NCT01290341

Evaluation of the Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis

A Phase 3 Double-Blind, Randomized, Placebo-Controlled,Multicenter, Parallel Group Evaluation of the Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 860 (actual)
• Sponsor: Merz North America, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tinea Pedis

Interventions

Type	Name	Description
DRUG	NAFT-600 (naftin 2 % gel)	Topical; applied once daily for two weeks
DRUG	Placebo	Topical; applied once daily for two weeks.

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-11-01
• Completion: 2011-12-01
• First posted: 2011-02-07
• Last updated: 2013-09-26
• Results posted: 2013-09-26

Locations

23 sites across 1 country: United States