NCT02394340

Study Evaluating the Drug Interaction Potential of Luliconazole Cream 1% in Participants With Tinea Pedis and Tinea Cruris

An Open-Label, Maximal Use Study Evaluating the Drug Interaction Potential of Luliconazole Cream 1% in Subjects With Tinea Pedis and Tinea Cruris

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, maximal use study to evaluate whether luliconazole in plasma acts as an inhibitor of cytochrome P2C19 (CYP2C19) as measured by circulating levels of omeprazole before and after treatment with a maximum dose of luliconazole cream 1% in participants with moderate to severe tinea pedis and tinea cruris.

Conditions

• Tinea Pedis
• Tinea Cruris

Interventions

Type	Name	Description
DRUG	Omeprazole 40 mg	Oral capsule to be taken as per the instructions regarding proper dosing technique.
DRUG	Luliconazole Cream 1%	Topical cream to be applied as per the instructions regarding proper study drug application technique.

Timeline

• Start date: 2015-02-03
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2015-03-20
• Last updated: 2019-11-27
• Results posted: 2019-11-27

Locations

1 site across 1 country: United States