Comparison · NCT05593445-95ded455
DBVC Period: Ruxolitinib Cream 1.5% BID vs DBVC Period: Vehicle Cream BID: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) During the Double-blind, Vehicle-controlled 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. DBVC Period: Ruxolitinib Cream 1.5% BID vs DBVC Period: Vehicle Cream BID: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) During the Double-blind, Vehicle-controlled Period. Trial comparisons, record NCT05593445-95ded455. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05593445-95ded455
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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 | 0.452 | 0.292 | 0.622 | wilson | |
| Risk in group 2 | 0.4 | 0.246 | 0.577 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0516 | -0.187 | 0.282 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.13 | 0.629 | 2.03 | log | |
| Odds ratio, group 1 over group 2 | 1.24 | 0.447 | 3.41 | log | |
| Number needed to treat, for one more participant with the outcome on DBVC Period: Ruxolitinib Cream 1.5% BID than on DBVC Period: Vehicle Cream BID | 19.4 | 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 | DBVC Period: Ruxolitinib Cream 1.5% BID | Participants applied ruxolitinib 1.5% cream twice daily (BID) for 12 weeks. | 14 | 31 | OG000 |
| Group 2 | DBVC Period: Vehicle Cream BID | Participants applied matching vehicle cream BID for 12 weeks. | 12 | 30 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Any Treatment-emergent Adverse Event (TEAE) During the Double-blind, Vehicle-controlled 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 it is considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug.
- Time frame
- from Baseline to Week 12 plus 30 days
- Population
Safety Population: all participants who applied ruxolitinib 1.5% 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 regardless of assigned treatment group.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Lichen Sclerosus
- NCT number
- NCT05593445
- Phases
- PHASE2
- Conditions
- Lichen Sclerosus
- Interventions
- Ruxolitinib cream, Vehicle cream
- Lead sponsor
- Incyte Corporation
- Results first posted
- 2024-09-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05593445?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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