18 and older, any sex, with Nonsegmental Vitiligo With Genital Involvement. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants Achieving a Genital Vitiligo Noticeability Scale (VNS) of "4 - A Lot Less Noticeable" or "5 - No Longer Noticeable" at Week 48Primary· Baseline; Week 48
The VNS is a patient-reported measure of vitiligo treatment success that has a 5-point scale. The participant was asked to respond to the following query: "Compared with before treatment, how noticeable is the vitiligo now? Responses: (1) more noticeable, (2) as noticeable, (3) slightly less noticeable, (4) a lot less noticeable, or (5) no longer noticeable. The baseline genital photograph was shown to the participant for reference. A VNS score of 4 or 5 can be interpreted as representing treatment success.
Group
Value
95% CI
Ruxolitinib 1.5% Cream BID
27.0
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)Secondary· up to approximately 14 months
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug and within 30 days of the last administration of study drug.
Group
Value
95% CI
Ruxolitinib 1.5% Cream BID
19
Percentage of Participants Achieving Genital-Physician Global Vitiligo Assessment (PhGVA) of 0 or 1 at Week 48Secondary· Week 48
The severity of genital vitiligo was assessed by the physician using the PhGVA, which has a 5-point scale: 0=clear, no signs of vitiligo or complete/near complete repigmentation; 1=almost clear, mostly pigmented areas with small depigmented or difficult to repigment areas (e.g., shaft of penis or labia minora); 2=mild disease, modest areas of depigmentation with approximately 50% pigmentation within vitiligo areas or significant perifollicular pattern present; 3=moderate disease, large areas of depigmented vitiligo areas/significant depigmentation within vitiligo areas; 4=severe disease, exten
Group
Value
95% CI
Ruxolitinib 1.5% Cream BID
10.8
Change From Baseline in Affected Body Surface Area (BSA) in the Genital Region at Weeks 24 and 48Secondary· Baseline; Weeks 24 and 48
BSA assessments were performed using the palmar method and was estimated to the nearest 0.1%. The approximate size of the participant's entire palmar surface (i.e., the palm plus 5 digits) was considered as 1% BSA, and the approximate size of the participant's thumb was considered as 0.1% BSA. Total BSA takes into account the depigmented areas for each of the following body regions: head/neck (including face and scalp), upper extremities (including axillae), hands, trunk (including genitalia), lower extremities (including buttocks), and feet. The BSA depigmented by vitiligo was assessed for th
Baseline
Group
Value
95% CI
Ruxolitinib 1.5% Cream BID
0.762
± 0.4899
Change from baseline at Week 24
Group
Value
95% CI
Ruxolitinib 1.5% Cream BID
-0.115
± 0.4224
Change from baseline at Week 48
Group
Value
95% CI
Ruxolitinib 1.5% Cream BID
-0.185
± 0.4129
Percentage of Participants Achieving ≥50% Improvement in Total Body Vitiligo Area Scoring Index (T-VASI50) at Weeks 24 and 48Secondary· Baseline; Weeks 24 and 48
A T-VASI50 responder achieved ≥50% improvement from Baseline in T-VASI, calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to the nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented ar
Week 24
Group
Value
95% CI
Ruxolitinib 1.5% Cream BID
24.4
Week 48
Group
Value
95% CI
Ruxolitinib 1.5% Cream BID
35.1
Percentage of Participants Achieving ≥75% Improvement in Total Body Vitiligo Area Scoring Index (T-VASI75) at Weeks 24 and 48Secondary· Baseline; Weeks 24 and 48
A T-VASI75 responder achieved ≥75% improvement from Baseline in T-VASI, calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to the nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented ar
Week 24
Group
Value
95% CI
Ruxolitinib 1.5% Cream BID
7.3
Week 48
Group
Value
95% CI
Ruxolitinib 1.5% Cream BID
16.2
Percentage of Participants Achieving ≥90% Improvement in Total Body Vitiligo Area Scoring Index (T-VASI90) at Weeks 24 and 48Secondary· Baseline; Weeks 24 and 48
A T-VASI90 responder achieved ≥90% improvement from Baseline in T-VASI, calculated with contributions from 6 sites. The percentage of vitiligo involvement was estimated in hand units (percentage of BSA estimated to the nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented ar
Week 24
Group
Value
95% CI
Ruxolitinib 1.5% Cream BID
0.0
Week 48
Group
Value
95% CI
Ruxolitinib 1.5% Cream BID
8.1
Percentage of Participants Achieving a Genital VNS of "4 - A Lot Less Noticeable" or "5 - No Longer Noticeable" at Week 24Secondary· Baseline; Week 24
The VNS is a patient-reported measure of vitiligo treatment success that has a 5-point scale. The participant was asked to respond to the following query: "Compared with before treatment, how noticeable is the vitiligo now? Responses: (1) more noticeable, (2) as noticeable, (3) slightly less noticeable, (4) a lot less noticeable, or (5) no longer noticeable. The baseline genital photograph was shown to the participant for reference. A VNS score of 4 or 5 can be interpreted as representing treatment success.
Group
Value
95% CI
Ruxolitinib 1.5% Cream BID
17.9
Percentage of Participants in Each Category of the Color-matching Question at Weeks 24 and 48Secondary· Baseline; Weeks 24 and 48
Participants were shown their baseline genital photograph for reference, and were asked to respond to the following query: "At this point of your treatment, how well does your genital skin color match between your treated vitiligo skin and normal skin?: Responses: (1) excellent, (2) very good, (3) good, (4) poor, or (5) very poor.
Week 24; Excellent
Group
Value
95% CI
Ruxolitinib 1.5% Cream BID
10.3
Week 24; Very good
Group
Value
95% CI
Ruxolitinib 1.5% Cream BID
15.4
Week 24; Good
Group
Value
95% CI
Ruxolitinib 1.5% Cream BID
25.6
Week 24; Poor
Group
Value
95% CI
Ruxolitinib 1.5% Cream BID
43.6
Week 24; Very poor
Group
Value
95% CI
Ruxolitinib 1.5% Cream BID
5.1
Week 48; Excellent
Group
Value
95% CI
Ruxolitinib 1.5% Cream BID
10.8
Week 48; Very good
Group
Value
95% CI
Ruxolitinib 1.5% Cream BID
16.2
Week 48; Good
Group
Value
95% CI
Ruxolitinib 1.5% Cream BID
40.5
Adverse events — posted to ClinicalTrials.gov
Time frame: up to approximately 14 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06804811 — A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Children (6 to < 12 Years Old) With Nonsegmental Vit
· Phase 3
· recruiting
NCT07049575 — Study to Evaluate the Maximal Use of Ruxolitinib Cream in Adult and Adolescent Participants With Hidradenitis Suppurativ
· Phase 1
· recruiting
NCT06959225 — Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS1)
· Phase 3
· recruiting
NCT06958211 — Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS2)
· Phase 3
· recruiting
NCT06548360 — A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo
· Phase 3
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Incyte Corporation
Last refreshed: 20 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05750823.