NCT00768599

A Study of Econazole Foam 1% in Athlete's Foot

A Multi-Center Randomized, Evaluator-Blinded, Vehicle Controlled, Parallel Group Comparison Study of the Safety and Efficacy of Econazole Nitrate Foam 1%, Econazole Nitrate 1% Cream, and Foam Vehicle in Subjects With Tinea Pedis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: AmDerma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a 6-week clinical study (4 weeks of treatment, once per day, plus a 2-week follow-up period) of a topical foam to treat athlete's foot. The active ingredient in the foam -- econazole nitrate 1% -- is the same active pharmaceutical ingredient in a cream that your doctor can currently prescribe to treat athlete's foot. This study will help to understand if the foam works the same as the cream to treat athlete's foot.

Detailed description

Treating athlete's foot with a cream can leave a greasy, wet feeling on the foot that is uncomfortable to the user and messy on clothing and foot wear. A foam formulation that spreads easily and rubs-in easily that is as effective as the (reference) cream formulation in treating athlete's foot would be a benefit to the user. This study is designed to substantiate a clinical bridge between econazole nitrate foam 1% and econazole nitrate cream 1% based on clinical outcome, safety, and pharmacokinetic data. The study is (foam) vehicle-controlled and is randomized 1 to 1 to 1 (foam:cream:vehicle).

Conditions

• Tinea Pedis
• Athlete's Foot

Interventions

Type	Name	Description
DRUG	Econazole Nitrate Cream 1%	Topical cream, applied once daily for 4 weeks.
DRUG	Econazole Nitrate Foam 1%	Topical foam, applied once daily for 4 weeks.
DRUG	Vehicle Foam	Topical foam, applied once daily for 4 weeks.

Timeline

• Start date: 2008-03-01
• Primary completion: 2008-09-01
• Completion: 2008-10-01
• First posted: 2008-10-08
• Last updated: 2013-01-09
• Results posted: 2013-01-09

Locations

6 sites across 1 country: United States