A Phase 3, Randomized, Double-Blind, Safety, and Efficacy Study of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo
Status: Recruiting
Location: See all (95) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to to evaluate the safety and efficacy of ruxolitinib cream in pediatric participants with nonsegmental vitiligo.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 11
Healthy Volunteers: f
View:
• Clinical diagnosis of nonsegmental vitiligo with depigmented area including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, ≥ 3 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.
Locations
United States
Alabama
University of Alabama At Birmingham-School of Medicine
NOT_YET_RECRUITING
Birmingham
Arkansas
Premier Dermatology Clinical Trials Institute At Northwest Arkansas
RECRUITING
Fayetteville
Burke Pharmaceutical Research
RECRUITING
Hot Springs
Arizona
Omni Dermatology
NOT_YET_RECRUITING
Phoenix
Phoenix Children'S Hospital
RECRUITING
Phoenix
Affiliated Dermatology
COMPLETED
Scottsdale
Banner - University Medicine Multispecialty Services Clinic
NOT_YET_RECRUITING
Tucson
California
Axon Clinical Research
RECRUITING
Inglewood
University of California Irvine
RECRUITING
Irvine
Dermatology Research Associates
RECRUITING
Los Angeles
La Universal Research Center, Inc
RECRUITING
Los Angeles
Vitiligo & Pigmentation Institute of Southern California
NOT_YET_RECRUITING
Los Angeles
Stanford School of Medicine
RECRUITING
Palo Alto
Empire Clinical Research
RECRUITING
Pomona
Norcal Clinical Research
NOT_YET_RECRUITING
Rocklin
Peninsula Research Associates Pra
RECRUITING
Rolling Hills Estates
Integrative Skin Science and Research
NOT_YET_RECRUITING
Sacramento
Rady Children'S Hospital-San Diego
RECRUITING
San Diego
Colorado
Children'S Hospital Colorado
RECRUITING
Aurora
Paradigm Clinical Research Centers, Inc.
RECRUITING
Wheat Ridge
Florida
Skin Care Research, Llc
RECRUITING
Boca Raton
Encore Medical Research, Llc Boynton Beach
NOT_YET_RECRUITING
Boynton Beach
Skin Care Research, Llc
RECRUITING
Hollywood
Solutions Through Advanced Research, Inc
RECRUITING
Jacksonville
Nicklaus Children'S Hospital
NOT_YET_RECRUITING
Miami
Pediatric Skin Research Llc
RECRUITING
Miami
Dh Tamarac Research Center Etna Medical Center Emc
RECRUITING
Tamarac
Usf Health Morsani Center For Advanced Healthcare
NOT_YET_RECRUITING
Tampa
Georgia
Emory University
NOT_YET_RECRUITING
Atlanta
Cleaver Medical Group
RECRUITING
Cumming
Advanced Medical Research Pc
RECRUITING
Sandy Springs
Idaho
Treasure Valley Medical Research
RECRUITING
Boise
Illinois
Illinois Dermatology Institute the Chicago Loop
RECRUITING
Chicago
Northwestern Memorial Hospital
RECRUITING
Chicago
Rush University Medical Center
RECRUITING
Chicago
Advanced Dermatology Lincolnshire
WITHDRAWN
Lincolnshire
Northshore University Healthsystem
RECRUITING
Skokie
Indiana
Indiana University School of Medicine
RECRUITING
Indianapolis
Kentucky
Wellskin Dermatology & Aesthetics
RECRUITING
Bowling Green
Louisiana
Tulane University Health Sciences Center
RECRUITING
New Orleans
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Metro Boston Clinical Partners
RECRUITING
Brighton
Maryland
Dermatology Associates Pc
RECRUITING
Rockville
Michigan
Michigan Center For Research Company
WITHDRAWN
Clarkston
Michigan Dermatology Institute
NOT_YET_RECRUITING
Waterford
Missouri
Medisearch Clinical Trials
RECRUITING
Saint Joseph
