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 range
2 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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