Assessment of Circulating Fubctional Mitochondrias in Vitiligo Patients (MFC)

Assessment of Circulating Fubctional Mitochondrias in Vitiligo Patients as Compared to Controls

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

Study Overview

• Status: Active, not recruiting
• Conditions: Skin and Connective Tissue Diseases
• Intervention / Treatment: Other: Non segmental vitiligo; Other: Health Volunteers

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Alpes-maritimes
    • Nice, Alpes-maritimes, France, 06200
      • CHU de Nice - Hôpital de l'Archet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vitiligo Group; If the subject consents and they meet all the criteria a 20 ml blood sample will be taken.	Other: Non segmental vitiligo; 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.
Other: Volunteers Group; If the subject consents and they meet all the criteria a 20 ml blood sample will be taken.	Other: Health Volunteers; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total number of circulating functionnal mitochondria (CFM) in the plasma	Level of CFM in vitiligo serum as compared to controls	at baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measuring the functionality of circulating mitochondria	Functional analysis of CFM in vitiligo patients as compared to controls analyzed by MFI Mito Tracker	At baseline

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: passeron thierry, PhD, CHU de Nice, Service de Dermatologie

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2022
• Primary Completion (Actual): April 1, 2023
• Study Completion (Estimated): August 30, 2024

Study Registration Dates

• First Submitted: August 23, 2022
• First Submitted That Met QC Criteria: August 30, 2022
• First Posted (Actual): September 2, 2022

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation; Connective Tissue Diseases; Vitiligo
• Other Study ID Numbers: 22-PP-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No