VitiligoVitiligo BLNCT06068218
Translational Assessment of Vitiligo According to Body Locations
A study testing Biopsy for the patient group and biopsy for the volunteer group in people with Vitiligo, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Vitiligo affects 0.5 to 2% of worldwide population and has a demonstrated impact on the quality of life. Optimal treatment of vitiligo requires to target the auto-immune inflammatory response (to halt the depigmentation process), but also to induce the differentiation of melanocyte stem cells (to induce… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitiligo
- What is being tested?
- Biopsy for the patient group and biopsy for the volunteer group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jun 2024to 23 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women with non-segmental vitiligo for the vitiligo group and men and women without any auto-immune disorder for the control group
- ≥ 18 and <70 years
- For women of child-bearing age, a urine pregnancy test (βHCG in urines) will be performed.
- Affiliation to a social security system
- Signed informed consent
Who cannot join
- Pregnant women
- Segmental or mixed vitiligo
- Vitiligo with less than 2 years duration
- Skin auto-immune or inflammatory skin disorders other than vitiligo (ie. active atopic dermatitis, psoriasis, lichen planus…)
- Exposure to sun (with intent to tan or repigment the skin) or artificial UV (UV cabins, lamps or lasers) during the month before inclusion
- Concomitant use of topical or systemic immunosuppressive medication or steroids
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- Contra-indication to xylocaine with 2 % adrenalin
- Pregnant or breast-feeding women
- Vulnerable people: minors, adult under guardianship or deprived of freedom, adult under curatorship
- Participants in other clinical therapeutic studies involving a drug that could interfere with the present evaluation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Translational Assessment of Vitiligo According to Body Locations Translational Study
Vitiligo affects 0.5 to 2% of worldwide population and has a demonstrated impact on the quality of life.
Optimal treatment of vitiligo requires to target the auto-immune inflammatory response (to halt the depigmentation process), but also to induce the differentiation of melanocyte stem cells (to induce repigmentation). There is a well demonstrated discrepancy in the repigmentation response between anatomical areas of the body. Face and neck are the best responder with complete or almost complete repigmentation achieved in most cases under treatment. Trunk and limbs could have a complete or almost complete repigmentation in approximately half of the cases. The repigmentation is much more difficult in wrists, elbows, knees, proximal part of the hands. Finally, some areas such as the extremities of hands and feet, palms, soles, are almost impossible to repigment.
Read more
The investigator hypothesize that there are some factors that are produced in the skin that prevent (or at least decrease) the differentiation but also probably the migration and proliferation of melanocytes.
Primary objective To compare the mRNA expression of each types of cells in the skin of vitiligo patients compared to healthy volunteers according to body locations
- Conditions
- Vitiligo
- Being tested
- Biopsy for the patient group, biopsy for the volunteer group
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy for the patient groupOther
The investigator will perform a 4mm skin biopsy will be performed on 5 body sites: neck, trunk, elbows, wrist and feet. For vitiligo patients, the biopsies will be taken on a non-depigmented skin.
biopsy for the volunteer groupOther
A publicity in the hospital will announce the study, and will be use to recruit the healthy volunteers. The investigator will perform a 4mm skin biopsy will be performed on 5 body sites: neck, trunk, elbows, wrist and feet.
| Study group | Role | What they receive |
|---|---|---|
| Patient Group | Other | Not described Receives: Other: Biopsy for the patient group |
| Volunteer group | Other | Not described Receives: Other: biopsy for the volunteer group |
What is being measured
The primary outcome is the main question the study is designed to answer.
skin samples
Transcriptomic profiling by sequencing method will be performed on the skin samples
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start18 Jun 2024
- Primary completion19 Feb 2025
- Study completion23 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies 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
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT06068218
- Sponsor's protocol ID
- 23-PP-06
- Acronym
- Vitiligo BL
- Status last verified
- Mar 2026
- First submitted
- 5 Sep 2023
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translational Assessment of Vitiligo According to Body Locations Translational Study
- ClinicalTrials.gov ID
- NCT06068218
- Acronym / sponsor ID
- Vitiligo BL / 23-PP-06
- Conditions
- Vitiligo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- 19 Feb 2025 (actual)
- Study completion
- 23 Dec 2025 (actual)
- First posted
- 5 Oct 2023 (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.
Vitiligo affects 0.5 to 2% of worldwide population and has a demonstrated impact on the quality of life.
Optimal treatment of vitiligo requires to target the auto-immune inflammatory response (to halt the depigmentation process), but also to induce the differentiation of melanocyte stem cells (to induce repigmentation). There is a well demonstrated discrepancy in the repigmentation response between anatomical areas of the body. Face and neck are the best responder with complete or almost complete repigmentation achieved in most cases under treatment. Trunk and limbs could have a complete or almost complete repigmentation in approximately half of the cases. The repigmentation is much more difficult in wrists, elbows, knees, proximal part of the hands. Finally, some areas such as the extremities of hands and feet, palms, soles, are almost impossible to repigment.
The investigator hypothesize that there are some factors that are produced in the skin that prevent (or at least decrease) the differentiation but also probably the migration and proliferation of melanocytes.
Primary objective To compare the mRNA expression of each types of cells in the skin of vitiligo patients compared to healthy volunteers according to body locations
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Group | Other | Other: Biopsy for the patient group |
| Volunteer group | Other | Other: biopsy for the volunteer group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women with non-segmental vitiligo for the vitiligo group and men and women without any auto-immune disorder for the control group
- ≥ 18 and <70 years
- For women of child-bearing age, a urine pregnancy test (βHCG in urines) will be performed.
- Affiliation to a social security system
- Signed informed consent
Key exclusion criteria (10 listed)
- Pregnant women
- Segmental or mixed vitiligo
- Vitiligo with less than 2 years duration
- Skin auto-immune or inflammatory skin disorders other than vitiligo (ie. active atopic dermatitis, psoriasis, lichen planus…)
- Exposure to sun (with intent to tan or repigment the skin) or artificial UV (UV cabins, lamps or lasers) during the month before inclusion
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 |
|---|---|---|
| Biopsy for the patient groupThe investigator will perform a 4mm skin biopsy will be performed on 5 body sites: neck, trunk, elbows, wrist and feet. For vitiligo patients, the biopsies will be taken on a non-depigmented skin. | Other | Patient Group |
| biopsy for the volunteer groupA publicity in the hospital will announce the study, and will be use to recruit the healthy volunteers. The investigator will perform a 4mm skin biopsy will be performed on 5 body sites: neck, trunk, elbows, wrist and feet. | Other | Volunteer group |
Primary outcome
skin samples
Time frame: at inclusion
Transcriptomic profiling by sequencing method will be performed on the skin samples
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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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 Biopsy for the patient group and biopsy for the volunteer group in people with Vitiligo, 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 18 Mar 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
skin samples (time frame: at inclusion). 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 18 Mar 2026.