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Ruxolitinib cream for children 6 to under 12 with nonsegmental vitiligo

A Phase 3, Randomized, Double-Blind, Efficacy, and Safety Study of Ruxolitinib Cream in Children (6 to < 12 Years Old) With Nonsegmental Vitiligo

PHASE3 · Incyte Corporation · NCT06804811

This will test whether ruxolitinib cream can safely produce skin repigmentation in children aged 6 to under 12 with nonsegmental vitiligo.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment250 (estimated)
Ages6 Years to 11 Years
SexAll
SponsorIncyte Corporation (industry)
Drugs / interventionsruxolitinib
Locations86 sites (Buenos Aires and 85 other locations)
Trial IDNCT06804811 on ClinicalTrials.gov

What this trial studies

This Phase 3 trial compares topical ruxolitinib cream to a matching vehicle cream in children aged 6 to under 12 with limited nonsegmental vitiligo. Eligible participants must have facial and nonfacial involvement meeting specific VASI and BSA thresholds and total body vitiligo area ≤10%. Participants agree to stop other vitiligo treatments and will be followed for safety and repigmentation outcomes using standardized scoring. The study is being conducted at multiple clinical sites in Buenos Aires, Argentina.

Who should consider this trial

Good fit: Children aged 6 to under 12 with nonsegmental vitiligo affecting ≤10% total body surface area, including at least 0.5% BSA on the face and meeting the study's VASI criteria, who can stop other vitiligo treatments and attend clinic visits.

Not a fit: Patients with segmental vitiligo, other depigmentation disorders, more extensive disease (>10% BSA), or those unable to discontinue other vitiligo treatments are unlikely to qualify or benefit from this study.

Why it matters

Potential benefit: If successful, it could offer a safe, effective topical option to restore pigment in young children with nonsegmental vitiligo.

How similar studies have performed: Topical ruxolitinib and other JAK inhibitors have shown repigmentation benefit in older adolescents and adults in prior trials, supporting testing in younger children.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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.

Exclusion Criteria:

* Diagnosis of other forms of vitiligo (eg, segmental).
* 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.
* Prior or current use of depigmentation treatments (eg, monobenzone).
* Concurrent conditions and history of protocol-defined diseases
* 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.
* Use of protocol-defined treatments within the indicated washout period before baseline.
* History of treatment failure with any systemic or topical JAK inhibitor for vitiligo or any other inflammatory condition.
* 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.
* 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.
* Known allergy or reaction to any component of the study cream formulation.
* 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.

Where this trial is running

Buenos Aires and 85 other locations

+36 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: NonSegmental Vitiligo, pediatric

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.