A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo

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 throughthe 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 daysafter 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, progressivemacule hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor).

• Any other skin disease that, in the opinion of the investigator, would interferewith 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 theinvestigator's opinion, would interfere with full participation in the study,including application of study cream and attending required study visits; pose asignificant risk to the participant; or interfere with interpretation of study data.

• Use of protocol-defined treatments within the indicated washout period beforebaseline.

• 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 BMIPercentile Calculator for Child and Teen.

• Pregnant or lactating participants or those considering pregnancy during the periodof their study participation.

• In the opinion of the investigator, unable or unlikely to comply with theapplication schedule and study evaluations.

• Living with anyone participating in any current Incyte-sponsored ruxolitinib creamstudy.

• 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.