Assessment of Circulating Fubctional Mitochondrias in Vitiligo Patients
MFC
1 other identifier
interventional
59
1 country
1
Brief Summary
To compare the level of circulating functional mitochondria in the serum of vitiligo patients as compared to controls
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2022
CompletedFirst Posted
Study publicly available on registry
September 2, 2022
CompletedStudy Start
First participant enrolled
October 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedDecember 4, 2024
December 1, 2024
5 months
August 23, 2022
December 3, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Total number of circulating functionnal mitochondria (CFM) in the plasma
Level of CFM in vitiligo serum as compared to controls
at baseline
Secondary Outcomes (1)
measuring the functionality of circulating mitochondria
At baseline
Study Arms (2)
Vitiligo Group
EXPERIMENTALIf the subject consents and they meet all the criteria a 20 ml blood sample will be taken.
Volunteers Group
OTHERIf the subject consents and they meet all the criteria a 20 ml blood sample will be taken.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Patients with non segmental vitiligo,
- atopic dermatitis, psoriais, alopecia areata,
- st degree relative of vitiligo patients.
You may not qualify if:
- segmental or mixed vitiligo,
- personnal history of other autoimmune disorders,
- oral use of antioxidant,
- pregant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Nice - Hôpital de l'Archet
Nice, Alpes-maritimes, 06200, France
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
passeron thierry, PhD
CHU de Nice, Service de Dermatologie
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2022
First Posted
September 2, 2022
Study Start
October 19, 2022
Primary Completion
April 1, 2023
Study Completion
June 30, 2025
Last Updated
December 4, 2024
Record last verified: 2024-12