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

Phase 2

Completed

• Conditions: Nonsegmental Vitiligo With Genital Involvement
• Interventions: Drug: Ruxolitinib Cream

• Registration Number: NCT05750823
• Lead Sponsor: Incyte Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-20
• Study First Submitted QC: 2023-02-20
• Study First Posted: 2023-03-02
• Study Start: 2023-04-11
• Primary Completion: 2025-03-06
• Study Completion: 2025-03-06
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• Clinical diagnosis of nonsegmental vitiligo with genital involvement
• At least ≥ 0.25% BSA of nonsegmental vitiligo in the genital area.
• Pigmented hair within some of the genital vitiligo areas.
• At least 1 genital target lesion that is ≥ 0.1% BSA that has a pigmented hair within it.
• Vitiligo on areas of the body besides the genitals.
• Total body vitiligo area not exceeding 10% BSA.
• Willing to have genital photography conducted.
• Must 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.
• Prior or current use of depigmentation treatments (eg, monobenzone).
• Active or recurrent genital warts or herpes.
• Male participants with partners with known current/active cervical intraepithelial neoplasia or anal intraepithelial neoplasia.
• An active sexually transmitted disease, sexually transmitted infection, or other skin disorder affecting the genital area (eg, scabies, fungal infection, molluscum).
• Had ≥ 3 laser hair removal treatments in an area to be treated for vitiligo.
• Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study or interpretation of study data.
• Clinical laboratory test results outside of protocol defined ranges
• Pregnant or lactating participants, or those considering pregnancy during the period of their study participation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ruxolitinib Cream	Ruxolitinib Cream	Participants with non-segmental vitiligo with genital involvement will receive ruxolitinib 1.5% cream BID for up to 48 weeks

Primary Outcome Measures

Name	Time	Method
Proportion of participants achieving a genital Vitiligo Noticeable Score (VNS) of 4 or 5	Week 48	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

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Treatment Emergent Adverse Events (TEAEs)	52 weeks	Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Proportion of participants achieving Genital- Physician Global Vitiligo Assessment (PhGVA)	Week 48	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
Change from baseline in affected Body Surface Area BSA in the genital region	Week 24 and 48	The BSA depigmented by vitiligo will be estimated at each visit.
Proportion of participants achieving T-VASI50/75/90	Week 24 and 48	≥ 50%/75%/90% improvement in total body Vitiligo Area Scoring Index
Proportion of participants achieving a genital Vitiligo Noticeable Score (VNS) of 4 or 5	Week 24	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
Proportion of participants in each category of the color-matching question	Week 24 and 48	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.

Trial Locations

Locations (13)

Vitiligo & Pigmentation Institute of Southern California; 🇺🇸 Los Angeles, California, United States

Research Toronto; 🇨🇦 Toronto, Ontario, Canada

Center For Dermatology Clinical Research, Inc; 🇺🇸 Fremont, California, United States

Hamzavi Dermatology; 🇺🇸 Fort Gratiot, Michigan, United States

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

Centre Hospitalier Universitaire de Bordeaux; 🇫🇷 Bordeaux, France

Hopital Henri Mondor Service de Dermatologie; 🇫🇷 Creteil, France

Chu Nice Hopital Archet 2; 🇫🇷 Nice, France