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

RecruitingPhase 3Ages 2 Years - 11 YearsAllIncyte Corporation
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Clinical diagnosis of nonsegmental vitiligo with depigmented area including โ‰ฅ 0.5% BSA on the face, โ‰ฅ 0.5 F-VASI, โ‰ฅ 2% BSA on nonfacial areas, โ‰ฅ 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. * 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 protocol-defined treatments within the indicated washout period before baseline. * History of treatment failure with any systemic or topical JAK inhibitor (eg, ruxolitinib, tofacitinib, baricitinib, abrocitinib, and upadacitinib) for vitiligo or any other inflammatory condition. * Protocol-defined clinically significant abnormal laboratory values at screening. * Pregnant or lactating participants or those considering pregnancy during the period of their study participation. * In the opinion of the investigator, unable or unlikely to comply with the application schedule and study evaluations. * Living with anyone participating in any current Incyte-sponsored ruxolitinib cream study. * 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.
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What it tests

  • Ruxolitinib Cream
  • Vehicle Cream
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Where

98 sites
University of Alabama At Birmingham-School of Medicine
Birmingham, United States
Saguaro Dermatology
Phoenix, United States
Phoenix Children'S Hospital
Phoenix, United States
Omni Dermatology
Phoenix, United States
Affiliated Dermatology
Scottsdale, United States
Banner - University Medicine Multispecialty Services Clinic
Tucson, United States
Premier Dermatology Clinical Trials Institute At Northwest Arkansas
Fayetteville, United States
Burke Pharmaceutical Research
Hot Springs, United States

โ€ฆand 90 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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