Evaluation of the Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis
Evaluation of the Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis
This is a 6-week, double-blind, randomized, placebo-controlled, multicenter, parallel group
 Phase 3 study of NAFT-600 applied once a day for 2 weeks compared to vehicle (placebo) in the
 treatment of tinea pedis.
This study is open to males and non-pregnant females, 12 years of age and over, with clinical
 signs and symptoms of tinea pedis consisting of at least moderate erythema, moderate scaling,
 mild pruritus, a positive screening KOH, and a positive culture.Subjects will be evaluated at
 Day 1 (baseline), Week 2, Week 4, and Week 6 (follow-up). Adverse events, concomitant
 medications,and study drug compliance will be reviewed at each visit. Efficacy assessments
 will include KOH and culture evaluations, clinical signs/symptoms (erythema, scaling,
 pruritus), and Investigator's Global Assessment.
Inclusion Criteria:

 -  Males or non-pregnant females, ≥12 years of age, of any race or sex. Females of
 child-bearing potential must have a negative urine pregnancy test.

 -  For minors (less than 18 years), the parent/legal guardian must complete the informed
 consent process AND the subject must complete the assent process and sign the
 appropriate form (if age appropriate).

 -  Presence of interdigital only or both interdigital and moccasin types of tinea pedis
 on one or both feet characterized by clinical evidence of a tinea infection (at least
 moderate erythema, moderate scaling and mild pruritus) based on signs and symptoms in
 the affected area(s).

 Exclusion Criteria:

 -  Subjects with life-threatening condition (ex. autoimmune deficiency syndrome, cancer,
 unstable angina or myocardial infarction) within the last 6 months.

 -  Subjects with abnormal findings - physical or laboratory - that are considered by the
 investigator to be clinically important and indicative of conditions that might
 complicate interpretation of study results.

 -  Subjects with a known hypersensitivity to study drugs or their components.

 -  Subjects who have a recent history or who are currently known to abuse alcohol or
 drugs.

 -  Uncontrolled diabetes mellitus.

 -  Hemodialysis or chronic ambulatory peritoneal dialysis therapy.

 -  Current diagnosis of immunocompromising conditions.

 -  Foot psoriasis, corns and/or callus involving any web spaces, atopic or contact
 dermatitis.

 -  Severe dermatophytoses, onychomycosis (on the evaluated foot), mucocutaneous
 candidiasis or bacterial skin infection.

 -  Extremely severe tinea pedis (incapacitating).

 -  Female subject who is pregnant or lactating, who is not using or does not agree to use
 an acceptable form of contraception during the study, or who intends to become
 pregnant during the study.