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

Recruiting now · Phase 3

Conditions studied: NonSegmental Vitiligo

In brief

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

Key facts

Study ID

NCT06548360

Run by

Incyte Corporation

People needed

180

Starts

2025-01-24

Expected to finish

2027-03-13

Last updated by the study team

2026-07-23

Who can join

Age: 2 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Usf Health Morsani Center For Advanced Healthcare — Tampa, Florida, United States (enrolling)
• Phoenix Children'S Hospital — Phoenix, Arizona, United States (enrolling)
• Dh Tamarac Research Center Etna Medical Center Emc — Tamarac, Florida, United States (enrolling)
• Saguaro Dermatology — Phoenix, Arizona, United States (enrolling)
• Banner - University Medicine Multispecialty Services Clinic — Tucson, Arizona, United States (enrolling)
• Premier Dermatology Clinical Trials Institute At Northwest Arkansas — Fayetteville, Arkansas, United States (enrolling)
• University of Alabama At Birmingham-School of Medicine — Birmingham, Alabama, United States (enrolling)
• Nicklaus Children'S Hospital — Miami, Florida, United States (enrolling)
• University of California Irvine — Irvine, California, United States (enrolling)
• Vitiligo & Pigmentation Institute of Southern California — Los Angeles, California, United States (enrolling)
• Dermatology Research Associates — Los Angeles, California, United States (enrolling)
• La Universal Research Center, Inc — Los Angeles, California, United States (enrolling)
• Stanford School of Medicine — Palo Alto, California, United States (enrolling)
• Empire Clinical Research — Pomona, California, United States (enrolling)
• Omni Dermatology — Phoenix, Arizona, United States (enrolling)
• Rady Children'S Hospital-San Diego — San Diego, California, United States (enrolling)
• Axon Clinical Research — Inglewood, California, United States (enrolling)
• Children'S Hospital Colorado — Aurora, Colorado, United States (enrolling)
• Paradigm Clinical Research Centers, Inc. — Wheat Ridge, Colorado, United States (enrolling)
• Skin Care Research, Llc — Boca Raton, Florida, United States (enrolling)
• Encore Medical Research, Llc Boynton Beach — Boynton Beach, Florida, United States (enrolling)
• Skin Care Research, Llc — Hollywood, Florida, United States (enrolling)
• Solutions Through Advanced Research, Inc — Jacksonville, Florida, United States (enrolling)
• Pediatric Skin Research Llc — Miami, Florida, United States (enrolling)
• Cleaver Medical Group — Cumming, Georgia, United States (enrolling)

Full record on ClinicalTrials.gov

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