Phase 2
Completed N=49
A Study to Assess the Safety and Efficacy of Ruxolitinib Cream in Participants With Genital Vitiligo
Nonsegmental Vitiligo With Genital Involvement
Source: ClinicalTrials.gov NCT05750823 ↗
Enrolled (actual)
49
Serious AEs
2.0%
Results posted
Mar 2026
Primary outcomePrimary: 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
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.
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 | — |
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. Informational only — not medical advice.