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

Bausch + Lomb

Status and phase: Completed; Phase 4

Conditions: Tinea Pedis; Tinea Cruris

Treatments: Drug: Omeprazole 40 mg; Drug: Luliconazole Cream 1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02394340

MP-1012

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Luliconazole Cream 1%

Experimental group

Description:

Participants will receive 1 oral capsule of omeprazole 40 milligrams (mg) on Day 1 and Day 8. Participants will also receive luliconazole cream 1% to cover the entire affected surface areas and adjacent areas once daily in the morning on Day 2 (24 hours after initial omeprazole dosing) through Day 8.

Treatment:

Drug: Omeprazole 40 mg

Drug: Luliconazole Cream 1%