A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo
NCT ID: NCT06548360
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
180 participants
INTERVENTIONAL
2025-01-24
2027-03-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ruxolitinib 1.5 % Cream
Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol.
Ruxolitinib Cream
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
Vehicle Cream
Participants received vehicle cream, applied topically to the affected area as defined by the protocol.
Vehicle Cream
Matching vehicle cream applied topically to the affected area as a thin film twice daily.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
* Current or previous use of JAK inhibitors, systemic or topical.
* Protocol-defined clinically significant abnormal laboratory values at screening.
* BMI-for-age \< 5th percentile or ≥ 85th percentile according to the CDC BMI Percentile Calculator for Child and Teen.
* 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.
2 Years
11 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Incyte Corporation
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Incyte Medical Monitor
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama At Birmingham-School of Medicine
Birmingham, Alabama, United States
Phoenix Children'S Hospital
Phoenix, Arizona, United States
Omni Dermatology
Phoenix, Arizona, United States
Affiliated Dermatology
Scottsdale, Arizona, United States
Banner - University Medicine Multispecialty Services Clinic
Tucson, Arizona, United States
Premier Dermatology Clinical Trials Institute At Northwest Arkansas
Fayetteville, Arkansas, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
Axon Clinical Research
Inglewood, California, United States
University of California Irvine
Irvine, California, United States
Vitiligo & Pigmentation Institute of Southern California
Los Angeles, California, United States
Dermatology Research Associates
Los Angeles, California, United States
La Universal Research Center, Inc
Los Angeles, California, United States
Stanford School of Medicine
Palo Alto, California, United States
Empire Clinical Research
Pomona, California, United States
Norcal Clinical Research
Rocklin, California, United States
Peninsula Research Associates Pra
Rolling Hills Estates, California, United States
Integrative Skin Science and Research
Sacramento, California, United States
Rady Children'S Hospital-San Diego
San Diego, California, United States
Children'S Hospital Colorado
Aurora, Colorado, United States
Paradigm Clinical Research Centers, Inc.
Wheat Ridge, Colorado, United States
Skin Care Research, Llc
Boca Raton, Florida, United States
Encore Medical Research, Llc Boynton Beach
Boynton Beach, Florida, United States
Skin Care Research, Llc
Hollywood, Florida, United States
Solutions Through Advanced Research, Inc
Jacksonville, Florida, United States
Pediatric Skin Research Llc
Miami, Florida, United States
Nicklaus Children'S Hospital
Miami, Florida, United States
Dh Tamarac Research Center Etna Medical Center Emc
Tamarac, Florida, United States
Usf Health Morsani Center For Advanced Healthcare
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Cleaver Medical Group
Cumming, Georgia, United States
Advanced Medical Research Pc
Sandy Springs, Georgia, United States
Treasure Valley Medical Research
Boise, Idaho, United States
Illinois Dermatology Institute the Chicago Loop
Chicago, Illinois, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Advanced Dermatology Lincolnshire
Lincolnshire, Illinois, United States
Northshore University Healthsystem
Skokie, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Wellskin Dermatology & Aesthetics
Bowling Green, Kentucky, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, United States
Dermatology Associates Pc
Rockville, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Metro Boston Clinical Partners
Brighton, Massachusetts, United States
Michigan Center For Research Company
Clarkston, Michigan, United States
Mi Skin Center, Pllc
Northville, Michigan, United States
Michigan Dermatology Institute
Waterford, Michigan, United States
Medisearch Clinical Trials
Saint Joseph, Missouri, United States
Boeson Research
Missoula, Montana, United States
Skin Specialists Pc the Advanced Skin Research Center
Omaha, Nebraska, United States
The University of New Mexico Unm Health Sciences Center Hsc
Albuquerque, New Mexico, United States
Suny Downstate Medical Center
Brooklyn, New York, United States
The Dermatology Specialists Greenwich
New York, New York, United States
Equity Medical, Llc
New York, New York, United States
Mount Sinai Doctors
New York, New York, United States
Sadick Dermatology Sadick Research Group
New York, New York, United States
Skin Search of Rochester
Rochester, New York, United States
Vitality Clinical Research Llc
Woodbury, New York, United States
Red River Research Partners
Fargo, North Dakota, United States
Dermatologists of Southwestern Ohio, Llc
Bexley, Ohio, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Columbia Dermatology
Columbia, South Carolina, United States
International Clinical Research Tennessee Llc
Murfreesboro, Tennessee, United States
Dell Children'S Medical Group
Austin, Texas, United States
The University of Texas Health Science Center At Houston
Bellaire, Texas, United States
Dfw Clinical Trials
Carrollton, Texas, United States
3A Research Llc West Location
El Paso, Texas, United States
Reveal Research Institute
Frisco, Texas, United States
Acrc Trials
Grapevine, Texas, United States
Us Dermatology Partners Longview
Longview, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
University of Utah Midvalley Dermatology
Murray, Utah, United States
Jordan Valley Dermatology Center
South Jordan, Utah, United States
Virginia Clinical Research, Inc Vcr Pariser Dermatology Specialists, Ltd Norfolk Location
Norfolk, Virginia, United States
Frontier Dermatology
Mill Creek, Washington, United States
Seattle Children'S Hospital
Seattle, Washington, United States
Dermatology Specialists of Spokane
Spokane, Washington, United States
University of Wisconsin School of Medicine
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Kirk Barber Research
Calgary, Alberta, Canada
Dermatology Research Institute
Calgary, Alberta, Canada
Alberta Health Services (Ahs) - Alberta Children'S Hospital (Ach)
Calgary, Alberta, Canada
Laser Rejuvenation Clinics Edmonton D.T. Inc
Edmonton, Alberta, Canada
Alberta Dermasurgery Centre
Edmonton, Alberta, Canada
Coal Harbour Rejuvenation Dermatology, Inc.
Vancouver, British Columbia, Canada
Winnipeg Clinic
Winnipeg, Manitoba, Canada
Maritime Dermatology
Halifax, Nova Scotia, Canada
Childrens Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Dar Clinical Research Inc
Ottawa, Ontario, Canada
Research Toronto
Toronto, Ontario, Canada
University of Toronto - the Hospital For Sick Children (Sickkids)
Toronto, Ontario, Canada
Dermatelier on Avenue
Toronto, Ontario, Canada
Centre de Recherche St-Louis
Montreal, Quebec, Canada
Universite de Montreal - Centre Hospitalier Universitaire (Chu) Sainte-Justine - Centre de Recherche
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec - Centre Hospitalier de L'Universite Laval (Chul)
Québec, Quebec, Canada
Centre de Recherche Saint-Louis
Québec, Quebec, Canada
Saskatoon Dermatology Centre
Saskatoon, Saskatchewan, Canada
Skincare Studio Dermatology Centre
St. John's, , Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Related Links
Access external resources that provide additional context or updates about the study.
A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
INCB18424-312
Identifier Type: -
Identifier Source: org_study_id