Study of ruxolitinib cream for children aged 6 to 12 years with non-segmental vitiligo

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What is this study about?

This study focuses on children aged 6 to 12 years with nonsegmental vitiligo, a condition where patches of skin lose their color. The study will test a medication called ruxolitinib cream (also known as Opzelura) compared to a placebo cream. Vitiligo occurs when the body’s immune system attacks and destroys the cells that produce skin color, leading to white patches on the skin.

The purpose of this research is to evaluate how well ruxolitinib cream works in treating children with nonsegmental vitiligo. During the study, participants will apply either ruxolitinib cream or placebo cream to their skin. The treatment will continue for up to 52 weeks, which is approximately one year. The maximum daily amount of cream that can be used is 8.5 grams.

The study will measure how well the treatment works by looking at improvements in the affected skin areas, particularly on the face. The cream is designed for cutaneous use, which means it is applied directly to the skin. Throughout the study, doctors will monitor the participants’ health and any changes in their vitiligo patches to ensure the treatment is safe and effective.

1 Initial treatment period

You will be randomly assigned to receive either ruxolitinib cream or a placebo cream for skin application

The treatment period will last for 24 weeks

You will need to apply the cream directly to the affected skin areas

Regular monitoring of your skin condition will occur during this period

2 Skin assessment at week 24

Your skin will be evaluated to measure the improvement in the light patches (vitiligo areas)

The medical team will assess the changes in affected areas on your face and body

You will be asked about how noticeable your skin patches are

Your satisfaction with the treatment will be evaluated

3 Extended treatment period

The treatment continues until week 52

Regular monitoring of your skin condition will continue

Blood samples will be collected at weeks 4, 24, 40, and 52 to measure medicine levels

Your height and weight will be monitored throughout the study

4 Final assessment at week 52

Final evaluation of your skin condition will be performed

The medical team will assess the overall treatment results

Your satisfaction with the treatment will be evaluated again

Final safety assessments will be conducted

5 Safety monitoring

Throughout the study, your health will be monitored through regular check-ups

Any changes in your condition will be recorded

Laboratory tests will be performed to ensure your safety

You must report any unusual symptoms or side effects to the medical team

Who Can Join the Study?

  • Must be between 6 and 11 years old at the time of joining the study
  • Must have a diagnosis of nonsegmental vitiligo with:
    • At least 0.5% of face area affected
    • At least 3% of body areas other than face affected
    • Total affected area must not exceed 10% of body surface
  • Must have some pigmented hair (hair with natural color) within the vitiligo areas on the face
  • Must be willing and able to understand and sign an informed consent form. Parents or legal guardians must provide written consent
  • Must stop using all vitiligo treatments during the study (except approved cosmetic products and camouflage makeup)
  • For children who have reached puberty:
    • Girls who have started menstruation must have negative pregnancy tests and avoid pregnancy during the study and for 30 days after
    • Boys must agree to avoid fathering children during the study and for 90 days after

Who Cannot Join the Study?

  • History of severe allergic reactions or skin conditions other than vitiligo
  • Current participation in other clinical trials or use of investigational drugs within 30 days
  • Presence of skin infections or open wounds in areas affected by vitiligo
  • Use of any treatments for vitiligo (including light therapy, creams, or oral medications) within the past 4 weeks
  • History of skin cancer or suspicious skin lesions
  • Significant medical conditions that could interfere with the study treatment
  • Pregnancy, breastfeeding, or planning to become pregnant during the study period
  • Known allergies to the study medication (ruxolitinib cream) or its components
  • History of immune system disorders (conditions affecting body’s defense system)
  • Inability to follow study procedures or attend scheduled visits
  • Previous treatment with JAK inhibitors (a type of medication that affects immune system response)
  • Active or chronic infections that require treatment
  • Severe sun sensitivity or extensive sun exposure