Montana
Boeson Research
RECRUITING
Missoula
North Dakota
Red River Research Partners
NOT_YET_RECRUITING
Fargo
Nebraska
Skin Specialists Pc the Advanced Skin Research Center
RECRUITING
Omaha
New Mexico
The University of New Mexico Unm Health Sciences Center Hsc
RECRUITING
Albuquerque
New York
Suny Downstate Medical Center
RECRUITING
Brooklyn
Equity Medical, Llc
RECRUITING
New York
Mount Sinai Doctors
RECRUITING
New York
Sadick Dermatology Sadick Research Group
RECRUITING
New York
The Dermatology Specialists Greenwich
RECRUITING
New York
Skin Search of Rochester
RECRUITING
Rochester
Ohio
Dermatologists of Southwestern Ohio, Llc
WITHDRAWN
Bexley
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Columbia Dermatology
RECRUITING
Columbia
Tennessee
International Clinical Research Tennessee Llc
RECRUITING
Murfreesboro
Texas
Dell Children'S Medical Group
NOT_YET_RECRUITING
Austin
The University of Texas Health Science Center At Houston
RECRUITING
Bellaire
Dfw Clinical Trials
NOT_YET_RECRUITING
Carrollton
3A Research Llc West Location
RECRUITING
El Paso
Reveal Research Institute
RECRUITING
Frisco
Pediatric Dermatology of North Texas
RECRUITING
Grapevine
Us Dermatology Partners Longview
RECRUITING
Longview
Texas Dermatology and Laser Specialists
RECRUITING
San Antonio
Utah
University of Utah Midvalley Dermatology
RECRUITING
Murray
Jordan Valley Dermatology Center
RECRUITING
South Jordan
Virginia
Virginia Clinical Research, Inc Vcr Pariser Dermatology Specialists, Ltd Norfolk Location
WITHDRAWN
Norfolk
Washington
Frontier Dermatology
RECRUITING
Mill Creek
Seattle Children'S Hospital
RECRUITING
Seattle
Dermatology Specialists of Spokane
RECRUITING
Spokane
Wisconsin
University of Wisconsin School of Medicine
NOT_YET_RECRUITING
Madison
Medical College of Wisconsin
RECRUITING
Milwaukee
Other Locations
Canada
Alberta Health Services (Ahs) - Alberta Children'S Hospital (Ach)
NOT_YET_RECRUITING
Calgary
Dermatology Research Institute
NOT_YET_RECRUITING
Calgary
Kirk Barber Research
NOT_YET_RECRUITING
Calgary
Alberta Dermasurgery Centre
RECRUITING
Edmonton
Laser Rejuvenation Clinics Edmonton D.T. Inc
NOT_YET_RECRUITING
Edmonton
Maritime Dermatology
RECRUITING
Halifax
Centre de Recherche St-Louis
NOT_YET_RECRUITING
Montreal
Universite de Montreal - Centre Hospitalier Universitaire (Chu) Sainte-Justine - Centre de Recherche
NOT_YET_RECRUITING
Montreal
Childrens Hospital of Eastern Ontario
WITHDRAWN
Ottawa
Dar Clinical Research Inc
RECRUITING
Ottawa
Centre de Recherche Saint-Louis
NOT_YET_RECRUITING
Québec
Centre Hospitalier Universitaire de Quebec - Centre Hospitalier de L'Universite Laval (Chul)
RECRUITING
Québec
Saskatoon Dermatology Centre
RECRUITING
Saskatoon
Skincare Studio Dermatology Centre
RECRUITING
St. John's
Dermatelier on Avenue
WITHDRAWN
Toronto
Research Toronto
RECRUITING
Toronto
University of Toronto - the Hospital For Sick Children (Sickkids)
NOT_YET_RECRUITING
Toronto
Coal Harbour Rejuvenation Dermatology, Inc.
RECRUITING
Vancouver
Winnipeg Clinic
RECRUITING
Winnipeg
Contact Information
Primary
Incyte Corporation Call Center (US)
medinfo@incyte.com
1.855.463.3463
Backup
Incyte Corporation Call Center (ex-US)
eumedinfo@incyte.com
+800 00027423
Time Frame
Start Date: 2025-01-24
Estimated Completion Date: 2027-03-13
Participants
Target number of participants: 180
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Incyte Corporation