VitiligoPhase 2METVINCT04237103
Combination of Methotrexate and Phototherapy Versus Phototherapy in Adults With Progressive Vitiligo
A Phase 2 study testing Methotrexate in people with Vitiligo, run by University Hospital, Bordeaux at 4 sites in France.
Trial summary
This is a phase 2, randomized, double blind, multicenter study evaluating the efficacy and safety of the combination of methotrexate plus UVB TL01 in vitiligo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitiligo
- What is being tested?
- Methotrexate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 4 sitesFrance
- Study dates
- 23 May 2023to 4 Nov 2025
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject male or female age over 18 years old
- Diagnosis of non-segmental (symmetrical) vitiligo with body surface area ≥10%
- Active non-segmental vitiligo 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.
- Signed informed consent document
- Male patients agreeing to use a reliable method of birth control during the study i. e. preservative and for at least 6 months following the last dose of investigational product, the patient's partner treated by methotrexate must be notified of the teratogenic risk of methotrexate and should be under effective contraception throughout the study and for at least 6 months following the last dose of investigational product.
- Women of childbearing potential who are negatively tested for pregnancy and agree to use a reliable method of birth control (every month) or remain abstinent during the study and for at least 6 months following the last dose of investigational product. Methods of contraception considered acceptable include oral contraceptives, contraceptive patch, intrauterine device, vaginal ring
- Patient registered to the French Social Security
Who cannot join
- Segmental or mixed vitiligo
- Patients who have known active liver disease (with the exception of a simple liver steatosis, transaminases and/or alkaline phosphatases > 2 ULM ) or history of liver disease in the past 2 years, whatever the related diagnosis but which could interfere with MTX safety and according to the summary of the SmPC.
- Intake of restricted medications (cf section VIII.5.) or other drugs considered likely to interfere with the safe conduct of the study, as assessed by the investigator and according to the Summary of the Product Characteristics (SmPC), including any drug intakes that could interfere with methotrexate metabolism or that could enhance liver and /or hematologic toxicity and according to the SmPC
- Patient with evidence or positive test for HIV, Hepatitis C virus, Hepatitis B virus (patients who are negative for hepatitis B surface antigen but positive for anti-hepatitis B anti body (HBsAb+ and HBcAb+) and negative for serum HBV DNA may participate in the study
- High alcohol intake defined as more than 60 g of daily intake (approx daily intake of 0.5 l of wine or equivalent),
- Patients who have a known allergy or hypersensitivity to MTX
Show all 25Show fewer
- Patients who have a known serious adverse event to MTX prior to the trial leading to MTX discontinuation in the past
- Presence of significant hematologic or renal disorder or abnormal laboratory values at screening that, in the opinion of the investigator is associated with an unacceptable risk to the patient to participate in the study
- Clinical laboratory test results at screening that are outside a normal reference rating for the population and are considered clinically significant, or/and have any of the following specific abnormalities:
- Total white blood cell count <3G/L
- Neutrophil count < 1.5 G/l
- Lymphocytes count < 0.5G/l
- Platelet count < 100 G/l
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)>3 times the upper limit of normal (ULM)
- Hemoglobin <8.5g/dL (85.0 g/L)
- Creatinine clearance <40ml/min (Cockcroft formula)
- For women: pregnant or breast feeding
- Patients who have an active or serious infection or history of infections (bacterial, viral, fungal or mycobacteria), requiring hospitalization or intra venous anti-infectives infusion within 4 weeks prior to the baseline,
- Patients who have primary or secondary active immunodeficiency
- Patients who had live vaccine administration within 4 weeks prior to baseline
- Patients who had already been treated by at least 250 sessions of phototherapy - Patients who have any current or active cancer (with the exception of patient with successfully treated with in situ cervix carcinoma)
- Patients who had history of malignancy within 5 years prior to the trial that could contraindicate the use of an immunosuppressant
- Patients who will not be available for protocol which require study visits or procedures
- Patients who is not affiliated to the French Social Security system
- Patients unable to give informed consent and/or comply with all required study procedures
Trial locations and contacts
4 sites in 1 country.
France4 sites
Service de Dermatologie - Hôpital Saint-André
Bordeaux, Bordeaux, 33075
Centre Hospitalier de Pau
Pau, 64000
Centre Hospitalier de Périgueux
Périgueux, 24000
Service de Dermatologie - CHU de Toulouse - Hopital Purpan
Toulouse, 31059 Toulouse Cedex
About this study
Official title: Efficacy and Tolerance of the Combination of Methotrexate and Phototherapy Versus Phototherapy in Adults With Progressive Vitiligo: a Randomized Double-blind Prospective Study
This is a phase 2, randomized, double blind, multicenter study evaluating the efficacy and safety of the combination of methotrexate plus UVB TL01 in vitiligo.
