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
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|
|Study Type :||Observational|
|Actual Enrollment :||750 participants|
|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|
Autoimmune bullous dermatoses
Patients with autoimmune bullous dermatoses
Other: Data collection
- 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
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
|Reims, France, 51092|