Register of Autoimmune Bullous Dermatoses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CHU de Reims
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- autoimmune bullous dermatosis according to physical examination, skin biopsy and autoantibodies detection in blood sample
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with autoimmune bullous dermatosis
- •patients cared for in dermatology referral center of Reims, Rouen or Limoges
- •patient consenting to participate to the study
排除标准
- •patient <18 years
结局指标
主要结局
autoimmune bullous dermatosis according to physical examination, skin biopsy and autoantibodies detection in blood sample
时间窗: 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
次要结局
未报告次要终点