Trial · NCT05750823
A Study to Assess the Safety and Efficacy of Ruxolitinib Cream in Participants With Genital Vitiligo
NCT05750823, Phase 2, Completed, Incyte Corporation; results first posted 2026-03-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Assess the Safety and Efficacy of Ruxolitinib Cream in Participants With Genital Vitiligo. Trials, record NCT05750823. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05750823
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Safety and Efficacy of Ruxolitinib Cream in Participants With Genital Vitiligo
- NCT number
- NCT05750823
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 49 participants, actual
- Lead sponsor
- Incyte Corporation
- Conditions
- Nonsegmental Vitiligo With Genital Involvement
- Interventions
- Ruxolitinib Cream
- First posted
- 2023-03-02
- Last updated
- 2026-03-20
- Results first posted
- 2026-03-20
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | 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. |
| Secondary | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | 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. |
| Secondary | Percentage of Participants Achieving Genital-Physician Global Vitiligo Assessment (PhGVA) of 0 or 1 at Week 48 | 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, extensive areas of vitiligo with complete depigmentation. Response was reported for the genital region (Genital-PhGVA). |
| Secondary | Change From Baseline in Affected Body Surface Area (BSA) in the Genital Region at Weeks 24 and 48 | 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 the genitals (which represents approximately 1% of the trunk). Genital BSA takes into account the depigmented areas of the labia majora, labia minora, and perineum in females and the penis, scrotum, and perineum in males. Change from baseline was calculated as the post-baseline value minus the baseline value. |
| Secondary | Percentage of Participants Achieving ≥50% Improvement in Total Body Vitiligo Area Scoring Index (T-VASI50) at Weeks 24 and 48 | 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 area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). |
| Secondary | Percentage of Participants Achieving ≥75% Improvement in Total Body Vitiligo Area Scoring Index (T-VASI75) at Weeks 24 and 48 | 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 area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). |
| Secondary | Percentage of Participants Achieving ≥90% Improvement in Total Body Vitiligo Area Scoring Index (T-VASI90) at Weeks 24 and 48 | 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 area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site and summing the values (range: 0-100; lower scores indicate increased improvement). |
| Secondary | Percentage of Participants Achieving a Genital VNS of "4 - A Lot Less Noticeable" or "5 - No Longer Noticeable" at Week 24 | 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. |
| Secondary | Percentage of Participants in Each Category of the Color-matching Question at Weeks 24 and 48 | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | Baseline; Week 48 | Full Analysis Set: all participants enrolled in the study who applied ruxolitinib cream at least once. Only participants with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | up to approximately 14 months | Full Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Achieving Genital-Physician Global Vitiligo Assessment (PhGVA) of 0 or 1 at Week 48 | Week 48 | Full Analysis Set. Only participants with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Affected Body Surface Area (BSA) in the Genital Region at Weeks 24 and 48 | Baseline; Weeks 24 and 48 | Full Analysis Set. Only participants with available data were analyzed. | BSA percentage | MEAN |
| SECONDARY | Percentage of Participants Achieving ≥50% Improvement in Total Body Vitiligo Area Scoring Index (T-VASI50) at Weeks 24 and 48 | Baseline; Weeks 24 and 48 | Full Analysis Set. Only participants with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving ≥75% Improvement in Total Body Vitiligo Area Scoring Index (T-VASI75) at Weeks 24 and 48 | Baseline; Weeks 24 and 48 | Full Analysis Set. Only participants with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving ≥90% Improvement in Total Body Vitiligo Area Scoring Index (T-VASI90) at Weeks 24 and 48 | Baseline; Weeks 24 and 48 | Full Analysis Set. Only participants with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a Genital VNS of 4 - A Lot Less Noticeable or 5 - No Longer Noticeable at Week 24 | Baseline; Week 24 | Full Analysis Set. Only participants with available data wee analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants in Each Category of the Color-matching Question at Weeks 24 and 48 | Baseline; Weeks 24 and 48 | Full Analysis Set. Only participants with available data were analyzed. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group23
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving a Genital Vitiligo Noticeability Scale (VNS) of 4 - A Lot Less Noticeable or 5 - No Longer Noticeable at Week 48 | Ruxolitinib 1.5% Cream BID | 27.0 | percentage of participants | ||
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Ruxolitinib 1.5% Cream BID | 19 | Participants | ||
| Percentage of Participants Achieving Genital-Physician Global Vitiligo Assessment (PhGVA) of 0 or 1 at Week 48 | Ruxolitinib 1.5% Cream BID | 10.8 | percentage of participants | ||
| Change From Baseline in Affected Body Surface Area (BSA) in the Genital Region at Weeks 24 and 48 | Ruxolitinib 1.5% Cream BID | Baseline | 0.762 | Standard Deviation 0.4899 | BSA percentage |
| Change From Baseline in Affected Body Surface Area (BSA) in the Genital Region at Weeks 24 and 48 | Ruxolitinib 1.5% Cream BID | Change from baseline at Week 24 | -0.115 | Standard Deviation 0.4224 | BSA percentage |
| Change From Baseline in Affected Body Surface Area (BSA) in the Genital Region at Weeks 24 and 48 | Ruxolitinib 1.5% Cream BID | Change from baseline at Week 48 | -0.185 | Standard Deviation 0.4129 | BSA percentage |
| Percentage of Participants Achieving ≥50% Improvement in Total Body Vitiligo Area Scoring Index (T-VASI50) at Weeks 24 and 48 | Ruxolitinib 1.5% Cream BID | Week 24 | 24.4 | percentage of participants | |
| Percentage of Participants Achieving ≥50% Improvement in Total Body Vitiligo Area Scoring Index (T-VASI50) at Weeks 24 and 48 | Ruxolitinib 1.5% Cream BID | Week 48 | 35.1 | percentage of participants | |
| Percentage of Participants Achieving ≥75% Improvement in Total Body Vitiligo Area Scoring Index (T-VASI75) at Weeks 24 and 48 | Ruxolitinib 1.5% Cream BID | Week 24 | 7.3 | percentage of participants | |
| Percentage of Participants Achieving ≥75% Improvement in Total Body Vitiligo Area Scoring Index (T-VASI75) at Weeks 24 and 48 | Ruxolitinib 1.5% Cream BID | Week 48 | 16.2 | percentage of participants |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ruxolitinib 1.5% Cream BID | 49 | |
| Overall Study | COMPLETED | Ruxolitinib 1.5% Cream BID | 35 | |
| Overall Study | NOT COMPLETED | Ruxolitinib 1.5% Cream BID | 14 |
Source ClinicalTrials.gov
Adverse events1
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Substance-induced psychotic disorder | Psychiatric disorders | Ruxolitinib 1.5% Cream BID | 1 | 49 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ruxolitinib 1.5% Cream BID | 0 | 49 |
| Total, other adverse events | Ruxolitinib 1.5% Cream BID | 0 | 49 |
| Total, serious adverse events | Ruxolitinib 1.5% Cream BID | 1 | 49 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05750823
GET https://conductscience.org/api/trials/v1/NCT05750823/results?page=2