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

Primary Purpose

Tinea Pedis, Tinea Cruris

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Omeprazole 40 mg
Luliconazole Cream 1%
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinea Pedis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • TKL Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Luliconazole Cream 1%

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 19, 2015
Last Updated
November 8, 2019
Sponsor
Bausch & Lomb Incorporated
Collaborators
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02394340
Brief Title
Study Evaluating the Drug Interaction Potential of Luliconazole Cream 1% in Participants With Tinea Pedis and Tinea Cruris
Official Title
An Open-Label, Maximal Use Study Evaluating the Drug Interaction Potential of Luliconazole Cream 1% in Subjects With Tinea Pedis and Tinea Cruris
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
February 3, 2015 (Actual)
Primary Completion Date
April 1, 2015 (Actual)
Study Completion Date
April 1, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated
Collaborators
Bausch Health Americas, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinea Pedis, Tinea Cruris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Luliconazole Cream 1%
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Omeprazole 40 mg
Intervention Description
Oral capsule to be taken as per the instructions regarding proper dosing technique.
Intervention Type
Drug
Intervention Name(s)
Luliconazole Cream 1%
Other Intervention Name(s)
LUZU Cream 1%
Intervention Description
Topical cream to be applied as per the instructions regarding proper study drug application technique.
Primary Outcome Measure Information:
Title
Circulating Levels (Plasma Concentration) of Omeprazole Prior to Treatment With Luliconazole Cream 1%
Description
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).
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
Title
Circulating Levels (Plasma Concentration) of Omeprazole After 1 Week of Treatment With Luliconazole Cream 1%
Description
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).
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anya Loncaric
Organizational Affiliation
Bausch Health Americas, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
TKL Research
City
Fair Lawn
State/Province
New Jersey
ZIP/Postal Code
07410
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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