Recruiting
Phase 3

Ruxolitinib Cream

Sponsor:

Incyte Corporation

Code:

NCT06548360

Conditions

NonSegmental Vitiligo

Eligibility Criteria

Sex: All

Age: 2 - 11

Healthy Volunteers: Not accepted

Interventions

Ruxolitinib Cream

Vehicle Cream

Study Details

Brief summary:

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

Conditions

NonSegmental Vitiligo

Study ID

NCT06548360

Start date

Jan 24, 2025

Status verified date

Jul, 2026

Completion date

Mar 13, 2027

Anticipated

Primary completion date

Aug 10, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 11

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ruxolitinib 1.5 % Cream

Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol.

placebo comparator: Vehicle Cream

Participants received vehicle cream, applied topically to the affected area as defined by the protocol.

Interventions

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.

Primary outcome measure

  • Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75) [ Time Frame: Week 24 ]

Central Contacts and Locations

Central contacts

Incyte Corporation Call Center (US)

1.855.463.3463medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

+800 00027423eumedinfo@incyte.com

Locations

University of Alabama At Birmingham-School of Medicine

Recruiting

Birmingham, Alabama, United States, 35233

Saguaro Dermatology

Recruiting

Phoenix, Arizona, United States, 85008

Phoenix Children'S Hospital

Recruiting

Phoenix, Arizona, United States, 85016

Omni Dermatology

Recruiting

Phoenix, Arizona, United States, 85037

Banner - University Medicine Multispecialty Services Clinic

Recruiting

Tucson, Arizona, United States, 85718

Premier Dermatology Clinical Trials Institute At Northwest Arkansas

Recruiting

Fayetteville, Arkansas, United States, 72703

Axon Clinical Research

Recruiting

Inglewood, California, United States, 90301

University of California Irvine

Recruiting

Irvine, California, United States, 92697

Vitiligo & Pigmentation Institute of Southern California

Recruiting

Los Angeles, California, United States, 90036-5609

Dermatology Research Associates

Recruiting

Los Angeles, California, United States, 90045

La Universal Research Center, Inc

Recruiting

Los Angeles, California, United States, 90057

Stanford School of Medicine

Recruiting

Palo Alto, California, United States, 94304

Empire Clinical Research

Recruiting

Pomona, California, United States, 91767

Rady Children'S Hospital-San Diego

Recruiting

San Diego, California, United States, 92123

Children'S Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Paradigm Clinical Research Centers, Inc.

Recruiting

Wheat Ridge, Colorado, United States, 80033

Skin Care Research, Llc

Recruiting

Boca Raton, Florida, United States, 33486

Encore Medical Research, Llc Boynton Beach

Recruiting

Boynton Beach, Florida, United States, 33436

Skin Care Research, Llc

Recruiting

Hollywood, Florida, United States, 33201

Solutions Through Advanced Research, Inc

Recruiting

Jacksonville, Florida, United States, 32256

Pediatric Skin Research Llc

Recruiting

Miami, Florida, United States, 33146

Nicklaus Children'S Hospital

Recruiting

Miami, Florida, United States, 33155

Dh Tamarac Research Center Etna Medical Center Emc

Recruiting

Tamarac, Florida, United States, 33321

Usf Health Morsani Center For Advanced Healthcare

Recruiting

Tampa, Florida, United States, 33612

Cleaver Medical Group

Recruiting

Cumming, Georgia, United States, 30040

Advanced Medical Research Pc

Recruiting

Sandy Springs, Georgia, United States, 30328

Treasure Valley Medical Research

Recruiting

Boise, Idaho, United States, 83706

Illinois Dermatology Institute the Chicago Loop

Recruiting

Chicago, Illinois, United States, 60602

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Northshore University Healthsystem

Recruiting

Skokie, Illinois, United States, 60077

Indiana University School of Medicine

Recruiting

Indianapolis, Indiana, United States, 46202

Skin and Hair Center

Recruiting

Overland Park, Kansas, United States, 66213

Tulane University Health Sciences Center

Recruiting

New Orleans, Louisiana, United States, 70112

Dermatology Associates Pc

Recruiting

Rockville, Maryland, United States, 20850

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Dermatology and Cosmetic Center

