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

RecruitingPhase 3Ages 6 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 evaluate the efficacy and safety of ruxolitinib cream in children (6 to \< 12 years old) with nonsegmental vitiligo.

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

📋 Eligibility rules (as published)
Inclusion Criteria: * 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. * 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 as defined in the protocol. 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). * Concurrent conditions and history of protocol-defined diseases * 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 for vitiligo or any other inflammatory condition. * Protocol-defined clinically significant abnormal laboratory values at screening. * BMI-for-age \< 5th percentile or ≥ 85th percentile according to the CDC BMI Percentile Calculator for Child and Teen. * 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. * The following participants are excluded in France: vulnerable populations according to article L.1121-6 of the French Public Health Code and adults under legal protection, or who are unable to express their consent per article L.1121-8 of the French Public Health Code, not affiliated to a social security per article L.1121-8-1 of the French Public Health code. * In the EU, participants considered incapacitated according to EU CTR No. 536/2014 Articles 2 and 31. Other protocol-defined Inclusion/Exclusion Criteria may apply.
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What it tests

  • Ruxolitinib Cream
  • Vehicle Cream
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Where

78 sites
Psoriahue
Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Instituto de Neumonologia Y Dermatologia
Buenos Aires, Argentina
Consultorios Medicos Dr. Doreski
Buenos Aires, Argentina
Derma Internacional S.A.
Buenos Aires, Argentina
Hospital Universitario Austral
Derqui-pilar, Argentina
Centro de Investigaciones Medicas Mar Del Plata
Mar del Plata, Argentina
Hospital Del Nino Jesus
San Miguel de Tucumán, Argentina

…and 70 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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