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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Luliconazole Cream 1% | Experimental | 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. |
|
| Vehicle Cream | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Luliconazole Cream 1% | Drug | Luliconazole cream will be applied per schedule specified in the arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 6 hours after the final dose of the drug on Day 7 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anya Loncaric | Valeant Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valeant Site 03 | San Cristobal | 91000 | Dominican Republic | |||
| Valeant Site 01 |
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A total of 75 participants with tinea corporis were enrolled and randomized in 4:1 ratio to receive either luliconazole cream 1% or vehicle cream.
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| ID | Title | Description |
|---|---|---|
| FG000 | Luliconazole Cream 1% | Luliconazole cream 1% was 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. |
| FG001 | Vehicle Cream | Vehicle cream (containing no active ingredient) was 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety population included all randomized participants who received at least 1 application of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Luliconazole Cream 1% | Luliconazole cream 1% was 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. |
| BG001 | Vehicle Cream |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | PK population included all randomized participants who received at least 1 application of study drug, and from whom blood samples were obtained for plasma level analysis both prior to (within 15 minutes) and 6 hours after the final dose (on Day 7). | Posted | Mean | Standard Deviation | nanograms/milliliter (ng/mL) | Pre-dose (within 15 minutes prior to the final dose of the drug) on Day 7 |
|
From Baseline (Day 1) to Day 28
Safety population included all randomized participants who received at least 1 application of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Luliconazole Cream 1% | Luliconazole cream 1% was 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operations | Bausch Health Americas, Inc | aloncaric@bauschhealth.com |
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| ID | Term |
|---|---|
| D014005 | Tinea |
| ID | Term |
|---|---|
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| Vehicle Cream | Drug | Vehicle cream will be applied per schedule specified in the arm. |
|
| Santo Domingo |
| 10700 |
| Dominican Republic |
| Valeant Site 02 | San Pedro Sula | CT1100 | Honduras |
Vehicle cream (containing no active ingredient) was 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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Vehicle Cream | Vehicle cream (containing no active ingredient) was 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. |
|
|
| Primary | 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). | PK population included all randomized participants who received at least 1 application of study drug, and from whom blood samples were obtained for plasma level analysis both prior to (within 15 minutes) and 6 hours after the final dose (on Day 7). | Posted | Mean | Standard Deviation | ng/mL | 6 hours after the final dose of the drug on Day 7 |
|
|
|
| 0 |
| 60 |
| 7 |
| 60 |
| EG001 | Vehicle Cream | Vehicle cream (containing no active ingredient) was 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. | 0 | 15 | 2 | 15 |
| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
Please contact Sponsor directly for additional information.
| D012874 |
| Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |