NCT01358240

Safety and Efficacy of Econazole Nitrate Foam 1% and Foam Vehicle in Subjects With Tinea Pedis

A Multi-Center, Randomized, Double-Blind, Vehicle Controlled, Parallel Group Comparison of Econazole Nitrate Foam 1% vs Foam Vehicle and an Evaluator-Blinded Comparison of Econazole Nitrate Foam 1% and Econazole Nitrate Cream 1% in Subjects With Interdigital Tinea Pedis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 336 (actual)
• Sponsor: AmDerma · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This is a study of the safety and efficacy of Econazole Nitrate Foam 1% and the Foam Vehicle in subjects with interdigital tinea pedis (athlete's foot between the toes). This is a 6 week study which has a 4 week treatment period and a 2 week follow-up evaluation. The study will also utilize Econazole Nitrate Cream 1% (for safety comparison) and a Placebo cream for blinding purposes only.

Conditions

• Tinea Pedis
• Athlete's Foot

Interventions

Type	Name	Description
DRUG	Econazole Nitrate Foam 1%	Econazole Nitrate Foam 1% applied once a day for 4 weeks
DRUG	Vehicle Foam	Vehicle Foam applied once a day for 4 week
DRUG	Econazole Nitrate Cream 1%	Econazole Nitrate Foam 1% applied once a day for 4 weeks
OTHER	Placebo Cream	Placebo cream applied once a day for 4 weeks

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-04-01
• Completion: 2012-08-01
• First posted: 2011-05-23
• Last updated: 2012-09-28

Locations

12 sites across 1 country: United States