Expired Study
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Fair Lawn, New Jersey 07410


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.


Inclusion Criteria: - Participants with a clinical diagnosis of moderate to severe interdigital tinea pedis, as defined by a Physician's Global Assessment (PGA) score of 2 or 3 on both feet, and moderate to severe tinea cruris, as defined by a PGA score of 2 or 3 - Participants with a mycological diagnosis of tinea pedis and tinea cruris confirmed by the detection of fungal hyphae on a microscopic potassium hydroxide (KOH) wet mount - Participants must be in good general health and free of any disease that might interfere with study evaluations - Participants with the ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study Exclusion Criteria: - Female participants who are pregnant and/or nursing or planning a pregnancy during the course of the trial - Participants who are immunocompromised - Participants who have a recent history of or currently known drug or alcohol abuse - Participants with a history of intolerance or hypersensitivity to imidazole compounds, proton pump inhibitors, or the inactive components of luliconazole cream 1% or omeprazole - Participants with a life-threatening condition within the last 6 months - Participants with uncontrolled diabetes mellitus - Participants who are unable to communicate or cooperate with the Investigator - Participants using medications for treatment of tinea pedis and/or tinea cruris (see Investigator for length of time prior to study start) - Participants receiving concomitant drugs that are known to inhibit and/or induce CYP2C19 and/or CYP3A4, or that interact with omeprazole - Because of the potential for drug interaction with luliconazole, administration with medications that are known to be substrates of CYP3A4, CYP2B6, CYP2C8, and CYP2C19 should be carefully monitored



Primary Contact:

Study Director
Anya Loncaric
Bausch Health Americas, Inc.

Backup Contact:


Location Contact:

Fair Lawn, New Jersey 07410
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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