A Study to Assess the Safety and Efficacy of Ruxolitinib Cream in Participants With Genital Vitiligo
Nonsegmental Vitiligo With Genital Involvement
About this trial
This is an interventional treatment trial for Nonsegmental Vitiligo With Genital Involvement focused on measuring Vitiligo, Genital Vitiligo, INCB18424, Ruxolitinib Cream
Eligibility Criteria
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.
Sites / Locations
- Center For Dermatology Clinical Research, IncRecruiting
- Vitiligo & Pigmentation Institute of Southern CaliforniaRecruiting
- Hamzavi DermatologyRecruiting
- Apex Clinical Research CenterRecruiting
- Austin Institute For Clinical Research Aicr PflugervilleRecruiting
- Innovative Dermatology: Legacy Medical Village
- Dermatology Research InstituteRecruiting
- Simcomed Health LtdRecruiting
- Skin Centre For DermatologyRecruiting
- Toronto Research CenreRecruiting
- Centre Hospitalier Universitaire de Bordeaux
- Hopital Henri Mondor Service de Dermatologie
- Chu Nice Hopital Archet 2
Arms of the Study
Arm 1
Experimental
Ruxolitinib Cream
Participants with non-segmental vitiligo with genital involvement will receive ruxolitinib 1.5% cream BID for up to 48 weeks