Trial · NCT04057573
Topical Ruxolitinib Evaluation in Vitiligo Study 2 (TRuE-V2)
NCT04057573, Phase 3, Completed, Incyte Corporation; results first posted 2022-09-21
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Topical Ruxolitinib Evaluation in Vitiligo Study 2 (TRuE-V2). Trials, record NCT04057573. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04057573
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Topical Ruxolitinib Evaluation in Vitiligo Study 2 (TRuE-V2)
- NCT number
- NCT04057573
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 344 participants, actual
- Lead sponsor
- Incyte Corporation
- Conditions
- Non-segmental Vitiligo
- Interventions
- Ruxolitinib cream, Vehicle
- First posted
- 2019-08-15
- Last updated
- 2025-08-22
- Other registries' IDs
- eudract:2019-000847-28
- Results first posted
- 2022-09-21
- Limitations and caveats
Data from participants at a single site were excluded from all efficacy analyses done on the Intent-to-Treat Population owing to serious noncompliance with the protocol resulting in serious concerns with the data quality.
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving a ≥ 75% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at Week 24 | Baseline; Week 24 | An F-VASI75 responder achieved at least 75% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of body surface area \[BSA\]) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was 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 the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). |
| Secondary | Percentage of Participants Achieving a ≥ 50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score at Week 24 | Baseline; Week 24 | An F-VASI50 responder achieved at least 50% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was 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 the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). |
| Secondary | Percentage of Participants Achieving a ≥ 90% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI90) Score at Week 24 | Baseline; Week 24 | An F-VASI90 responder achieved at least 90% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was 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 the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). |
| Secondary | Percentage of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score at Week 24 | Baseline; Week 24 | A T-VASI50 responder achieved at least 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 a Vitiligo Noticeability Scale (VNS) of 4 or 5 at Week 24 | Baseline; Week 24 | The VNS is a patient-reported measure of vitiligo treatment success that is rated on a 5-point scale. The Baseline facial photograph was shown to the participants for reference, and a mirror was provided for the participants to assess the vitiligo on their face. 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, and (5) no longer noticeable. |
| Secondary | Percentage Change From Baseline in Facial Body Surface Area (F-BSA) at Week 24 | Baseline; Week 24 | F-BSA involvement was the proportion of the facial body surface area with vitiligo. The area "Face" was defined as including the area on the forehead to the original hairline, on the cheek to the jawline vertically to the jawline and laterally from the corner of the mouth to the tragus. The area "Face" did not include surface area of the lips, scalp, ears, or neck, but included the nose and eyelids. Body surface area assessment was performed by the Palmar Method. Body surface area 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. Percentage change = (\[post-Baseline (BL) value minus BL value\]/BL value) X 100. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Double-Blind Period | from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 24) | An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Treatment-Extension Period | from the completion of the Week 24 assessments until at least 30 days after the last application of study drug (up to Week 52 + 30 days) | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. |
| Secondary | Percentage of Participants Achieving a ≥ 25% Improvement in the Face Vitiligo Area Scoring Index (F-VASI25) Score at Week 24 | Baseline; Week 24 | An F-VASI25 responder achieved at least 25% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was 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 the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). |
| Secondary | Percentage of Participants Achieving a ≥ %25, ≥ %50, ≥ 75%, and ≥ 90% Improvement in the Face Vitiligo Area Scoring Index (F-VASI25/50/75/90) Score at Week 52 | Baseline; Week 52 | An F-VASI25/50/75/90 responder achieved at least 25/50/75/90% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of BSA) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was 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 the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement). |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
