Trial · NCT04052425
Outcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| 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. 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. 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. 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. 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. 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. 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. 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. Only participants with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage Change From Baseline in F-VASI at Week 24 | Baseline; Week 24 | ITT Population. Only participants with available data were analyzed. MMRM model: (Response Variable = Treatment + Stratification Factors \[Skin Type Fitzpatrick Scale Type I and II versus Type III, IV, V, and VI, Region North America/Europe\] + Visit + Treatment\*Visit). | percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Change From Baseline in F-VASI at Week 52 | Baseline; Week 52 | ITT Population. Only participants with available data were analyzed. | percentage change | MEAN |
| SECONDARY | Percentage Change From Baseline in F-BSA at Week 52 | Baseline; Week 52 | ITT Population. Only participants with available data were analyzed. | percentage change | MEAN |
| SECONDARY | Percentage Change From Baseline in T-VASI at Week 24 | Baseline; Week 24 | ITT Population. Only participants with available data were analyzed. MMRM model: (Response Variable = Treatment + Stratification Factors \[Skin Type Fitzpatrick scale Type I and II vs Type III, IV, V, and VI, Region North America/Europe\] + Visit + Treatment\*Visit). | percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Change From Baseline in T-VASI at Week 52 | Baseline; Week 52 | ITT Population. Only participants with available data were analyzed. | percentage change | MEAN |
| SECONDARY | Percentage Change From Baseline in T-BSA at Week 24 | Baseline; Week 24 | ITT Population. Only participants with available data were analyzed. MMRM model: (Response Variable = Treatment + Stratification Factors \[Skin Type Fitzpatrick scale Type I and II vs Type III, IV, V, and VI, Region North America/Europe\] + Visit + Treatment\*Visit). | percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Change From Baseline in T-BSA at Week 52 | Baseline; Week 52 | ITT Population. Only participants with available data were analyzed. | percentage change | MEAN |
| SECONDARY | Percentage of Participants Achieving a ≥ 25%, ≥ 75%, and ≥ 90% Improvement in the Total Body Vitiligo Area Scoring Index (T-VASI25/75/90) Score at Week 24 | Baseline; Week 24 | ITT Population. 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 ≥ 25%, ≥ 50%, ≥ 75%, and ≥ 90% Improvement in the Total Body Vitiligo Area Scoring Index (T-VASI25/50/75/90) Score at Week 52 | Baseline; Week 52 | ITT Population. Only participants with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants in Each Category of VNS During the Treatment Period (Double-Blind and Treatment-Extension Periods) | Baseline; Week 24 and Week 52 | ITT Population. Only participants with available data were analyzed. | percentage of participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT04052425/outcomes