Register of Autoimmune Bullous Dermatoses (REGIBUL)

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.

Study Overview

• Status: Completed
• Conditions: Autoimmune Bullous Dermatoses
• Intervention / Treatment: Other: Data collection

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 750

Contacts and Locations

Study Locations

• France
  • Reims, France, 51092
    • CHU Reims

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with autoimmune bullous dermatosis

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Autoimmune bullous dermatoses; Patients with autoimmune bullous dermatoses	Other: Data collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: CHU de Reims

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: September 1, 2016
• First Submitted That Met QC Criteria: September 8, 2016
• First Posted (Estimate): September 14, 2016

Study Record Updates

• Last Update Posted (Actual): November 22, 2017
• Last Update Submitted That Met QC Criteria: November 20, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Vesiculobullous
• Other Study ID Numbers: PO16091