Read the detailed description
Treatment Strategy: Multicentric, parallel double blind randomized phase 2 prospective study comparing MTX taken orally once a week + narrowband UVB TL01 versus placebo + narrowband UVB TL01 Follow-up of the study: patients included in this study will start MTX 2 months before starting narrowband UVB TL01. Phototherapy will be performed twice a week during 6 months. Follow-up visit will be done at month 2, 4 and month 8. Phone calls to the patient will be done at month 6
- Conditions
- Vitiligo
- Being tested
- Methotrexate, Placebos
- Keywords
- vitiligo, pigmentation, phototherapy, methotrexate
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Also called narrow-band UVB phototherapy
oral capsules taken once a week
PlacebosDrug
Also called narrow-band UVB phototherapy
Administered identically to the experimental group
| Study group | Role | What they receive |
|---|---|---|
| methotrexate | Experimental | Methotrexate once a week orally for 8 months in conjunction with narrow band UVB phototherapy starting 2 months after Methotrexate therapy for 6 months. Receives: Drug: Methotrexate |
| placebo | Placebo comparator | Placebo once a week orally for 8 months in conjunction with narrow band UVB phototherapy starting 2 months afterplacebo therapy, for 6 months. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score with VASI formule
The VASI Score is used to assess the severity and extent of Vitilgo. VASI is calculated using a formula that includes contributions from all body regions (possible range, 0-100). The body is divided into 6 separate and mutually exclusive sites (head/neck, hands, upper extremities [excluding hands], trunk, lower extremities [excluding feet], and feet), with percentage of vitiligo involvement estimated in hand units by the same investigator throughout the study.
Measured: month 8
Secondary outcomes (14)
Score with VASI formule
Change in percentage of repigmented Surface area 4 months after-inclusion, by using the VASI score at M4.
The VASI Score is used to assess the severity and extent of Vitilgo. VASI is calculated using a formula that includes contributions from all body regions (possible range, 0-100). The body is divided into 6 separate and mutually exclusive sites (head/neck, hands, upper extremities [excluding hands], trunk, lower extremities [excluding feet], and feet), with percentage of vitiligo involvement estimated in hand units by the same investigator throughout the study.
Measured: month 4
Number of Adverse Events (AE) and serious adverse events (SAE), as well as the proportion of discontinuation due to AEs and/or SAEs
AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related, that occurs after a subject provides informed consent. Abnormal laboratory values or test results occurring after informed consent constitute AEs only if they induce clinical signs or symptoms, are considered clinically meaningful, require therapy, or require changes in the study drug.
Measured: Month 8
Evaluation of score Vitiligo European Task Force (VETF)
Variation of the score Vitiligo European Task Force (VETF) The VETF score is used to assess the severity and extent of vitiligo. The VETF assesses 3 dimensions of the disease in 5 areas (Head/neck, hands and feet, trunk, arms, legs) namely 1/ extent: percentage of vitiligo involvement estimated using the rule of nines, 2/ depigmentation severity grading (stage 0: normal pigmentation Stage 1: incomplete pigmentation , stage 2 complete depigmentation, stage 3: partial hair whitening <30% stage 4: complete hair whitening) and 3/ spreading (score O: similar limits, Score 1: progressive vitiligo; score -1: regressive vitiligo).
Measured: Month 4
Evaluation of score Vitiligo European Task Force (VETF)
Variation of the score Vitiligo European Task Force (VETF) The VETF score is used to assess the severity and extent of vitiligo. The VETF assesses 3 dimensions of the disease in 5 areas (Head/neck, hands and feet, trunk, arms, legs) namely 1/ extent: percentage of vitiligo involvement estimated using the rule of nines, 2/ depigmentation severity grading (stage 0: normal pigmentation Stage 1: incomplete pigmentation , stage 2 complete depigmentation, stage 3: partial hair whitening <30% stage 4: complete hair whitening) and 3/ spreading (score O: similar limits, Score 1: progressive vitiligo; score -1: regressive vitiligo).
Measured: Month 8
Evaluation of score of the Vitiligo Extent Score (VES)
Variation in percentage of the Vitiligo Extent Score (VES). The VES score is used to assess the severity and extent of vitiligo. Using the VES calculator www.vitiligo-calculator.com, investigator choose the pictures that best represent the patient's skin lesions and then the percentage of depigmented area is calculated.
