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 Victor Dupouy Argenteuil France
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Sanos A/S Gandrup Denmark
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Fondazione Luigi Maria Monti Rome Italy
Universitair Ziekenhuis Gent Gent Belgium
Hospital Sant Joan De Deu Barcelona Esplugues De Llobregat Spain
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. Szczecin Poland
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o. Nowa Sol Poland
Asclepius Medical Center OOD Dupnitsa Bulgaria
Katholisches Kinderkrankenhaus Wilhelmstift gGmbH Hamburg Germany
UNIMED Medical Center EOOD Plovdiv Bulgaria
Azienda Ospedaliera di Padova Padua Italy
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie Rzeszow Poland
University Of Debrecen Debrecen Hungary
Clinexpert Kft. Budapest Hungary
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Universitaetsklinikum Erlangen AöR Erlangen Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Multiprofile Hospital For Active Treatment Dr. Tota Venkova AD Gabrovo Bulgaria
Centre Hospitalier Universitaire De Nantes Nantes France
Diagnostic Consultation Center XX-Sofia EOOD Sofia Bulgaria
Centre Hospitalier Universitaire De Nice Nice France
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
University Of Pecs Pecs Hungary
Gentofte Hospital Hellerup Denmark
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Universita Degli Studi Di Brescia Brescia Italy
Ospedale Pediatrico Bambino Gesu’ Rome Italy
University Of Szeged Szeged Hungary
Ambulatoria Za Specializirana Medicinska Pomosht-Grupova Praktika Po Dermatologia Clinica Evroderma OOD Sofia Bulgaria
Care Clinic Sp. z o.o. Katowice Poland
Courlancy Sante Reims France
Coimfdvii Uckaowmauipvbs Smfgbvtud Woluwe-Saint-Lambert Belgium
Deyiewizbt Axd Czwbtctnlu Ctgbad Xqvqinvpuasi Eqyp Sofia Bulgaria
Cwftvyf Bioaf Kpdvjyogorp Paspekgd Sgz z oxup Gdansk Poland
Azdzuvasn Uvu Amsterdam The Netherlands
Mclfsuu Ueidxgczaf Of Glhu Graz Austria
Uaagvsezbgyhjflboxxod Mxnctqhw Aaw Munster Germany
Cxjb Db Nsxqq Vandoeuvre Les Nancy France
Arhkbit Usqqn Srdgeazyp Lnpjob Db Bfehibh Bologna Italy
Hfeiwvff Db Le Sxumt Ccto I Scso Pcg Barcelona Spain
Hiwfmdpf Usdswtbgtfkuo Hceikmje Tgfup y Pzodye Ikykgdov Ctagyd dgckoowbtprwqrokp (askp Badalona Spain
Cuxexy Hiincpplzq E Ujweqbjgmsggu Df Cdmknoe Egfqik Coimbra Portugal
Zuphczi Map Sak z opkn Lublin Poland

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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