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The purpose of this study is to to evaluate the safety and efficacy of ruxolitinib cream in pediatric participants with nonsegmental vitiligo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ruxolitinib 1.5 % Cream | Experimental | Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol. |
|
| Vehicle Cream | Placebo Comparator | Participants received vehicle cream, applied topically to the affected area as defined by the protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ruxolitinib Cream | Drug | Ruxolitinib cream applied topically to the affected area as a thin film twice daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75) | ≥75% improvement in facial Vitiligo Area Scoring Index. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50) | ≥50% improvement in facial Vitiligo Area Scoring Index. | Week 24 |
| Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion Criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Incyte Corporation Call Center (US) | Contact | 1.855.463.3463 | medinfo@incyte.com | |
| Incyte Corporation Call Center (ex-US) | Contact | +800 00027423 | eumedinfo@incyte.com |
| Name | Affiliation | Role |
|---|---|---|
| Incyte Medical Monitor | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama At Birmingham-School of Medicine | Recruiting | Birmingham | Alabama | 35233 | United States | |
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| Label | URL |
|---|---|
| A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo | View source |
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Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
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| Vehicle Cream | Drug | Matching vehicle cream applied topically to the affected area as a thin film twice daily. |
|
≥90% improvement in facial Vitiligo Area Scoring Index.
| Week 24 |
| Proportion of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) | ≥50% improvement in total body Vitiligo Area Scoring Index. | Week 24 |
| Percentage change from baseline in F-BSA | Facial body surface area (F-BSA) takes into account the facial depigmented areas as a percentage of the total body area. | Week 24 |
| Number of Treatment Emergent Adverse Events (TEAEs) | TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. | Up to Week 52 and 30 days |
| Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50) | ≥50% improvement in facial Vitiligo Area Scoring Index. | Week 52 |
| Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI75) | ≥75% improvement in facial Vitiligo Area Scoring Index. | Week 52 |
| Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90) | ≥90% improvement in facial Vitiligo Area Scoring Index. | Week 52 |
| Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI50) | ≥50% improvement in total body Vitiligo Area Scoring Index. | Week 52 |
| Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI25) | ≥25% improvement in total body Vitiligo Area Scoring Index. | Week 24 and Week 52 |
| Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI75) | ≥75% improvement in total body Vitiligo Area Scoring Index | Week 24 and Week 52 |
| Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI90) | ≥90% improvement in total body Vitiligo Area Scoring Index | Week 24 and Week 52 |
| Pharmacokinetic (PK) of Ruxolitinib: Trough concentrations | Trough is defined as the concentration reached by a drug immediately before the next dose is administered. | Weeks 6, 24, 30 and 52 |
| Saguaro Dermatology |
| Recruiting |
| Phoenix |
| Arizona |
| 85008 |
| United States |
| Phoenix Children'S Hospital | Recruiting | Phoenix | Arizona | 85016 | United States |
| Omni Dermatology | Recruiting | Phoenix | Arizona | 85037 | United States |
| Affiliated Dermatology | Completed | Scottsdale | Arizona | 85255 | United States |
| Banner - University Medicine Multispecialty Services Clinic | Recruiting | Tucson | Arizona | 85718 | United States |
| Premier Dermatology Clinical Trials Institute At Northwest Arkansas | Recruiting | Fayetteville | Arkansas | 72703 | United States |
| Burke Pharmaceutical Research | Completed | Hot Springs | Arkansas | 71913 | United States |
| Axon Clinical Research | Recruiting | Inglewood | California | 90301 | United States |
| University of California Irvine | Recruiting | Irvine | California | 92697 | United States |
