A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Pediatric Participants With N… (NCT06548360) | Clinical Trial Compass
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo
United States180 participantsStarted 2025-01-24
Plain-language summary
The purpose of this study is to to evaluate the safety and efficacy of ruxolitinib cream in pediatric participants with nonsegmental vitiligo.
Who can participate
Age range2 Years – 11 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 pr…
What they're measuring
1
Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75)