NCT00750139

Multicenter Study of the Safety and Efficacy of NAFT-500 in Tinea Pedis

A Phase 3 Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel Group Evaluation of the Efficacy and Safety of NAFT-500 in Subjects With Tinea Pedis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 707 (actual)
• Sponsor: Merz North America, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

Summary

A research study to compare the safety and effectiveness of an investigational medication called NAFT-500 to placebo, when used in subjects with tinea pedis (athlete's foot).

Detailed description

To evaluate the efficacy and safety of NAFT-500 compared to placebo in the treatment of subjects with potassium hydroxide (KOH) and culture positive symptomatic tinea pedis.

Conditions

• Tinea Pedis
• Athlete's Foot

Interventions

Type	Name	Description
DRUG	NAFT-500	topical cream 1 application every day up to 4 weeks weeks
DRUG	Placebo 2-weeks	placebo cream 1 application every day for up to 4 weeks
DRUG	Naftin 1%	topical allylamine cream applied once a day for up to 4 weeks
DRUG	Placebo 4-weeks	topical placebo cream applied once a day for up to 4 weeks

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-08-01
• Completion: 2009-12-01
• First posted: 2008-09-10
• Last updated: 2013-04-26
• Results posted: 2013-01-29

Locations

17 sites across 1 country: United States