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.
Who can participate
Age range2 Years – 17 Years
SexALL
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Key Inclusion Criteria:
* Participants (or legal guardian/caregiver) with the ability and willingness to sign a written informed consent and/or assent (age appropriate).
* Participants of either gender must be at least 2 years to less than (\<) 18 years of age (2 to 17 years, inclusive).
* Participants with a clinical diagnosis of tinea corporis characterized by clinical evidence of a tinea infection (at least moderate erythema, mild scaling, and moderate pruritus).
* 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/caregiver 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 active atopic or contact dermatitis in the area to be treated.
* Participants with severe dermatophytoses, mucocutaneous candidiasis, or bacterial skin infection.
* 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 study drug will be discontinued from study drug 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.
What they're measuring
1
Circulating Plasma Concentration of Luliconazole at Day 7 (Pre-Dose)
Timeframe: Pre-dose (within 15 minutes prior to the final dose of the drug) on Day 7
2
Circulating Plasma Concentration of Luliconazole at Day 7 (6 Hours Post-Dose)
Timeframe: 6 hours after the final dose of the drug on Day 7