A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Children (6 to < 12 Years Old) With Nonsegmental Vitiligo
NCT ID: NCT06804811
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
250 participants
INTERVENTIONAL
2025-11-13
2027-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ruxolitinib 0.75 % Cream
Participants received ruxolitinib 0.75% cream, applied topically to the affected area as defined in the protocol.
Ruxolitinib Cream
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
Ruxolitinib 1.5 % Cream
Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol.
Ruxolitinib Cream
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
Vehicle Cream
Participants received vehicle cream, applied topically to the affected area as defined by the protocol.
Vehicle Cream
Matching vehicle cream applied topically to the affected area as a thin film twice daily.
Interventions
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Ruxolitinib Cream
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
Vehicle Cream
Matching vehicle cream applied topically to the affected area as a thin film twice daily.
Other Intervention Names
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Eligibility Criteria
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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 as defined in the protocol.
Exclusion Criteria
* 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.
6 Years
11 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Incyte Medical Monitor
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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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
Centro de Investigaciones Medicas Mar Del Plata
Mar del Plata, , Argentina
Hospital Universitario Austral
Pilar, , Argentina
Hospital Del Nino Jesus
San Miguel de Tucumán, , Argentina
Universitaetsklinikum Graz
Graz, , Austria
Medical University Innsbruck
Innsbruck, , Austria
Hopital Universitaire de Bruxelles (Academisch Ziekenhuis Brussel)
Brussels, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Universitair Ziekenhuis Leuven
Leuven, , Belgium
Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, , Belgium
Medical Center Asklepii Ood
Dupnitsa, , Bulgaria
Mhat Dr. Tota Venkova Ad
Gabrovo, , Bulgaria
Medical Center Medkonsult Pleven Ood
Pleven, , Bulgaria
Medical Center Unimed Eood
Sevlievo, , Bulgaria
Umhat Aleksandrovska
Sofia, , Bulgaria
28 Diagnostic and Consultative Center
Sofia, , Bulgaria
Mc Euroderma Clinic
Sofia, , Bulgaria
Diagnostic Consultation Center Xx - Sofia Eood
Sofia, , Bulgaria
Sanos Clinic
Gandrup, , Denmark
Herlev and Gentofte Hospital
Hellerup, , Denmark
Centre Hospitalier Victor Dupouy
Argenteuil, , France
Centre Hospitalier Universitaire (Chu) de Bordeaux - Groupe Hospitalier Pellegrin
Bordeaux, , France
Centre Hospitalier Intercommunal de Creteil
Créteil, , France
Hospices Civils de Lyon (Hcl) - Hopital Edouard Herriot (Heh)
Lyon, , France
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hopital Hotel Dieu
Nantes, , France
Centre Hospitalier Universitaire de Nice,Hopital L Archet
Nice, , France
Hopital Universitaire Necker Enfants Malades
Paris, , France
Polyclinique de Courlancy
Reims, , France
Centre Hospitalier Universitaire (Chu) de Toulouse - Hopital Larrey
Toulouse, , France
Chu Nancy
Vandœuvre-lès-Nancy, , France
Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (Ccm)
Berlin, , Germany
Universitaetsklinikum Der Ruhr Universitaet Bochum (Ukrub), St. Josef Hospital
Bochum, , Germany
Drk Krankenhaus Chemnitz-Rabenstein
Chemnitz, , Germany
Hautklinik Universitatsklinikum Erlangen
Erlangen, , Germany
Universitaetsklinik Frankfurt
Frankfurt, , Germany
Katholisches Kinderkrankenhaus Wilhelmstift
Hamburg, , Germany
University Medical Center Schleswig-Holstein
Kiel, , Germany
Universitaetsklinikum Leipzig
Leipzig, , Germany
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
Mainz, , Germany
Klinikum Rechts Der Isar Der Technischen Universitaet Muenchen (Hopital Rechts Der Isar)
München, , Germany
University Hospital Muenster
Münster, , Germany
Clinexpert
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika
Debrecen, , Hungary
University of Pecs-Clinical Center
Pécs, , Hungary
University of Szeged
Szeged, , Hungary
A.O. Policlinico Sant'Orsola Malpighi-Universita Degli Studi Di Bologna
Bologna, , Italy
Azienda Ospedaliera Spedali Civili Di Brescia-Universita Degli Studi Di Brescia
Brescia, , Italy
Azienda Ospedaliero-Universitaria Policlinico Vittorio Emanuele Ospedale Gaspare Rodolico Di Catania
Catania, , Italy
Uoc Dermatologia Ospedale Maggiore Policlinico, Fondazione Irccs Ca' Granda
Milan, , Italy
Universita Degli Studi Di Napoli Federico Ii
Napoli, , Italy
Azienda Ospedale Universita Di Padova
Padua, , Italy
Fondazione Ptv Policlinico Tor Vergata
Roma, , Italy
Istituto Di Ricovero E Cura A Carattere Scientifico (Ircss)
Roma, , Italy
Irccs Ospedale Pediatrico Bambino Gesu
Rome, , Italy
Fondazione Policlinico Universitario Agostino Gemelli Irccs
Rome, , Italy
Amsterdam Umc Research Bv
Amsterdam, , Netherlands
Centrum Badan Klinicznych Pi-House Sp. Z O.O.
Gdansk, , Poland
Care Clinic Sp. Z O.O.
Katowice, , Poland
Diamond Clinic Specjalistyczne Poradnie Lekarskie
Krakow, , Poland
Dermedic Iwona Zdybska
Lublin, , Poland
Twoja Przychodnia - Medyczne Nowa Sol
Nowa Sól, , Poland
Dermodent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski
Osielsko, , Poland
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski, , Poland
Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
Rzeszów, , Poland
Twoja Przychodnia Scm
Szczecin, , Poland
Evimed Sp. Z O. O.
Warsaw, , Poland
Centro Hospitalar E Universitario Coimbra
Coimbra, , Portugal
Centro Hospitalar de Lisboa Central - Hospital Santo Antonio Dos Capuchos
Lisbon, , Portugal
Hospital Geral de Santo Antonio
Porto, , Portugal
Hospital Universitario Fundacion Alcorcon
Alcorcón, , Spain
Hospital Universitari Germans Trias I Pujol
Badalona, , Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, , Spain
Hospital Sant Joan de Deu Barcelona
Esplugues de Llobregat, , Spain
Hospital Infantil Unversitario Nino Jesus
Madrid, , Spain
Hospital Universitario Miguel Servet de Zaragoza
Zaragoza, , Spain
Croydon University Hospital
Croydon, , United Kingdom
The Royal London Hospital - Barts Health Nhs Trust
London, , United Kingdom
Guys Hospital
London, , United Kingdom
Great Ormond Street Hospital For Children Nhs Foundation Trust
London, , United Kingdom
Queen'S Medical Centre - Nottingham University Hospitals Nhs Trust
Nottingham, , United Kingdom
Sheffield Childrens Hospital
Sheffield, , United Kingdom
Manor Hospital (Walsall) - Walsall Healthcare Nhs Trust
Walsall, , United Kingdom
Countries
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Central Contacts
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Related Links
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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
Other Identifiers
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INCB18424-309
Identifier Type: -
Identifier Source: org_study_id
2024-513171-41-00
Identifier Type: REGISTRY
Identifier Source: secondary_id