Register of Autoimmune Bullous Dermatoses

NCT02899923 | Completed

• 1 other identifier: PO16091
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmune Bullous Dermatoses

Outcome Measures

Primary Outcomes (1)

• 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

  Day 0

Study Arms (1)

Autoimmune bullous dermatoses

Patients with autoimmune bullous dermatoses

Other: Data collection

Interventions

Data collection OTHER

Autoimmune bullous dermatoses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with autoimmune bullous dermatosis

You may qualify if:

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

You may not qualify if:

• \- patient \<18 years

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu Reims

Reims, 51092, France

Location

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2016
• First Posted: September 14, 2016
• Study Start: January 1, 2010
• Primary Completion: December 1, 2016
• Study Completion: November 1, 2017
• Last Updated: November 22, 2017

Record last verified: 2017-11

Locations

FR (1)