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Bullous pemphigoid (BP) is the most frequent autoimmune skin disease and mainly affects elderly individuals. BP classically manifests with tense blisters over urticarial plaques on the trunk and extremities accompanied by intense itches. However, BP is characterized by a large spectrum of clinical presentations allowing to distinguish between typical (with blisters) and atypical forms (non bullous, mucosal damage).
High potency topical steroids and systemic steroids are the current first line intention treatments. While very efficient, these therapies are non-targeted and cause numerous side-effects, especially in these elderly patients that are the most affected. Furthermore, around 30% of BP patients will relapse during the first year of treatment when corticotherapy is decreased or stopped.
The investigators and others have highlighted the presence of Il-17 family belonging-inflammatory cytokines in BP patients. Their functions in the amplification of the inflammatory response and in the mechanisms of relapse have to be precisely determined in order to develop innovative therapeutic approaches and to move forwards precision medicine.
This is a pathophysiological study with prospective and monocentric inclusion.
90 patients with bullous phemphigoid will be recruited from the department of dermatology at the Reims University Hospital.
The main objectives of this study are to identify the cellular and molecular actors of the IL-17B/IL-17RB axis at diagnosis in patients with bullous pemphigoid and to determine their functions in the pathophysiological mechanisms associated with BP at systemic and in situ levels.
The secondary aims of this research are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Bullous Pemphigoid | Experimental |
| |
| Control subjects | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Biological | Venous blood sampling will be carried out for each patient included in the study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood | Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood from whole blood of patients with BP or control subjects using flow cytometry | Day 1 |
| Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood | Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood from whole blood of patients with BP or control subjects using flow cytometry | Day 30 |
| Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood | Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood from whole blood of patients with BP or control subjects using flow cytometry | Day 60 |
| Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood | Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood from whole blood of patients with BP or control subjects using flow cytometry | Day 90 |
| Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood | Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood from whole blood of patients with BP or control subjects using flow cytometry | Day 150 |
| Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood | Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood from whole blood of patients with BP or control subjects using flow cytometry |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of IL-17B concentrations in sera | Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique | Day 1 |
| Measurement of IL-17B concentrations in sera | Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manuelle VIGUIER, Pr. | Contact | 03.10.73.66.76 | mviguier@chu-reims.fr | |
| Sébastien LE JAN, Dr. | Contact | 03.26.91.35.24 | sebastien.le-jan@univ-reims.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Reims | Recruiting | Reims | 51092 | France |
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| ID | Term |
|---|---|
| D010391 | Pemphigoid, Bullous |
| ID | Term |
|---|---|
| D012872 | Skin Diseases, Vesiculobullous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Liquid bubble sampling | Biological | Liquid bubble sampling will be carried out for each patients with Bullous Pemphigoid included in the study. |
|
| Cutaneous biopsy | Procedure | At least the first cutaneous biopsy will be carried out for each patients with Bullous Pemphigoid included in the study. |
|
| Day 270 |
| Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood | Identification of IL-17RB-expressing cells and IL-17B-producing cells in blood from whole blood of patients with BP or control subjects using flow cytometry | Day 365 |
| Identification of IL-17RB-expressing cells at the lesional site | Identification of IL-17RB-expressing cells at the lesional site from BP skin biopsy specimen harvested using histocytometry | Day 1 |
| Identification of IL-17RB-expressing cells at the lesional site | Identification of IL-17RB-expressing cells at the lesional site from BP skin biopsy specimen harvested using histocytometry | Day 60 |
| Day 30 |
| Measurement of IL-17B concentrations in sera | Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique | Day 60 |
| Measurement of IL-17B concentrations in sera | Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique | Day 90 |
| Measurement of IL-17B concentrations in sera | Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique | Day 150 |
| Measurement of IL-17B concentrations in sera | Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique | Day 270 |
| Measurement of IL-17B concentrations in sera | Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique | Day 365 |
| D007154 | Immune System Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |