Completed

NCT Number: NCT02899923

Register of Autoimmune Bullous Dermatoses

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.

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Key information

Conditions

Autoimmune Bullous Dermatoses

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Reims

Reims, 51092, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data Collection

Other

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

CHU de Reims