VitiligoSTRAVINCT05927272
Deciphering the Vitiligo Transcriptomic Signature Between Repigmented and Non Repigmented Lesions
A study testing SKIN SAMPLES, BLOOD SAMPLES and narrowband UVB in people with Vitiligo, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The purpose of this study is to perform an in-depth analysis of the molecular pathways involved in lesions responding to current treatment and lesions not responding to current treatment Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- SKIN SAMPLES, BLOOD SAMPLES and narrowband UVB
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 10 Apr 2024to 9 Oct 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject: male or female aged ≥ 18 years and ≤ 65 years
- Diagnosis of non-segmental (symmetrical) vitiligo with a body surface area involved >5% excluding hands and feet, with lesions located on arms
- Active non-segmental vitiligo is defined by:
- Non-segmental vitiligo with new patches or extension of old lesions during the last 6 months AND
- Presence of hypochromic aspect under Wood's lamp examination and/or perifollicular hypopigmentation under Wood's lamp examination.
- Able to read, understand, and give documented informed consent
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- Registered in the French Social Security
- Patients that could receive the combination of oral steroids and phototherapy according the recommendation
- Signed informed consent form
Who cannot join
- Segmental or mixed vitiligo
- Are unable or unwilling to make themselves available for the duration of the study and/or are unwilling to follow study restrictions/procedures.
- Are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital of Bordeaux - St André Hospital
Bordeaux, 33000
Julien SENESCHAL, MD, PhD, +335.56.79.47.05, juline.seneschal@chu-bordeaux.fr
Nicolas ANDREU, +335 57 82 06 55, nicolas.andreu@chu-bordeaux.fr
About this study
The purpose of this study is to perform an in-depth analysis of the molecular pathways involved in lesions responding to current treatment and lesions not responding to current treatment
Read the detailed description
Treatment strategy: combination of oral mini-pulse of methylprednisolone 16mg twice a week + phototherapy Ultraviolet B (UVB) TL01, 2 times a week.
One skin biopsy will be performed at baseline and two skin biopsies at month 3 and month 6 on the same area forearms (excluding skin folds) Blood samples will be taken (30 mL) at week 0, week 12, week 24 for the measurement of pro-inflammatory cytokines and chemokines ligands in blood sera.
Principal Objective:
The aim of this study is to perform an in-depth analysis of vitiligo skin and blood samples taken during the course of a standard therapy to identify pathways involved in the repigmentation.
Secondary Objectives:
- Evolution of Vitiligo Disease in relation of patient profile
- Evolution of the activity of vitiligo in relation of patient profile The statistical and bioinformatics analyzes will be carried out on the data resulting from research with correlation to clinical data.
- Conditions
- Vitiligo
- Being tested
- SKIN SAMPLES, BLOOD SAMPLES, narrowband UVB, Systemic Steroids
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKIN SAMPLESProcedure or surgery
At baseline: one 4 mm Ø skin biopsies: on forearms (excluding skin folds): fresh At month 3 and month 6: Two 4 mm Ø skin biopsies will be performed on the same lesion selected at baseline (one on a repigmented area, one on a non-responded area): fresh
Fresh Skin biopsies will be analyzed the same day using Single-cell RNA sequencing (scRNAseq).
BLOOD SAMPLESProcedure or surgery
Blood samples will be taken (30 mL) at week 0, week 12, week 24 for the measurement of pro-inflammatory cytokines and chemokines ligands in blood sera.
narrowband UVBDevice
narrowband UVB (Nb-UVB) 2 times a week
Systemic SteroidsDrug
Oral minipuls of systemic steroids (Medrol 16mg twice a week) for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Patients with active non-segmental vitiligo | Experimental | Not described Receives: Procedure: SKIN SAMPLES; Procedure: BLOOD SAMPLES; Device: narrowband UVB; Drug: Systemic Steroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the evolution of skin biological pathways, assessed by single cell RNAseq in the peri-lesional and lesional skin of a target lesion
Identify pathways involved in the repigmentation using transcriptomic analyses with Single-cell RNA sequencing (scRNA-seq), comparing molecular/cellular background between vitiligo skin lesions responding to current treatment and lesions not responding to current treatment.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start10 Apr 2024
- Primary completion9 Oct 2025 (estimated)
- Study completion9 Oct 2025 (estimated)
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.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- monocentric, open-label study, and translational research.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Responsible party
- Sponsor
- Investigators
- Julien SENESCHAL, MD, PhD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927272
- Sponsor's protocol ID
- CHUBX 2021/54
- Acronym
- STRAVI
- Status last verified
- Apr 2024
- First submitted
- 5 Jun 2023
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deciphering the Vitiligo Transcriptomic Signature Between Repigmented and Non Repigmented Lesions
- ClinicalTrials.gov ID
- NCT05927272
- Acronym / sponsor ID
- STRAVI / CHUBX 2021/54
- Conditions
- Vitiligo
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 9 Oct 2025 (estimated)
- Study completion
- 9 Oct 2025 (estimated)
- First posted
- 3 Jul 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.
