Actively Recruiting
A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Children (6 to < 12 Years Old) With Nonsegmental Vitiligo
Led by Incyte Corporation · Updated on 2025-12-17
250
Participants Needed
86
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Children (6 to < 12 Years Old) With Nonsegmental Vitiligo
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 6 to < 12 years at the time of signing the informed consent form
- Clinical diagnosis of nonsegmental vitiligo with depigmented area including ≥ 0.5% body surface area (BSA) on the face, ≥ 0.5 Facial Vitiligo Area Scoring Index (F-VASI), ≥ 3% BSA on nonfacial areas, and ≥ 3 Total Vitiligo Area Scoring Index (T-VASI)
- Total body vitiligo area does not exceed 10% BSA
- Presence of pigmented hair within some of the areas of vitiligo on the face
- Agreement to stop all vitiligo treatments from screening through the final safety follow-up visit
- For sexually active participants (except prepubescent), willingness to avoid pregnancy or fathering a child as defined in the protocol
You will not qualify if you...
- Diagnosis of segmental or other forms of vitiligo
- Other skin depigmentation disorders such as piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, or tinea versicolor
- Any other skin disease that may interfere with study drug application or assessments
- Prior or current use of depigmentation treatments like monobenzone
- Concurrent conditions or history of diseases defined by the protocol
- Serious illness or medical, physical, or psychiatric conditions that may affect participation or study data interpretation
- Use of protocol-defined treatments within specified washout periods before baseline
- History of treatment failure with any systemic or topical Janus kinase (JAK) inhibitor for vitiligo or other inflammatory conditions
- Clinically significant abnormal laboratory values at screening
- Body mass index (BMI) below 5th percentile or above or equal to 85th percentile for age
- Pregnant or breastfeeding participants or those considering pregnancy during the study
- Inability or unlikely to comply with application schedule and study evaluations
- Living with anyone participating in any current Incyte-sponsored ruxolitinib cream study
- Employees or dependents of the sponsor or investigator
- Known allergy or reaction to any component of the study cream
- In France, vulnerable populations and adults under legal protection or unable to consent as defined by French Public Health Code
- In the EU, participants considered incapacitated under EU Clinical Trial Regulation
- Other protocol-defined inclusion/exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 86 locations
1
Psoriahue
Buenos Aires, Argentina, 01425
Not Yet Recruiting
2
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina, C1181ACH
Not Yet Recruiting
3
Instituto de Neumonologia Y Dermatologia
Buenos Aires, Argentina, C1425BEA
Not Yet Recruiting
4
Consultorios Medicos Dr. Doreski
Buenos Aires, Argentina, C1426
Not Yet Recruiting
5
Derma Internacional S.A.
Buenos Aires, Argentina, C1426
Not Yet Recruiting
6
Centro de Investigaciones Medicas Mar Del Plata
Mar del Plata, Argentina, B7600FYK
Not Yet Recruiting
7
Hospital Universitario Austral
Pilar, Argentina, B16290DT
Not Yet Recruiting
8
Hospital Del Nino Jesus
San Miguel de Tucumán, Argentina, 04000
Not Yet Recruiting
9
Universitaetsklinikum Graz
Graz, Austria, 08036
Actively Recruiting
10
Medical University Innsbruck
Innsbruck, Austria, 06020
Not Yet Recruiting
11
Hopital Universitaire de Bruxelles (Academisch Ziekenhuis Brussel)
Brussels, Belgium, 01070
Actively Recruiting
12
Universitair Ziekenhuis Gent
Ghent, Belgium, 09000
Actively Recruiting
13
Universitair Ziekenhuis Leuven
Leuven, Belgium, 03000
Actively Recruiting
14
Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium, 01200
Not Yet Recruiting
15
Medical Center Asklepii Ood
Dupnitsa, Bulgaria, 02600
Actively Recruiting
16
Mhat Dr. Tota Venkova Ad
Gabrovo, Bulgaria, 05300
Actively Recruiting
17
