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

June 3, 2019 updated by: University Hospital, Bordeaux
It is a study of translational research with mechanistically objectives and including biological samples of patients with chronic inflammatory disorders

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bordeaux, France, 33075
        • Service de Dermatologie - Hôpital Saint-André

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 3, 2019

Primary Completion (ANTICIPATED)

June 3, 2023

Study Completion (ANTICIPATED)

June 3, 2023

Study Registration Dates

First Submitted

June 3, 2019

First Submitted That Met QC Criteria

June 3, 2019

First Posted (ACTUAL)

June 6, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 6, 2019

Last Update Submitted That Met QC Criteria

June 3, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2017/55

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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