The purpose of this study is to perform an in-depth analysis of the molecular pathways involved in lesions responding to current treatment and lesions not responding to current treatment
Detailed description
Treatment strategy: combination of oral mini-pulse of methylprednisolone 16mg twice a week + phototherapy Ultraviolet B (UVB) TL01, 2 times a week.
One skin biopsy will be performed at baseline and two skin biopsies at month 3 and month 6 on the same area forearms (excluding skin folds) Blood samples will be taken (30 mL) at week 0, week 12, week 24 for the measurement of pro-inflammatory cytokines and chemokines ligands in blood sera.
Principal Objective:
The aim of this study is to perform an in-depth analysis of vitiligo skin and blood samples taken during the course of a standard therapy to identify pathways involved in the repigmentation.
Secondary Objectives:
- Evolution of Vitiligo Disease in relation of patient profile
- Evolution of the activity of vitiligo in relation of patient profile The statistical and bioinformatics analyzes will be carried out on the data resulting from research with correlation to clinical data.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- monocentric, open-label study, and translational research.
| Arm | Type | Receives |
|---|---|---|
| Patients with active non-segmental vitiligo | Experimental | Procedure: SKIN SAMPLES, Procedure: BLOOD SAMPLES, Device: narrowband UVB, Drug: Systemic Steroids |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject: male or female aged ≥ 18 years and ≤ 65 years
- Diagnosis of non-segmental (symmetrical) vitiligo with a body surface area involved >5% excluding hands and feet, with lesions located on arms
- Active non-segmental vitiligo is defined by:
- Able to read, understand, and give documented informed consent
- Registered in the French Social Security
Key exclusion criteria (3 listed)
- Segmental or mixed vitiligo
- Are unable or unwilling to make themselves available for the duration of the study and/or are unwilling to follow study restrictions/procedures.
- Are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
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 |
|---|---|---|
| SKIN SAMPLESAt baseline: one 4 mm Ø skin biopsies: on forearms (excluding skin folds): fresh At month 3 and month 6: Two 4 mm Ø skin biopsies will be performed on the same lesion selected at baseline (one on a repigmented area, one on a non-responded area): fresh Fresh Skin biopsies will be analyzed the same day using Single-cell RNA sequencing (scRNAseq). | Procedure or surgery | Patients with active non-segmental vitiligo |
| BLOOD SAMPLESBlood samples will be taken (30 mL) at week 0, week 12, week 24 for the measurement of pro-inflammatory cytokines and chemokines ligands in blood sera. | Procedure or surgery | Patients with active non-segmental vitiligo |
| narrowband UVBnarrowband UVB (Nb-UVB) 2 times a week | Device | Patients with active non-segmental vitiligo |
| Systemic SteroidsOral minipuls of systemic steroids (Medrol 16mg twice a week) for 24 weeks | Drug | Patients with active non-segmental vitiligo |
Primary outcome
Evaluate the evolution of skin biological pathways, assessed by single cell RNAseq in the peri-lesional and lesional skin of a target lesion
Time frame: Month 6
Identify pathways involved in the repigmentation using transcriptomic analyses with Single-cell RNA sequencing (scRNA-seq), comparing molecular/cellular background between vitiligo skin lesions responding to current treatment and lesions not responding to current treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
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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.
Julien SENESCHAL, MD, PhD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SKIN SAMPLES, BLOOD SAMPLES and narrowband UVB in people with Vitiligo, run by University Hospital, Bordeaux 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 9 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julien SENESCHAL, MD, PhD (+33 (0)5 56 79 49 63, julien.seneschal@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the evolution of skin biological pathways, assessed by single cell RNAseq in the peri-lesional and lesional skin of a target lesion (time frame: Month 6). 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 19 Apr 2024; AzTrials last refreshed its copy on 31 Oct 2026.