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Study of ruxolitinib cream for children aged 6 to 12 years with non-segmental vitiligo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on children aged 6 to 12 years with nonsegmental vitiligo, a condition where patches of skin lose their color. The study will test a medication called ruxolitinib cream (also known as Opzelura) compared to a placebo cream. Vitiligo occurs when the body's immune system attacks and destroys the cells that produce skin color, leading to white patches on the skin.

The purpose of this research is to evaluate how well ruxolitinib cream works in treating children with nonsegmental vitiligo. During the study, participants will apply either ruxolitinib cream or placebo cream to their skin. The treatment will continue for up to 52 weeks, which is approximately one year. The maximum daily amount of cream that can be used is 8.5 grams.

The study will measure how well the treatment works by looking at improvements in the affected skin areas, particularly on the face. The cream is designed for cutaneous use, which means it is applied directly to the skin. Throughout the study, doctors will monitor the participants' health and any changes in their vitiligo patches to ensure the treatment is safe and effective.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment period

    You will be randomly assigned to receive either ruxolitinib cream or a placebo cream for skin application

    The treatment period will last for 24 weeks

    You will need to apply the cream directly to the affected skin areas

    Regular monitoring of your skin condition will occur during this period

  2. Step 2

    Skin assessment at week 24

    Your skin will be evaluated to measure the improvement in the light patches (vitiligo areas)

    The medical team will assess the changes in affected areas on your face and body

    You will be asked about how noticeable your skin patches are

    Your satisfaction with the treatment will be evaluated

  3. Step 3

    Extended treatment period

    The treatment continues until week 52

    Regular monitoring of your skin condition will continue

    Blood samples will be collected at weeks 4, 24, 40, and 52 to measure medicine levels

    Your height and weight will be monitored throughout the study

  4. Step 4

    Final assessment at week 52

    Final evaluation of your skin condition will be performed

    The medical team will assess the overall treatment results

    Your satisfaction with the treatment will be evaluated again

    Final safety assessments will be conducted

  5. Step 5

    Safety monitoring

    Throughout the study, your health will be monitored through regular check-ups

    Any changes in your condition will be recorded

    Laboratory tests will be performed to ensure your safety

    You must report any unusual symptoms or side effects to the medical team

Who can join the trial?

9 criteria

  • Must be between 6 and 11 years old at the time of joining the study
  • Must have a diagnosis of nonsegmental vitiligo with:
    • At least 0.5% of face area affected
    • At least 3% of body areas other than face affected
    • Total affected area must not exceed 10% of body surface
    • Must have some pigmented hair (hair with natural color) within the vitiligo areas on the face
    • Must be willing and able to understand and sign an informed consent form. Parents or legal guardians must provide written consent
    • Must stop using all vitiligo treatments during the study (except approved cosmetic products and camouflage makeup)
    • For children who have reached puberty:
      • Girls who have started menstruation must have negative pregnancy tests and avoid pregnancy during the study and for 30 days after
      • Boys must agree to avoid fathering children during the study and for 90 days after

Who cannot join the trial?

13 criteria

  • History of severe allergic reactions or skin conditions other than vitiligo
  • Current participation in other clinical trials or use of investigational drugs within 30 days
  • Presence of skin infections or open wounds in areas affected by vitiligo
  • Use of any treatments for vitiligo (including light therapy, creams, or oral medications) within the past 4 weeks
  • History of skin cancer or suspicious skin lesions
  • Significant medical conditions that could interfere with the study treatment
  • Pregnancy, breastfeeding, or planning to become pregnant during the study period
  • Known allergies to the study medication (ruxolitinib cream) or its components
  • History of immune system disorders (conditions affecting body's defense system)
  • Inability to follow study procedures or attend scheduled visits
  • Previous treatment with JAK inhibitors (a type of medication that affects immune system response)
  • Active or chronic infections that require treatment
  • Severe sun sensitivity or extensive sun exposure
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Investigated drugs

Ruxolitinib cream is a topical medication applied to the skin that helps treat vitiligo, a condition where patches of skin lose their color. This cream works by targeting specific proteins in the immune system that are involved in causing vitiligo. It helps to reduce inflammation and may help restore skin pigmentation in the affected areas. The medication is being studied specifically for children between 6 and 12 years old who have nonsegmental vitiligo, which is the most common form of vitiligo affecting both sides of the body in a somewhat symmetric pattern.

What is already known about the treatment

Ruxolitinib cream - A topical medication applied directly to the skin for treating nonsegmental vitiligo, particularly in pediatric patients aged 6 to 12 years old. This JAK inhibitor works by blocking specific cellular pathways that cause inflammation and autoimmune responses responsible for the loss of skin pigmentation in vitiligo. The cream formulation represents a targeted approach to treating vitiligo patches, with the medication being absorbed through the skin to affect only the areas where it's needed, which helps minimize systemic side effects. Currently, it is being evaluated in Phase 3 clinical trials as one of the promising treatments for repigmentation in vitiligo patients, offering a potential breakthrough in managing this challenging autoimmune skin condition.

Investigated diseases

Vitiligo - A skin condition that causes the loss of skin color in patches due to the destruction of pigment-producing cells called melanocytes. The depigmented patches typically appear on various parts of the body, most commonly on the face, hands, arms, and other areas exposed to sunlight. The condition usually develops gradually, with patches slowly enlarging over time. The white or light patches are more noticeable in people with darker skin tones. Vitiligo can affect people of any age, gender, or ethnic background. The patches may be accompanied by premature whitening or graying of the hair in affected areas.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2024-513171-41-00Protocol codeINCB 18424-309Estimated enrolment250 patientsSponsorIncyte Corp.

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