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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-11
SponsorIncyte Corporation

About this trial

The purpose of this study is to to evaluate the safety and efficacy of ruxolitinib cream in pediatric participants with nonsegmental vitiligo.

Eligibility criteria

Qualifiers

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.

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

180 Participants
are divided into 2 treatment groups

Sponsors and collaborators