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

Phase 3 Completed 707 enrolled Merz North America, Inc.

RandomizedParallel-groupDouble-blindTreatment

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).

Timeline

Start: 2008-08
Primary completion: 2009-08
Completion: 2009-12

Outcome

Met primary endpoint

registry analysis (superiority or other test); NAFT-500 vs Placebo 2-weeks; p = 0.010; Cochran-Mantel-Haenszel NCT00750139 ↗

registry analysis (superiority or other test); Naftin 1% vs Placebo 4-wks; p = 0.001; Cochran-Mantel-Haenszel NCT00750139 ↗

Publications

Parish LC, Parish JL, Routh HB, Fleischer AB Jr, Avakian EV, Plaum S, Hardas B. A randomized, double-blind, vehicle-controlled efficacy and safety study of naftifine 2% cream in the treatment of tinea pedis. J Drugs Dermatol. 2011 Nov;10(11):1282-8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Naftifine	Other / unclassified	1 %	Topical
Subject	Naftifine	Other / unclassified	2 %	Topical