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

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ClinicalTrials.gov Identifier: NCT03976622
Recruitment Status : Not yet recruiting
First Posted : June 6, 2019
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

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

Condition or disease Intervention/treatment
Vitiligo Psoriasis Alopecia Areata Atopic Dermatitis Biological: Blood samples Biological: Skin biopsies

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.

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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of Inflammation in the Vitiligo and Other Inflammatory Skin Diseases: Psoriasis, Atopic Dermatitis and Alopecia Areata
Estimated Study Start Date : June 3, 2019
Estimated Primary Completion Date : June 3, 2023
Estimated Study Completion Date : June 3, 2023


Group/Cohort Intervention/treatment
vitiligo
Patients aged 18 to 75 years with non-segmental vitiligo;
Biological: Blood samples
Blood samples: serum and PBMC
Other Name: 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.

psoriasis
Patients aged 18 to 75 years with plaque psoriasis;
Biological: Blood samples
Blood samples: serum and PBMC
Other Name: 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.

atopic dermatitis
Patients aged 18 to 75 years with atopic dermatitis;
Biological: Blood samples
Blood samples: serum and PBMC
Other Name: 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.

alopecia areata
Patients aged 18 to 75 years with alopecia areata sclerosis;
Biological: Blood samples
Blood samples: serum and PBMC
Other Name: 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 :
  1. 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 ]
    Description of the phenotypic analysis of cutaneous T-cell and blood of vitiligo patients evaluated by flow cytometry


Biospecimen Retention:   Samples Without DNA
Peripheral mononuclear cells, Serum, paraffine-embedded/ frozen skin.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
450 patients (300 patients with vitiligo, 50 psoriasis patients, 50 patients with atopic dermatitis, 50 patients with alopecia areata)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03976622


Contacts
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Contact: Julien SENESCHAL, MD,PhD +335 56 79 49 63 julien.seneschal@chu-bordeaux.fr
Contact: Sitraka ANDRIAMIASY +335.56.82.06.55 sitraka.andriamiasy@chu-bordeaux.fr

Locations
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France
Service de Dermatologie - Hôpital Saint-André
Bordeaux, France, 33075
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Principal Investigator: Julien SENESCHAL, MD, PhD University Hospital, Bordeaux

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03976622     History of Changes
Other Study ID Numbers: CHUBX 2017/55
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Bordeaux:
Skin inflammation
Cytokines

Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Inflammation
Psoriasis
Dermatitis
Dermatitis, Atopic
Eczema
Vitiligo
Skin Diseases
Pathologic Processes
Skin Diseases, Papulosquamous
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Hypotrichosis
Hair Diseases
Pathological Conditions, Anatomical
Hypopigmentation
Pigmentation Disorders