Luliconazole Cream 1%
DrugLuliconazole cream will be applied per schedule specified in the arm.
Other names: Product 33525
NCT Number: NCT02767947
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.
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Notify Me2 year–17 year
All sexes
Interventional
Phase 4
Valeant Site 03, San Cristobal, Dominican Republic
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Luliconazole cream will be applied per schedule specified in the arm.
Other names: Product 33525
Vehicle cream will be applied per schedule specified in the arm.
Time frame: Pre-dose (within 15 minutes prior to the final dose of the drug) on Day 7
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: 6 hours after the final dose of the drug on Day 7
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).
Bausch Health Americas, Inc.
Industry
A Randomized, Multi-Center, Double-Blind, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Product 33525 in Pediatric Subjects With Tinea Corporis
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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