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

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ClinicalTrials.gov Identifier: NCT02394340
Recruitment Status : Completed
First Posted : March 20, 2015
Results First Posted : November 27, 2019
Last Update Posted : November 27, 2019
Sponsor:
Collaborator:
Bausch Health Americas, Inc.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

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

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Study Type : Interventional  (Clinical Trial)
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 : February 3, 2015
Actual Primary Completion Date : April 1, 2015
Actual Study Completion Date : April 1, 2015

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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 Name: LUZU Cream 1%




Primary Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02394340


Locations
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United States, New Jersey
TKL Research
Fair Lawn, New Jersey, United States, 07410
Sponsors and Collaborators
Bausch & Lomb Incorporated
Bausch Health Americas, Inc.
Investigators
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Study Director: Anya Loncaric Bausch Health Americas, Inc.
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Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT02394340    
Other Study ID Numbers: MP-1012
First Posted: March 20, 2015    Key Record Dates
Results First Posted: November 27, 2019
Last Update Posted: November 27, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
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Tinea
Tinea Pedis
Tinea cruris
Dermatomycoses
Mycoses
Bacterial Infections and Mycoses
Infections
Skin Diseases, Infectious
Skin Diseases
Foot Dermatoses
Foot Diseases
Pruritus
Skin Manifestations
Intertrigo
Dermatitis
Skin Diseases, Eczematous
Luliconazole
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents