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Completed

NCT Number: NCT02466867

An Open Label Pharmacokinetic Study of Naftin for Tinea Corporis

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

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Key information

Conditions

Tinea Corporis Bacterial Infections and Mycoses Dermatomycoses Infections Mycoses Skin Diseases Skin Diseases, Infectious Skin and Connective Tissue Diseases Tinea

Age range

2 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Merz Investigative Site#180001, Santo Domingo, Dominican Republic

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Naftin® Cream, 2% (younger pediatric cohort)

Drug

Approximately 3 grams of Naftin® Cream, 2% ist to be applied once per day for subjects aged 2 to 5 years, 11 months.

Naftin® Cream, 2% (older pediatric cohort)

Drug

Approximately 4 grams of Naftin® Cream, 2% ist to be applied once per day for subjects aged 6 to 11 years, 11 months.

Primary outcomes

  1. 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

Secondary outcomes

  1. Evaluate plasma PK single and multiple dose PK variables

    Time frame: 2 weeks

    tmax and tmax,ss

  2. Evaluate trough plasma PK concentration

    Time frame: 2 weeks

    Ctrough, ttrough,max, Ctrough,max

  3. Evaluate urine PK single and multiple dose variables

    Time frame: 2 weeks

    Ae0-24, fe, CLR, AEt,ss

Sponsors and collaborators

Lead sponsor

Merz North America, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 9, 2015
Registry last updated
Oct 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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