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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05399433
Other study ID # 21-PP-25
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 30, 2022
Est. completion date September 1, 2026

Study information

Verified date September 2023
Source Centre Hospitalier Universitaire de Nice
Contact PASSERON Thierry, PhD
Phone +33492036488
Email passeron.t@chu-nice.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Dendritic cells (DC) paly a key role in the induction and chronicity of psoriasis by capturing the antigenes and activating the T cell repsonse. This activation requires their migration from the cutaneous sensitisation site to the lymph nodes. This migration requires an important intracellular metabolic activity, with a strong involvmenet of glucdic metabolism. This activity is linked with the systemic activity. This study aims to compare the migration and the phenotypic and metabolic caracteristics of blood and skin DCs in patients with or without psoriasis and with or without type 2 diabetes,


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date September 1, 2026
Est. primary completion date June 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Biopsy and venous blood
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

Locations

Country Name City State
France CHU de Nice Nice Alpes-maritimes

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of dentridic cells producers of IL-23 Alterations in the percentage of dentridic cells that have migrated with the metabolic status of patients at baseline
Secondary Percentage of subpopulations dentridic cells producers Study of the percentage of the various cDC subpopulations according to the metabolic status of the patients. At baseline
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