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

Completed · Phase 2

Conditions studied: Nonsegmental Vitiligo With Genital Involvement

In brief

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 facts

Study ID

NCT05750823

Run by

Incyte Corporation

People needed

49

Starts

2023-04-11

Expected to finish

2025-03-06

Last updated by the study team

2026-03-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• 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
• Centre Hospitalier Universitaire de Bordeaux — Bordeaux, France
• Hopital Henri Mondor Service de Dermatologie — Créteil, France
• Chu Nice Hopital Archet 2 — Nice, France

Full record on ClinicalTrials.gov

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