Autoimmune Bullous Dermatoses Clinical Trial
— REGIBULOfficial title:
Register of Autoimmune Bullous Dermatoses
| Verified date | November 2017 |
| Source | CHU de Reims |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 750 |
| Est. completion date | November 2017 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Chu Reims | Reims |
| Lead Sponsor | Collaborator |
|---|---|
| CHU de Reims |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | autoimmune bullous dermatosis according to physical examination, skin biopsy and autoantibodies detection in blood sample | 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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