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

Incyte

Status and phase

Active, not recruiting

Phase 2

Conditions

Nonsegmental Vitiligo With Genital Involvement

Treatments

Drug: Ruxolitinib Cream

Study type

Interventional

Funder types

Industry

Identifiers

NCT05750823

INCB 18424-219

Details and patient eligibility

About

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.

Enrollment

49 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.