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Completed

NCT Number: NCT02394340

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.

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Key information

Conditions

Tinea Pedis Bacterial Infections and Mycoses Dermatitis Dermatomycoses Foot Dermatoses Foot Diseases Infections Intertrigo Mycoses Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Diseases, Eczematous Skin Diseases, Infectious Skin Manifestations Skin and Connective Tissue Diseases Tinea Tinea Cruris

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

TKL Research

Fair Lawn, New Jersey, 07410, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omeprazole 40 MG

Drug

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

Luliconazole Cream 1%

Drug

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

Other names: LUZU Cream 1%

Primary outcomes

  1. Circulating Levels (Plasma Concentration) of Omeprazole Prior to Treatment With Luliconazole Cream 1%

    Time frame: 15 minutes predose; 15, 30, 45, and 60 minutes postdose; and 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 24 hours postdose of omeprazole on Day 1

    Circulating plasma levels of omeprazole were measured using validated liquid chromatography with tandem mass spectrometry detection (LS/MS-MS) methods. The range for omeprazole determination was 4.64-9.27 nanograms/milliliter (ng/mL). Serial blood sampling occurred in each enrolled participant up to 24 hours post treatment (Day 1) with omeprazole (before the start of luliconazole cream 1% treatment on Day 2).

  2. Circulating Levels (Plasma Concentration) of Omeprazole After 1 Week of Treatment With Luliconazole Cream 1%

    Time frame: 15 minutes predose; 15, 30, 45, and 60 minutes postdose; and 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 24 hours postdose of omeprazole on Day 8

    Circulating plasma levels of omeprazole were measured using validated LS/MS-MS methods. The range for omeprazole determination was 4.64-9.27 ng/mL. Serial blood sampling occurred in each enrolled participant up to 24 hours post treatment (Day 8) with omeprazole (after using luliconazole cream 1% treatment for 1 week).

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Collaborators

  • Bausch Health Americas, Inc.

Registry information

Official study title

An Open-Label, Maximal Use Study Evaluating the Drug Interaction Potential of Luliconazole Cream 1% in Subjects With Tinea Pedis and Tinea Cruris

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 20, 2015
Registry last updated
Nov 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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