Actively Recruiting

Phase 3
Age: 2Years - 11Years
All Genders
NCT06548360

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

Led by Incyte Corporation · Updated on 2025-12-18

180

Participants Needed

99

Research Sites

111 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 2Years - 11Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis of nonsegmental vitiligo with depigmented area including 6 0.5% BSA on the face, 6 0.5 F-VASI, 6 3% BSA on nonfacial areas, 6 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 stop all vitiligo treatments from screening through final safety follow-up
  • Sexually active participants (except prepubescent) must agree to avoid pregnancy or fathering a child from screening through 30 days after last cream application
Not Eligible

You will not qualify if you...

  • Diagnosis of other forms of vitiligo such as segmental
  • Other skin conditions causing depigmentation (e.g., piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, tinea versicolor)
  • Any other skin disease interfering with cream application or assessments
  • Prior or current use of depigmentation treatments like monobenzone
  • Serious illness or medical, physical, or psychiatric conditions interfering with participation or safety
  • Use of protocol-defined treatments within washout period before baseline
  • Current or previous use of JAK inhibitors, systemic or topical
  • Clinically significant abnormal lab values at screening
  • BMI-for-age below 5th percentile or above 85th percentile per CDC calculator
  • Pregnant or lactating participants or considering pregnancy during study
  • Unable or unlikely to comply with application schedule and evaluations
  • Living with anyone in any current Incyte-sponsored ruxolitinib cream study
  • Employees or dependents of sponsor or investigator
  • Known allergy or reaction to any study cream component
  • Other protocol-defined inclusion/exclusion criteria may apply

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 99 locations

1

University of Alabama At Birmingham-School of Medicine

Birmingham, Alabama, United States, 35233

Not Yet Recruiting

2

Phoenix Children'S Hospital

Phoenix, Arizona, United States, 85016

Actively Recruiting

3

Omni Dermatology

Phoenix, Arizona, United States, 85037

Not Yet Recruiting

4

Affiliated Dermatology

Scottsdale, Arizona, United States, 85255

Completed

5

Banner - University Medicine Multispecialty Services Clinic

Tucson, Arizona, United States, 85718

Actively Recruiting

6

Premier Dermatology Clinical Trials Institute At Northwest Arkansas

Fayetteville, Arkansas, United States, 72703

Actively Recruiting

7

Burke Pharmaceutical Research

Hot Springs, Arkansas, United States, 71913

Actively Recruiting

8

Axon Clinical Research

Inglewood, California, United States, 90301

Actively Recruiting

9

University of California Irvine

Irvine, California, United States, 92697

Actively Recruiting

10

Vitiligo & Pigmentation Institute of Southern California

Los Angeles, California, United States, 90036-5609

Actively Recruiting

11

Dermatology Research Associates

Los Angeles, California, United States, 90045

Actively Recruiting

12

La Universal Research Center, Inc

Los Angeles, California, United States, 90057

Actively Recruiting

13

Stanford School of Medicine

Palo Alto, California, United States, 94304

Actively Recruiting

14

Empire Clinical Research

Pomona, California, United States, 91767

Actively Recruiting

15

Norcal Clinical Research

Rocklin, California, United States, 95765

Not Yet Recruiting

16

Peninsula Research Associates Pra

Rolling Hills Estates, California, United States, 90274-7604

Completed

17

Integrative Skin Science and Research

Sacramento, California, United States, 95815

Not Yet Recruiting

18

Rady Children'S Hospital-San Diego

San Diego, California, United States, 92123

Actively Recruiting

19

Children'S Hospital Colorado

Aurora, Colorado, United States, 80045

Actively Recruiting

20

Paradigm Clinical Research Centers, Inc.

