A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Children (6 to < 12 Years Old) With Nonsegmental Vitiligo

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-11
SponsorIncyte Corporation

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Ruxolitinib Cream
  • Vehicle Cream

Treatment groups

250 Participants
are divided into 3 treatment groups

Sponsors and collaborators