Comparison · NCT05593432-cb412be5
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 ≥Grade 3 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 ≥Grade 3 TEAE During the Open-label Extension Period. Trial comparisons, record NCT05593432-cb412be5. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05593432-cb412be5
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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 | 0 | 0.114 | wilson | |
| Risk in group 2 | 0.0345 | 0.00611 | 0.172 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0345 | -0.172 | 0.0825 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
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 | 29 | 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. | 0 | 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. | 1 | 29 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Any ≥Grade 3 TEAE During the Open-label Extension Period
- Description
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. The severity of AEs was assessed using the CTCAE v5.0 Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
- Time frame
- from Week 17 to Week 32 plus 30 days
- Population
- Open-label Extension Evaluable Population
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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