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

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02394340
• Collaborator: Bausch Health Americas, Inc. (Industry)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 1.9
• Patients Per Site Per Month: 10.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Tinea Pedis; Tinea Cruris	Drug: Omeprazole 40 mg; Drug: Luliconazole Cream 1%	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Feb 3, 2015
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Omeprazole 40 mg; Oral capsule to be taken as per the instructions regarding proper dosing technique.; Drug: Luliconazole Cream 1%; Topical cream to be applied as per the instructions regarding proper study drug application technique.; Other Names: LUZU Cream 1%

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	TKL Research	Fair Lawn	New Jersey	United States	07410

Sponsors and Collaborators

• Bausch & Lomb Incorporated
• Bausch Health Americas, Inc.

Investigators

• Study Director: Anya Loncaric, Bausch Health Americas, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT02394340
• Other Study ID Numbers: MP-1012
• First Posted: Mar 20, 2015
• Last Update Posted: Nov 27, 2019
• Last Verified: Nov 1, 2019

• Additional relevant MeSH terms: Tinea; Tinea Pedis; Tinea cruris; Luliconazole; Omeprazole

Study Results

Participant Flow

Arm/Group Title	Luliconazole Cream 1%
Arm/Group Description	Participants received 1 oral capsule of omeprazole 40 milligrams (mg) on Day 1 and Day 8. Participants also received 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.
Period Title: Overall Study
STARTED	20
Received at Least 1 Dose of Study Drug	20
COMPLETED	18
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Luliconazole Cream 1%
Arm/Group Description	Participants received 1 oral capsule of omeprazole 40 mg on Day 1 and Day 8. Participants also received 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.
Overall Participants	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.05 (10.47)
Sex: Female, Male (Count of Participants)
Female	1 5%
Male	19 95%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Randomized participants who received at least 1 dose of study drug and had evaluable data at the specified time point.

Arm/Group Title	Luliconazole Cream 1%
Arm/Group Description	Participants received 1 oral capsule of omeprazole 40 mg on Day 1 and Day 8. Participants also received 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.
Measure Participants	20
Predose	0 (0)
15 minutes postdose	0 (0)
30 minutes postdose	23.67 (89.46)
45 minutes postdose	196.30 (301.31)
1 hour postdose	463.74 (546.51)
1.5 hours postdose	526.98 (499.60)
2 hours postdose	655.70 (520.31)
2.5 hours postdose	621.08 (464.55)
3 hours postdose	636.60 (508.53)
4 hours postdose	468.79 (355.49)
6 hours postdose	235.20 (214.29)
8 hours postdose	129.70 (129.08)
10 hours postdose	74.24 (84.54)
24 hours postdose	3.32 (6.18)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Randomized participants who received at least 1 dose of study drug and had evaluable data at the specified time point.

Arm/Group Title	Luliconazole Cream 1%
Arm/Group Description	Participants received 1 oral capsule of omeprazole 40 mg on Day 1 and Day 8. Participants also received 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.
Measure Participants	18
Predose	0 (0)
15 minutes postdose	0 (0)
30 minutes postdose	18.11 (68.24)
45 minutes postdose	142.72 (298.29)
1 hour postdose	317.21 (401.97)
1.5 hours postdose	637.56 (509.09)
2 hours postdose	763.51 (607.80)
2.5 hours postdose	700.91 (423.74)
3 hours postdose	730.56 (349.10)
4 hours postdose	586.83 (309.83)
6 hours postdose	323.40 (219.50)
8 hours postdose	190.15 (154.82)
10 hours postdose	111.51 (102.30)
24 hours postdose	6.84 (10.01)

Adverse Events

Time Frame	Baseline up to Day 9
Adverse Event Reporting Description	All participants who received at least 1 application of study drug and had at least 1 post-Baseline assessment.
Arm/Group Title	Luliconazole Cream 1%
Arm/Group Description	Participants received 1 oral capsule of omeprazole 40 mg on Day 1 and Day 8. Participants also received 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.
All Cause Mortality
	Luliconazole Cream 1%
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Luliconazole Cream 1%
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	Luliconazole Cream 1%
	Affected / at Risk (%)	# Events
Total	4/20 (20%)
Injury, poisoning and procedural complications
Muscle strain	1/20 (5%)
Investigations
Alanine aminotransferase increased	1/20 (5%)
Aspartate Aminotransferase increased	1/20 (5%)
Hemoglobin decreased	1/20 (5%)
Musculoskeletal and connective tissue disorders
Back pain	1/20 (5%)

Limitations/Caveats

This study was designed to test a maximal use of luliconazole cream 1% to evaluate the highest systemic exposure of luliconazole, but the doses administered were higher than intended by approximately 25%.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Please contact Sponsor directly for additional information.