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Evaluating Ruxolitinib Cream for Children with Nonsegmental Vitiligo

A Phase 3, Randomized, Double-Blind, Safety, and Efficacy Study of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo

Phase 3 Interventional Incyte Corporation · NCT06548360

This study is testing if ruxolitinib cream can help children with nonsegmental vitiligo regain skin color better than a regular cream.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment180 (estimated)
Ages2 Years to 11 Years
SexAll
SponsorIncyte Corporation Industry-sponsored
Drugs / interventionsruxolitinib
Locations99 sites (Birmingham, Alabama and 98 other locations)
Trial IDNCT06548360 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of ruxolitinib cream in pediatric patients diagnosed with nonsegmental vitiligo. Participants must have specific criteria regarding the extent of their vitiligo and agree to discontinue other treatments during the study. The trial involves applying ruxolitinib cream compared to a vehicle cream to assess its effectiveness in repigmenting the skin. The study aims to provide insights into a potential new treatment option for this skin condition in children.

Who should consider this trial

Good fit: Ideal candidates are pediatric patients with a clinical diagnosis of nonsegmental vitiligo and specific criteria regarding the extent of their condition.

Not a fit: Patients with other forms of vitiligo or skin depigmentation disorders will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve skin pigmentation and quality of life for children suffering from nonsegmental vitiligo.

How similar studies have performed: Other studies have shown promise in using topical treatments for vitiligo, but this specific approach with ruxolitinib cream is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 from screening through 30 days after the last application of study cream.

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).
* 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.
* Current or previous use of JAK inhibitors, systemic or topical.
* 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.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Where this trial is running

Birmingham, Alabama and 98 other locations

+49 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 → Find more trials like this →
Conditions NonSegmental Vitiligopediatric
Last reviewed 2026-06-13 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.