NCT05525741

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 2, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

October 19, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

December 4, 2024

Status Verified

December 1, 2024

Enrollment Period

5 months

First QC Date

August 23, 2022

Last Update Submit

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

EXPERIMENTAL

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

Other: Non segmental vitiligo

Volunteers Group

OTHER

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

Other: Health Volunteers

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.

Vitiligo Group

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.

Volunteers Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Skin and Connective Tissue Diseases

Study Officials

  • passeron thierry, PhD

    CHU de Nice, Service de Dermatologie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Patients with non segmental vitiligo compared to healthy volunteers (1st degree family of vitiligo patients) atopic dermatitis, psoriasis and alopecia areata patients
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

Locations