NCT00750152

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 334 (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 (no active treatment), when used in subjects with tinea cruris, also known as jock itch.

Detailed description

To evaluate the efficacy and safety of NAFT-500, applied once daily for 2 weeks, compared to placebo in the treatment of subjects with potassium hydroxide (KOH) and culture positive symptomatic tinea cruris.

Conditions

• Tinea Cruris
• Jock Itch

Interventions

Type	Name	Description
DRUG	NAFT-500	topical cream application up to 4 weeks
DRUG	Placebo	placebo cream applied for up to 4 weeks

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-08-01
• Completion: 2010-02-01
• First posted: 2008-09-10
• Last updated: 2013-04-22
• Results posted: 2012-03-13

Locations

20 sites across 2 countries: United States, Puerto Rico