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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03859518
Recruitment Status : Completed
First Posted : March 1, 2019
Last Update Posted : December 9, 2019
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Brief Summary:
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.

Condition or disease Intervention/treatment
Vitiligo Other: blood and skin samples

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.

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of the Role of Innate Lymphoid Cells and Natural Killer Cells in Immune Activation of Vitiligo
Actual Study Start Date : July 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Vitiligo
MedlinePlus related topics: Vitiligo

Group/Cohort Intervention/treatment
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.

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.




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

  2. study the presence and type of ILC and NK in the skin [ Time Frame: 1 day ]
    Compare vitiligo patients to control subjects.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.

Criteria

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

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): NCT03859518


Locations
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France
CH de Frejus
Fréjus, France
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Thierry PASSERON, MD; PhD Centre Hospitalier Universitaire de Nice
Publications:

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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT03859518    
Other Study ID Numbers: 18-GIRCI-01
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: December 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases