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Enrolling by invitation NCT03976622

Analysis of Inflammation in the Vitiligo and Other Inflammatory Skin Diseases: Psoriasis, Atopic Dermatitis and Alopecia Areata

Observational Vitiligo Psoriasis Alopecia Areata Atopic Dermatitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood samples, Skin biopsies.
Who it may be relevant to
Registry conditions: Vitiligo, Psoriasis, Alopecia Areata, Atopic Dermatitis. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Detailed description

This study was a single-center prospective study to collect blood and skin tissue at the time of consultation with a patient with non-segmental vitiligo, psoriasis, atopic dermatitis or alopecia areata, in order to better understand and compare blood and skin immune response in chronic inflammatory skin disorders: psoriasis, alopecia areata, atopic dermatitis and vitiligo.

Interventions

  • Biological Blood samples
    Blood samples: serum and PBMC
  • Biological Skin biopsies
    These superficial skin biopsies under local anesthesia in skin areas with the exception of the face and folds.

Primary outcome measures

  • Description of the phenotype and function of blood and skin T-cell in chronic inflammatory skin disorders: psoriasis, vitiligo, atopic dermatitis, alopecia areata [Time frame: Day 1]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Service de Dermatologie - Hôpital Saint-André — Bordeaux

Publications

  • Jacquemin C, Taieb A, Boniface K, Seneschal J; FHU ACRONIM. Imbalance of peripheral follicular helper T lymphocyte subsets in active vitiligo. Pigment Cell Melanoma Res. 2019 Jul;32(4):588-592. doi: 10.1111/pcmr.12763. Epub 2019 Feb 15. PMID 30552832

Identifiers

NCT: NCT03976622 · CHUBX 2017/55

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