NCT02767271

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

An Open-Label Study to Assess the Pharmacokinetics With Maximal Use of Luliconazole Cream 1% in Pediatric Patients With Moderate to Severe Tinea Pedis or Tinea Cruris

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Tinea Pedis
• Tinea Cruris

Interventions

Type	Name	Description
DRUG	Luliconazole Cream 1%	Luliconazole cream will be applied topically per schedule specified in the arms.

Timeline

• Start date: 2015-12-02
• Primary completion: 2016-04-27
• Completion: 2016-04-27
• First posted: 2016-05-10
• Last updated: 2019-11-27
• Results posted: 2019-11-27

Locations

2 sites across 2 countries: Dominican Republic, Honduras