Tinea PedisPhase 4NCT02394340

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

A Phase 4 study testing Omeprazole 40 mg and Luliconazole Cream 1% in people with Tinea Pedis and Tinea Cruris, run by Bausch & Lomb Incorporated at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Tinea Pedis, Tinea Cruris
What is being tested?: Omeprazole 40 mg and Luliconazole Cream 1%
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 3 Feb 2015to 1 Apr 2015
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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 locations and contacts

1 site in 1 country.

United States1 site

TKL Research
Fair Lawn, New Jersey, 07410

Other trials in United States

About this study

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

Conditions: Tinea Pedis, Tinea Cruris
Being tested: Omeprazole 40 mg, Luliconazole Cream 1%
Medical subject headings: Tinea Pedis, Tinea Cruris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Omeprazole 40 mgDrug
Oral capsule to be taken as per the instructions regarding proper dosing technique.
Luliconazole Cream 1%Drug
Also called LUZU Cream 1%
Topical cream to be applied as per the instructions regarding proper study drug application technique.

Study groups in NCT02394340
Study group	Role	What they receive
Luliconazole Cream 1%	Experimental	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. Receives: Drug: Omeprazole 40 mg; Drug: Luliconazole Cream 1%

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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 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).
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Feb 20151 Apr 2015

First posted20 Mar 2015 (estimated)
Study start3 Feb 2015
Primary completion1 Apr 2015
Study completion1 Apr 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Tinea PedisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02394340
Sponsor's protocol ID: MP-1012
Status last verified: Nov 2019
First submitted: 19 Feb 2015
Last updated: 27 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Phase 1b Study of ZYG24004 in Participants With Tinea Pedis Caused by Dermatophytes
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All Tinea Pedis trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02394340
Acronym / sponsor ID: MP-1012
Conditions: Tinea Pedis, Tinea Cruris
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
Collaborators: Bausch Health Americas, Inc.
Study start: 3 Feb 2015 (actual)
Primary completion: 1 Apr 2015 (actual)
Study completion: 1 Apr 2015 (actual)
First posted: 20 Mar 2015 (estimated)
Results: Posted 27 Nov 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Luliconazole Cream 1%	Experimental	Drug: Omeprazole 40 mg, Drug: 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Omeprazole 40 mgOral capsule to be taken as per the instructions regarding proper dosing technique.	Drug	Luliconazole Cream 1%
Luliconazole Cream 1%Also: LUZU Cream 1%Topical cream to be applied as per the instructions regarding proper study drug application technique.	Drug	Luliconazole Cream 1%

Primary outcome

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).
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).

Results and safety

Results posted to the registry on 27 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Luliconazole Cream 1%	20	18

Primary outcome: 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. Mean (Standard Deviation). Unit: ng/mL

Measure	Luliconazole Cream 1% n = 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)

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

Primary outcome: 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. Mean (Standard Deviation). Unit: ng/mL

Measure	Luliconazole Cream 1% n = 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)

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

Adverse events

Time frame: Baseline up to Day 9. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Luliconazole Cream 1%	0 of 20 (0%)	4 of 20 (20%)	Not reported

Limitations and caveats (from the sponsor): 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%.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Tinea Pedis

RecruitingObservational study
In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
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RecruitingPhase 1
A Phase 1b Study of ZYG24004 in Participants With Tinea Pedis Caused by Dermatophytes
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anya Loncaric study director

Bausch Health Americas, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Omeprazole 40 mg and Luliconazole Cream 1% in people with Tinea Pedis and Tinea Cruris, run by Bausch & Lomb Incorporated at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02394340.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2019.