A Phase 4 interventional study of Luliconazole Cream 1% and Vehicle Cream in Tinea Corporis, sponsored by Bausch Health Americas, Inc.. Completed at 3 sites in 2 countries. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2019-11-27.
Sponsored by Bausch Health Americas, Inc. (part of Bausch Health Companies Inc.) · Phase 4, Interventional, and Treatment
The objective of this study was to evaluate the safety, efficacy, and pharmacokinetics of luliconazole cream 1% when applied topically for 7 days in pediatric participants 2 years to 17 years of age (inclusive) with tinea corporis.
90 studies on the registry are indexed under Tinea; 6 are open to participants now.
This study's enrollment of 75 is below the median of 131 across 84 interventional studies indexed under Tinea.
Browse Tinea studies →Bausch Health Americas, Inc. is the lead sponsor of 213 studies on the registry; 9 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 17 (71%) have results posted.
First submitted after Bausch Health Americas, Inc. became part of Bausch Health Companies Inc..
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Luliconazole cream 1% will be applied once daily in the morning for 7 days to the area affected with tinea corporis and approximately 1 inch of the immediate surrounding area.
Drug: Luliconazole Cream 1%
Vehicle cream (containing no active ingredient) will be applied once daily in the morning for 7 days to the area affected with tinea corporis and approximately 1 inch of the immediate surrounding area.
Drug: Vehicle Cream
Luliconazole cream will be applied per schedule specified in the arm.
Also known as: Product 33525
Vehicle cream will be applied per schedule specified in the arm.
Circulating Plasma Concentration of Luliconazole at Day 7 (Pre-Dose)
Plasma levels of luliconazole were obtained at steady-state (within 15 minutes prior to the final dose of the study drug on Day 7) and approximately the time of maximum concentration (tmax) (6 hours after the final dose of study drug on Day 7).
Time frame: Pre-dose (within 15 minutes prior to the final dose of the drug) on Day 7
Circulating Plasma Concentration of Luliconazole at Day 7 (6 Hours Post-Dose)
Plasma levels of luliconazole were obtained at steady-state (within 15 minutes prior to the final dose of the study drug on Day 7) and approximately the tmax (6 hours after the final dose of study drug on Day 7).
Time frame: 6 hours after the final dose of the drug on Day 7
| Milestone | Luliconazole Cream 1% | Vehicle Cream |
|---|---|---|
| Started | 60 | 15 |
| Safety population | 60 | 15 |
| Pharmacokinetic (pk) population | 12 | 3 |
| Completed | 60 | 15 |
| Not completed | 0 | 0 |
Plasma levels of luliconazole were obtained at steady-state (within 15 minutes prior to the final dose of the study drug on Day 7) and approximately the time of maximum concentration (tmax) (6 hours after the final dose of study drug on Day 7).
| nanograms/milliliter (ng/mL) | Luliconazole Cream 1% | Vehicle Cream |
|---|---|---|
| Circulating Plasma Concentration of Luliconazole at Day 7 (Pre-Dose) | 4.63 ± 2.93 | NA ± NA |
Plasma levels of luliconazole were obtained at steady-state (within 15 minutes prior to the final dose of the study drug on Day 7) and approximately the tmax (6 hours after the final dose of study drug on Day 7).
| ng/mL | Luliconazole Cream 1% | Vehicle Cream |
|---|---|---|
| Circulating Plasma Concentration of Luliconazole at Day 7 (6 Hours Post-Dose) | 4.84 ± 3.33 | 0.07 ± 0.12 |
Collected over From Baseline (Day 1) to Day 28. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Luliconazole Cream 1% | — | 0/60 (0%) | 7/60 (11.7%) |
| Vehicle Cream | — | 0/15 (0%) | 2/15 (13.3%) |
| Event | Luliconazole Cream 1% | Vehicle Cream |
|---|---|---|
| NasopharyngitisInfections and infestations | 4/60 | 2/15 |
| HeadacheNervous system disorders | 3/60 | 0/15 |
Safety population included all randomized participants who received at least 1 application of study drug.
| Age, Continuous(years) | Luliconazole Cream 1% | Vehicle Cream | Total |
|---|---|---|---|
| Mean | 8.18 ± 3.87 | 9.13 ± 5.18 | 8.37 ± 4.14 |
| Sex: Female, Male(Participants) | Luliconazole Cream 1% | Vehicle Cream | Total |
|---|---|---|---|
| Female | 18 | 3 | 21 |
| Male | 42 | 12 | 54 |
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2016 to primary completion in Jun 2016, 4 months.
Results were first posted in Nov 2019, 3 years 4 months after primary completion. A results delay was requested in Dec 2017.
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This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Luliconazole
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