Study of the Role of Innate Lymphoid Cells and Natural Killer Cells in Immune Activation of Vitiligo - INNATE Vitiligo (INNATEvitiligo)

December 6, 2019 updated by: Centre Hospitalier Universitaire de Nice

Study of the Role of Innate Lymphoid Cells and Natural Killer Cells in Immune Activation of Vitiligo

The cohort included only major patients with non-segmental vitiligo and no other autoimmune or inflammatory associated diseases (except thyroiditis). Control subjects should have no autoimmune or inflammatory diseases. Patients and controls should not take treatment with corticosteroids or other potentially immunomodulatory therapies. Patients and controls are recruited in the Dermatology Department of the University Hospital of Nice and the Hospital of Fréjus. The investigators have already initiated the collection of tissues and blood from patients and control subjects and we have succeeded in isolating ILCs and NKs from a blood volume of 50ml. We were able to sort the ILC subpopulations. Early data suggest an increase in Natural Killer (NK) and Innate Lymphoïdes Cells 1 (ILC1) in the blood of vitiligo patients compared to control subjects. The investigators also managed to extract the melanocytes from the skin biopsies of the first patients and control subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators want study the presence and type of ILC and NK in the blood and skin of vitiligo patients compared to control subjects.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

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

Study Locations

  • France
      • Fréjus, France
        • CH de Frejus

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

in this study, there are 2 groups. First with vitiligo and the second only with control subjects without autoimmune or inflammatory diseases.

All this subjects were include in the dermatolgy servive of the CHU of Nice.

Description

Inclusion Criteria:

vitiligo subjects :

  • patients in the cohort with non-segmental vitiligo
  • without other autoimmune or inflammatory diseases associated

control subjects :

  • subject without autoimmune or inflammatory disease

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
control
Other: blood and skin samples
To study the presence and type of ILC and NK in the blood and skin of vitiligo patients compared to control subjects.
patients with Vitiligo
Other: blood and skin samples
To study the presence and type of ILC and NK in the blood and skin of vitiligo patients compared to control subjects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
study the presence and type of ILC and NK in the blood and skin
Time Frame: 1 day
Compare vitiligo patients to control subjects.
1 day
study the presence and type of ILC and NK in the skin
Time Frame: 1 day
Compare vitiligo patients to control subjects.
1 day

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Nice

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: Thierry PASSERON, MD; PhD, Centre Hospitalier Universitaire de Nice

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

July 1, 2016

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

February 26, 2019

First Submitted That Met QC Criteria

February 27, 2019

First Posted (Actual)

March 1, 2019

Study Record Updates

Last Update Posted (Actual)

December 9, 2019

Last Update Submitted That Met QC Criteria

December 6, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-GIRCI-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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