Skin and Connective Tissue DiseasesMFCNCT05525741
Assessment of Circulating Fubctional Mitochondrias in Vitiligo Patients
A study testing Non segmental vitiligo and Health Volunteers in people with Skin and Connective Tissue Diseases, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
To compare the level of circulating functional mitochondria in the serum of vitiligo patients as compared to controls Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin and Connective Tissue Diseases
- What is being tested?
- Non segmental vitiligo and Health Volunteers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- 19 Oct 2022to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with non segmental vitiligo,
- atopic dermatitis, psoriais, alopecia areata,
- 1st degree relative of vitiligo patients.
Who cannot join
- segmental or mixed vitiligo,
- personnal history of other autoimmune disorders,
- oral use of antioxidant,
- pregant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Skin and Connective Tissue Diseases
- Being tested
- Non segmental vitiligo, Health Volunteers
- Medical subject headings
- Skin and Connective Tissue Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non segmental vitiligoOther
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.
Health VolunteersOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Vitiligo Group | Experimental | If the subject consents and they meet all the criteria a 20 ml blood sample will be taken. Receives: 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. Receives: Other: Health Volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of circulating functionnal mitochondria (CFM) in the plasma
Level of CFM in vitiligo serum as compared to controls
Measured: at baseline
Secondary outcomes (1)
measuring the functionality of circulating mitochondria
Functional analysis of CFM in vitiligo patients as compared to controls analyzed by MFI Mito Tracker
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start19 Oct 2022
- Primary completion1 Apr 2023
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin and Connective Tissue DiseasesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- passeron thierry, PhD, Principal investigator, CHU de Nice, Service de Dermatologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525741
- Sponsor's protocol ID
- 22-PP-10
- Acronym
- MFC
- Status last verified
- Dec 2024
- First submitted
- 23 Aug 2022
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Circulating Fubctional Mitochondrias in Vitiligo Patients as Compared to Controls
- ClinicalTrials.gov ID
- NCT05525741
- Acronym / sponsor ID
- MFC / 22-PP-10
- Conditions
- Skin and Connective Tissue Diseases
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the level of circulating functional mitochondria in the serum of vitiligo patients as compared to controls
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with non segmental vitiligo compared to healthy volunteers (1st degree family of vitiligo patients) atopic dermatitis, psoriasis and alopecia areata patients
| Arm | Type | Receives |
|---|---|---|
| Vitiligo Group | Experimental | Other: Non segmental vitiligoIf the subject consents and they meet all the criteria a 20 ml blood sample will be taken. |
| Volunteers Group | Other | Other: Health VolunteersIf the subject consents and they meet all the criteria a 20 ml blood sample will be taken. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with non segmental vitiligo,
- atopic dermatitis, psoriais, alopecia areata,
- 1st degree relative of vitiligo patients.
Key exclusion criteria (4 listed)
- segmental or mixed vitiligo,
- personnal history of other autoimmune disorders,
- oral use of antioxidant,
- pregant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non segmental vitiligoThe 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 | Vitiligo Group |
| Health VolunteersThe 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. | Other | Volunteers Group |
Primary outcome
Total number of circulating functionnal mitochondria (CFM) in the plasma
Time frame: at baseline
Level of CFM in vitiligo serum as compared to controls
1 secondary outcome
measuring the functionality of circulating mitochondria
Time frame: At baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
passeron thierry, PhD principal investigator
CHU de Nice, Service de Dermatologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non segmental vitiligo and Health Volunteers in people with Skin and Connective Tissue Diseases, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of circulating functionnal mitochondria (CFM) in the plasma (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.