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

NCT ID: NCT02394340

Last Updated: 2019-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-03
• Study Completion Date: 2015-04-01

Brief 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.

Conditions

Tinea Pedis; Tinea Cruris

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Luliconazole Cream 1%

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.

Group Type: EXPERIMENTAL

Omeprazole 40 mg

Intervention Type: DRUG

Oral capsule to be taken as per the instructions regarding proper dosing technique.

Luliconazole Cream 1%

Intervention Type: DRUG

Topical cream to be applied as per the instructions regarding proper study drug application technique.

Interventions

Omeprazole 40 mg

Oral capsule to be taken as per the instructions regarding proper dosing technique.

Intervention Type: DRUG

Luliconazole Cream 1%

Topical cream to be applied as per the instructions regarding proper study drug application technique.

Intervention Type: DRUG

Other Intervention Names

LUZU Cream 1%

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: collaborator

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anya Loncaric

Role: STUDY_DIRECTOR

Bausch Health Americas, Inc.

Locations

TKL Research

Fair Lawn, New Jersey, United States

Countries

United States

Other Identifiers

MP-1012

Identifier Type: -

Identifier Source: org_study_id