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nantes Nantes France
Diagnostic Consultation Center XX-Sofia EOOD Sofia Bulgaria
Centre Hospitalier Universitaire De Nice Nice France
Hopital Beaujon Clichy France
Clinexpert Kft. Budapest Hungary
Sanos A/S Gandrup Denmark
Care Clinic Sp. z o.o. Katowice Poland
Covkxooju Udulxlvtdwfsjg Sbdttrcqf Woluwe-Saint-Lambert Belgium
Agozqmn Oglatcnlkkn du Ptwdux Padua Italy
Ctcfrx Hhqiqitukku Vcmjjq Dnjglu Argenteuil France
Uspxbcfnmf Or Daarzxjx Debrecen Hungary
Dgyltdwvquzwfbnglccgolh cyhjrl “iralzbcwssmtxpf Ejvz Sofia Bulgaria
Uyiwyllmllfmzujbpflyb Eobcbfmf Axz Erlangen Germany
Fqplgmchqq Iaxtx Cv Guolvg Opbnloyf Mghxmjmw Ppihkxkfaon Milan Italy
Aslpiypsw Ucn Amsterdam The Netherlands
Cttvnxs Uzzyhzcqjttzqfcbeaeh Bkynqq Kbc Berlin Germany
Mrduyyd Ukxpygxwvh Od Gfsi Graz Austria
Cnujbd Hiskvruhsh E Udwgedyalboxo De Ctenacw Elqctt Coimbra Portugal
Uwaeewwxuksqzqwvhlror Maomgqym Afm Munster Germany
Ahmidgs Oyauhmezgfl Uycctrkhwwmzi Frcndtel Iy De Nbikty Naples Italy
Cogo Df Nujaq Vandoeuvre Les Nancy France
Udibmsefxw Ok Sufpqb Szeged Hungary
Uuazorvdirtt Lnjmvfy Leipzig Germany
Akfsoho Uqexb Stjfnrkht Lvwgxv Dx Bdqgnvo Bologna Italy
Crikth Hqzdesjpkv Upltbohhrbxko Da Syjim Adurokh Edfzwt Porto Portugal
Hfrytedo Dq Ly Samnl Chgw I Suby Phs Barcelona Spain
Ktfujmtb dlm Tvpahnmqxom Uibvfozedfep Mgyawnro (det Ktvvmoewz Munich Germany
Ubjdhqtktudo Zzyaeexnfe Gnjd Gent Belgium
Hzymwovg Szqg Jkmj Ds Dbt Bjarfxkcp Esplugues De Llobregat Spain
Utnnvcpumxvtdklndkeqn Snjwyyncszlugqpbir Ack Kiel Germany
Czriff Hotnvptynqn Lfbw Sai Pierre Benite France
Ujodcegpvm Dxgyq Slhzh Du Bccdszu Brescia Italy
Cvcdgsg Bmjvm Kjzvuxhkbak Pwjojjzg Svf z ohlz Gdansk Poland
Okdvvbbk Plntymsuaz Blxxntl Gttzfhaeqtn Rome Italy
Agldwhc Orsogocyxfhimapmcdrjlwjzt Pficsdkbkvd Gb Rberubsaftqo Midfy Dy Crougpt Catania Italy
Uimkutgvpnnai Sjtyuhd Kbbpflrbb Istsfiqrobwo Cmtorup W Rybzgpkof Rzeszow Poland
Kfvoeuzqfqpx Koghqlczhiupyrftb Wwmmxazmkbdl gslli Hamburg Germany
Uieljq Mhenkoq Ckjoee Ebjk Plovdiv Bulgaria
Dbpvtcbgcs Auw Cyifpxhgji Cknitc Xmsgjfhlsvbt Eyux Sofia Bulgaria
Amuezbpynmi Zh Sigzhzpljmbpfs Mvbjphzrau Pgtcjbocpejvznf Pekaknzl Ph Ddfvrdgfbgvd Ctjoeiq Eduuivoxe Owo Sofia Bulgaria
Miridfkbykxe Hspcvjxn Fjj Ajeupb Tbyigwgvo Dec Taoj Vfdossa Al Gabrovo Bulgaria
Ujqnbpbotn Og Pwih Pecs Hungary
Gatdimwi Hnhnxjud Hellerup Denmark
Fokayywpnr Lvfyt Mcjly Mxfqi Rome Italy
Tmguk Pmmqhfcxbne Stzmrupsdryb Ccjaxsc Mwhmeqkh Szj z ovtt Szczecin Poland
Tfums Pyelapvunzy Nrfsulnaizd Ccjcexf Mlcblsce Sqs z oydl Nowa Sol Poland
Akrhnjvuy Mvcnbvn Cwqyoq Ofx Dupnitsa Bulgaria
Hfpnihky Uewqsbeeoffcr Herxfmgh Trexr y Poekzh Ifqruent Csiode dekoquowelbvheucm (vsux Badalona Spain
Znnvhla Muh Sbp z optj Lublin Poland
Caivdblml Sbvfq Reims France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
15.09.2025
Belgium Belgium
Recruiting
15.09.2025
Bulgaria Bulgaria
Recruiting
15.09.2025
Denmark Denmark
Recruiting
15.09.2025
France France
Recruiting
15.09.2025
Germany Germany
Recruiting
15.09.2025
Hungary Hungary
Recruiting
15.09.2025
Italy Italy
Recruiting
15.09.2025
Poland Poland
Recruiting
15.09.2025
Portugal Portugal
Recruiting
15.09.2025
Spain Spain
Recruiting
15.09.2025
The Netherlands The Netherlands
Recruiting
15.09.2025

Trial locations

Investigated Drugs:

Ruxolitinib cream is a topical medication applied to the skin that helps treat vitiligo, a condition where patches of skin lose their color. This cream works by targeting specific proteins in the immune system that are involved in causing vitiligo. It helps to reduce inflammation and may help restore skin pigmentation in the affected areas. The medication is being studied specifically for children between 6 and 12 years old who have nonsegmental vitiligo, which is the most common form of vitiligo affecting both sides of the body in a somewhat symmetric pattern.

Investigated Diseases:

Vitiligo – A skin condition that causes the loss of skin color in patches due to the destruction of pigment-producing cells called melanocytes. The depigmented patches typically appear on various parts of the body, most commonly on the face, hands, arms, and other areas exposed to sunlight. The condition usually develops gradually, with patches slowly enlarging over time. The white or light patches are more noticeable in people with darker skin tones. Vitiligo can affect people of any age, gender, or ethnic background. The patches may be accompanied by premature whitening or graying of the hair in affected areas.

Trial ID:
2024-513171-41-00
Protocol code:
INCB 18424-309
NCT ID:
NCT06804811
Trial Phase:
Therapeutic confirmatory (Phase III)

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