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 ≥ 75% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at Week 24 | Baseline; Week 24 | Intent-to-Treat Population: all randomized participants. Treatment groups for this population were defined according to the treatment assignment at the time of randomization. Data from participants at a single site were excluded from this analysis owing to serious noncompliance with the protocol. Missing F-VASI scores were imputed by Multiple Imputation with Fully Conditional Specification. The multiple imputation method used treatment and observed stratification factors as predicators. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a ≥ 50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score at Week 24 | Baseline; Week 24 | ITT Population. Data from participants at a single site were excluded from this analysis owing to serious noncompliance with the protocol. Missing F-VASI scores were imputed by Multiple Imputation with Fully Conditional Specification. The multiple imputation method used treatment and observed stratification factors as predicators. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a ≥ 90% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI90) Score at Week 24 | Baseline; Week 24 | ITT Population. Data from participants at a single site were excluded from this analysis owing to serious noncompliance with the protocol. Missing F-VASI scores were imputed by Multiple Imputation with Fully Conditional Specification. The multiple imputation method used treatment and observed stratification factors as predicators. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score at Week 24 | Baseline; Week 24 | ITT Population. Data from participants at a single site were excluded from this analysis owing to serious noncompliance with the protocol. Missing T-VASI scores were imputed by Multiple Imputation with Fully Conditional Specification. The multiple imputation method used treatment and observed stratification factors as predicators. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) of 4 or 5 at Week 24 | Baseline; Week 24 | ITT Population. Data from participants at a single site were excluded from this analysis owing to serious noncompliance with the protocol. Missing VNS scores were imputed by Multiple Imputation with Fully Conditional Specification. The multiple imputation method used treatment and observed stratification factors as predicators. | percentage of participants | NUMBER |
| SECONDARY | Percentage Change From Baseline in Facial Body Surface Area (F-BSA) at Week 24 | Baseline; Week 24 | ITT Population. Data from participants at a single site were excluded from this analysis owing to serious noncompliance with the protocol. Missing F-BSA scores were imputed by Multiple Imputation with Fully Conditional Specification. The multiple imputation method used treatment and observed stratification factors as predicators. | percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Double-Blind Period | from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 24) | Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. Treatment groups for this population were determined according to the actual treatment the participant applied on Day 1. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Treatment-Extension Period | from the completion of the Week 24 assessments until at least 30 days after the last application of study drug (up to Week 52 + 30 days) | Treatment-Extension (TE) Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Achieving a ≥ 25% Improvement in the Face Vitiligo Area Scoring Index (F-VASI25) Score at Week 24 | Baseline; Week 24 | ITT Population. Data from participants at a single site were excluded from this analysis owing to serious noncompliance with the protocol. Missing F-VASI scores were imputed by Multiple Imputation with Fully Conditional Specification. The multiple imputation method used treatment and observed stratification factors as predicators. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a ≥ %25, ≥ %50, ≥ 75%, and ≥ 90% Improvement in the Face Vitiligo Area Scoring Index (F-VASI25/50/75/90) Score at Week 52 | Baseline; Week 52 | ITT Population. Data from participants at a single site were excluded from this analysis owing to serious noncompliance with the protocol. Only participants with available data were analyzed. | percentage of participants | NUMBER |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group90
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 ≥ 75% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at Week 24 | Double-Blind Period: Ruxolitinib Cream 1.5% BID | 30.9 | percentage of participants | ||
| Percentage of Participants Achieving a ≥ 75% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at Week 24 | Double-Blind Period: Vehicle Cream BID | 11.4 | percentage of participants | ||
