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New cream could help kids with vitiligo regain skin color

NCT ID NCT06804811

Disease control Sponsor: Incyte Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 23, 2026 · Updated 5 times

Summary

This study tests a cream called ruxolitinib in children aged 6 to 12 with nonsegmental vitiligo, a condition that causes white patches on the skin. The cream is applied twice daily to affected areas. The goal is to see if it can safely restore skin color. About 250 children will participate.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ruxolitinib cream
What this could lead to
If successful, this could offer a topical treatment to restore skin color in children with vitiligo, reducing visible patches.
What could go wrong
This is a phase 3 trial, but results may not work for all children, and long-term safety is still being studied. Side effects like skin irritation are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 11 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

generalized vitiligo vitiligo

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Nonsegmental vitiligo

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    79 sites in 14 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • 28 Diagnostic and Consultative Center

    RECRUITING

    Sofia, 01528, Bulgaria

  • A.O. Policlinico Sant'Orsola Malpighi-Universita Degli Studi Di Bologna

    RECRUITING

    Bologna, 40138, Italy

  • Amsterdam Umc Research Bv

    RECRUITING

    Amsterdam, 1105 AZ, Netherlands

  • Azienda Ospedale Universita Di Padova

    RECRUITING

    Padua, 35100, Italy

  • Azienda Ospedaliera Spedali Civili Di Brescia-Universita Degli Studi Di Brescia

    RECRUITING

    Brescia, 25123, Italy

  • Azienda Ospedaliero Universitaria Federico Ii Di Napoli

    RECRUITING

    Naples, 80131, Italy

  • Azienda Ospedaliero-Universitaria Policlinico Vittorio Emanuele Ospedale Gaspare Rodolico Di Catania

    RECRUITING

    Catania, 95123, Italy

  • Care Clinic Sp. Z O.O.

    RECRUITING

    Katowice, 40-568, Poland

  • Centre Hospitalier Intercommunal de Creteil

    RECRUITING

    Créteil, 75571, France

  • Centre Hospitalier Universitaire (Chu) de Bordeaux - Groupe Hospitalier Pellegrin

    RECRUITING

    Bordeaux, 33076, France

  • Centre Hospitalier Universitaire (Chu) de Toulouse - Hopital Larrey

    RECRUITING

    Toulouse, 31059, France

  • Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hopital Hotel Dieu

    RECRUITING

    Nantes, 44093, France

  • Centre Hospitalier Universitaire de Nice,Hopital L Archet

    RECRUITING

    Nice, 06200, France

  • Centre Hospitalier Victor Dupouy

    RECRUITING

    Argenteuil, 95107, France

  • Centro Hospitalar E Universitario Coimbra

    RECRUITING

    Coimbra, 3000-075, Portugal

  • Centro Hospitalar de Lisboa Central - Hospital Santo Antonio Dos Capuchos

    RECRUITING

    Lisbon, 1169-050, Portugal

  • Centro de Investigaciones Medicas Mar Del Plata

    RECRUITING

    Mar del Plata, B7600FYK, Argentina

  • Centrum Badan Klinicznych Pi-House Sp. Z O.O.

    RECRUITING

    Gdansk, 80-546, Poland

  • Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (Ccm)

    RECRUITING

    Berlin, 10117, Germany

  • Chu Nancy

    RECRUITING

    Vandœuvre-lès-Nancy, 54500, France

  • Clinexpert

    RECRUITING

    Budapest, 01033, Hungary

  • Consultorios Medicos Dr. Doreski

    RECRUITING

    Buenos Aires, C1426ABP, Argentina

  • Croydon University Hospital

    NOT_YET_RECRUITING

    Croydon, CR7 7YE, United Kingdom

  • Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika

    RECRUITING

    Debrecen, 04032, Hungary

  • Derma Internacional S.A.

    RECRUITING

    Buenos Aires, C1426, Argentina

  • Dermedic Iwona Zdybska

    RECRUITING

    Lublin, 20-607, Poland

  • Dermodent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski

    RECRUITING

    Osielsko, 86-031, Poland

  • Diagnostic Consultation Center Xx - Sofia Eood

    RECRUITING

    Sofia, 01618, Bulgaria

  • Diamond Clinic Specjalistyczne Poradnie Lekarskie

    RECRUITING

    Krakow, 31-559, Poland

  • Evimed Sp. Z O. O.

