Can a common arthritis drug help stop vitiligo from spreading?
NCT ID NCT04237103
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tested whether adding methotrexate (a drug used for arthritis) to standard UVB light therapy works better than light therapy alone for adults with active, spreading vitiligo. Thirty-two participants were randomly assigned to receive either methotrexate pills plus light therapy or placebo pills plus light therapy for several months. The study measured changes in skin color using the VASI score to see if the combination slowed disease progression and improved repigmentation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- methotrexate (oral capsules once weekly) plus narrow-band UVB phototherapy
- What this could lead to
- If it works, this combination could offer a more effective way to stop vitiligo from spreading and help restore skin color.
- What could go wrong
- This is a small, early-phase trial with only 32 people, so results may not apply to everyone. Methotrexate can have side effects like nausea or liver issues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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32 people
The number who actually took part.
- Started
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May 2023
- Finished
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Nov 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Centre Hospitalier de Pau
Pau, 64000, France
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Centre Hospitalier de Périgueux
Périgueux, 24000, France
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Service de Dermatologie - CHU de Toulouse - Hopital Purpan
Toulouse, 31059 Toulouse Cedex, France
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Service de Dermatologie - Hôpital Saint-André
Bordeaux, Bordeaux, 33075, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Skin markers may reveal how light therapy fights vitiligo
- Can Real-World data unlock better skin disease care?
- New ointment aims to restore skin color in vitiligo
- Skin microbes linked to vitiligo and immunotherapy reactions in melanoma patients
- New vitiligo registry aims to uncover disease trends in 2,500 patients