseases with chronic course. They are provoked by the production of autoantibodies against the dermal-epidermal junction or against the inter-keratinocyte junctions, resulting in the formation of intra-epidermal or sub-epidermal blisters.

The diagnosis of autoimmune bullous dermatoses is based on clinical and immunopathological findings, including skin direct immunofluorescence.

Systemic corticosteroid therapy is generally considered as the mainstay of treatment for many years both for bullous pemphigoid and pemphigus which are the most frequent diseases.


Condition or disease Intervention/treatment
Autoimmune Bullous Dermatoses Other: Data collection

Detailed Description:
The aim of the study is the creation of a register of patients suffering from autoimmune bullous dermatoses to quickly identify patients who can be included in clinical trials or retrospective epidemiological studies

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Study Type : Observational
Actual Enrollment : 750 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Register of Autoimmune Bullous Dermatoses
Actual Study Start Date : January 2010
Actual Primary Completion Date : December 2016
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Autoimmune bullous dermatoses
Patients with autoimmune bullous dermatoses
Other: Data collection



Primary Outcome Measures :
  1. autoimmune bullous dermatosis according to physical examination, skin biopsy and autoantibodies detection in blood sample [ Time Frame: Day 0 ]

    Each autoimmune bullous dermatosis is classified according one of the following diagnoses : 1/ bullous pemphigoid, 2/ Mucous membrane pemphigoid, 3/ Pemphigoid gestationis, 4/ Epidermolysis bullosa acquisita, 5/ Linear IgA bullous dermatosis, 6/ pemphigus (vulgaris or foliaceus)

    This classification will be performed according :

    • clinical characteristics including location, clinical aspect and number of cutaneous and/or mucosal blisters
    • skin biopsy for routine histology (subepidermal blister or intra-epidermal blister) and direct immunofluorescence (IgG and/or I gA and/or C3 deposits along the epidermal basement membrane zone or on the cell surface of keratinocytes)
    • blood sample for serum autoantibodies detection against epidermal autoantigens using ELISA or indirect immunofluorescence techniques



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with autoimmune bullous dermatosis
Criteria

Inclusion Criteria:

  • patients with autoimmune bullous dermatosis
  • patients cared for in dermatology referral center of Reims, Rouen or Limoges
  • patient consenting to participate to the study

Exclusion Criteria:

- patient <18 years


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02899923


Locations
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France
Chu Reims
Reims, France, 51092
Sponsors and Collaborators
CHU de Reims

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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT02899923     History of Changes
Other Study ID Numbers: PO16091
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017
Additional relevant MeSH terms:
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Skin Diseases
Skin Diseases, Vesiculobullous