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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03976622
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital, Bordeaux
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Julien SENESCHAL, MD, PhD
Principal Investigator Affiliation University Hospital, Bordeaux
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Vitiligo, Psoriasis, Alopecia Areata, Atopic Dermatitis
Additional Details

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.

Arms & Interventions

Arms

: vitiligo

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

: psoriasis

Patients aged 18 to 75 years with plaque psoriasis;

: atopic dermatitis

Patients aged 18 to 75 years with atopic dermatitis;

: alopecia areata

Patients aged 18 to 75 years with alopecia areata sclerosis;

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.

Contact a Trial Team

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International Sites

Bordeaux, France

Status

Address

Service de Dermatologie - Hôpital Saint-André

Bordeaux, , 33075

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