Fair Lawn, New Jersey 07410


Purpose:

This is an open-label, maximal use study evaluating the drug interaction potential of luliconazole cream 1% in subjects with tinea pedis and tinea cruris


Criteria:

Inclusion Criteria: - Subjects with a clinical diagnosis of moderate to severe interdigital tinea pedis, as defined by a 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 - Subjects with a mycological diagnosis of tinea pedis AND tinea cruris confirmed by the detection of fungal hyphae on a microscopic KOH wet mount - Subjects must be in good general health and free of any disease that might interfere with study evaluations - Subjects with the ability and willingness to follow all study procedures, attend all scheduled visits and successfully complete the study Exclusion Criteria: - Female subjects who are pregnant and/or nursing or planning a pregnancy during the course of the trial - Subjects who are immunocompromised - Subjects who have a recent history of or currently known drug or alcohol abuse - Subjects with a history of intolerance or hypersensitivity to imidazole compounds, proton pump inhibitors or the inactive components of Luliconazole Cream 1% or omeprazole - Subjects with a life-threatening condition within the last 6 months - Subjects with uncontrolled diabetes mellitus - Subjects who are unable to communicate or cooperate with the investigator - Subjects using medications for treatment of tinea pedis and/or tinea cruris (see investigator for length of time prior to study start) - Subjects 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


NCT ID:

NCT02394340


Primary Contact:

Study Director
Anya Loncaric
Valeant Pharmaceuticals, NA

Laurie Marinovich
Phone: 949-398-5775
Email: laurie.marinovich@bausch.com


Backup Contact:

Email: aloncaric@solta.com
Anya Loncaric
Phone: 510-782-2286


Location Contact:

Fair Lawn, New Jersey 07410
United States

Irina Krause, RN
Phone: 201-587-0505
Email: ikrause@tklresearch.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

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