Recruiting

Flint, Michigan, United States, 48507

Mi Skin Center, Pllc

Recruiting

Northville, Michigan, United States, 48167

Michigan Dermatology Institute

Recruiting

Waterford, Michigan, United States, 48328

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Boeson Research

Recruiting

Missoula, Montana, United States, 59804

Skin Specialists Pc the Advanced Skin Research Center

Recruiting

Omaha, Nebraska, United States, 68144

The University of New Mexico Unm Health Sciences Center Hsc

Recruiting

Albuquerque, New Mexico, United States, 87102

Suny Downstate Medical Center

Recruiting

Brooklyn, New York, United States, 11203

The Dermatology Specialists Greenwich

Recruiting

New York, New York, United States, 10012

Mount Sinai Doctors

Recruiting

New York, New York, United States, 10028-3135

Skin Search of Rochester

Recruiting

Rochester, New York, United States, 14623

Vitality Clinical Research Llc

Recruiting

Woodbury, New York, United States, 11797

Red River Research Partners

Recruiting

Fargo, North Dakota, United States, 58103

Wright State Physicians Health Center

Recruiting

Beavercreek, Ohio, United States, 45324

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Columbia Dermatology

Recruiting

Columbia, South Carolina, United States, 29212

Dell Children'S Medical Group

Recruiting

Austin, Texas, United States, 78723

The University of Texas Health Science Center At Houston

Recruiting

Bellaire, Texas, United States, 77401

3A Research Llc West Location

Recruiting

El Paso, Texas, United States, 79902

Reveal Research Institute

Recruiting

Frisco, Texas, United States, 75033

Acrc Trials

Recruiting

Grapevine, Texas, United States, 07605

Texas Dermatology and Laser Specialists

Recruiting

San Antonio, Texas, United States, 78218

Stryde Research

Recruiting

Southlake, Texas, United States, 76092

University of Utah Midvalley Dermatology

Recruiting

Murray, Utah, United States, 84107

Jordan Valley Dermatology Center

Recruiting

South Jordan, Utah, United States, 84095

Frontier Dermatology

Recruiting

Mill Creek, Washington, United States, 98012

Seattle Children'S Hospital

Recruiting

Seattle, Washington, United States, 98105

Dermatology Specialists of Spokane

Recruiting

Spokane, Washington, United States, 99202

University of Wisconsin School of Medicine

Recruiting

Madison, Wisconsin, United States, 53715

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Kirk Barber Research

Recruiting

Calgary, Alberta, Canada, T2G 1B1

Dermatology Research Institute

Recruiting

Calgary, Alberta, Canada, T2J 7E1

Alberta Health Services (Ahs) - Alberta Children'S Hospital (Ach)

Recruiting

Calgary, Alberta, Canada, T3B 6A8

Laser Rejuvenation Clinics Edmonton D.T. Inc

Recruiting

Edmonton, Alberta, Canada, T5J 3S9

Alberta Dermasurgery Centre

Recruiting

Edmonton, Alberta, Canada, T6G 1C3

Coal Harbour Rejuvenation Dermatology, Inc.

Recruiting

Vancouver, British Columbia, Canada, V6C 0C3

Winnipeg Clinic

Recruiting

Winnipeg, Manitoba, Canada, R3C 1T6

Maritime Dermatology

Recruiting

Halifax, Nova Scotia, Canada, B3K5R3

Dar Clinical Research Inc

Recruiting

Ottawa, Ontario, Canada, K2T 0N7

University of Toronto - the Hospital For Sick Children (Sickkids)

Recruiting

Toronto, Ontario, Canada, M5G1X8

Cosmetic Dermatology on Bloor

Recruiting

Toronto, Ontario, Canada, M5S 3B4

Centre de Recherche St-Louis

Recruiting

Montreal, Quebec, Canada, H1Y 3L1

Universite de Montreal - Centre Hospitalier Universitaire (Chu) Sainte-Justine - Centre de Recherche

Recruiting

Montreal, Quebec, Canada, H3T 1C5

Centre Hospitalier Universitaire de Quebec - Centre Hospitalier de L'Universite Laval (Chul)

Recruiting

Québec, Quebec, Canada, G1V 4G2

Centre de Recherche Saint-Louis

Recruiting

Québec, Quebec, Canada, G1W 4R4

Saskatoon Dermatology Centre

Recruiting

Saskatoon, Saskatchewan, Canada, S7T 0G3

Skincare Studio Dermatology Centre

Recruiting

St. John's, Canada, A1E 1V4

More Information

Sponsor

Incyte Corporation

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Keywords

  • NonSegmental Vitiligo
  • pediatric

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Incyte Corporation on 2026-07-23.