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

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