NCT05399433

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,

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Jun 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress93%
Jun 2022Sep 2026

First Submitted

Initial submission to the registry

May 16, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
29 days until next milestone

Study Start

First participant enrolled

June 30, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

3.9 years

First QC Date

May 16, 2022

Last Update Submit

October 14, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Percentage of subpopulations dentridic cells producers

    At baseline

Study Arms (1)

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

OTHER

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.

Other: Biopsy and venous blood

Interventions

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

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Minor or incapable or unwilling to consent freely or in an informed manner Pregnant or nursing woman.
  • Patient with generalized chronic inflammatory disease or other inflammatory dermatosis
  • Contraindication to cutaneous biospsis (known hemostasis disorder, taking anticoagulants, allergy to xylocaine, history of cheloid scars, congenital immune deficiency)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice

Nice, Alpes-maritimes, 06001, France

RECRUITING

MeSH Terms

Conditions

Psoriasis

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • passeron thierry

    CHU de Nice, Service de Dermatologie

    PRINCIPAL INVESTIGATOR

Central Study Contacts

PASSERON Thierry, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2022

First Posted

June 1, 2022

Study Start

June 30, 2022

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

October 15, 2024

Record last verified: 2024-10

Locations