Measured: Month 4
Evaluation of score of the Vitiligo Extent Score (VES)
Variation in percentage of the Vitiligo Extent Score (VES). The VES score is used to assess the severity and extent of vitiligo. Using the VES calculator www.vitiligo-calculator.com, investigator choose the pictures that best represent the patient's skin lesions and then the percentage of depigmented area is calculated.
Measured: Month 8
Evaluation of score of the Dermatology Life Quality Index (DLQI)
Variation of the score of the Dermatology Life Quality Index (DLQI). DLQI is a 10-item instrument, each item scored from 0 to 3 where higher scores correspond to worse symptom impact, full range from 0 to 30.
Measured: Month 4
Evaluation of score of the Dermatology Life Quality Index (DLQI)
Variation of the score of the Dermatology Life Quality Index (DLQI). DLQI is a 10-item instrument, each item scored from 0 to 3 where higher scores correspond to worse symptom impact, full range from 0 to 3.
Measured: Month 8
Evaluation of the score of the Skindex 29
Variation of the score of the Skindex 29. SkinDex29 is a 30-item instrument, each item scored from 1 to 5 where higher scores correspond to worse symptom impact, full range from 0 to 150.
Measured: Month 4
Evaluation of the score of the Skindex 29
Variation of the score of the Skindex 29. SkinDex29 is a 30-item instrument, each item scored from 1 to 5 where higher scores correspond to worse symptom impact, full range from 0 to 150.
Measured: Month 8
Evaluation of the score of the Vitiligo Impact Scale (VIP)
Variation of the score of the Vitiligo Impact Scale (VIP). Vitiligo Impact Scale is a 2-item instrument, each item scored from 0 to 5 where higher scores correspond to worse symptom impact, full range from 0 to 145
Measured: Month 4
Evaluation of the score of the Vitiligo Impact Scale (VIP)
Variation of the score of the Vitiligo Impact Scale (VIP). Vitiligo Impact Scale is a 2-item instrument, each item scored from 0 to 5 where higher scores correspond to worse symptom impact, full range from 0 to 145
Measured: Month 8
Evaluation of blood inflammatory markers using immunofluorescence on skin biopsies and ELISA multiplex.
Epression of MxA CD3, CD4, CD8, CXCR3, CCR6, CXCL9, 10, 11, CCL20 et HSP70
Measured: Day 1
Evaluation of skin inflammatory markers using immunofluorescence on skin biopsies and ELISA multiplex.
Expression of IFN-α, TNF-α, IFN-γ, IL-17, IL-22, CXCL4, CXCL9, CXCL10, CXCL11, CXCL12, CXCL16, CCL20, HSP70 soluble
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start23 May 2023
- Primary completion4 Nov 2025
- Study completion4 Nov 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 University Hospital, BordeauxThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Methotrexate taken orraly once a weekcombination with UVB TL01 in a population of adult patients with progressive vitiligo
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien SENESCHAL, MD, PhD, Principal investigator, University of Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237103
- Sponsor's protocol ID
- CHUBX 2017/44
- Other IDs
- 2018-004536-29, 2018
- Acronym
- METVI
- Status last verified
- Jan 2026
- First submitted
- 23 May 2019
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerance of the Combination of Methotrexate and Phototherapy Versus Phototherapy in Adults With Progressive Vitiligo: a Randomized Double-blind Prospective Study
- ClinicalTrials.gov ID
- NCT04237103
- Acronym / sponsor ID
- METVI / CHUBX 2017/44
- Conditions
- Vitiligo
- Keywords
- vitiligo, pigmentation, phototherapy, methotrexate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 23 May 2023 (actual)
- Primary completion
- 4 Nov 2025 (actual)
- Study completion
- 4 Nov 2025 (actual)
- First posted
- 23 Jan 2020 (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.
This is a phase 2, randomized, double blind, multicenter study evaluating the efficacy and safety of the combination of methotrexate plus UVB TL01 in vitiligo.
