An Open Label Pharmacokinetic Study of Naftin for Tinea Corporis

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02466867

Enrollment

Registered

2015-06-09

Start date

2014-01-31

Completion date

2015-12-31

Last updated

2016-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinea Corporis

Keywords

Ringworm

Brief summary

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

Interventions

DRUGNaftin® 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.

DRUGNaftin® 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 11 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

Dominican Republic, Honduras, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026