Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to evaluate the pharmacokinetics of luliconazole cream 1%, as measured by circulating plasma levels of luliconazole, when maximal quantity of luliconazole cream 1% is applied to participants of 12 years to less than (<) 18 years of age with moderate to severe inter-digital tinea pedis or tinea cruris.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tinea Pedis | Experimental | Participants with tinea pedis received luliconazole cream 1% topically once daily in the morning for 15 days (Day 1 through 15). The dose was approximately 3.0 grams per application and covered all affected and adjacent areas, including up to the ankles. |
|
| Tinea Cruris | Experimental | Participants with tinea cruris received luliconazole cream 1% topically once daily in the morning for 8 days (Day 1 through 8). The dose was approximately 3.0 grams per application and covered all affected and adjacent areas, including up to the groin, thighs, and abdomen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Luliconazole Cream 1% | Drug | Luliconazole cream will be applied topically per schedule specified in the arms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Maximum Observed Plasma Concentration (Cmax) of Luliconazole | Plasma concentration of luliconazole was determined using validated liquid chromatography-mass spectrometry (LC/MS) method. | Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15 |
| Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) of Luliconazole | Plasma concentration of luliconazole was determined using validated LC/MS method. AUC0-24 was calculated by linear trapezoidal method. | Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15 |
| Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Elimination Half-Life (t1/2) of Luliconazole | Plasma concentration of luliconazole was determined using validated LC/MS method. | Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15 |
| Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: Cmax of Luliconazole | Plasma concentration of luliconazole was determined using validated LC/MS method. | Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8 |
| Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: AUC0-24 of Luliconazole | Plasma concentration of luliconazole was determined using validated LC/MS method. AUC0-24 was calculated by linear trapezoidal method. | Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8 |
Not provided
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anya Loncaric | Valeant Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valeant Site 01 | Santo Domingo | 10700 | Dominican Republic | |||
| Valeant Site 02 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Tinea Pedis | Participants with tinea pedis received luliconazole cream 1% topically once daily in the morning for 15 days (Day 1 through 15). The dose was approximately 3.0 grams per application and covered all affected and adjacent areas. |
| FG001 | Tinea Cruris | Participants with tinea cruris received luliconazole cream 1% topically once daily in the morning for 8 days (Day 1 through 8). The dose was approximately 3.0 grams per application and covered all affected and adjacent areas. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety population included all participants who were enrolled and received at least 1 application of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tinea Pedis | Participants with tinea pedis received luliconazole cream 1% topically once daily in the morning for 15 days (Day 1 through 15). The dose was approximately 3.0 grams per application and covered all affected and adjacent areas. |
| BG001 | Tinea Cruris |
| 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 | Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Maximum Observed Plasma Concentration (Cmax) of Luliconazole | Plasma concentration of luliconazole was determined using validated liquid chromatography-mass spectrometry (LC/MS) method. | PKP population included all participants with tinea pedis who were enrolled, received at least 1 application of study drug, and had at least 1 pharmacokinetic (PK) assessment. | Posted | Mean | Standard Deviation | nanograms/milliliter (ng/mL) | Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15 |
|
Baseline (Day 1) up to Day 16
Safety population included all participants who were enrolled and received at least 1 application of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tinea Pedis | Participants with tinea pedis received luliconazole cream 1% topically once daily in the morning for 15 days (Day 1 through 15). The dose was approximately 3.0 grams per application and covered all affected and adjacent areas. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operations | Bausch Health Americas, Inc | aloncaric@bauschhealth.com |
Not provided
| ID | Term |
|---|---|
| D014008 | Tinea Pedis |
| D000084002 | Tinea Cruris |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: t1/2 of Luliconazole | Plasma concentration of luliconazole was determined using validated LC/MS method. | Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8 |
| San Pedro Sula |
| CT1100 |
| Honduras |
Participants with tinea cruris received luliconazole cream 1% topically once daily in the morning for 8 days (Day 1 through 8). The dose was approximately 3.0 grams per application and covered all affected and adjacent areas. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) of Luliconazole | Plasma concentration of luliconazole was determined using validated LC/MS method. AUC0-24 was calculated by linear trapezoidal method. | PKP population included all participants with tinea pedis who were enrolled, received at least 1 application of study drug, and had at least 1 PK assessment. | Posted | Mean | Standard Deviation | nanograms*hour/milliliter (ng*hr/mL) | Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15 |
|
|
|
| Primary | Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Elimination Half-Life (t1/2) of Luliconazole | Plasma concentration of luliconazole was determined using validated LC/MS method. | PKP population included all participants with tinea pedis who were enrolled, received at least 1 application of study drug, and had at least 1 PK assessment. None of the participants in this population was evaluable for this outcome measure at specified timepoint. | Posted | Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15 |
|
|
| Primary | Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: Cmax of Luliconazole | Plasma concentration of luliconazole was determined using validated LC/MS method. | PKC population included all participants with tinea cruris who were enrolled, received at least 1 application of study drug, and had at least 1 PK assessment. | Posted | Mean | Standard Deviation | ng/mL | Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8 |
|
|
|
| Primary | Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: AUC0-24 of Luliconazole | Plasma concentration of luliconazole was determined using validated LC/MS method. AUC0-24 was calculated by linear trapezoidal method. | PKC population included all participants with tinea cruris who were enrolled, received at least 1 application of study drug, and had at least 1 PK assessment. | Posted | Mean | Standard Deviation | ng*hr/mL | Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8 |
|
|
|
| Primary | Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: t1/2 of Luliconazole | Plasma concentration of luliconazole was determined using validated LC/MS method. | PKC population included all participants with tinea cruris who were enrolled, received at least 1 application of study drug, and had at least 1 PK assessment. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | hours | Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8 |
|
|
|
| 0 |
| 15 |
| 2 |
| 15 |
| EG001 | Tinea Cruris | Participants with tinea cruris received luliconazole cream 1% topically once daily in the morning for 8 days (Day 1 through 8). The dose was approximately 3.0 grams per application and covered all affected and adjacent areas. | 0 | 15 | 1 | 15 |
| Nasopharyngitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
Please contact Sponsor directly for additional information.
| D007239 |
| Infections |
| D012874 | Skin Diseases, Infectious |
| D005533 | Foot Dermatoses |
| D005534 | Foot Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011537 | Pruritus |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007402 | Intertrigo |
| D003872 | Dermatitis |
| D017443 | Skin Diseases, Eczematous |