Conditions: Tinea Pedis
Keywords: fungal infection athlete foot
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 860
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Topical; applied once daily for two weeks arm 2: Topical; applied once daily for two weeks.

Interventions: intervention 1: NAFT-600 (naftin 2 % gel) intervention 2: Placebo
Intervention descriptions: intervention 1: Topical; applied once daily for two weeks intervention 2: Topical; applied once daily for two weeks.

Protocol document: