Study of the Role of Innate Lymphoid Cells and Natural Killer Cells in Immune Activation of Vitiligo - INNATE Vitiligo (INNATEvitiligo)
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ClinicalTrials.gov Identifier: NCT03859518 |
Recruitment Status :
Completed
First Posted : March 1, 2019
Last Update Posted : December 9, 2019
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Sponsor:
Centre Hospitalier Universitaire de Nice
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
Tracking Information | |||||
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First Submitted Date | February 26, 2019 | ||||
First Posted Date | March 1, 2019 | ||||
Last Update Posted Date | December 9, 2019 | ||||
Actual Study Start Date | July 2016 | ||||
Actual Primary Completion Date | July 2016 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures | Not Provided | ||||
Original Secondary Outcome Measures | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Study of the Role of Innate Lymphoid Cells and Natural Killer Cells in Immune Activation of Vitiligo - INNATE Vitiligo | ||||
Official Title | Study of the Role of Innate Lymphoid Cells and Natural Killer Cells in Immune Activation of Vitiligo | ||||
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. | ||||
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 | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
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. |
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Condition | Vitiligo | ||||
Intervention | 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.
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Study Groups/Cohorts |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment |
20 | ||||
Original Estimated Enrollment | Same as current | ||||
Actual Study Completion Date | December 2019 | ||||
Actual Primary Completion Date | July 2016 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria: vitiligo subjects :
control subjects :
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | Not Provided | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03859518 | ||||
Other Study ID Numbers | 18-GIRCI-01 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Current Responsible Party | Centre Hospitalier Universitaire de Nice | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor | Centre Hospitalier Universitaire de Nice | ||||
Original Study Sponsor | Same as current | ||||
Collaborators | Institut National de la Santé Et de la Recherche Médicale, France | ||||
Investigators |
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PRS Account | Centre Hospitalier Universitaire de Nice | ||||
Verification Date | January 2019 |