Early access
Sign in
Taking people in United KingdomPhase 3

Ruxolitinib cream for children with nonsegmental vitiligo

Tests ruxolitinib cream against a plain cream in children with nonsegmental vitiligo.

Key facts

Who runs it
Incyte Corporation
Where
London, Sheffield, and Walsall, United KingdomSee the 5 sitesAlso in 13 other countries, 73 sites
Registry title
A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Children (6 to < 12 Years Old) With Nonsegmental Vitiligo
Status
Recruiting
Phase
Phase 3
People taking part
250 people, planned
Started
13 Nov 2025
Expected to end
1 Dec 2027
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Ruxolitinib Cream
  • Vehicle Cream
Record updated
9 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children aged 6 to under 12 years with nonsegmental vitiligo on the face and body. It tests ruxolitinib cream against a cream with no drug.

Age
6 to < 12 years
Sex
All sexes
Disease stage
Nonsegmental vitiligo with pale patches covering ≥ 0.5% BSA (body surface area) on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on other areas and ≥ 3 T-VASI. Total vitiligo area no more than 10% BSA. Some pale patches on the face must still have coloured hair.
Earlier treatment
Must stop all vitiligo treatments from screening to the last safety visit. Cannot join after prior or current depigmentation treatment (eg, monobenzone). Cannot join if a JAK inhibitor, taken by mouth or put on the skin, did not work before.

Main reasons for not taking part

  • Other forms of vitiligo (eg, segmental) or other skin conditions that cause pale skin
  • BMI-for-age < 5th percentile or ≥ 85th percentile
  • Pregnant or breastfeeding, or planning pregnancy during the trial
  • Serious illness or abnormal lab values set by the protocol
  • Allergy to any part of the study cream

The registry criteria, word for word

Show all 23 criteriaShow less

Who can take part

  • Aged 6 to < 12 years at the time of signing the ICF
  • Clinical diagnosis of nonsegmental vitiligo with depigmented area including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, ≥ 3 T-VASI
  • Total body vitiligo area does not exceed 10% BSA
  • Pigmented hair within some of the areas of vitiligo on the face
  • Must agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit
  • For sexually active participants (except participants who are prepubescent) willingness to avoid pregnancy or fathering a child as defined in the protocol

Who cannot take part

  • Prior or current use of depigmentation treatments (eg, monobenzone)
  • Concurrent conditions and history of protocol-defined diseases
  • Use of protocol-defined treatments within the indicated washout period before baseline
  • Other differential diagnosis of vitiligo or other skin depigmentation disorders (eg, piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor)
  • Any other skin disease that, in the opinion of the investigator, would interfere with the study drug application or study assessments
  • Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including application of study cream and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data
  • History of treatment failure with any systemic or topical JAK inhibitor for vitiligo or any other inflammatory condition
  • Known allergy or reaction to any component of the study cream formulation
  • Protocol-defined clinically significant abnormal laboratory values at screening
  • BMI-for-age < 5th percentile or ≥ 85th percentile according to the CDC BMI Percentile Calculator for Child and Teen
  • Diagnosis of other forms of vitiligo (eg, segmental)
  • Pregnant or lactating participants or those considering pregnancy during the period of their study participation
  • In the opinion of the investigator, unable or unlikely to comply with the application schedule and study evaluations
  • Living with anyone participating in any current Incyte-sponsored ruxolitinib cream study
  • Employees of the sponsor or investigator or are otherwise dependents of them
  • The following participants are excluded in France: vulnerable populations according to article L.1121-6 of the French Public Health Code and adults under legal protection, or who are unable to express their consent per article L.1121-8 of the French Public Health Code, not affiliated to a social security per article L.1121-8-1 of the French Public Health code
  • In the EU, participants considered incapacitated according to EU CTR No. 536/2014 Articles 2 and 31; Other protocol-defined Inclusion/Exclusion Criteria may apply

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 6 and 11 years old?

Where in United Kingdom

Also in 13 other countries, 73 sites

  • Great Ormond Street Hospital For Children NHS Foundation TrustLondon, United KingdomTaking people
  • Guys HospitalLondon, United KingdomTaking people
  • The Royal London Hospital - Barts Health Nhs TrustLondon, United KingdomTaking people
  • Sheffield Childrens HospitalSheffield, United KingdomTaking people
  • Manor Hospital (Walsall) - Walsall Healthcare Nhs TrustWalsall, United KingdomTaking people

About the trial

What the trial wants to find out

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in children (6 to < 12 years old) with nonsegmental vitiligo.

The 3 groups in the trial

  • Ruxolitinib 0.75 % CreamTreatment being tested

    Participants received ruxolitinib 0.75% cream, applied topically to the affected area as defined in the protocol.

    Treatment: Ruxolitinib Cream

  • Ruxolitinib 1.5 % CreamTreatment being tested

    Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol.

    Treatment: Ruxolitinib Cream

  • Vehicle CreamPlacebo, for comparison

    Participants received vehicle cream, applied topically to the affected area as defined by the protocol.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 3, Randomized, Double-Blind, Efficacy, and Safety Study of Ruxolitinib Cream in Children (6 to < 12 Years Old) With Nonsegmental Vitiligo
Plain-language title
Ruxolitinib cream for children with nonsegmental vitiligoGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT06804811, who can take part
Record updated
9 October 2026