An Open Label Pharmacokinetic Study of Naftin for Tinea Corporis

October 27, 2016 updated by: Merz North America, Inc.

An Open-Label, Multi-Center, Multiple-Application Pharmacokinetic Study of Naftin® (Naftifine Hydrochloride) Cream, 2% in Pediatric Subjects With Tinea Corporis

This is an open label, multi-center, multi-application pharmacokinetic study in pediatric subjects with tinea corporis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • 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
      • College Station, Texas, United States, 77845
        • 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

Ages Eligible for Study

2 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or females 2 to 11 years, 11 months of any race. Females of child producing age (started menarche) must have a negative urine pregnancy test.
  • Presence of tinea corporis characterized by clinical evidence of a tinea infection at multiple sites covering a total of at least 1% body surface area.
  • KOH positive and culture positive baseline skin scrapings obtained from the site most severely affected of the overall severity.
  • Subjects must be in good health and free from clinically significant disease that might interfere with the study evaluations.

Exclusion Criteria:

  • Tinea infection of the scalp, face, groin, and/or feet.
  • A life-threatening condition (ex. autoimmune deficiency syndrome, cancer) within the last 6 months
  • Subject with abnormal findings-physically or laboratory- that considered by the investigator to be clinically important and indicative of conditions that might complicate interpretation of study results.
  • Subjects with a known hypersensitivity or other contradictions to study medications or their components.

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
Intervention / Treatment
Experimental: Naftin® Cream, 2% (younger pediatric cohort)
Subject aged 2 years to 5 years, 11 months with tinea corporis
Drug: Naftin® Cream, 2% (younger pediatric cohort)
Approximately 3 grams of Naftin® Cream, 2% ist to be applied once per day for subjects aged 2 to 5 years, 11 months.
Experimental: Naftin® Cream, 2% (older pediatric cohort)
Subject aged 6 years to 11 years, 11 months with tinea corporis
Drug: Naftin® Cream, 2% (older pediatric cohort)
Approximately 4 grams of Naftin® Cream, 2% ist to be applied once per day for subjects aged 6 to 11 years, 11 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To quantify the plasma concentration of single and multiple dose of naftifine hydrochloride cream, 2% in pediatric subjects with tinea corporis
Time Frame: 2 weeks
AUC0-24, Cmax, AUC0-24/D, Cmax/D, AUCt,ss, Cmax,ss, AUCt,,ss/D, Cmax,ss/D
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate plasma PK single and multiple dose PK variables
Time Frame: 2 weeks
tmax and tmax,ss
2 weeks
Evaluate trough plasma PK concentration
Time Frame: 2 weeks
Ctrough, ttrough,max, Ctrough,max
2 weeks
Evaluate urine PK single and multiple dose variables
Time Frame: 2 weeks
Ae0-24, fe, CLR, AEt,ss
2 weeks

Collaborators and Investigators

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

Sponsor

Merz North America, Inc.

Investigators

  • Study Director: Alan B. Fleischer, MD, Merz North America, 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

January 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

October 29, 2014

First Submitted That Met QC Criteria

June 4, 2015

First Posted (Estimate)

June 9, 2015

Study Record Updates

Last Update Posted (Estimate)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUS90200_4025_1

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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