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

Bausch Health Americas, Inc.30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tinea Pedis Tinea Cruris

Interventions

Luliconazole Cream 1%DRUG

Luliconazole cream will be applied topically per schedule specified in the arms.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 17 Years

Medical Language ↔ Plain English

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.

Locations (2)

Valeant Site 01

Santo Domingo, Dominican Republic

Valeant Site 02

San Pedro Sula, Honduras

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.