A Study to Evaluate the Mechanism of Action of Ruxolitinib Cream in Subjects With Vitiligo (TRuE-V MOA)
NCT ID: NCT04896385
Last Updated: 2025-08-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2021-06-23
2023-07-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Ruxolitinib cream
Ruxolitinib cream will be administered twice a day (BID) for 24 weeks
Ruxolitinib cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
Vehicle Cream
Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
Vehicle Cream
Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
Interventions
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Ruxolitinib cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
Vehicle Cream
Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 1 active vitiligo lesion (eg, such as confetti lesion, trichrome appearance, pinkish rim, or other evidence of inflammatory activity) at the site for skin biopsy.
* Agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit. Over-the-counter preparations deemed acceptable by the investigator and camouflage makeups are permitted.
Exclusion Criteria
* Other forms of vitiligo (eg, segmental) or 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).
* Used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas except hydroquinone.
* Any other skin disease that, in the opinion of the investigator, would interfere with the study medication application or study assessments.
* Conditions at baseline that would interfere with evaluation of vitiligo.
* Use of any protocol-defined treatments within the indicated washout period before baseline.
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Locations
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First Oc Dermatology
Fountain Valley, California, United States
UC Irvine
Irvine, California, United States
George Washington Medical Faculty Associates
Washington D.C., District of Columbia, United States
Suny Downstate Medical Center
Brooklyn, New York, United States
Mount Sinai Hospital
New York, New York, United States
Dermatology Specialists of Spokane
Spokane, Washington, United States
Dermatology Research Institute
Calgary, Alberta, Canada
Simcoderm Medical and Surgical Dermatology Center
Barrie, Ontario, Canada
Lynderm Research Inc
Markham, Ontario, Canada
JRB Research Inc
Ottawa, Ontario, Canada
Hopital Saint Andre
Bordeaux, , France
Centre Hospitalier Universitaire Henri Mondor
Créteil, , France
Hopital Archet 2 Derm Dept
Nice, , France
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2021-000361-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCB 18424-214
Identifier Type: -
Identifier Source: org_study_id
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