Deciphering IL-17-dependant Inflammatory Response in Bullous Pemphigoid
NCT ID: NCT06479018
Last Updated: 2024-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
140 participants
INTERVENTIONAL
2022-02-10
2026-01-10
Brief Summary
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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.
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Detailed Description
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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:
1. To confirm IL-17B concentrations in sera at diagnosis as predictive biomarker of BP outcome under local corticotherapy
2. To study the expression kinetics of IL-17B and its receptor IL-17RB in BP patients under treatment
3. To study the implication of IL-17B/IL-17RB axis in BP relapse
4. To establish inflammatory cell composition profile in skin and blood issued from clinical variants of BP as well as from BP patients during the first year of treatment.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Patients with Bullous Pemphigoid
Blood sampling
Venous blood sampling will be carried out for each patient included in the study.
Liquid bubble sampling
Liquid bubble sampling will be carried out for each patients with Bullous Pemphigoid included in the study.
Cutaneous biopsy
At least the first cutaneous biopsy will be carried out for each patients with Bullous Pemphigoid included in the study.
Control subjects
Blood sampling
Venous blood sampling will be carried out for each patient included in the study.
Interventions
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Blood sampling
Venous blood sampling will be carried out for each patient included in the study.
Liquid bubble sampling
Liquid bubble sampling will be carried out for each patients with Bullous Pemphigoid included in the study.
Cutaneous biopsy
At least the first cutaneous biopsy will be carried out for each patients with Bullous Pemphigoid included in the study.
Eligibility Criteria
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Inclusion Criteria
* patient agreed to participate to the study
* patient affiliated to the French Healthcare System
Exclusion Criteria
* patient with a pemphigoid gestationis
* patient with a relapse of Bullous Pemphigoid
* patient with Bullous Pemphigoid that already received local superpotent corticotherapy during the last 14 days before inclusion or systemic corticoid treatment during the last 28 days before inclusion
* anemic patient (hemoglobin \< 10 g/dL)
18 Years
ALL
No
Sponsors
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CHU de Reims
OTHER
Responsible Party
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Locations
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Chu Reims
Reims, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PO21096
Identifier Type: -
Identifier Source: org_study_id
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