Efficacy and Tolerance of the Combination of Methotrexate and Phototherapy Versus Phototherapy in Adults With Progressive Vitiligo: a Randomized Doubleblind Prospective Study - METVI
This research trial, called METVI, is for adults in the UK who have vitiligo that is getting worse, meaning new white patches have appeared or existing ones have grown in the last six months. The study wants to find out if adding a medicine called methotrexate to standard light therapy (phototherapy) is more effective than light therapy alone. Researchers will look at how much the white patches improve over eight months using a special scoring system. They will also carefully check for any side effects and how the treatments affect people's quality of life. This is an early-stage study to understand if this new combination could be a good treatment option.
At a glance
What is this study about?
Vitiligo is a condition where patches of your skin lose their colour, appearing as white spots. This can happen when the cells that make skin pigment stop working properly. For some people, these white patches can grow or new ones can appear over time, which is called progressive vitiligo. Finding ways to stop this progression and help the skin regain its colour is an important area of research.
This study, named METVI, is looking at a new way to treat progressive vitiligo. Currently, light therapy (often called phototherapy) is a common treatment. This trial wants to see if adding an existing medicine called methotrexate to light therapy works better than using light therapy by itself. Methotrexate is a medicine already used for other conditions, but its use in combination with light therapy for vitiligo is being explored here.
The main goal of the study is to measure if the white patches on a person's skin shrink or become less noticeable after eight months of treatment. Researchers will also be checking very carefully for any side effects from either treatment. They will also be interested in how the treatments affect a person's daily life and overall well-being. This is a "Phase II" study, which means it's an early step to see if this new combination treatment is promising and safe enough for larger studies in the future.
Key takeaways
- Targets adults with vitiligo that's recently gotten worse.
- Compares light therapy alone vs. light therapy plus methotrexate.
- Aims to see if the combination reduces white patches more effectively.
- Includes regular health checks and monitoring for side effects.
- Participation will last for 8 months.
- Contributes to understanding a new vitiligo treatment.
Who may be eligible?
This study is for adults who are 18 years old or older. You could be considered if you have vitiligo that has been spreading or getting worse recently.
Specifically, your vitiligo must have shown new white patches, or existing patches must have grown, within the last six months. Both men and women are welcome to take part in this study.
The research team will carefully check to make sure the study is a good fit for you and that taking part would be safe.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Has your vitiligo been spreading or have new patches appeared in the last 6 months?
- Are you able to attend regular clinic appointments for 8 months?
- Are you comfortable potentially taking an additional medication or a dummy pill during the study?
- Are you willing to have regular blood tests?
What does participation involve?
If you join this study, you'll be randomly assigned to one of two groups. One group will receive light therapy plus a daily medicine called methotrexate, and the other group will receive light therapy plus a placebo (a dummy pill that looks like methotrexate). Both groups will also take folic acid, which helps reduce certain side effects of methotrexate.
Over the course of eight months, you'll have regular visits to the clinic. At these visits, doctors will assess your skin, take measurements of your vitiligo patches, and ask you about your well-being. You'll also have blood tests at various times to check how you're responding to the treatment and to monitor for any side effects. The total duration of active treatment and follow-up for this study is 8 months.
Potential risks and benefits
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Common questions
What is vitiligo?
Vitiligo is a skin condition where patches of your skin lose their colour, creating white spots. It happens when the cells that make pigment (melanin) stop working.
What is 'progressive' vitiligo?
Progressive vitiligo means your white patches have been growing, or new ones have appeared, within the last six months.
What is light therapy (phototherapy)?
Light therapy uses special lamps to shine ultraviolet (UV) light on your skin. It's a common treatment for vitiligo that can help stimulate pigment production.
What is methotrexate?
Methotrexate is a medicine that helps to calm down an overactive immune system. It's used for several conditions, and this study is exploring its potential for vitiligo.
How long will the study last if I take part?
If you join, the study will involve treatment and follow-up over an 8-month period.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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