| Percentage of Participants Achieving a ≥ 50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score at Week 24 | Double-Blind Period: Ruxolitinib Cream 1.5% BID | 51.4 | percentage of participants | ||
| Percentage of Participants Achieving a ≥ 50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score at Week 24 | Double-Blind Period: Vehicle Cream BID | 20.9 | percentage of participants | ||
| Percentage of Participants Achieving a ≥ 90% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI90) Score at Week 24 | Double-Blind Period: Ruxolitinib Cream 1.5% BID | 16.3 | percentage of participants | ||
| Percentage of Participants Achieving a ≥ 90% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI90) Score at Week 24 | Double-Blind Period: Vehicle Cream BID | 1.3 | percentage of participants | ||
| Percentage of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score at Week 24 | Double-Blind Period: Ruxolitinib Cream 1.5% BID | 23.9 | percentage of participants | ||
| Percentage of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score at Week 24 | Double-Blind Period: Vehicle Cream BID | 6.8 | percentage of participants | ||
| Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) of 4 or 5 at Week 24 | Double-Blind Period: Ruxolitinib Cream 1.5% BID | 20.5 | percentage of participants | ||
| Percentage of Participants Achieving a Vitiligo Noticeability Scale (VNS) of 4 or 5 at Week 24 | Double-Blind Period: Vehicle Cream BID | 4.9 | percentage of participants |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 results by groupParticipant flow32
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 24-Week Double-Blind Period | STARTED | Double-Blind Period: Ruxolitinib Cream 1.5% BID | 229 | |
| 24-Week Double-Blind Period | STARTED | Double-Blind Period: Vehicle Cream BID | 115 | |
| 24-Week Double-Blind Period | STARTED | Treatment-Extension Period: Ruxolitinib Cream 1.5% BID | 0 | |
| 24-Week Double-Blind Period | STARTED | Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID | 0 | |
| 24-Week Double-Blind Period | ITT Population | Double-Blind Period: Ruxolitinib Cream 1.5% BID | 229 | |
| 24-Week Double-Blind Period | ITT Population | Double-Blind Period: Vehicle Cream BID | 115 | |
| 24-Week Double-Blind Period | ITT Population | Treatment-Extension Period: Ruxolitinib Cream 1.5% BID | 0 | |
| 24-Week Double-Blind Period | ITT Population | Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID | 0 | |
| 24-Week Double-Blind Period | ITT Population, Excluding Non-compliant Site | Double-Blind Period: Ruxolitinib Cream 1.5% BID | 222 | |
| 24-Week Double-Blind Period | ITT Population, Excluding Non-compliant Site | Double-Blind Period: Vehicle Cream BID | 109 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 participant flowAdverse events18
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 |
|---|---|---|---|---|---|---|
| other | Application site acne | General disorders | Vehicle Cream BID | 3 | 115 | 3 |
| other | Application site acne | General disorders | Ruxolitinib Cream 1.5% BID | 20 | 326 | 24 |
| other | COVID-19 | Infections and infestations | Vehicle Cream BID | 2 | 115 | 2 |
| other | COVID-19 | Infections and infestations | Ruxolitinib Cream 1.5% BID | 24 | 326 | 25 |
| other | Nasopharyngitis | Infections and infestations | Vehicle Cream BID | 1 | 115 | 1 |
| other | Nasopharyngitis | Infections and infestations | Ruxolitinib Cream 1.5% BID | 17 | 326 | 17 |
| serious | Appendiceal abscess | Infections and infestations | Vehicle Cream BID | 0 | 115 | 0 |
| serious | Appendiceal abscess | Infections and infestations | Ruxolitinib Cream 1.5% BID | 1 | 326 | 1 |
| serious | Coronary artery stenosis | Cardiac disorders | Vehicle Cream BID | 0 | 115 | 0 |
| serious | Coronary artery stenosis | Cardiac disorders | Ruxolitinib Cream 1.5% BID | 1 | 326 | 1 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vehicle Cream BID | 0 | 115 |
| Total, all-cause mortality | Ruxolitinib Cream 1.5% BID | 0 | 326 |
| Total, other adverse events | Vehicle Cream BID | 6 | 115 |
| Total, other adverse events | Ruxolitinib Cream 1.5% BID | 56 | 326 |
| Total, serious adverse events | Vehicle Cream BID | 0 | 115 |
| Total, serious adverse events | Ruxolitinib Cream 1.5% BID | 6 | 326 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Treatment-Extension Period: Ruxolitinib Cream 1.5% BID vs Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID: Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Treatment-Extension Period | Trial comparisons |
| Double-Blind Period: Ruxolitinib Cream 1.5% BID vs Double-Blind Period: Vehicle Cream BID: Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Double-Blind Period | Trial comparisons |
| Ruxolitinib Cream 1.5% BID vs Vehicle Cream BID: deaths from any cause | Trial comparisons |
| Ruxolitinib Cream 1.5% BID vs Vehicle Cream BID: serious adverse events | Trial comparisons |
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/NCT04057573
GET https://conductscience.org/api/trials/v1/NCT04057573/registered?page=2