NCT02633813

BE Study of Naftifine HCL

A Randomized, Prospective Multicenter, Double Blind, Parallel Assignment Placebo Controlled BE Study Of Naftifine Hydrochloride 2% Topical Cream With Naftin® In Patients With Tinea Pedis Using Clinical Endpoints

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 693 (actual)
• Sponsor: Genzum Life Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The current study was randomized, double blind, placebo-controlled, prospective, multicenter, comparative therapeutic equivalence study. The study duration for each patient was 6 weeks: Following were the visit details. V1-Baseline and Randomization Visit (Day 1). V2- End of therapy visit (at the end of week 2 + 2 days). V3- Follow up visit (at the end of week 4 + 2 days). V4 - Test of cure visit ( at the end of week 6 + 4 days).

Conditions

• Tinea Pedis

Interventions

Type	Name	Description
DRUG	Naftifine hydrochloride 2%	Topical application for two weeks
DRUG	Placebo	Topical application for two weeks
DRUG	Naftin® 2% (Naftifine hydrochloride 2%)	Topical application for two weeks

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-11-01
• Completion: 2015-12-01
• First posted: 2015-12-17
• Last updated: 2017-05-11

Locations

14 sites across 2 countries: United States, Dominican Republic