Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis
Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and 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 has
 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 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.
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