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

Merz North America, Inc.3 sites in 3 countries27 target enrollmentJanuary 2014

Overview

Phase: Phase 4
Intervention: Naftin® Cream, 2% (younger pediatric cohort)
Conditions: Tinea Corporis
Sponsor: Merz North America, Inc.
Enrollment: 27
Locations: 3
Primary Endpoint: To quantify the plasma concentration of single and multiple dose of naftifine hydrochloride cream, 2% in pediatric subjects with tinea corporis
Status: Completed
Last Updated: 9 years ago

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

Registry

clinicaltrials.gov

Start Date

January 2014

End Date

December 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•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.

•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.