Maximal Use of Luliconazole Cream 1% in Pediatric Participants With Moderate to Severe Tinea Pedis or Tinea Cruris

November 8, 2019 updated by: Bausch Health Americas, Inc.

An Open-Label Study to Assess the Pharmacokinetics With Maximal Use of Luliconazole Cream 1% in Pediatric Patients With Moderate to Severe Tinea Pedis or Tinea Cruris

The objective of this study is to evaluate the pharmacokinetics of luliconazole cream 1%, as measured by circulating plasma levels of luliconazole, when maximal quantity of luliconazole cream 1% is applied to participants of 12 years to less than (<) 18 years of age with moderate to severe inter-digital tinea pedis or tinea cruris.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Dominican Republic
      • Santo Domingo, Dominican Republic, 10700
        • Valeant Site 01
  • Honduras
      • San Pedro Sula, Honduras, CT1100
        • Valeant Site 02

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Participants (or legal guardian) with the ability and willingness to sign a written informed consent.
  • Participants of either gender at least 12 years to <18 years old (12 to 17 years, inclusive).
  • Participants with a mycological diagnosis of tinea pedis or tinea cruris confirmed by the detection of fungal hyphae on a microscopic potassium hydroxide (KOH) wet mount.
  • Participants with the ability and willingness to follow all study procedures, attend all scheduled visits, have all blood draws, and successfully complete the study.
  • Participants must be in good general health and free of any disease that in the Investigator's opinion might interfere with the study evaluations.
  • Participants must be able to communicate, be able to understand the study procedures, and be willing to comply with the study requirements.

Key Exclusion Criteria:

  • Participants with both tinea pedis and tinea cruris.
  • Participants with active atopic or contact dermatitis in the treatment area.
  • Female participants who are pregnant and/or nursing or planning a pregnancy during the course of the trial. Participants who test positive for pregnancy after start of test treatment will be discontinued from test treatment but will be followed for safety purposes.
  • Participants who are immunocompromised (due to disease, for example; human immunodeficiency virus [HIV] or medications).
  • Participants who have a recent history of or current drug or alcohol abuse.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tinea Pedis
Participants with tinea pedis received luliconazole cream 1% topically once daily in the morning for 15 days (Day 1 through 15). The dose was approximately 3.0 grams per application and covered all affected and adjacent areas, including up to the ankles.
Drug: Luliconazole Cream 1%
Luliconazole cream will be applied topically per schedule specified in the arms.
Experimental: Tinea Cruris
Participants with tinea cruris received luliconazole cream 1% topically once daily in the morning for 8 days (Day 1 through 8). The dose was approximately 3.0 grams per application and covered all affected and adjacent areas, including up to the groin, thighs, and abdomen.
Drug: Luliconazole Cream 1%
Luliconazole cream will be applied topically per schedule specified in the arms.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Maximum Observed Plasma Concentration (Cmax) of Luliconazole
Time Frame: Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15
Plasma concentration of luliconazole was determined using validated liquid chromatography-mass spectrometry (LC/MS) method.
Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15
Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) of Luliconazole
Time Frame: Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15
Plasma concentration of luliconazole was determined using validated LC/MS method. AUC0-24 was calculated by linear trapezoidal method.
Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15
Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Elimination Half-Life (t1/2) of Luliconazole
Time Frame: Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15
Plasma concentration of luliconazole was determined using validated LC/MS method.
Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15
Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: Cmax of Luliconazole
Time Frame: Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8
Plasma concentration of luliconazole was determined using validated LC/MS method.
Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8
Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: AUC0-24 of Luliconazole
Time Frame: Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8
Plasma concentration of luliconazole was determined using validated LC/MS method. AUC0-24 was calculated by linear trapezoidal method.
Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8
Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: t1/2 of Luliconazole
Time Frame: Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8
Plasma concentration of luliconazole was determined using validated LC/MS method.
Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bausch Health Americas, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 2, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 27, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 27, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 10, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 27, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • V01-LUZA-401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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