Trial · NCT03099304
Outcomes49
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 49
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Treated With Ruxolitinib Cream Who Achieved a ≥ 50% Improvement From Baseline in Facial Assessment of the Vitiligo Area and Severity Index Score (F-VASI50) Compared With Participants Treated With Vehicle at Week 24 | Baseline; Week 24 | Intent-to-Treat (ITT) Population: all randomized participants. Treatment groups were to be defined according to the treatment assignment at the time of randomization regardless of the actual ruxolitinib cream or vehicle cream participants might have applied during their participation in the study. Missing post-Baseline values were considered as not having achieved responses for visits up to Week 52. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved a Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) of Clear or Almost Clear | Week 24 | ITT Population. Missing post-Baseline values were considered as not having achieved F-PhGVA response for visits up to Week 24. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved a ≥ 50% Improvement From Baseline in Full Body Assessment of Vitiligo Area and Severity Index (T-VASI) at Week 52 | Baseline; Week 52 | ITT Population. Missing post-Baseline values were considered as not having achieved responses for visits up to Week 52. Only participants with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Dose Response on Percentage Change From Baseline in F-VASI | up to 156 weeks | Based on the data for percentage change from Baseline in F-VASI and T-VASI scores during the treatment periods, the Emax model was not appropriate; therefore, the dose responses were not assessed. | ||
| SECONDARY | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Grade 3 or Higher TEAE up to Week 24 | up to 24 weeks | Safety Population: all participants who applied at least 1 dose of study drug. Treatment groups for this population were to be determined according to the actual treatment the participant received on Day 1. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE up to Week 52 | up to 52 weeks | Safety Population. Treatment groups for this population were to be determined according to the actual treatment the participant received on Day 1. Analysis from Day 1 to Week 52 was conducted in participants randomized to receive ruxolitinib cream 0.5% QD, ruxolitinib cream 1.5% QD, or ruxolitinib cream 1.5% BID during the vehicle-controlled period (Day 1 to Week 24). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE From Week 24 to Week 52 | Week 24 to Week 52 | Safety Population. Treatment groups for this population were to be determined according to the actual treatment the participant received on Day 1. Analysis was conducted in participants who were randomized to ruxolitinib cream 0.15% QD and vehicle groups in the vehicle-controlled period (Day 1 to Week 24) and then had a dose in the continued double-blind period (Week 24 to Week 52). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Applied Ruxolitinib 1.5% Cream BID Throughout Study Participation With Any TEAE and Any Grade 3 or Higher TEAE | up to Week 156 | Safety Population. Treatment groups for this population were to be determined according to the actual treatment the participant received on Day 1. Analysis was only conducted in participants who received ruxolitinib cream 1.5% BID on Day 1. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE From Week 52 to Week 156 | Week 52 to Week 156 | Open-label Evaluable Population: all randomized participants who received at least 1 dose of study drug in the Open-label Period | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change From Baseline in F-VASI Score at Week 24 | Baseline; Week 24 | ITT Population. Only participants with available data were analyzed. Mixed-model for Repeated Measures (MMRM) model for post-Baseline measures: (response variable = treatment + stratification factor \[age ≤30 versus \>30\] + visit + treatment\*visit). All post-Baseline visits up to Week 24 were included in the model. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Baseline; Weeks 52, 104, and 156 | ITT Population. Only participants with available data were analyzed. | scores on a scale | MEAN |
| SECONDARY | Percentage Change From Baseline in F-VASI Score at Week 24 | Baseline; Week 24 | ITT Population. Only participants with available data were analyzed. MMRM model for post-Baseline measures: (response variable = treatment + stratification factor \[age ≤30 versus \>30\] + visit + treatment\*visit). All post-Baseline visits up to Week 24 were included in the model. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Change From Baseline in F-VASI Score at Weeks 52, 104, and 156 | Baseline; Weeks 52, 104, and 156 | ITT Population. Only participants with available data were analyzed. | percent change | MEAN |
| SECONDARY | Percentage of Participants Who Achieved an F-VASI50 at Weeks 52, 104, and 156 | Baseline; Weeks 52, 104, and 156 | ITT Population. Only participants with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage Change From Baseline in F-BSA Repigmentation at Week 24 | Baseline; Week 24 | ITT Population. Only participants with available data were analyzed. | percent change | MEAN |
| SECONDARY | Percentage Change From Baseline in F-BSA Repigmentation at Weeks 52, 104, and 156 | Baseline; Weeks 52, 104, and 156 | ITT Population. Only participants with available data were analyzed. | percent change | MEAN |
| SECONDARY | Percentage Change From Baseline in T-BSA Repigmentation at Week 24 | Baseline; Week 24 | ITT Population. Only participants with available data were analyzed. | percent change | MEAN |
| SECONDARY | Percentage Change From Baseline in T-BSA Repigmentation at Weeks 52, 104, and 156 | Baseline; Weeks 52, 104, and 156 | ITT Population. Only participants with available data were analyzed. | percent change | MEAN |
| SECONDARY | Mean Change From Baseline in T-VASI Score at Week 24 | Baseline; Week 24 | ITT Population. Only participants with available data were analyzed. MMRM model for post-Baseline measures: (response variable = treatment + stratification factor \[age ≤30 versus \>30\] + visit + treatment\*visit). All post-Baseline visits up to Week 24 were included in the model. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in T-VASI Score at Weeks 52, 104, and 156 | Baseline; Weeks 52, 104, and 156 | ITT Population. Only participants with available data were analyzed. | scores on a scale | MEAN |
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.
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