A Study to Assess the Safety and Efficacy of Ruxolitinib Cream in Participants With Genital Vitiligo

Conditions

• Nonsegmental Vitiligo With Genital Involvement

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ruxolitinib Cream — DRUG
  Ruxolitinib cream will be applied twice daily for upto 48 weeks

Study Details

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.

Key Dates

Start date

Apr 11, 2023

Status verified

Jan 2026

Primary completion

Mar 6, 2025

Completion

Mar 6, 2025

Study Design

Enrollment

49 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Ruxolitinib Cream
  Participants with non-segmental vitiligo with genital involvement will receive ruxolitinib 1.5% cream BID for up to 48 weeks

Primary Outcome Measure

Percentage of Participants Achieving a Genital Vitiligo Noticeability Scale (VNS) of "4 - A Lot Less Noticeable" or "5 - No Longer Noticeable" at Week 48 [ Time Frame: Baseline; Week 48 ]

Locations (6)

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