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RecruitingPHASE3INTERVENTIONAL

A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Children (6 to < 12 Years Old) With Nonsegmental Vitiligo

This research study is testing a cream called ruxolitinib on children between 6 and 11 years old who have nonsegmental vitiligo. Vitiligo causes white patches on the skin. The study aims to find out if this cream can help bring back colour to these patches and if it is safe for children to use. Participants will use either the ruxolitinib cream or a cream without the active medicine (a 'vehicle cream') to see which is more effective. This is a common way to compare new treatments. The study will carefully check how children respond to the cream and if they experience any side effects.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Incyte Corporation
Enrolment target
250
Start
13 Nov 2025
Estimated completion
01 Dec 2027

What is this study about?

Vitiligo is a skin condition where patches of skin lose their colour, creating white areas. In this study, doctors are focusing on a type called nonsegmental vitiligo in children aged 6 to 11. They want to see if a cream called ruxolitinib can help bring back the natural skin colour to these white patches.

The research involves comparing ruxolitinib cream with a 'vehicle cream'. This vehicle cream looks just like the ruxolitinib cream but doesn't contain the active ingredient. This comparison helps the researchers understand if any improvements are genuinely due to the study cream or if they might happen anyway.

The main goal is to check how well the ruxolitinib cream works (its 'efficacy') and if it's safe for children to use. Doctors and medical staff will regularly check on the children taking part to monitor their skin, record any changes, and make sure they are feeling well throughout the study.

Key takeaways

  • This study tests a new cream (ruxolitinib) for children with vitiligo.
  • It's for children aged 6 to 11 with nonsegmental vitiligo.
  • The study compares ruxolitinib cream with a plain 'dummy' cream.
  • It aims to check how well the cream works and if it's safe.
  • Participation involves regular clinic visits and stopping other vitiligo treatments.

Who may be eligible?

To join this study, children need to be between 6 and 11 years old and have a specific type of vitiligo called nonsegmental vitiligo. They need to have a certain amount of white patches on their face and body, but not too much overall. There also needs to be some coloured hair within the white patches on their face.

There are also some reasons why a child might not be able to join. For example, if they have other types of vitiligo or other skin conditions that could look similar. Children who have recently used other vitiligo treatments, or who have certain other health issues or serious illnesses, might not be suitable. Also, if a child's weight is very low or very high for their age, they would not be able to participate. It's important that any child joining the study can follow the study instructions and attend all appointments.

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.

  1. Is your child aged between 6 and 11 years old?
  2. Does your child have nonsegmental vitiligo?
  3. Does your child have some white patches on their face and body (but not too much overall)?
  4. Are there some coloured hairs within the white patches on their face?
  5. Could your child attend all scheduled study appointments?
Answer every question to see your result.

What does participation involve?

If your child takes part, they will receive either the ruxolitinib cream or a cream without the active medicine (the 'vehicle cream') to apply to their skin. The study will involve regular visits to the clinic where doctors and nurses will check your child's skin, look for changes in the white patches, and ask about how they are feeling. They will also carry out assessments to monitor your child's general health.

During the study, your child will need to stop using any other treatments for vitiligo. You will be given clear instructions on how and when to apply the cream. There will also be a follow-up period after your child finishes using the cream to make sure they are still well. The total length of time your child will be involved in the study, including all visits and the follow-up, will be explained in full detail by the study team.

Potential risks and benefits

Participating in this study might offer your child the chance to try a new cream that could help improve their vitiligo. You would also be contributing important information that could help other children with vitiligo in the future. However, there's no guarantee that the cream will work for your child, and there's a chance they might receive the cream without the active medicine. As with any medicine, there could be some side effects or risks, which the study team will explain to you in detail. You are always free to withdraw your child from the study at any time, for any reason, without it affecting their usual medical care.

Locations (86)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Psoriahue
    Verified postcode
    Buenos Aires, Argentina· Not yet recruiting
  • Hospital Italiano de Buenos Aires
    Verified postcode
    Buenos Aires, Argentina· Not yet recruiting
  • Instituto de Neumonologia Y Dermatologia
    Verified postcode
    Buenos Aires, Argentina· Not yet recruiting
  • Consultorios Medicos Dr. Doreski
    Verified postcode
    Buenos Aires, Argentina· Not yet recruiting
  • Derma Internacional S.A.
    Verified postcode
    Buenos Aires, Argentina· Not yet recruiting
  • Centro de Investigaciones Medicas Mar Del Plata
    Verified postcode
    Mar del Plata, Argentina· Not yet recruiting
  • Hospital Universitario Austral
    Verified postcode
    Pilar, Argentina· Not yet recruiting
  • Hospital Del Nino Jesus
    Verified postcode
    San Miguel de Tucumán, Argentina· Not yet recruiting
  • Universitaetsklinikum Graz
    Verified postcode
    Graz, Austria· Recruiting
  • Medical University Innsbruck
    Verified postcode
    Innsbruck, Austria· Not yet recruiting
  • Hopital Universitaire de Bruxelles (Academisch Ziekenhuis Brussel)
    Verified postcode
    Brussels, Belgium· Recruiting
  • Universitair Ziekenhuis Gent
    Verified postcode
    Ghent, Belgium· Recruiting

Common questions

What is nonsegmental vitiligo?

It's a common type of vitiligo where white patches can appear on both sides of the body and often spread over time.

What is ruxolitinib cream?

It's a skin cream being tested to see if it can help bring back colour to vitiligo patches.

Will my child definitely get the new cream?

No, your child might get the active cream or a cream that looks the same but doesn't contain the medicine, so it's a 50/50 chance.

Can my child use other vitiligo treatments during the study?

No, if your child joins the study, they will need to stop all other vitiligo treatments.

How long will my child be in the study?

The study team will explain the exact duration, which includes regular visits and a follow-up period after treatment ends.

How to find out more

Incyte Corporation Call Center (US)

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Study to Evaluate the Efficacy and Safety of Ruxolitinib C…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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