Frontlight ResearchEarly access
Taking people in United StatesPhase 3
Ruxolitinib cream for children with nonsegmental vitiligo
Tests ruxolitinib cream against a plain cream in children with nonsegmental vitiligo.
Key facts
- Who runs it
- Incyte Corporation
- Where
- Albuquerque, Aurora, Austin, Beavercreek, Bellaire, Birmingham, Boca Raton, Boise, Boston, Bowling Green, Boynton Beach, Brighton, Brooklyn, Charleston, Chicago, Columbia, Cumming, El Paso, Fargo, Fayetteville, Flint, Frisco, Grapevine, Hollywood, Hot Springs, Indianapolis, Inglewood, Irvine, Jacksonville, Kansas City, Libertyville, Longview, Los Angeles, Madison, Miami, Mill Creek, Milwaukee, Missoula, Murfreesboro, Murray, New Orleans, New York, Northville, Omaha, Overland Park, Palo Alto, Phoenix, Pomona, Rochester, Rockville, Rolling Hills Estates, Saint Joseph, San Antonio, San Diego, Sandy Springs, Scottsdale, Seattle, Skokie, South Jordan, Southlake, Spokane, St Louis, Tamarac, Tampa, Tucson, Walnut Creek, Waterford, Wheat Ridge, and Woodbury, United StatesSee the 79 sitesAlso in 1 other country, 19 sites
- Trial code
- Registry title
- A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 180 people, planned
- Started
- 24 Jan 2025
- Expected to end
- 20 Dec 2028
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Ruxolitinib Cream
- Vehicle Cream
- Record updated
- 14 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children aged 2 to 11 with nonsegmental vitiligo, a condition where patches of skin lose their color. It tests ruxolitinib cream against a cream with no drug.
- Age
- 2 Years to 11 Years
- Sex
- All
- Disease stage
- Nonsegmental vitiligo with light patches covering ≥ 0.5% BSA (body surface area) on the face, ≥ 0.5 F-VASI, ≥ 2% BSA on other areas and ≥ 2 T-VASI. Total vitiligo area no more than 10% BSA. Some colored hair inside vitiligo patches on the face.
- Earlier treatment
- Must stop all vitiligo treatments from screening to the final safety visit. Cannot join after past or current use of skin-lightening treatments (eg, monobenzone). Cannot join if a JAK inhibitor pill or cream (eg, ruxolitinib, tofacitinib, baricitinib, abrocitinib, upadacitinib) did not work before.
Main reasons for not taking part
- Other forms of vitiligo (eg, segmental) or other skin color-loss disorders
- Other skin disease or serious illness that would interfere with the study
- Pregnant or breastfeeding, or planning pregnancy during the study
- Known allergy to any part of the study cream
- Living with someone in another Incyte ruxolitinib cream study
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- Clinical diagnosis of nonsegmental vitiligo with depigmented area including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 2% BSA on nonfacial areas, ≥ 2 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 from screening through 30 days after the last application of study cream
Who cannot take part
- Prior or current use of depigmentation treatments (eg, monobenzone)
- Use of protocol-defined treatments within the indicated washout period before baseline
- 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
- 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
- History of treatment failure with any systemic or topical JAK inhibitor (eg, ruxolitinib, tofacitinib, baricitinib, abrocitinib, and upadacitinib) for vitiligo or any other inflammatory condition
- Known allergy or reaction to any component of the study cream formulation; Other protocol-defined Inclusion/Exclusion Criteria may apply
- Protocol-defined clinically significant abnormal laboratory values at screening
- Diagnosis of other forms of vitiligo (eg, segmental)
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 2 and 11 years old?
