Comparison · NCT05593432-fffd0ccc
Open-Label Extension Period: Ruxolitinib Cream 1.5% BID vs Open-Label Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID: Number of Participants With Any TEAE During the Open-label Extension 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. Open-Label Extension Period: Ruxolitinib Cream 1.5% BID vs Open-Label Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID: Number of Participants With Any TEAE During the Open-label Extension Period. Trial comparisons, record NCT05593432-fffd0ccc. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05593432-fffd0ccc
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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 | 0.267 | 0.142 | 0.444 | wilson | |
| Risk in group 2 | 0.379 | 0.227 | 0.56 | wilson | |
| Risk difference, group 1 minus group 2 | -0.113 | -0.332 | 0.122 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.703 | 0.331 | 1.49 | log | |
| Odds ratio, group 1 over group 2 | 0.595 | 0.197 | 1.79 | log | |
Number needed to treat, for one fewer participant with the outcome on Open-Label Extension Period: Ruxolitinib Cream 1.5% BID than on Open-Label Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID | 8.88 | 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 | Open-Label Extension Period: Ruxolitinib Cream 1.5% BID | Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week Open-label Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-blind, Vehicle-controlled Period continued to apply ruxolitinib cream 1.5% BID for an additional 16 weeks in the Open-label Extension Period. | 8 | 30 | OG000 |
| Group 2 | Open-Label Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID | Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week Open-label Extension Period. Participants who applied vehicle cream BID during the Double-blind, Vehicle-controlled Period applied ruxolitinib cream 1.5% BID for 16 weeks in the Open-label Extension Period. | 11 | 29 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Any TEAE During the Open-label Extension Period
- Description
An 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 Week 17 to Week 32 plus 30 days
- Population
- Open-label Extension Evaluable Population: all participants who applied ruxolitinib 1.5% cream at least once during the Open-label Extension Period
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Cutaneous Lichen Planus
- NCT number
- NCT05593432
- Phases
- PHASE2
- Conditions
- Cutaneous Lichen Planus
- Interventions
- Ruxolitinib cream, Vehicle cream
- Lead sponsor
- Incyte Corporation
- Results first posted
- 2024-10-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05593432?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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