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Clinical Trials in the USA / NCT06548360
Recruiting Phase 3

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

NCT06548360 · tracked via the Priya Life Science USA tracker
Sponsor
Incyte Corporation
Phase
Phase 3
Started
2025-01-24
Last updated
2026-09-14

Condition(s) studied

NonSegmental Vitiligo

Investigational drug(s) / intervention(s)

Ruxolitinib CreamVehicle Cream

Ruxolitinib Cream: Ruxolitinib cream applied topically to the affected area as a thin film twice daily.

Vehicle Cream: Matching vehicle cream applied topically to the affected area as a thin film twice daily.

Study summary

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

Eligibility

Sex
ALL
Min age
2 Years
Max age
11 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (98)

FacilityCityRegionStatus
University of Alabama At Birmingham-School of Medicine Birmingham Alabama Recruiting
Saguaro Dermatology Phoenix Arizona Recruiting
Phoenix Children'S Hospital Phoenix Arizona Recruiting
Omni Dermatology Phoenix Arizona Recruiting
Affiliated Dermatology Scottsdale Arizona Completed
Banner - University Medicine Multispecialty Services Clinic Tucson Arizona Recruiting
Premier Dermatology Clinical Trials Institute At Northwest Arkansas Fayetteville Arkansas Recruiting
Burke Pharmaceutical Research Hot Springs Arkansas Completed
Axon Clinical Research Inglewood California Recruiting
University of California Irvine Irvine California Recruiting
Vitiligo & Pigmentation Institute of Southern California Los Angeles California Recruiting
Dermatology Research Associates Los Angeles California Recruiting
La Universal Research Center, Inc Los Angeles California Recruiting
Stanford School of Medicine Palo Alto California Recruiting
Empire Clinical Research Pomona California Recruiting
Peninsula Research Associates Pra Rolling Hills Estates California Completed
Rady Children'S Hospital-San Diego San Diego California Recruiting
Golden State Dermatology Walnut Creek California Not Yet Recruiting
Children'S Hospital Colorado Aurora Colorado Recruiting
Paradigm Clinical Research Centers, Inc. Wheat Ridge Colorado Recruiting
Skin Care Research, Llc Boca Raton Florida Recruiting
Encore Medical Research, Llc Boynton Beach Boynton Beach Florida Recruiting
Skin Care Research, Llc Hollywood Florida Recruiting
Solutions Through Advanced Research, Inc Jacksonville Florida Recruiting
Pediatric Skin Research Llc Miami Florida Recruiting
Nicklaus Children'S Hospital Miami Florida Recruiting
Dh Tamarac Research Center Etna Medical Center Emc Tamarac Florida Recruiting
Usf Health Morsani Center For Advanced Healthcare Tampa Florida Recruiting
Cleaver Medical Group Cumming Georgia Recruiting
Advanced Medical Research Pc Sandy Springs Georgia Recruiting
Treasure Valley Medical Research Boise Idaho Recruiting
Illinois Dermatology Institute the Chicago Loop Chicago Illinois Recruiting
Northwestern Memorial Hospital Chicago Illinois Recruiting
Rush University Medical Center Chicago Illinois Recruiting
Forefront Dermatology Libertyville Illinois Not Yet Recruiting
Northshore University Healthsystem Skokie Illinois Recruiting
Indiana University School of Medicine Indianapolis Indiana Recruiting
Skin and Hair Center Overland Park Kansas Recruiting
Wellskin Dermatology & Aesthetics Bowling Green Kentucky Completed
Tulane University Health Sciences Center New Orleans Louisiana Recruiting

+ 58 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06548360 on ClinicalTrials.gov ↗ ← All trials in the USA