An open-label study in which participants with non-segmental vitiligo with genital involvement will apply ruxolitinib 1.5% cream twice a day (BID) to all depigmented areas (up to 10% BSA) for up to 48 weeks. Participants should continue to treat depigmented areas identified for treatment at baseline regardless of whether the area begins to improve or fully repigment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Ruxolitinib cream will be applied twice daily for upto 48 weeks
Center For Dermatology Clinical Research, Inc
Fremont, California, United States
Vitiligo & Pigmentation Institute of Southern California
Los Angeles, California, United States
Hamzavi Dermatology
Fort Gratiot, Michigan, United States
Proportion of participants achieving a genital Vitiligo Noticeable Score (VNS) of 4 or 5
Vitiligo Noticeable Score (VNS) is a patient-reported outcome measure on a scale of 1-5, 1- more noticeable, 4 - a lot less noticeable, and 5- no longer noticeable
Time frame: Week 48
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Time frame: 52 weeks
Proportion of participants achieving Genital- Physician Global Vitiligo Assessment (PhGVA)
The severity of total body vitiligo will be assessed by the physician using the PhGVA on a scale of 0-4, 0 being clear to 4 being severe disease
Time frame: Week 48
Change from baseline in affected Body Surface Area BSA in the genital region
The BSA depigmented by vitiligo will be estimated at each visit.
Time frame: Week 24 and 48
Proportion of participants achieving T-VASI50/75/90
≥ 50%/75%/90% improvement in total body Vitiligo Area Scoring Index
Time frame: Week 24 and 48
Proportion of participants achieving a genital Vitiligo Noticeable Score (VNS) of 4 or 5
Vitiligo Noticeable Score (VNS) is a patient-reported outcome measure on a scale of 1-5, 1- more noticeable, 4 - a lot less noticeable, and 5- no longer noticeable
Time frame: Week 24
Proportion of participants in each category of the color-matching question
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Apex Clinical Research Center
Mayfield, Ohio, United States
Austin Institute For Clinical Research Aicr Pflugerville
Pflugerville, Texas, United States
Innovative Dermatology: Legacy Medical Village
Plano, Texas, United States
Dermatology Research Institute
Calgary, Alberta, Canada
Simcomed Health Ltd
Barrie, Ontario, Canada
Skin Centre For Dermatology
Peterborough, Ontario, Canada
Research Toronto
Toronto, Ontario, Canada
...and 3 more locations
Participants will answer how well the color of the treated skin matches the normal skin on a scale of 1-5, 1 being excellent to 5 being very poor.
Time frame: Week 24 and 48