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