Tinea Pedis Clinical Trial
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
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 have both athlete's foot and jock itch. Safety of the drug and how well the drug works will also be measured.
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 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 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 KOH analysis from both feet. Both feet must be
characterized by clinical evidence of a Tinea pedis infection. Additional, approximately 4
PK evaluable adult subjects with the same condition will serve as a control.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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