CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
Omeprazole 40 mg +1 moredrug
Likely dose
Omeprazole 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02394340
NCT02394340Phase 4Completed
CompareCT.gov

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

Bausch & Lomb Incorporated·interventional·Posted Mar 20, 2015·Updated Nov 27, 2019

In Brief

A Phase 4 clinical trial evaluating Omeprazole 40 mg and Luliconazole Cream 1% for Tinea Pedis and Tinea Cruris. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTinea Pedis, Tinea Cruris
CountriesUnited States
CollaboratorsBausch Health Americas, Inc.

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 20, 2015
Enrollment StartFeb 3, 2015
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 11.3 years ago

Interventions

Omeprazole 40 mgdrug

Oral capsule to be taken as per the instructions regarding proper dosing technique.

Luliconazole Cream 1%drug

Topical cream to be applied as per the instructions regarding proper study drug application technique.