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An Open Label Pharmacokinetic Study of Naftin for Tinea Corporis

NCT02466867 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2016-10-28

No results posted yet for this study

Summary

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

Conditions

  • Tinea Corporis

Interventions

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.

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.

Sponsors & Collaborators

  • Merz North America, Inc.

    lead INDUSTRY

Principal Investigators

  • Alan B. Fleischer, MD · Merz North America, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-10-31
Completion
2015-12-31

Countries

  • United States
  • Dominican Republic
  • Honduras

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02466867 on ClinicalTrials.gov