CompletedPhase 2
A Study to Assess the Safety and Efficacy of Ruxolitinib Cream in Participants With Genital Vitiligo
Key facts
- Who runs it
- Incyte Corporation
- Where
- Fort Gratiot, Fremont, Los Angeles, Mayfield, Pflugerville, and Plano, United StatesSee the 6 sitesAlso in 2 other countries, 7 sites
- Trial code
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 49 people enrolled
- Started
- 11 Apr 2023
- Ended
- 6 Mar 2025
- Type of study
- Interventional
- Treatments tested
- Ruxolitinib Cream
- Record updated
- 20 March 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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
Who cannot take part
- Prior or current use of depigmentation treatments (eg, monobenzone)
- Other forms of vitiligo (eg, segmental) or other differential diagnosis of vitiligo or other skin depigmentation disorders
- An active sexually transmitted disease, sexually transmitted infection, or other skin disorder affecting the genital area (eg, scabies, fungal infection, molluscum)
- 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
- Active or recurrent genital warts or herpes
- Male participants with partners with known current/active cervical intraepithelial neoplasia or anal intraepithelial neoplasia
- Had ≥ 3 laser hair removal treatments in an area to be treated for vitiligo
- Pregnant or lactating participants, or those considering pregnancy during the period of their study participation
Where in United States
Also in 2 other countries, 7 sites
- Hamzavi DermatologyFort Gratiot, United StatesNo longer taking part
- Center For Dermatology Clinical Research, Inc.Fremont, United StatesNo longer taking part
- Vitiligo & Pigmentation Institute of Southern CaliforniaLos Angeles, United StatesNo longer taking part
- Apex Clinical Research CenterMayfield, United StatesNo longer taking part
- Austin Institute For Clinical Research Aicr PflugervillePflugerville, United StatesNo longer taking part
- Innovative Dermatology: Legacy Medical VillagePlano, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The group in the trial
- Ruxolitinib CreamTreatment being tested
Participants with non-segmental vitiligo with genital involvement will receive ruxolitinib 1.5% cream BID for up to 48 weeks
Data and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- An Open-Label, Phase 2, Safety, and Efficacy Study of Ruxolitinib Cream in Participants With Genital Vitiligo
- Record updated
- 20 March 2026