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

An Open-Label, Phase 2, Safety, and Efficacy Study of Ruxolitinib Cream in Participants With Genital Vitiligo

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.

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.