Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis

Study Overview
=================
Brief Summary
-----------------
This study is being done to see how the body is affected when a study drug is applied to both feet if the subject has athlete's foot or to both feet and the groin area if the subject has both athlete's foot and jock itch. Safety of the drug and how well the drug works will also be measured.

Detailed Description
-----------------
Study population, diagnosis, and main criteria for inclusion: Tinea pedis and Tinea cruris (NAFT-500): Male or non-pregnant female subjects aged 12 to 17 years, 11 months old of any race with Tinea pedis and Tinea cruris infections confirmed by a positive potassium hydroxide (KOH) analysis from both the feet and bikini area. Both cases (feet and bikini area) must be characterized by clinical evidence of a Tinea pedis and Tinea cruris infection. Additional, approximately 4 pharmacokinetic (PK) evaluable adult subjects with the same condition will serve as a control. Tinea pedis (NAFT-600): Male or non-pregnant female subjects aged 12 to 17 years, 11 months old of any race with Tinea pedis infection confirmed by a positive potassium hydroxide (KOH) analysis from both feet. Both feet must be characterized by clinical evidence of a Tinea pedis infection. Additional, approximately 4 pharmacokinetic (PK) evaluable adult subjects with the same condition will serve as a control.

Official Title
-----------------
An Open-Label, Multi-Center, Multiple-Application Pharmacokinetic Study of NAFT-500 in Pediatric Subjects With Tinea Cruris and Tinea Pedis and NAFT-600 in Pediatric Subjects With Tinea Pedis

Conditions
-----------------
Tinea Pedis, Tinea Cruris

Intervention / Treatment
-----------------
* Drug: NAFT500 (pediatric)
* Drug: NAFT600 (pediatric)
* Drug: NAFT500 (adult)
* Drug: NAFT600 (adult)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must have Tinea pedis on both feet and Tinea cruris infections for NAFT-500; both conditions must be characterized by clinical evidence of a Tinea infection. Subjects must have Tinea pedis on both feet for NAFT-600; the condition must be characterized by clinical evidence of a Tinea infection. Exclusion Criteria: A known hypersensitivity to study medications or their components Any severe condition of Tinea pedis (incapacitating) Any dermatological disease and or condition in the treatment or surrounding area that may prevent application of the study product such as foot psoriasis, corns and /or callus involving any web spaces, or atopic or contact dermatitis Positive pregnancy test Any history or current evidence (physical or laboratory) of anemia

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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: NAFT500 (pediatric)<br>Topical once a day for two weeks | Drug: NAFT500 (pediatric)<br>* Applied to both feet and groin area<br>* Other names: naftifine hydrochloride;|
| Experimental: NAFT600 (pediatric)<br>Topical once a day for two weeks | Drug: NAFT600 (pediatric)<br>* Applied to both feet only<br>* Other names: naftifine hydrochloride;|
| Experimental: NAFT500 (adult)<br>Topical once a day for two weeks | Drug: NAFT500 (adult)<br>* Applied to both feet and groin area<br>* Other names: naftifine hydrochloride;|
| Experimental: NAFT600 (adult)<br>Topical once a day for two weeks | Drug: NAFT600 (adult)<br>* Applied to both feet<br>* Other names: naftifine hydrochloride;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose | Variables will be derived from naftifine plasma concentration at day 1. Variables to be analyzed: - Partial area under the plasma concentration-time curve (0-24 hours postdose) (AUC), as calculated using the linear trapezoid rule. Variables will be derived from naftifine plasma concentration at day 14. Variables to be analyzed: - Area under the plasma concentration-time curve (AUC) within one dosing interval at steady state (SS). AUCτ,ss= Area under the concentration curve within a dosing interval (τ = 24 hours) at steady state | Day 1 and Day 14 | 
| Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose | Variables will be derived from naftifine plasma concentration at day 1. Variables to be analyzed: - Maximum observed plasma concentration (Cmax): the highest plasma concentration in each subject after single dose. Variables will be derived from naftifine plasma concentration at day 14. Variables to be analyzed: - Maximum observed plasma concentration (Cmax): the highest plasma concentration in each subject at steady state (SS). | Day 1 and Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy Variables | Efficacy variables to be analyzed after 2 weeks of once daily application of both products (NAFT-500 or NAFT-600). Efficacy variables to be analyzed: Complete cure Treatment effectiveness Mycological cure Clinical success Clinical cure | Day 28 | 
| Efficacy Variables | Efficacy variables to be analyzed after 2 weeks of once daily application of both products (NAFT-500 or NAFT-600). Efficacy variables to be analyzed: - Subject satisfaction | Day 28 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tinea Pedis, Tinea Cruris, Athlete foot, Jock itch