- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05399433
Role of Glucose Metabolism in Migration of Cutaneous Dendritic Cells in Psoriasis
Rôle du métabolisme du Glucose Dans la Migration Des Cellules Dendritiques cutanées Dans le Psoriasis : étude Pilote Translationnelle
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: PASSERON Thierry, PhD
- Phone Number: +33492036488
- Email: passeron.t@chu-nice.fr
Study Locations
-
-
Alpes-maritimes
-
Nice, Alpes-maritimes, France, 06001
- Recruiting
- CHU de Nice
-
Contact:
- Passeron Thierry
- Phone Number: +3349204688
- Email: passeron.t@chu-nice.fr
-
Principal Investigator:
- Passeron Thierry, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients of both sexes
- hospitalized in the Dermatology department of the CHU of Nice for moderate to severe psoriasis (defined by a PASI > or = 10)
- covered by a social security scheme after obtaining a free
- Clinical diagnosis of plaque psoriasis by a dermatologist with or without type 2 diabetes (defined by glycated hemoglobin >7%)
- For the control group: without psoriasis or other inflammatory dermatosis aged in the presence or not of type 2 diabetes (glycated hemoglobin >7%).
- free and informed consent
Exclusion Criteria:
- Minor or incapable or unwilling to consent freely or in an informed manner Pregnant or nursing woman.
- Patient in a period of exclusion from other biomedical research
- Patient with generalized chronic inflammatory disease or other inflammatory dermatosis
- Patients on general corticosteroid, immunomodulator or immunosuppressant therapy in the month prior to local inclusion or treatment with corticosteroid therapy in the 15 days prior to inclusion, on anti- treatmentIL-23 or anti IL12/23 for less than 3 months or under anti-IL-17 or anti-TNF treatment for less than 1 month.
- Contraindication to cutaneous biospsis (known hemostasis disorder, taking anticoagulants, allergy to xylocaine, history of cheloid scars, congenital immune deficiency)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Production of IL-23 of blood and skin dendriti cells (CD)
Simultaneously evaluate the migratory capacity and production of IL-23 of blood and skin cDC on peripheral venous blood and skin biopsies of psoriatic patients with and without type 2 diabetes and control patients (with or without type II diabetes) depending on their metabolic status.
|
A skin biopsy will be performed under local anesthesia in diabetic and non-diabetic psoriatic patients (25 per group) in the injured area (joint extension) and in the non-injured area more than 2 cm from any lesion in the same area. In patients in the diabetic or non-diabetic control group (25 per group) only one biopsy will be performed. Peripheral venous blood will be collected in heparin tubes for metabolic parameter analysis and blood CD analysis |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of dentridic cells producers of IL-23
Time Frame: at baseline
|
Alterations in the percentage of dentridic cells that have migrated with the metabolic status of patients
|
at baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of subpopulations dentridic cells producers
Time Frame: At baseline
|
Study of the percentage of the various cDC subpopulations according to the metabolic status of the patients.
|
At baseline
|
Collaborators and Investigators
Investigators
- Principal Investigator: passeron thierry, CHU de Nice, Service de Dermatologie
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-PP-25
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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