The purpose of this study is to to evaluate the safety and efficacy of ruxolitinib cream in pediatric participants with nonsegmental vitiligo.
Clinical diagnosis of nonsegmental vitiligo with depigmented area including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 2% BSA on nonfacial areas, ≥ 2 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.
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).
Parallel
Ruxolitinib Cream
DrugRuxolitinib cream applied topically to the affected area as a thin film twice daily.
Vehicle Cream
DrugMatching vehicle cream applied topically to the affected area as a thin film twice daily.
Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75)
≥75% improvement in facial Vitiligo Area Scoring Index.
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50)
≥50% improvement in facial Vitiligo Area Scoring Index.
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90)
≥90% improvement in facial Vitiligo Area Scoring Index.
Proportion of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50)
≥50% improvement in total body Vitiligo Area Scoring Index.
Percentage change from baseline in F-BSA
Facial body surface area (F-BSA) takes into account the facial depigmented areas as a percentage of the total body area.
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