| Vitiligo & Pigmentation Institute of Southern California | Recruiting | Los Angeles | California | 90036-5609 | United States |
| Dermatology Research Associates | Recruiting | Los Angeles | California | 90045 | United States |
| La Universal Research Center, Inc | Recruiting | Los Angeles | California | 90057 | United States |
| Stanford School of Medicine | Recruiting | Palo Alto | California | 94304 | United States |
| Empire Clinical Research | Recruiting | Pomona | California | 91767 | United States |
| Peninsula Research Associates Pra | Completed | Rolling Hills Estates | California | 90274-7604 | United States |
| Rady Children'S Hospital-San Diego | Recruiting | San Diego | California | 92123 | United States |
| Golden State Dermatology | Not yet recruiting | Walnut Creek | California | 94598 | United States |
| Children'S Hospital Colorado | Recruiting | Aurora | Colorado | 80045 | United States |
| Paradigm Clinical Research Centers, Inc. | Recruiting | Wheat Ridge | Colorado | 80033 | United States |
| Skin Care Research, Llc | Recruiting | Boca Raton | Florida | 33486 | United States |
| Encore Medical Research, Llc Boynton Beach | Recruiting | Boynton Beach | Florida | 33436 | United States |
| Skin Care Research, Llc | Recruiting | Hollywood | Florida | 33201 | United States |
| Solutions Through Advanced Research, Inc | Recruiting | Jacksonville | Florida | 32256 | United States |
| Pediatric Skin Research Llc | Recruiting | Miami | Florida | 33146 | United States |
| Nicklaus Children'S Hospital | Recruiting | Miami | Florida | 33155 | United States |
| Dh Tamarac Research Center Etna Medical Center Emc | Recruiting | Tamarac | Florida | 33321 | United States |
| Usf Health Morsani Center For Advanced Healthcare | Recruiting | Tampa | Florida | 33612 | United States |
| Cleaver Medical Group | Recruiting | Cumming | Georgia | 30040 | United States |
| Advanced Medical Research Pc | Recruiting | Sandy Springs | Georgia | 30328 | United States |
| Treasure Valley Medical Research | Recruiting | Boise | Idaho | 83706 | United States |
| Illinois Dermatology Institute the Chicago Loop | Recruiting | Chicago | Illinois | 60602 | United States |
| Northwestern Memorial Hospital | Recruiting | Chicago | Illinois | 60611 | United States |
| Rush University Medical Center | Recruiting | Chicago | Illinois | 60612 | United States |
| Forefront Dermatology | Not yet recruiting | Libertyville | Illinois | 60048 | United States |
| Advanced Dermatology Lincolnshire | Withdrawn | Lincolnshire | Illinois | 60069-4344 | United States |
| Northshore University Healthsystem | Recruiting | Skokie | Illinois | 60077 | United States |
| Indiana University School of Medicine | Recruiting | Indianapolis | Indiana | 46202 | United States |
| Skin and Hair Center | Recruiting | Overland Park | Kansas | 66213 | United States |
| Wellskin Dermatology & Aesthetics | Completed | Bowling Green | Kentucky | 42104 | United States |
| Tulane University Health Sciences Center | Recruiting | New Orleans | Louisiana | 70112 | United States |
| Dermatology Associates Pc | Recruiting | Rockville | Maryland | 20850 | United States |
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| Metro Boston Clinical Partners | Completed | Brighton | Massachusetts | 02135-3511 | United States |
| Michigan Center For Research Company | Withdrawn | Clarkston | Michigan | 48346 | United States |
| Dermatology and Cosmetic Center | Recruiting | Flint | Michigan | 48507 | United States |
| Mi Skin Center, Pllc | Recruiting | Northville | Michigan | 48167 | United States |
| Michigan Dermatology Institute | Recruiting | Waterford | Michigan | 48328 | United States |
| University of Missouri Kansas City | Not yet recruiting | Kansas City | Missouri | 64108 | United States |
| Medisearch Clinical Trials | Completed | Saint Joseph | Missouri | 64506 | United States |
| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
| Boeson Research | Recruiting | Missoula | Montana | 59804 | United States |
| Skin Specialists Pc the Advanced Skin Research Center | Recruiting | Omaha | Nebraska | 68144 | United States |
| The University of New Mexico Unm Health Sciences Center Hsc | Recruiting | Albuquerque | New Mexico | 87102 | United States |
| Suny Downstate Medical Center | Recruiting | Brooklyn | New York | 11203 | United States |