Wheat Ridge, Colorado, United States, 80033

Actively Recruiting

21

Skin Care Research, Llc

Boca Raton, Florida, United States, 33486

Actively Recruiting

22

Encore Medical Research, Llc Boynton Beach

Boynton Beach, Florida, United States, 33436

Actively Recruiting

23

Skin Care Research, Llc

Hollywood, Florida, United States, 33201

Actively Recruiting

24

Solutions Through Advanced Research, Inc

Jacksonville, Florida, United States, 32256

Actively Recruiting

25

Pediatric Skin Research Llc

Miami, Florida, United States, 33146

Actively Recruiting

26

Nicklaus Children'S Hospital

Miami, Florida, United States, 33155

Actively Recruiting

27

Dh Tamarac Research Center Etna Medical Center Emc

Tamarac, Florida, United States, 33321

Actively Recruiting

28

Usf Health Morsani Center For Advanced Healthcare

Tampa, Florida, United States, 33612

Actively Recruiting

29

Emory University

Atlanta, Georgia, United States, 30322

Not Yet Recruiting

30

Cleaver Medical Group

Cumming, Georgia, United States, 30040

Actively Recruiting

31

Advanced Medical Research Pc

Sandy Springs, Georgia, United States, 30328

Actively Recruiting

32

Treasure Valley Medical Research

Boise, Idaho, United States, 83706

Actively Recruiting

33

Illinois Dermatology Institute the Chicago Loop

Chicago, Illinois, United States, 60602

Actively Recruiting

34

Northwestern Memorial Hospital

Chicago, Illinois, United States, 60611

Actively Recruiting

35

Rush University Medical Center

Chicago, Illinois, United States, 60612

Actively Recruiting

36

Forefront Dermatology

Libertyville, Illinois, United States, 60048

Not Yet Recruiting

37

Advanced Dermatology Lincolnshire

Lincolnshire, Illinois, United States, 60069-4344

Withdrawn

38

Northshore University Healthsystem

Skokie, Illinois, United States, 60077

Actively Recruiting

39

Indiana University School of Medicine

Indianapolis, Indiana, United States, 46202

Actively Recruiting

40

Wellskin Dermatology & Aesthetics

Bowling Green, Kentucky, United States, 42104

Completed

41

Tulane University Health Sciences Center

New Orleans, Louisiana, United States, 70112

Actively Recruiting

42

Dermatology Associates Pc

Rockville, Maryland, United States, 20850

Actively Recruiting

43

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

44

Metro Boston Clinical Partners

Brighton, Massachusetts, United States, 02135-3511

Completed

45

Michigan Center For Research Company

Clarkston, Michigan, United States, 48346

Withdrawn

46

Mi Skin Center, Pllc

Northville, Michigan, United States, 48167

Not Yet Recruiting

47

Michigan Dermatology Institute

Waterford, Michigan, United States, 48328

Not Yet Recruiting

48

Medisearch Clinical Trials

Saint Joseph, Missouri, United States, 64506

Completed

49

Boeson Research

Missoula, Montana, United States, 59804

Actively Recruiting

50

Skin Specialists Pc the Advanced Skin Research Center

Omaha, Nebraska, United States, 68144

Actively Recruiting

51

The University of New Mexico Unm Health Sciences Center Hsc

Albuquerque, New Mexico, United States, 87102

Actively Recruiting

52

Suny Downstate Medical Center

Brooklyn, New York, United States, 11203

Actively Recruiting

53

The Dermatology Specialists Greenwich

New York, New York, United States, 10012

Actively Recruiting

54

Equity Medical, Llc

New York, New York, United States, 10023

Actively Recruiting

55

Mount Sinai Doctors

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

Actively Recruiting

56

Sadick Dermatology Sadick Research Group

New York, New York, United States, 10075

Completed

57

Skin Search of Rochester

Rochester, New York, United States, 14623

Actively Recruiting

58

Vitality Clinical Research Llc

Woodbury, New York, United States, 11797

Not Yet Recruiting

59

Red River Research Partners

Fargo, North Dakota, United States, 58103

Actively Recruiting

60

Dermatologists of Southwestern Ohio, Llc

Bexley, Ohio, United States, 43209

