An interventional study of Blood sampling and Liquid bubble sampling in Bullous Pemphigoid, sponsored by CHU de Reims. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-27.
Sponsored by CHU de Reims · Not applicable, Interventional, and Basic science
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:
64 studies on the registry are indexed under Pemphigoid, Bullous; 8 are open to participants now.
This study's planned enrollment of 140 is above the median of 30 across 39 interventional studies indexed under Pemphigoid, Bullous.
Browse Pemphigoid, Bullous studies →CHU de Reims is the lead sponsor of 276 studies on the registry; 50 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: Blood sampling · Biological: Liquid bubble sampling · Procedure: Cutaneous biopsy
Biological: Blood sampling
Venous blood sampling will be carried out for each patient included in the study.
Liquid bubble sampling will be carried out for each patients with Bullous Pemphigoid included in the study.
At least the first cutaneous biopsy will be carried out for each patients with Bullous Pemphigoid included in the study.
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 60
Measurement of IL-17B concentrations in sera
Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique
Time frame: Day 1
Measurement of IL-17B concentrations in sera
Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique
Time frame: Day 30
Measurement of IL-17B concentrations in sera
Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique
Time frame: Day 60
Measurement of IL-17B concentrations in sera
Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique
Time frame: Day 90
Measurement of IL-17B concentrations in sera
Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique
Time frame: Day 150
Measurement of IL-17B concentrations in sera
Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique
Time frame: Day 270
Measurement of IL-17B concentrations in sera
Measurement of IL-17B concentrations in sera of patients with BP using ELISA technique
Time frame: Day 365
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