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A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo

RecruitingPhase 3

A Phase 3, Randomized, Double-Blind, Safety, and Efficacy Study of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo

Who can join

Ages 2 to 11 · All sexes

Full eligibility criteria
Inclusion Criteria:

* 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.

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).
* 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 (eg, ruxolitinib, tofacitinib, baricitinib, abrocitinib, and upadacitinib) for vitiligo or any other inflammatory condition.
* Protocol-defined clinically significant abnormal laboratory values at screening.
* 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.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

About the study

The purpose of this study is to to evaluate the safety and efficacy of ruxolitinib cream in pediatric participants with nonsegmental vitiligo.

What is being tested

Sponsor: Incyte Corporation · Participants: 180 · Started: Jan 24, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06548360

Locations in the U.S.

AlabamaUniversity of Alabama At Birmingham-School of Medicine, Birmingham
ArizonaOmni Dermatology, Phoenix
Phoenix Children'S Hospital, Phoenix
Saguaro Dermatology, Phoenix
Banner - University Medicine Multispecialty Services Clinic, Tucson
ArkansasPremier Dermatology Clinical Trials Institute At Northwest Arkansas, Fayetteville
CaliforniaAxon Clinical Research, Inglewood
University of California Irvine, Irvine
Dermatology Research Associates, Los Angeles
La Universal Research Center, Inc, Los Angeles
Vitiligo & Pigmentation Institute of Southern California, Los Angeles
Stanford School of Medicine, Palo Alto
Empire Clinical Research, Pomona
Rady Children'S Hospital-San Diego, San Diego
Golden State Dermatology, Walnut Creek (Not yet recruiting)
ColoradoChildren'S Hospital Colorado, Aurora
Paradigm Clinical Research Centers, Inc., Wheat Ridge
FloridaSkin Care Research, Llc, Boca Raton
Encore Medical Research, Llc Boynton Beach, Boynton Beach
Skin Care Research, Llc, Hollywood
Solutions Through Advanced Research, Inc, Jacksonville
Nicklaus Children'S Hospital, Miami
Pediatric Skin Research Llc, Miami
Dh Tamarac Research Center Etna Medical Center Emc, Tamarac
Usf Health Morsani Center For Advanced Healthcare, Tampa
GeorgiaCleaver Medical Group, Cumming
Advanced Medical Research Pc, Sandy Springs
IdahoTreasure Valley Medical Research, Boise
IllinoisIllinois Dermatology Institute the Chicago Loop, Chicago
Northwestern Memorial Hospital, Chicago
Rush University Medical Center, Chicago
Forefront Dermatology, Libertyville (Not yet recruiting)
Northshore University Healthsystem, Skokie
IndianaIndiana University School of Medicine, Indianapolis
KansasSkin and Hair Center, Overland Park
LouisianaTulane University Health Sciences Center, New Orleans
MarylandDermatology Associates Pc, Rockville
MassachusettsMassachusetts General Hospital, Boston
MichiganDermatology and Cosmetic Center, Flint
Mi Skin Center, Pllc, Northville
Michigan Dermatology Institute, Waterford
MissouriUniversity of Missouri Kansas City, Kansas City (Not yet recruiting)
Washington University School of Medicine, St Louis
MontanaBoeson Research, Missoula
NebraskaSkin Specialists Pc the Advanced Skin Research Center, Omaha
New MexicoThe University of New Mexico Unm Health Sciences Center Hsc, Albuquerque
New YorkSuny Downstate Medical Center, Brooklyn
Mount Sinai Doctors, New York
The Dermatology Specialists Greenwich, New York
Skin Search of Rochester, Rochester
Vitality Clinical Research Llc, Woodbury
North DakotaRed River Research Partners, Fargo
OhioWright State Physicians Health Center, Beavercreek
South CarolinaMedical University of South Carolina, Charleston
Columbia Dermatology, Columbia
TexasDell Children'S Medical Group, Austin
The University of Texas Health Science Center At Houston, Bellaire
3A Research Llc West Location, El Paso
Reveal Research Institute, Frisco
Acrc Trials, Grapevine
Texas Dermatology and Laser Specialists, San Antonio
Stryde Research, Southlake
UtahUniversity of Utah Midvalley Dermatology, Murray
Jordan Valley Dermatology Center, South Jordan
WashingtonFrontier Dermatology, Mill Creek
Seattle Children'S Hospital, Seattle
Dermatology Specialists of Spokane, Spokane
WisconsinUniversity of Wisconsin School of Medicine, Madison
Medical College of Wisconsin, Milwaukee

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.