An Open Label Pharmacokinetic Study of Naftin for Tinea Corporis

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

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

Conditions
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Tinea Corporis

Intervention / Treatment
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* Drug: Naftin® Cream, 2% (younger pediatric cohort)
* Drug: Naftin® Cream, 2% (older pediatric cohort)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naftin® Cream, 2% (younger pediatric cohort)<br>Subject aged 2 years to 5 years, 11 months with tinea corporis | Drug: Naftin® Cream, 2% (younger pediatric cohort)<br>* Approximately 3 grams of Naftin® Cream, 2% ist to be applied once per day for subjects aged 2 to 5 years, 11 months.<br>|
| Experimental: Naftin® Cream, 2% (older pediatric cohort)<br>Subject aged 6 years to 11 years, 11 months with tinea corporis | Drug: Naftin® Cream, 2% (older pediatric cohort)<br>* Approximately 4 grams of Naftin® Cream, 2% ist to be applied once per day for subjects aged 6 to 11 years, 11 months.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ringworm