    RECRUITING

    Warsaw, 02-625, Poland

  • Fondazione Policlinico Universitario Agostino Gemelli Irccs

    RECRUITING

    Rome, 00137, Italy

  • Great Ormond Street Hospital For Children Nhs Foundation Trust

    NOT_YET_RECRUITING

    London, WC1N 3JH, United Kingdom

  • Guys Hospital

    NOT_YET_RECRUITING

    London, SE1 9RT, United Kingdom

  • Hautklinik Universitatsklinikum Erlangen

    RECRUITING

    Erlangen, 91054, Germany

  • Herlev and Gentofte Hospital

    RECRUITING

    Hellerup, 02900, Denmark

  • Hopital Universitaire Necker Enfants Malades

    RECRUITING

    Paris, 75015, France

  • Hopital Universitaire de Bruxelles (Academisch Ziekenhuis Brussel)

    RECRUITING

    Brussels, 01070, Belgium

  • Hospices Civils de Lyon (Hcl) - Hopital Edouard Herriot (Heh)

    RECRUITING

    Lyon, 69003, France

  • Hospital Del Nino Jesus

    RECRUITING

    San Miguel de Tucumán, 04000, Argentina

  • Hospital Geral de Santo Antonio

    RECRUITING

    Porto, 4099-001, Portugal

  • Hospital Infantil Unversitario Nino Jesus

    RECRUITING

    Madrid, 28009, Spain

  • Hospital Italiano de Buenos Aires

    RECRUITING

    Buenos Aires, C1181ACH, Argentina

  • Hospital Sant Joan de Deu Barcelona

    RECRUITING

    Esplugues de Llobregat, 08950, Spain

  • Hospital Universitari Germans Trias I Pujol

    RECRUITING

    Badalona, 08916, Spain

  • Hospital Universitario Austral

    RECRUITING

    Derqui-pilar, B16290DT, Argentina

  • Hospital Universitario Fundacion Alcorcon

    RECRUITING

    Alcorcón, 28922, Spain

  • Hospital Universitario Miguel Servet de Zaragoza

    RECRUITING

    Zaragoza, 50009, Spain

  • Hospital de La Santa Creu I Sant Pau

    RECRUITING

    Barcelona, 08026, Spain

  • Instituto de Neumonologia Y Dermatologia

    RECRUITING

    Buenos Aires, C1425BEA, Argentina

  • Irccs Ospedale Pediatrico Bambino Gesu

    NOT_YET_RECRUITING

    Rome, 00165, Italy

  • Istituto Di Ricovero E Cura A Carattere Scientifico (Ircss)

    RECRUITING

    Roma, 00167, Italy

  • Katholisches Kinderkrankenhaus Wilhelmstift

    RECRUITING

    Hamburg, 22149, Germany

  • Klinikum Rechts Der Isar Der Technischen Universitaet Muenchen (Hopital Rechts Der Isar)

    RECRUITING

    München, 81675, Germany

  • Manor Hospital (Walsall) - Walsall Healthcare Nhs Trust

    NOT_YET_RECRUITING

    Walsall, WS2 9PS, United Kingdom

  • Mc Euroderma Clinic

    RECRUITING

    Sofia, 01606, Bulgaria

  • Medical Center Asklepii Ood

    RECRUITING

    Dupnitsa, 02600, Bulgaria

  • Medical Center Unimed Eood

    RECRUITING

    Sevlievo, 05400, Bulgaria

  • Medical University Innsbruck

    RECRUITING

    Innsbruck, 06020, Austria

  • Mhat Dr. Tota Venkova Ad

    RECRUITING

    Gabrovo, 05300, Bulgaria

  • Polyclinique de Courlancy

    NOT_YET_RECRUITING

    Reims, 51100, France

  • Psoriahue

    RECRUITING

    Buenos Aires, 01425, Argentina

  • Sanos Clinic

    RECRUITING

    Herlev, 02730, Denmark

  • Sheffield Childrens Hospital

    RECRUITING

    Sheffield, S10 2TH, United Kingdom

  • The Royal London Hospital - Barts Health Nhs Trust

    RECRUITING

    London, E1 1FR, United Kingdom

  • Twoja Przychodnia - Medyczne Nowa Sol

    RECRUITING

    Nowa Sól, 67-100, Poland

  • Twoja Przychodnia Scm

    RECRUITING

    Szczecin, 71-500, Poland

  • Umhat Aleksandrovska

    RECRUITING

    Sofia, 01431, Bulgaria

  • Universitaetsklinikum Graz

    RECRUITING

    Graz, 08036, Austria

  • Universitaetsklinikum Leipzig

    RECRUITING

    Leipzig, 04103, Germany

  • Universitair Ziekenhuis Gent

    RECRUITING

    Ghent, 09000, Belgium

  • Universitair Ziekenhuis Leuven

    RECRUITING

    Leuven, 03000, Belgium

  • Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

    RECRUITING

    Mainz, 55131, Germany

  • Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc

    RECRUITING

    Woluwe-Saint-Lambert, 01200, Belgium

  • University Hospital Muenster

    RECRUITING

    Münster, 48149, Germany

  • University Medical Center Schleswig-Holstein

    RECRUITING

    Kiel, 24105, Germany

  • University of Pecs-Clinical Center

    RECRUITING

    Pécs, 07632, Hungary

  • University of Szeged

    RECRUITING

    Szeged, 06720, Hungary

  • Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie

    RECRUITING

    Rzeszów, 35-055, Poland

  • Uoc Dermatologia Ospedale Maggiore Policlinico, Fondazione Irccs Ca' Granda

    RECRUITING

    Milan, 20122, Italy

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