Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis

June 3, 2016 updated by: Merz North America, Inc.

An Open-Label, Multi-Center, Multiple-Application Pharmacokinetic Study of NAFT-500 in Pediatric Subjects With Tinea Cruris and Tinea Pedis and NAFT-600 in Pediatric Subjects With Tinea Pedis

This study is being done to see how the body is affected when a study drug is applied to both feet if the subject has athlete's foot or to both feet and the groin area if the subject has both athlete's foot and jock itch. Safety of the drug and how well the drug works will also be measured.

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.

Detailed Description

Study population, diagnosis, and main criteria for inclusion:

Tinea pedis and Tinea cruris (NAFT-500):

Male or non-pregnant female subjects aged 12 to 17 years, 11 months old of any race with Tinea pedis and Tinea cruris infections confirmed by a positive potassium hydroxide (KOH) analysis from both the feet and bikini area. Both cases (feet and bikini area) must be characterized by clinical evidence of a Tinea pedis and Tinea cruris infection. Additional, approximately 4 pharmacokinetic (PK) evaluable adult subjects with the same condition will serve as a control.

Tinea pedis (NAFT-600):

Male or non-pregnant female subjects aged 12 to 17 years, 11 months old of any race with Tinea pedis infection confirmed by a positive potassium hydroxide (KOH) analysis from both feet. Both feet must be characterized by clinical evidence of a Tinea pedis infection. Additional, approximately 4 pharmacokinetic (PK) evaluable adult subjects with the same condition will serve as a control.

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.
56

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
        • Merz Investigative Site #180001
  • Honduras
      • San Pedro Sula, Honduras
        • Merz Investigative Site #504001
  • United States
    • Texas
      • Austin, Texas, United States, 78759
        • Merz Investigative Site #001272
      • College Station, Texas, United States, 77802
        • Merz Investigative Site #001261

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 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects must have Tinea pedis on both feet and Tinea cruris infections for NAFT-500; both conditions must be characterized by clinical evidence of a Tinea infection.
  • Subjects must have Tinea pedis on both feet for NAFT-600; the condition must be characterized by clinical evidence of a Tinea infection.

Exclusion Criteria:

  • A known hypersensitivity to study medications or their components
  • Any severe condition of Tinea pedis (incapacitating)
  • Any dermatological disease and or condition in the treatment or surrounding area that may prevent application of the study product such as foot psoriasis, corns and /or callus involving any web spaces, or atopic or contact dermatitis
  • Positive pregnancy test
  • Any history or current evidence (physical or laboratory) of anemia

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: NAFT500 (pediatric)
Topical once a day for two weeks
Drug: NAFT500 (pediatric)
Applied to both feet and groin area
Other Names:
  • NAFT500
  • naftifine
  • naftifine hydrochloride
Experimental: NAFT600 (pediatric)
Topical once a day for two weeks
Drug: NAFT600 (pediatric)
Applied to both feet only
Other Names:
  • naftifine
  • naftifine hydrochloride
  • NAFT600
Experimental: NAFT500 (adult)
Topical once a day for two weeks
Drug: NAFT500 (adult)
Applied to both feet and groin area
Other Names:
  • NAFT500
  • naftifine
  • naftifine hydrochloride
Experimental: NAFT600 (adult)
Topical once a day for two weeks
Drug: NAFT600 (adult)
Applied to both feet
Other Names:
  • naftifine
  • naftifine hydrochloride
  • NAFT600

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
Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose
Time Frame: Day 1 and Day 14

Variables will be derived from naftifine plasma concentration at day 1. Variables to be analyzed:

- Partial area under the plasma concentration-time curve (0-24 hours postdose) (AUC), as calculated using the linear trapezoid rule.

Variables will be derived from naftifine plasma concentration at day 14. Variables to be analyzed:

- Area under the plasma concentration-time curve (AUC) within one dosing interval at steady state (SS). AUCτ,ss= Area under the concentration curve within a dosing interval (τ = 24 hours) at steady state
Day 1 and Day 14
Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose
Time Frame: Day 1 and Day 14

Variables will be derived from naftifine plasma concentration at day 1. Variables to be analyzed:

- Maximum observed plasma concentration (Cmax): the highest plasma concentration in each subject after single dose.

Variables will be derived from naftifine plasma concentration at day 14. Variables to be analyzed:

- Maximum observed plasma concentration (Cmax): the highest plasma concentration in each subject at steady state (SS).
Day 1 and Day 14

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Efficacy Variables
Time Frame: Day 28

Efficacy variables to be analyzed after 2 weeks of once daily application of both products (NAFT-500 or NAFT-600).

Efficacy variables to be analyzed:

  • Complete cure
  • Treatment effectiveness
  • Mycological cure
  • Clinical success
  • Clinical cure
Day 28
Efficacy Variables
Time Frame: Day 28

Efficacy variables to be analyzed after 2 weeks of once daily application of both products (NAFT-500 or NAFT-600).

Efficacy variables to be analyzed:

- Subject satisfaction
Day 28

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.
Merz North America, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Alan Fleischer, MD, Merz Pharmaceutical, LLC

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

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.
October 1, 2012

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.
November 1, 2013

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.
November 1, 2013

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).
October 16, 2012

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.
October 19, 2012

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.
October 23, 2012

Study Record Updates

Last Update Posted (Estimate)

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.
July 14, 2016

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.
June 3, 2016

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.
June 1, 2016

More Information

Terms related to this study

Keywords

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.
  • MUS 90200/1023/0
  • Tinea Pedis and Cruris

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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