search
Back to results

Assessment of Circulating Fubctional Mitochondrias in Vitiligo Patients (MFC)

Primary Purpose

Skin and Connective Tissue Diseases

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Non segmental vitiligo
Health Volunteers
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Skin and Connective Tissue Diseases

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with non segmental vitiligo,
  • atopic dermatitis, psoriais, alopecia areata,
  • 1st degree relative of vitiligo patients.

Exclusion Criteria:

  • segmental or mixed vitiligo,
  • personnal history of other autoimmune disorders,
  • oral use of antioxidant,
  • pregant women

Sites / Locations

  • CHU de Nice - Hôpital de l'ArchetRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Vitiligo Group

Volunteers Group

Arm Description

If the subject consents and they meet all the criteria a 20 ml blood sample will be taken.

If the subject consents and they meet all the criteria a 20 ml blood sample will be taken.

Outcomes

Primary Outcome Measures

Total number of circulating functionnal mitochondria (CFM) in the plasma
Level of CFM in vitiligo serum as compared to controls

Secondary Outcome Measures

measuring the functionality of circulating mitochondria
Functional analysis of CFM in vitiligo patients as compared to controls analyzed by MFI Mito Tracker

Full Information

First Posted
August 23, 2022
Last Updated
September 5, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
search

1. Study Identification

Unique Protocol Identification Number
NCT05525741
Brief Title
Assessment of Circulating Fubctional Mitochondrias in Vitiligo Patients
Acronym
MFC
Official Title
Assessment of Circulating Fubctional Mitochondrias in Vitiligo Patients as Compared to Controls
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Actual)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To compare the level of circulating functional mitochondria in the serum of vitiligo patients as compared to controls

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin and Connective Tissue Diseases

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients with non segmental vitiligo compared to healthy volunteers (1st degree family of vitiligo patients) atopic dermatitis, psoriasis and alopecia areata patients
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vitiligo Group
Arm Type
Experimental
Arm Description
If the subject consents and they meet all the criteria a 20 ml blood sample will be taken.
Arm Title
Volunteers Group
Arm Type
Other
Arm Description
If the subject consents and they meet all the criteria a 20 ml blood sample will be taken.
Intervention Type
Other
Intervention Name(s)
Non segmental vitiligo
Intervention Description
The subjects will be selected from among those presenting for the consultation or hospitalization of the Dermatology department of the CHU de Nice. All necessary information will be given to the subjects and a briefing note will be given to them. A reflection period will be left for the subjects to sign the informed consent, and if necessary, another appointment will be scheduled for the inclusion visit. The Investigator: Inform the subject of the goals, constraints and risks of the study and obtain written consent. Conduct an examination of the subject's medical history Will verify that the subject meets all inclusion criteria and does not present any of the criteria for not including. If the subject consents and they meet all the criteria a 20 ml blood sample will be taken.
Intervention Type
Other
Intervention Name(s)
Health Volunteers
Intervention Description
The subjects will be selected from among those presenting for the consultation or hospitalization of the Dermatology department of the CHU de Nice. The family control subjects will be recruited from the vitiligos patients coming into our department. All necessary information will be given to the subjects and a briefing note will be given to them. A reflection period will be left for the subjects to sign the informed consent, and if necessary, another appointment will be scheduled for the inclusion visit. The Investigator: Inform the subject of the goals, constraints and risks of the study and obtain written consent. Conduct an examination of the subject's medical history Will verify that the subject meets all inclusion criteria and does not present any of the criteria for not including. If the subject consents and they meet all the criteria a 20 ml blood sample will be taken.
Primary Outcome Measure Information:
Title
Total number of circulating functionnal mitochondria (CFM) in the plasma
Description
Level of CFM in vitiligo serum as compared to controls
Time Frame
at baseline
Secondary Outcome Measure Information:
Title
measuring the functionality of circulating mitochondria
Description
Functional analysis of CFM in vitiligo patients as compared to controls analyzed by MFI Mito Tracker
Time Frame
At baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with non segmental vitiligo, atopic dermatitis, psoriais, alopecia areata, 1st degree relative of vitiligo patients. Exclusion Criteria: segmental or mixed vitiligo, personnal history of other autoimmune disorders, oral use of antioxidant, pregant women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
PASSERON Thierry, PhD
Phone
+33492036488
Email
passeron.t@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
passeron thierry, PhD
Organizational Affiliation
CHU de Nice, Service de Dermatologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nice - Hôpital de l'Archet
City
Nice
State/Province
Alpes-maritimes
ZIP/Postal Code
06200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Passeron Thierry, PhD
Phone
+3349204688
Email
passeron.t@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Passeron Thierry, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Assessment of Circulating Fubctional Mitochondrias in Vitiligo Patients

We'll reach out to this number within 24 hrs