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Role of Glucose Metabolism in Migration of Cutaneous Dendritic Cells in Psoriasis

Primary Purpose

Psoriasis

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Biopsy and venous blood

About this trial

This is an interventional other trial for Psoriasis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

CHU de NiceRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Production of IL-23 of blood and skin dendriti cells (CD)

Arm Description

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.

Outcomes

Primary Outcome Measures

Percentage of dentridic cells producers of IL-23

Alterations in the percentage of dentridic cells that have migrated with the metabolic status of patients

Secondary Outcome Measures

Percentage of subpopulations dentridic cells producers

Study of the percentage of the various cDC subpopulations according to the metabolic status of the patients.

Full Information

NCT ID

NCT05399433

First Posted

May 16, 2022

Last Updated

September 5, 2023

Sponsor

Centre Hospitalier Universitaire de Nice

1. Study Identification

Unique Protocol Identification Number

NCT05399433

Brief Title

Role of Glucose Metabolism in Migration of Cutaneous Dendritic Cells in Psoriasis

Official Title

Rôle du métabolisme du Glucose Dans la Migration Des Cellules Dendritiques cutanées Dans le Psoriasis : étude Pilote Translationnelle

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 30, 2022 (Actual)

Primary Completion Date

June 1, 2026 (Anticipated)

Study Completion Date

September 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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,

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Production of IL-23 of blood and skin dendriti cells (CD)

Arm Type

Other

Arm Description

Intervention Type

Other

Intervention Name(s)

Biopsy and venous blood

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage of dentridic cells producers of IL-23

Description

Alterations in the percentage of dentridic cells that have migrated with the metabolic status of patients

Time Frame

at baseline

Secondary Outcome Measure Information:

Title

Percentage of subpopulations dentridic cells producers

Description

Study of the percentage of the various cDC subpopulations according to the metabolic status of the patients.

Time Frame

At baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

PASSERON Thierry, PhD

Phone

+33492036488

passeron.t@chu-nice.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

passeron thierry

Organizational Affiliation

CHU de Nice, Service de Dermatologie

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU de Nice

City

Nice

State/Province

Alpes-maritimes

ZIP/Postal Code

06001

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Passeron Thierry

Phone

+3349204688

passeron.t@chu-nice.fr

First Name & Middle Initial & Last Name & Degree

Passeron Thierry, PhD

12. IPD Sharing Statement

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Role of Glucose Metabolism in Migration of Cutaneous Dendritic Cells in Psoriasis

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