Medical Center Medkonsult Pleven Ood
Pleven, Bulgaria, 05800
Not Yet Recruiting
18
Medical Center Unimed Eood
Sevlievo, Bulgaria, 05400
Actively Recruiting
19
Umhat Aleksandrovska
Sofia, Bulgaria, 01431
Not Yet Recruiting
20
28 Diagnostic and Consultative Center
Sofia, Bulgaria, 01528
Actively Recruiting
21
Mc Euroderma Clinic
Sofia, Bulgaria, 01606
Actively Recruiting
22
Diagnostic Consultation Center Xx - Sofia Eood
Sofia, Bulgaria, 01618
Actively Recruiting
23
Sanos Clinic
Gandrup, Denmark, 09362
Not Yet Recruiting
24
Herlev and Gentofte Hospital
Hellerup, Denmark, 02900
Actively Recruiting
25
Centre Hospitalier Victor Dupouy
Argenteuil, France, 95107
Not Yet Recruiting
26
Centre Hospitalier Universitaire (Chu) de Bordeaux - Groupe Hospitalier Pellegrin
Bordeaux, France, 33076
Actively Recruiting
27
Centre Hospitalier Intercommunal de Creteil
Créteil, France, 94010
Not Yet Recruiting
28
Hospices Civils de Lyon (Hcl) - Hopital Edouard Herriot (Heh)
Lyon, France, 69003
Actively Recruiting
29
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hopital Hotel Dieu
Nantes, France, 44093
Not Yet Recruiting
30
Centre Hospitalier Universitaire de Nice,Hopital L Archet
Nice, France, 06200
Not Yet Recruiting
31
Hopital Universitaire Necker Enfants Malades
Paris, France, 75015
Not Yet Recruiting
32
Polyclinique de Courlancy
Reims, France, 51100
Not Yet Recruiting
33
Centre Hospitalier Universitaire (Chu) de Toulouse - Hopital Larrey
Toulouse, France, 31059
Actively Recruiting
34
Chu Nancy
Vandœuvre-lès-Nancy, France, 54500
Not Yet Recruiting
35
Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (Ccm)
Berlin, Germany, 10117
Actively Recruiting
36
Universitaetsklinikum Der Ruhr Universitaet Bochum (Ukrub), St. Josef Hospital
Bochum, Germany, 44791
Not Yet Recruiting
37
Drk Krankenhaus Chemnitz-Rabenstein
Chemnitz, Germany, 09117
Withdrawn
38
Hautklinik Universitatsklinikum Erlangen
Erlangen, Germany, 91054
Not Yet Recruiting
39
Universitaetsklinik Frankfurt
Frankfurt, Germany, 60590
Withdrawn
40
Katholisches Kinderkrankenhaus Wilhelmstift
Hamburg, Germany, 22149
Actively Recruiting
41
University Medical Center Schleswig-Holstein
Kiel, Germany, 24105
Actively Recruiting
42
Universitaetsklinikum Leipzig
Leipzig, Germany, 04103
Actively Recruiting
43
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
Mainz, Germany, 55131
Not Yet Recruiting
44
Klinikum Rechts Der Isar Der Technischen Universitaet Muenchen (Hopital Rechts Der Isar)
München, Germany, 81675
Actively Recruiting
45
University Hospital Muenster
Münster, Germany, 48149
Actively Recruiting
46
Clinexpert
Budapest, Hungary, 01033
Actively Recruiting
47
Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika
Debrecen, Hungary, 04032
Actively Recruiting
48
University of Pecs-Clinical Center
Pécs, Hungary, 07632
Not Yet Recruiting
49
University of Szeged
Szeged, Hungary, 06720
Not Yet Recruiting
50
A.O. Policlinico Sant'Orsola Malpighi-Universita Degli Studi Di Bologna
Bologna, Italy, 40138
Not Yet Recruiting
51
Azienda Ospedaliera Spedali Civili Di Brescia-Universita Degli Studi Di Brescia
Brescia, Italy, 25123
Not Yet Recruiting
52
Azienda Ospedaliero-Universitaria Policlinico Vittorio Emanuele Ospedale Gaspare Rodolico Di Catania
Catania, Italy, 95123
Not Yet Recruiting
53
Uoc Dermatologia Ospedale Maggiore Policlinico, Fondazione Irccs Ca' Granda
Milan, Italy, 20122
Not Yet Recruiting
54
Universita Degli Studi Di Napoli Federico Ii
Naples, Italy, 80131
Not Yet Recruiting
55
Azienda Ospedale Universita Di Padova
Padua, Italy, 35100
Not Yet Recruiting
56
Fondazione Ptv Policlinico Tor Vergata
Roma, Italy, 00133
Withdrawn
57
Istituto Di Ricovero E Cura A Carattere Scientifico (Ircss)
Roma, Italy, 00167
Not Yet Recruiting
58
Irccs Ospedale Pediatrico Bambino Gesu
Rome, Italy, 00165
Not Yet Recruiting
59
Fondazione Policlinico Universitario Agostino Gemelli Irccs
Rome, Italy, 00168
Not Yet Recruiting
60
Amsterdam Umc Research Bv
Amsterdam, Netherlands, 1105 AZ
Actively Recruiting
61
Centrum Badan Klinicznych Pi-House Sp. Z O.O.
