An Open Label Pharmacokinetic Study of Naftin for Tinea Corporis

Condition(s) targeted: Tinea Corporis

Intervention: Naftin® Cream, 2% (younger pediatric cohort) (Drug); Naftin® Cream, 2% (older pediatric cohort) (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Merz Pharmaceuticals, LLC

Official(s) and/or principal investigator(s):
Alan B. Fleischer, MD, Study Director, Affiliation: Merz Pharmaceuticals, LLC

Overall contact:
Merz Pharmaceuticals, LLC, Email: clinicaltrials@merzusa.com

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

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To quantify the plasma concentration of single and multiple dose of naftifine hydrochloride cream, 2% in pediatric subjects with tinea corporis

Secondary outcome:

Evaluate plasma PK single and multiple dose PK variables

Evaluate trough plasma PK concentration

Evaluate urine PK single and multiple dose variables

Minimum age: 2 Years. Maximum age: 11 Years. Gender(s): Both.

Criteria:

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.

Merz Pharmaceuticals, LLC, Email: clinicaltrials@merzusa.com

Merz Investigative Site#180001, Santo Domingo, Dominican Republic; Recruiting

Merz Investigative Site #504001, San Pedro Sula, Honduras; Recruiting

Merz Investigative Site#001261, College Station, Texas 77845, United States; Recruiting

Starting date: January 2014
Last updated: June 4, 2015