| The Dermatology Specialists Greenwich | Recruiting | New York | New York | 10012 | United States |
| Equity Medical, Llc | Completed | New York | New York | 10023 | United States |
| Mount Sinai Doctors | Recruiting | New York | New York | 10028-3135 | United States |
| Sadick Dermatology Sadick Research Group | Completed | New York | New York | 10075 | United States |
| Skin Search of Rochester | Recruiting | Rochester | New York | 14623 | United States |
| Vitality Clinical Research Llc | Not yet recruiting | Woodbury | New York | 11797 | United States |
| Red River Research Partners | Recruiting | Fargo | North Dakota | 58103 | United States |
| Wright State Physicians Health Center | Recruiting | Beavercreek | Ohio | 45324 | United States |
| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
| Columbia Dermatology | Recruiting | Columbia | South Carolina | 29212 | United States |
| International Clinical Research Tennessee Llc | Completed | Murfreesboro | Tennessee | 37130 | United States |
| Dell Children'S Medical Group | Recruiting | Austin | Texas | 78723 | United States |
| The University of Texas Health Science Center At Houston | Recruiting | Bellaire | Texas | 77401 | United States |
| 3A Research Llc West Location | Recruiting | El Paso | Texas | 79902 | United States |
| Reveal Research Institute | Recruiting | Frisco | Texas | 75033 | United States |
| Acrc Trials | Recruiting | Grapevine | Texas | 07605 | United States |
| Us Dermatology Partners Longview | Completed | Longview | Texas | 75601 | United States |
| Texas Dermatology and Laser Specialists | Recruiting | San Antonio | Texas | 78218 | United States |
| Stryde Research | Recruiting | Southlake | Texas | 76092 | United States |
| University of Utah Midvalley Dermatology | Recruiting | Murray | Utah | 84107 | United States |
| Jordan Valley Dermatology Center | Recruiting | South Jordan | Utah | 84095 | United States |
| Frontier Dermatology | Recruiting | Mill Creek | Washington | 98012 | United States |
| Seattle Children'S Hospital | Recruiting | Seattle | Washington | 98105 | United States |
| Dermatology Specialists of Spokane | Recruiting | Spokane | Washington | 99202 | United States |
| University of Wisconsin School of Medicine | Recruiting | Madison | Wisconsin | 53715 | United States |
| Medical College of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
| Kirk Barber Research | Recruiting | Calgary | Alberta | T2G 1B1 | Canada |
| Dermatology Research Institute | Recruiting | Calgary | Alberta | T2J 7E1 | Canada |
| Alberta Health Services (Ahs) - Alberta Children'S Hospital (Ach) | Recruiting | Calgary | Alberta | T3B 6A8 | Canada |
| Laser Rejuvenation Clinics Edmonton D.T. Inc | Recruiting | Edmonton | Alberta | T5J 3S9 | Canada |
| Alberta Dermasurgery Centre | Recruiting | Edmonton | Alberta | T6G 1C3 | Canada |
| Skin Physicians | Not yet recruiting | Edmonton | Alberta | T6W 4V4 | Canada |
| Coal Harbour Rejuvenation Dermatology, Inc. | Recruiting | Vancouver | British Columbia | V6C 0C3 | Canada |
| Winnipeg Clinic | Recruiting | Winnipeg | Manitoba | R3C 1T6 | Canada |
| Maritime Dermatology | Recruiting | Halifax | Nova Scotia | B3K5R3 | Canada |
| Dermcare Clinic | Not yet recruiting | Mississauga | Ontario | L4W 0C2 | Canada |
| Childrens Hospital of Eastern Ontario | Withdrawn | Ottawa | Ontario | K1H 8L1 | Canada |
| Dar Clinical Research Inc | Recruiting | Ottawa | Ontario | K2T 0N7 | Canada |
| University of Toronto - the Hospital For Sick Children (Sickkids) | Recruiting | Toronto | Ontario | M5G1X8 | Canada |
| Cosmetic Dermatology on Bloor | Recruiting | Toronto | Ontario | M5S 3B4 | Canada |
| Centre de Recherche St-Louis | Recruiting | Montreal | Quebec | H1Y 3L1 | Canada |
| Universite de Montreal - Centre Hospitalier Universitaire (Chu) Sainte-Justine - Centre de Recherche | Recruiting | Montreal | Quebec | H3T 1C5 | Canada |
| Centre Hospitalier Universitaire de Quebec - Centre Hospitalier de L'Universite Laval (Chul) | Recruiting | Québec | Quebec | G1V 4G2 | Canada |
| Centre de Recherche Saint-Louis | Recruiting | Québec | Quebec | G1W 4R4 | Canada |
| Saskatoon Dermatology Centre | Recruiting | Saskatoon | Saskatchewan | S7T 0G3 | Canada |
| Skincare Studio Dermatology Centre | Recruiting | St. John's | A1E 1V4 | Canada |