Where in United States
Also in 1 other country, 19 sites
- The University of New Mexico Unm Health Sciences Center HscAlbuquerque, United StatesTaking people
- Children's Hospital ColoradoAurora, United StatesTaking people
- Dell Children'S Medical GroupAustin, United StatesTaking people
- Wright State Physicians Health CenterBeavercreek, United StatesTaking people
- The University of Texas Health Science Center at HoustonBellaire, United StatesTaking people
- University of Alabama at Birmingham School of MedicineBirmingham, United StatesTaking people
- Skin Care Research, LLCBoca Raton, United StatesTaking people
- Treasure Valley Medical ResearchBoise, United StatesTaking people
- Massachusetts General HospitalBoston, United StatesTaking people
- Wellskin Dermatology & AestheticsBowling Green, United StatesNo longer taking part
- Encore Medical Research, Llc Boynton BeachBoynton Beach, United StatesTaking people
- Metro Boston Clinical PartnersBrighton, United StatesNo longer taking part
- SUNY Downstate Medical CenterBrooklyn, United StatesTaking people
- Medical University of South CarolinaCharleston, United StatesTaking people
- Illinois Dermatology Institute the Chicago LoopChicago, United StatesTaking people
- Northwestern Memorial HospitalChicago, United StatesTaking people
- Rush University Medical CenterChicago, United StatesTaking people
- Columbia DermatologyColumbia, United StatesTaking people
- Cleaver Medical GroupCumming, United StatesTaking people
- 3A Research Llc West LocationEl Paso, United StatesTaking people
- Red River Research PartnersFargo, United StatesTaking people
- Premier Dermatology Clinical Trials Institute At Northwest ArkansasFayetteville, United StatesTaking people
- Dermatology and Cosmetic CenterFlint, United StatesTaking people
- Reveal Research InstituteFrisco, United StatesTaking people
- Acrc TrialsGrapevine, United StatesTaking people
- Skin Care Research, LlcHollywood, United StatesTaking people
- Burke Pharmaceutical ResearchHot Springs, United StatesNo longer taking part
- Indiana University School of MedicineIndianapolis, United StatesTaking people
- Axon Clinical ResearchInglewood, United StatesTaking people
- University of California, IrvineIrvine, United StatesTaking people
- Solutions Through Advanced Research, IncJacksonville, United StatesTaking people
- University of Missouri-Kansas CityKansas City, United StatesNot yet recruiting
- Forefront DermatologyLibertyville, United StatesNot yet recruiting
- Us Dermatology Partners LongviewLongview, United StatesNo longer taking part
- Dermatology Research AssociatesLos Angeles, United StatesTaking people
- LA Universal Research Center, Inc.Los Angeles, United StatesTaking people
- Vitiligo & Pigmentation Institute of Southern CaliforniaLos Angeles, United StatesTaking people
- University of Wisconsin School of MedicineMadison, United StatesTaking people
- Nicklaus Children's HospitalMiami, United StatesTaking people
- Pediatric Skin Research LlcMiami, United StatesTaking people
- Frontier DermatologyMill Creek, United StatesTaking people
- Medical College of WisconsinMilwaukee, United StatesTaking people
- Boeson ResearchMissoula, United StatesTaking people
- International Clinical Research - Tennessee LLCMurfreesboro, United StatesNo longer taking part
- University of Utah Midvalley DermatologyMurray, United StatesTaking people
- Tulane University Health Sciences CenterNew Orleans, United StatesTaking people
- Mount Sinai DoctorsNew York, United StatesTaking people
- The Dermatology Specialists GreenwichNew York, United StatesTaking people
- Equity Medical LLCNew York, United StatesNo longer taking part
- Sadick Dermatology Sadick Research GroupNew York, United StatesNo longer taking part
- Mi Skin Center, PllcNorthville, United StatesTaking people
- Skin Specialists Pc the Advanced Skin Research CenterOmaha, United StatesTaking people
- Skin and Hair CenterOverland Park, United StatesTaking people
- Stanford School of MedicinePalo Alto, United StatesTaking people
- Omni DermatologyPhoenix, United StatesTaking people
- Phoenix Children s HospitalPhoenix, United StatesTaking people
- Saguaro DermatologyPhoenix, United StatesTaking people
- Empire Clinical ResearchPomona, United StatesTaking people
- Skin Search of RochesterRochester, United StatesTaking people
- Dermatology Associates PcRockville, United StatesTaking people
- Peninsula Research Associates PraRolling Hills Estates, United StatesNo longer taking part
- Medisearch Clinical TrialsSaint Joseph, United StatesNo longer taking part
- Texas Dermatology and Laser SpecialistsSan Antonio, United StatesTaking people
- Rady Children's Hospital - San DiegoSan Diego, United StatesTaking people
- Advanced Medical Research, PC.Sandy Springs, United StatesTaking people
- Affiliated DermatologyScottsdale, United StatesNo longer taking part
- Seattle Children's HospitalSeattle, United StatesTaking people
- NorthShore University HealthSystemSkokie, United StatesTaking people
- Jordan Valley Dermatology CenterSouth Jordan, United StatesTaking people
- Stryde ResearchSouthlake, United StatesTaking people
- Dermatology Specialists of SpokaneSpokane, United StatesTaking people
- Washington University School of MedicineSt Louis, United StatesTaking people
- Dh Tamarac Research Center Etna Medical Center EmcTamarac, United StatesTaking people
- USF Health Morsani Center for Advanced HealthcareTampa, United StatesTaking people
- Banner - University Medicine Multispecialty Services ClinicTucson, United StatesTaking people
- Golden State DermatologyWalnut Creek, United StatesNot yet recruiting
- Michigan Dermatology InstituteWaterford, United StatesTaking people
- Paradigm Clinical Research Centers, Inc.Wheat Ridge, United StatesTaking people
- Vitality Clinical Research LlcWoodbury, United StatesTaking people
About the trial
What the trial wants to find out
The purpose of this study is to to evaluate the safety and efficacy of ruxolitinib cream in pediatric participants with nonsegmental vitiligo.
The 2 groups in the trial
- Ruxolitinib 1.5 % CreamTreatment being tested
Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol.
Treatment: Ruxolitinib Cream
- Vehicle CreamPlacebo, for comparison
Participants received vehicle cream, applied topically to the affected area as defined by the protocol.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase 3, Randomized, Double-Blind, Safety, and Efficacy Study of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo
- Plain-language title
- Ruxolitinib cream for children with nonsegmental vitiligoGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT06548360, who can take part
- Record updated
- 14 September 2026