NCT03976622

Brief Summary

It is a study of translational research with mechanistically objectives and including biological samples of patients with chronic inflammatory disorders

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

June 3, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 6, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2023

Completed
Last Updated

June 6, 2019

Status Verified

May 1, 2019

Enrollment Period

4 years

First QC Date

June 3, 2019

Last Update Submit

June 3, 2019

Conditions

VitiligoPsoriasisAlopecia AreataAtopic Dermatitis

Keywords

Skin inflammationCytokines

Outcome Measures

Primary Outcomes (1)

  • Description of the phenotype and function of blood and skin T-cell in chronic inflammatory skin disorders: psoriasis, vitiligo, atopic dermatitis, alopecia areata

    Description of the phenotypic analysis of cutaneous T-cell and blood of vitiligo patients evaluated by flow cytometry

    Day 1

Study Arms (4)

vitiligo

Patients aged 18 to 75 years with non-segmental vitiligo;

Biological: Blood samplesBiological: Skin biopsies

psoriasis

Patients aged 18 to 75 years with plaque psoriasis;

Biological: Blood samplesBiological: Skin biopsies

atopic dermatitis

Patients aged 18 to 75 years with atopic dermatitis;

Biological: Blood samplesBiological: Skin biopsies

alopecia areata

Patients aged 18 to 75 years with alopecia areata sclerosis;

Biological: Blood samplesBiological: Skin biopsies

Interventions

Blood samplesBIOLOGICAL

Blood samples: serum and PBMC

Also known as: Blood samples: serum and PBMC
alopecia areataatopic dermatitispsoriasisvitiligo
Skin biopsiesBIOLOGICAL

These superficial skin biopsies under local anesthesia in skin areas with the exception of the face and folds.

alopecia areataatopic dermatitispsoriasisvitiligo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

450 patients (300 patients with vitiligo, 50 psoriasis patients, 50 patients with atopic dermatitis, 50 patients with alopecia areata)

You may qualify if:

  • Patients aged 18 to 75 years;
  • Patients with non-segmental vitiligo;
  • Patients with plaque psoriasis;
  • Patients with atopic dermatitis;
  • Patients with alopecia areata sclerosis;
  • written consent, free, informed and signed by the patient and the investigator (before any examination required by the study);
  • Subject affiliated or beneficiary of a social security system.

You may not qualify if:

  • Patients with segmental vitiligo
  • Patients under local treatment (topical corticosteroid-Calcineurin inhibitor) for less than two weeks.
  • Patients on therapy, systemic treatments: acitretin, methotrexate, cyclosporine, Apremilast, infliximab, adalimumab, etanercept, ustekinumab, secukinumab, ixekizumab, dupilumab) for less than 4 weeks.
  • Pregnant or breastfeeding women
  • Patient (e) under guardianship
  • Patient (e) Non-affiliated (e) a social protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Dermatologie - Hôpital Saint-André

Bordeaux, 33075, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral mononuclear cells, Serum, paraffine-embedded/ frozen skin.

MeSH Terms

Conditions

VitiligoPsoriasisAlopecia AreataDermatitis, AtopicDermatitis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, PapulosquamousAlopeciaHypotrichosisHair DiseasesSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Julien SENESCHAL, MD, PhD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julien SENESCHAL, MD,PhD

CONTACT

+335 56 79 49 63julien.seneschal@chu-bordeaux.fr

Sitraka ANDRIAMIASY

CONTACT

+335.56.82.06.55sitraka.andriamiasy@chu-bordeaux.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2019

First Posted

June 6, 2019

Study Start

June 3, 2019

Primary Completion

June 3, 2023

Study Completion

June 3, 2023

Last Updated

June 6, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)