Study Evaluating the Drug Interaction Potential of Luliconazole Cream 1% in Participants With Tinea Pedis and Tinea Cruris
Condition: Tinea Pedis; Tinea Cruris
MeSH terms: Tinea; Tinea Pedis; Tinea cruris
Intervention: Omeprazole 40 mg; Luliconazole Cream 1%
Intervention description: Oral capsule to be taken as per the instructions regarding proper dosing technique.; Topical cream to be applied as per the instructions regarding proper study drug application technique.
Intervention MeSH terms: Luliconazole; Omeprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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