Comparison · NCT04052425-bffbb86a
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
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. 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, record NCT04052425-bffbb86a. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04052425-bffbb86a
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.457 | 0.393 | 0.523 | wilson | |
| Risk in group 2 | 0.385 | 0.299 | 0.479 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0717 | -0.0421 | 0.18 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.19 | 0.899 | 1.57 | log | |
| Odds ratio, group 1 over group 2 | 1.34 | 0.841 | 2.14 | log | |
| Number needed to treat, for one more participant with the outcome on Double-Blind Period: Ruxolitinib Cream 1.5% BID than on Double-Blind Period: Vehicle Cream BID | 13.9 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: vehicle.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Double-Blind Period: Ruxolitinib Cream 1.5% BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks. | 101 | 221 | OG000 |
| Group 2 | Double-Blind Period: Vehicle Cream BID | Participants applied matching vehicle cream BID for 24 weeks. | 42 | 109 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Double-Blind Period
- Description
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.
- Time frame
- from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 24)
- Population
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.
Source ClinicalTrials.gov
Trial
- Title
- Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1)
- NCT number
- NCT04052425
- Phases
- PHASE3
- Conditions
- Non-segmental Vitiligo
- Interventions
- Ruxolitinib cream, Vehicle
- Lead sponsor
- Incyte Corporation
- Results first posted
- 2022-09-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04052425?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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