Two studies, one medicine: what is the difference?

What they share: Both are Phase 3 studies of ruxolitinib cream for nonsegmental vitiligo. Both compare the medicine with a similar-looking cream without the active ingredient during the first part of treatment.

Could a child ages 6–11 fit either study? Possibly by age, but not by location. Families in the United States or Canada should review TRuE-ViP. Families in the countries listed below should review this international study. The research team makes the final eligibility decision.

Study at a glance

Ages: 6 to 11 years

Condition: Nonsegmental vitiligo

Study medicine: Ruxolitinib cream

Phase: Phase 3

Planned enrollment: About 250 children

Registry: NCT06804811 · EU CT 2024-513171-41-00 · Incyte study INCB18424-309

Where is the study running?

VRF currently lists 79 sites across 14 countries:

Argentina, Austria, Belgium, Bulgaria, Denmark, France, Germany, Hungary, Italy, the Netherlands, Poland, Portugal, Spain and the United Kingdom.

Not every listed site is necessarily accepting participants today. Recruitment changes as sites open, pause or fill their places. Check the current listing before planning a heroic international road trip.

Is there a study site near you?

Explore the country and site list, then contact the research team to ask whether screening may be appropriate.

Why is this study being conducted?

Ruxolitinib cream—sold as Opzelura—is already approved for nonsegmental vitiligo in people ages 12 and older in several countries. Approval and availability vary by country. This study asks whether the treatment is safe and effective for children ages 6 to 11.

Children can respond to medicines differently from adults and teenagers. Researchers need evidence collected specifically from younger children. The outcome is not known yet. Clinical trials exist because “we assume it works the same” is not a scientific method.

Who may qualify?

• Children ages 6 to 11 when consent is signed
• A clinical diagnosis of nonsegmental vitiligo
• Measurable vitiligo on the face and elsewhere on the body
• Vitiligo affecting no more than 10% of the body

Detailed criteria include minimum amounts of affected skin on the face and body, plus other health and treatment requirements. The study team will measure the affected areas during screening.

Current treatment matters

Participants must generally stop other treatments used for vitiligo from screening through the final safety follow-up. This may include prescription creams, oral medicines or phototherapy.

Do not stop treatment on your own. Ask the study team exactly what would need to pause and when. Then discuss the change with your child’s regular dermatologist.

What would participation involve?

Visits may include physical checks, skin measurements, photographs, blood tests and questions about symptoms or side effects. Ask how long visits take and what help is available for children who consider needles a personal insult.

How will researchers judge whether it works?

The main Week 24 measurement looks at how many children achieve at least a 75% improvement in facial vitiligo using a standard score called F-VASI.

Researchers will also study other levels of facial improvement, changes across the body, how noticeable the vitiligo appears, and safety. These are research targets—not promises about an individual child’s result.

What should families ask?

• Is this site recruiting children now?
• Which treatments would my child need to stop?
• What risks and side effects are known?
• How many visits are required, and how long do they take?
• Which costs and travel expenses are reimbursed?
• Who do we contact between visits?
• What happens if we decide to leave?

Participation remains your choice

Joining is voluntary. Choosing not to participate will not affect a child’s usual medical care. A parent or guardian may withdraw the child later, and the child may also be asked to give assent—an explanation they can understand and an invitation to agree.

Consent is an ongoing conversation, not a one-time signature followed by radio silence.

Could this international study fit your family?

Review the countries and current locations, then contact a participating study site for the complete eligibility check.

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