Detailed description
Treatment Strategy: Multicentric, parallel double blind randomized phase 2 prospective study comparing MTX taken orally once a week + narrowband UVB TL01 versus placebo + narrowband UVB TL01 Follow-up of the study: patients included in this study will start MTX 2 months before starting narrowband UVB TL01. Phototherapy will be performed twice a week during 6 months. Follow-up visit will be done at month 2, 4 and month 8. Phone calls to the patient will be done at month 6
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Methotrexate taken orraly once a weekcombination with UVB TL01 in a population of adult patients with progressive vitiligo
| Arm | Type | Receives |
|---|---|---|
| methotrexate | Experimental | Drug: MethotrexateMethotrexate once a week orally for 8 months in conjunction with narrow band UVB phototherapy starting 2 months after Methotrexate therapy for 6 months. |
| placebo | Placebo comparator | Drug: PlacebosPlacebo once a week orally for 8 months in conjunction with narrow band UVB phototherapy starting 2 months afterplacebo therapy, for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject male or female age over 18 years old
- Diagnosis of non-segmental (symmetrical) vitiligo with body surface area ≥10%
- Active non-segmental vitiligo 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.
- Signed informed consent document
- Male patients agreeing to use a reliable method of birth control during the study i. e. preservative and for at least 6 months following the last dose of investigational product, the patient's partner treated by methotrexate must be notified of the teratogenic risk of methotrexate and should be under effective contraception throughout the study and for at least 6 months following the last dose of investigational product.
Key exclusion criteria (25 listed)
- Segmental or mixed vitiligo
- Patients who have known active liver disease (with the exception of a simple liver steatosis, transaminases and/or alkaline phosphatases > 2 ULM ) or history of liver disease in the past 2 years, whatever the related diagnosis but which could interfere with MTX safety and according to the summary of the SmPC.
- Intake of restricted medications (cf section VIII.5.) or other drugs considered likely to interfere with the safe conduct of the study, as assessed by the investigator and according to the Summary of the Product Characteristics (SmPC), including any drug intakes that could interfere with methotrexate metabolism or that could enhance liver and /or hematologic toxicity and according to the SmPC
- Patient with evidence or positive test for HIV, Hepatitis C virus, Hepatitis B virus (patients who are negative for hepatitis B surface antigen but positive for anti-hepatitis B anti body (HBsAb+ and HBcAb+) and negative for serum HBV DNA may participate in the study
- High alcohol intake defined as more than 60 g of daily intake (approx daily intake of 0.5 l of wine or equivalent),
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 |
|---|---|---|
| MethotrexateAlso: narrow-band UVB phototherapyoral capsules taken once a week | Drug | methotrexate |
| PlacebosAlso: narrow-band UVB phototherapyAdministered identically to the experimental group | Drug | placebo |
Primary outcome
Score with VASI formule
Time frame: month 8
The VASI Score is used to assess the severity and extent of Vitilgo. VASI is calculated using a formula that includes contributions from all body regions (possible range, 0-100). The body is divided into 6 separate and mutually exclusive sites (head/neck, hands, upper extremities [excluding hands], trunk, lower extremities [excluding feet], and feet), with percentage of vitiligo involvement estimated in hand units by the same investigator throughout the study.
14 secondary outcomes
Score with VASI formule
Time frame: month 4
Number of Adverse Events (AE) and serious adverse events (SAE), as well as the proportion of discontinuation due to AEs and/or SAEs
Time frame: Month 8
Evaluation of score Vitiligo European Task Force (VETF)
Time frame: Month 4
Evaluation of score Vitiligo European Task Force (VETF)
Time frame: Month 8
Evaluation of score of the Vitiligo Extent Score (VES)
Time frame: Month 4
Evaluation of score of the Vitiligo Extent Score (VES)
Time frame: Month 8
Evaluation of score of the Dermatology Life Quality Index (DLQI)
Time frame: Month 4
Evaluation of score of the Dermatology Life Quality Index (DLQI)
Time frame: Month 8
Evaluation of the score of the Skindex 29
Time frame: Month 4
Evaluation of the score of the Skindex 29
Time frame: Month 8
Evaluation of the score of the Vitiligo Impact Scale (VIP)
Time frame: Month 4
Evaluation of the score of the Vitiligo Impact Scale (VIP)
Time frame: Month 8
Evaluation of blood inflammatory markers using immunofluorescence on skin biopsies and ELISA multiplex.
Time frame: Day 1
Evaluation of skin inflammatory markers using immunofluorescence on skin biopsies and ELISA multiplex.
Time frame: Day 1
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 22 May 2026.
- Individual participant dataSharing planned: Yes
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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 of Bordeaux
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methotrexate in people with Vitiligo, run by University Hospital, Bordeaux at 4 sites 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 7 inclusion and 25 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 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Score with VASI formule (time frame: month 8). 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 22 May 2026.