Who is sponsoring NCT01358240?

NCT01358240 is sponsored by AmDerma.

What condition does NCT01358240 study?

NCT01358240 studies Tinea Pedis, Athlete's Foot.

What drugs are being tested in NCT01358240?

Interventions: Econazole Nitrate Foam 1%, Vehicle Foam, Econazole Nitrate Cream 1%, Placebo Cream.

What is the status of NCT01358240?

NCT01358240 is currently COMPLETED.

Last reviewed 2012-09-27 · How we verify

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

NCT01358240 Phase 3 COMPLETED

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.

Details

Lead sponsor	AmDerma
Phase	Phase 3
Status	COMPLETED
Enrolment	336
Start date	2011-06
Completion	2012-08

Conditions

Tinea Pedis
Athlete's Foot

Interventions

Econazole Nitrate Foam 1%
Vehicle Foam
Econazole Nitrate Cream 1%
Placebo Cream

Primary outcomes

Complete Cure — Day 43
Complete Cure is defined as a negative KOH and negative fungal culture and no evidence of clinical disease as indicated by scores of 0 (none) for each sign and system at Day 43, analysis of the Econazole Nitrate Foam 1% and Foam Vehicle treatment groups only.

Countries

United States