Maximal Use of Luliconazole Cream 1% in Pediatric Participants With Moderate to Severe Tinea Pedis or Tinea Cruris

Study Overview
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Brief Summary
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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.

Official Title
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An Open-Label Study to Assess the Pharmacokinetics With Maximal Use of Luliconazole Cream 1% in Pediatric Patients With Moderate to Severe Tinea Pedis or Tinea Cruris

Conditions
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Tinea Pedis, Tinea Cruris

Intervention / Treatment
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* Drug: Luliconazole Cream 1%


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Participants (or legal guardian) with the ability and willingness to sign a written informed consent. Participants of either gender at least 12 years to <18 years old (12 to 17 years, inclusive). Participants with a mycological diagnosis of tinea pedis or tinea cruris confirmed by the detection of fungal hyphae on a microscopic potassium hydroxide (KOH) wet mount. Participants with the ability and willingness to follow all study procedures, attend all scheduled visits, have all blood draws, and successfully complete the study. Participants must be in good general health and free of any disease that in the Investigator's opinion might interfere with the study evaluations. Participants must be able to communicate, be able to understand the study procedures, and be willing to comply with the study requirements. Key Exclusion Criteria: Participants with both tinea pedis and tinea cruris. Participants with active atopic or contact dermatitis in the treatment area. Female participants who are pregnant and/or nursing or planning a pregnancy during the course of the trial. Participants who test positive for pregnancy after start of test treatment will be discontinued from test treatment but will be followed for safety purposes. Participants who are immunocompromised (due to disease, for example; human immunodeficiency virus [HIV] or medications). Participants who have a recent history of or current drug or alcohol abuse.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tinea Pedis<br>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. | Drug: Luliconazole Cream 1%<br>* Luliconazole cream will be applied topically per schedule specified in the arms.<br>|
| Experimental: Tinea Cruris<br>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. | Drug: Luliconazole Cream 1%<br>* Luliconazole cream will be applied topically per schedule specified in the arms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| 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 |