NCT06213688

Brief Summary

Introduction Pollution is a significant public health issue. Research has shown a positive correlation between air pollution and chronic inflammatory dermatoses, including psoriasis and eczema. The incidence of these diseases has been steadily increasing since the beginning of industrialization. The mechanism behind this association involves the activation of the aromatic hydrocarbon receptor (AhR). The aryl hydrocarbon receptor (AhR) plays a role in regulating the balance between T helper 17 (TH17) and regulatory T cells (TREG), as well as in generating oxidative stress and producing pro-inflammatory cytokines. Studies in cultured keratinocytes have shown that a non-competitive antagonist that modulates AhR activity can reduce cutaneous inflammatory processes induced by polycyclic aromatic hydrocarbons (PAHs). Objectives: It has been suggested that activation of the AhR by PAHs and dioxins may be related to the pathogenesis of atopic dermatitis and psoriasis. The main objective is to compare the levels of AhR pathway activation markers between cases and controls. Secondary objectives include correlating environmental exposure to AhR ligands with disease severity in patients. Finally, we will compare the expression of inflammatory and AhR activation markers in cultured peripheral blood mononuclear cells (PBMCs) after in vitro stimulation with benzo(a)pyrene. Material and methods: The study will measure exposure to pollutants by determining blood dioxins and urinary PAH metabolites. Pro-inflammatory cytokines IL1β, TNFα, IL23, IL17 and IFNγ and Malondialdehyde (MDA) serum concentrations will be measured by ELISA. The TREG and TH17 lymphocyte population ratio will be evaluated by flow cytometry on isolated PBMCs. Additionally, the level of expression of CYP 1A1 and 1B1, pollutant-metabolizing enzymes induced by AhR, will be assessed on isolated PBMCs. The expression levels of the AhR and NfkB active fractions will be determined by immunofluorescence. Subsequently, levels of AhR activation markers will be compared after stimulation of PBMCs with benzo(a)pyrene.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Status
unknown

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

First Submitted

Initial submission to the registry

January 10, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 19, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

January 19, 2024

Status Verified

January 1, 2024

Enrollment Period

1 year

First QC Date

January 10, 2024

Last Update Submit

January 10, 2024

Conditions

Keywords

Atopic dermatitisPsoriasisAryl hydrocarbon receptorDioxinsPolycyclic aromatic hydrocarbonsPollution

Outcome Measures

Primary Outcomes (1)

  • Determination of CYP 1A1/1B1 in PBMCs

    The expression of CYP1A1 and CYP1B1 in PBMCs in ng/mL is used as primary endpoint;

    Inclusion

Study Arms (2)

Cases

OTHER

Patients with atopic dermatitis or psoriasis

Other: blood samplingOther: urine sampling

Controls

OTHER

Patients have consulted or been hospitalized for dermatological reasons without psoriasis or atopic dermatitis

Other: blood samplingOther: urine sampling

Interventions

blood sampling at inclusion

CasesControls

urine sampling at inclusion

CasesControls

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 to 85.
  • The study's participants possess the capacity to comprehend the research.
  • Patients have consulted or been hospitalized for dermatological reasons
  • Patients undergo biological monitoring as part of their routine care.
  • Having psoriasis or atopic dermatitis for more than 6 weeks (cases)

You may not qualify if:

  • Active smoking or less than 3 months since quitting
  • Pregnancy
  • Person in an emergency situation, adult subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice).
  • Non-affiliation with a social security scheme (beneficiary or dependent).
  • Subjects with a history of autoimmune diseases (controls)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PsoriasisDermatitis, Atopic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Richard Marie-Aleth

    AP-HM

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2024

First Posted

January 19, 2024

Study Start

March 1, 2024

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

January 19, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share