Withdrawn

61

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Actively Recruiting

62

Columbia Dermatology

Columbia, South Carolina, United States, 29212

Actively Recruiting

63

International Clinical Research Tennessee Llc

Murfreesboro, Tennessee, United States, 37130

Completed

64

Dell Children'S Medical Group

Austin, Texas, United States, 78723

Not Yet Recruiting

65

The University of Texas Health Science Center At Houston

Bellaire, Texas, United States, 77401

Actively Recruiting

66

Dfw Clinical Trials

Carrollton, Texas, United States, 75010

Not Yet Recruiting

67

3A Research Llc West Location

El Paso, Texas, United States, 79902

Actively Recruiting

68

Reveal Research Institute

Frisco, Texas, United States, 75033

Actively Recruiting

69

Acrc Trials

Grapevine, Texas, United States, 07605

Actively Recruiting

70

Us Dermatology Partners Longview

Longview, Texas, United States, 75601

Actively Recruiting

71

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States, 78218

Actively Recruiting

72

Stryde Research

Southlake, Texas, United States, 76092

Not Yet Recruiting

73

University of Utah Midvalley Dermatology

Murray, Utah, United States, 84107

Actively Recruiting

74

Jordan Valley Dermatology Center

South Jordan, Utah, United States, 84095

Actively Recruiting

75

Virginia Clinical Research, Inc Vcr Pariser Dermatology Specialists, Ltd Norfolk Location

Norfolk, Virginia, United States, 23502

Withdrawn

76

Frontier Dermatology

Mill Creek, Washington, United States, 98012

Actively Recruiting

77

Seattle Children'S Hospital

Seattle, Washington, United States, 98105

Actively Recruiting

78

Dermatology Specialists of Spokane

Spokane, Washington, United States, 99202

Actively Recruiting

79

University of Wisconsin School of Medicine

Madison, Wisconsin, United States, 53715

Not Yet Recruiting

80

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

81

Kirk Barber Research

Calgary, Alberta, Canada, T2G 1B1

Actively Recruiting

82

Dermatology Research Institute

Calgary, Alberta, Canada, T2J 7E1

Not Yet Recruiting

83

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

Calgary, Alberta, Canada, T3B 6A8

Not Yet Recruiting

84

Laser Rejuvenation Clinics Edmonton D.T. Inc

Edmonton, Alberta, Canada, T5J 3S9

Actively Recruiting

85

Alberta Dermasurgery Centre

Edmonton, Alberta, Canada, T6G 1C3

Actively Recruiting

86

Coal Harbour Rejuvenation Dermatology, Inc.

Vancouver, British Columbia, Canada, V6C 0C3

Actively Recruiting

87

Winnipeg Clinic

Winnipeg, Manitoba, Canada, R3C 1T6

Actively Recruiting

88

Maritime Dermatology

Halifax, Nova Scotia, Canada, B3K5R3

Actively Recruiting

89

Childrens Hospital of Eastern Ontario

Ottawa, Ontario, Canada, K1H 8L1

Withdrawn

90

Dar Clinical Research Inc

Ottawa, Ontario, Canada, K2T 0N7

Actively Recruiting

91

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

Toronto, Ontario, Canada, M5G1X8

Not Yet Recruiting

92

Dermatelier on Avenue

Toronto, Ontario, Canada, M5M 3Z8

Withdrawn

93

Cosmetic Dermatology on Bloor

Toronto, Ontario, Canada, M5S 3B4

Actively Recruiting

94

Centre de Recherche St-Louis

Montreal, Quebec, Canada, H1Y 3L1

Actively Recruiting

95

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

Montreal, Quebec, Canada, H3T 1C5

Not Yet Recruiting

96

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

Québec, Quebec, Canada, G1V 4G2

Actively Recruiting

97

Centre de Recherche Saint-Louis

Québec, Quebec, Canada, G1W 4R4

Actively Recruiting

98

Saskatoon Dermatology Centre

Saskatoon, Saskatchewan, Canada, S7T 0G3

Actively Recruiting

99

Skincare Studio Dermatology Centre

St. John's, Canada, A1E 1V4

Actively Recruiting

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Research Team

I

Incyte Corporation Call Center (US)

CONTACT

I

Incyte Corporation Call Center (ex-US)

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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