Gdansk, Poland, 80-546
Actively Recruiting
62
Care Clinic Sp. Z O.O.
Katowice, Poland, 40-568
Actively Recruiting
63
Diamond Clinic Specjalistyczne Poradnie Lekarskie
Krakow, Poland, 31-559
Actively Recruiting
64
Dermedic Iwona Zdybska
Lublin, Poland, 20-607
Actively Recruiting
65
Twoja Przychodnia - Medyczne Nowa Sol
Nowa Sól, Poland, 67-100
Actively Recruiting
66
Dermodent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski
Osielsko, Poland, 86-031
Actively Recruiting
67
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski, Poland, 27-400
Withdrawn
68
Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
Rzeszów, Poland, 35-055
Actively Recruiting
69
Twoja Przychodnia Scm
Szczecin, Poland, 71-500
Actively Recruiting
70
Evimed Sp. Z O. O.
Warsaw, Poland, 02-625
Actively Recruiting
71
Centro Hospitalar E Universitario Coimbra
Coimbra, Portugal, 3000-602
Not Yet Recruiting
72
Centro Hospitalar de Lisboa Central - Hospital Santo Antonio Dos Capuchos
Lisbon, Portugal, 1169-050
Not Yet Recruiting
73
Hospital Geral de Santo Antonio
Porto, Portugal, 4099-001
Actively Recruiting
74
Hospital Universitario Fundacion Alcorcon
Alcorcón, Spain, 28922
Actively Recruiting
75
Hospital Universitari Germans Trias I Pujol
Badalona, Spain, 08916
Actively Recruiting
76
Hospital de La Santa Creu I Sant Pau
Barcelona, Spain, 08026
Actively Recruiting
77
Hospital Sant Joan de Deu Barcelona
Esplugues de Llobregat, Spain, 08950
Actively Recruiting
78
Hospital Infantil Unversitario Nino Jesus
Madrid, Spain, 28009
Actively Recruiting
79
Hospital Universitario Miguel Servet de Zaragoza
Zaragoza, Spain, 50009
Actively Recruiting
80
Croydon University Hospital
Croydon, United Kingdom, CR7 7YE
Not Yet Recruiting
81
The Royal London Hospital - Barts Health Nhs Trust
London, United Kingdom, E1 1FR
Not Yet Recruiting
82
Guys Hospital
London, United Kingdom, SE1 9RT
Not Yet Recruiting
83
Great Ormond Street Hospital For Children Nhs Foundation Trust
London, United Kingdom, WC1N 3JH
Not Yet Recruiting
84
Queen'S Medical Centre - Nottingham University Hospitals Nhs Trust
Nottingham, United Kingdom, NG7 2UH
Not Yet Recruiting
85
Sheffield Childrens Hospital
Sheffield, United Kingdom, S10 2TH
Not Yet Recruiting
86
Manor Hospital (Walsall) - Walsall Healthcare Nhs Trust
Walsall, United Kingdom, WS2 9PS
Not Yet Recruiting
Research Team
I
Incyte Corporation Call Center (US)
CONTACT
I
Incyte Corporation Call Center (ex-US)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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