drugset / Trial / NCT01290341

Evaluation of the Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis

NCT01290341 ↗

Phase 3 Completed 860 enrolled Merz North America, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a 6-week, double-blind, randomized, placebo-controlled, multicenter, parallel group Phase 3 study of NAFT-600 applied once a day for 2 weeks compared to vehicle (placebo) in the treatment of tinea pedis.

Timeline

Start
2011-02
Primary completion
2011-11
Completion
2011-12

Outcome

Met primary endpoint

registry NUMBER NAFT-600: 26.0 percentage of subjects NUMBER Placebo: 3.3 percentage of subjects analysis (superiority or other test); NAFT-600 vs Placebo; p <0.025; p-value 0.001; NCT01290341 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Naftifine Other / unclassified 2 % Topical

Indications