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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
75
Luliconazole cream will be applied per schedule specified in the arm.
Vehicle cream will be applied per schedule specified in the arm.
Valeant Site 03
San Cristóbal, Dominican Republic
Valeant Site 01
Santo Domingo, Dominican Republic
Valeant Site 02
San Pedro Sula, Honduras
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
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