Phase 2
N=49
A Study to Assess the Safety and Efficacy of Ruxolitinib Cream in Participants With Genital Vitiligo
Nonsegmental Vitiligo With Genital Involvement
Bottom Line
View on ClinicalTrials.gov: NCT05750823 ↗Enrolled (actual)
49
Serious AEs
2.0%
Results posted
Mar 2026
Primary outcome: Primary: Percentage of Participants Achieving a Genital Vitiligo Noticeability Scale (VNS) of "4 - A Lot Less Noticeable" or "5 - No Longer Noticeable" at Week 48 — 27.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ruxolitinib Cream (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Incyte Corporation
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving a Genital Vitiligo Noticeability Scale (VNS) of "4 - A Lot Less Noticeable" or "5 - No Longer Noticeable" at Week 48 |
27.0 | — |
| SECONDARY Number of Participants With Any Treatment-emergent Adverse Event (TEAE) |
19 | — |
| SECONDARY Percentage of Participants Achieving Genital-Physician Global Vitiligo Assessment (PhGVA) of 0 or 1 at Week 48 |
10.8 | — |
| SECONDARY Change From Baseline in Affected Body Surface Area (BSA) in the Genital Region at Weeks 24 and 48 |
0.762; -0.115; -0.185 | — |
| SECONDARY Percentage of Participants Achieving ≥50% Improvement in Total Body Vitiligo Area Scoring Index (T-VASI50) at Weeks 24 and 48 |
24.4; 35.1 | — |
| SECONDARY Percentage of Participants Achieving ≥75% Improvement in Total Body Vitiligo Area Scoring Index (T-VASI75) at Weeks 24 and 48 |
7.3; 16.2 | — |
| SECONDARY Percentage of Participants Achieving ≥90% Improvement in Total Body Vitiligo Area Scoring Index (T-VASI90) at Weeks 24 and 48 |
0.0; 8.1 | — |
| SECONDARY Percentage of Participants Achieving a Genital VNS of "4 - A Lot Less Noticeable" or "5 - No Longer Noticeable" at Week 24 |
17.9 | — |
| SECONDARY Percentage of Participants in Each Category of the Color-matching Question at Weeks 24 and 48 |
10.3; 15.4; 25.6; 43.6; 5.1; 10.8 | — |
Summary
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.
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.
Data sourced from ClinicalTrials.gov (NCT05750823). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.