Conditions: Tinea Pedis Tinea Cruris
Keywords: Tinea Pedis Tinea Cruris Athlete foot Jock itch
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 56
Healthy volunteers: no

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.

Arms:
arm 1: Topical once a day for two weeks arm 2: Topical once a day for two weeks arm 3: Topical once a day for two weeks arm 4: Topical once a day for two weeks

Interventions: intervention 1: NAFT500 (pediatric) intervention 2: NAFT600 (pediatric) intervention 3: NAFT500 (adult) intervention 4: NAFT600 (adult)
Intervention descriptions: intervention 1: Applied to both feet and groin area intervention 2: Applied to both feet only intervention 3: Applied to both feet and groin area intervention 4: Applied to both feet

Protocol document: