NCT02335255

Evaluate Safety and Efficacy of Naftifine Hydrochloride Gel 2% and Naftin® Gel 2% in Tinea Pedis

A Multi-Center, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Naftifine Hydrochloride Gel 2% and Naftin® (Naftifine Hydrochloride) Gel 2% in Patients With Tinea Pedis.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1,519 (actual)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compare the efficacy and safety of the test formulation Naftifine Hydrochloride Gel 2% to Naftin® (Naftifine Hydrochloride) Gel 2%

Detailed description

The purpose of this study is to compare the efficacy and safety of the test formulation Naftifine Hydrochloride Gel 2% to Naftin® (Naftifine Hydrochloride) Gel 2% in a six week study (four weeks after the end of two week treatment) in patients with tinea pedis.

Conditions

• Tinea Pedis

Interventions

Type	Name	Description
DRUG	Naftifine Hydrochloride Gel 2%	Naftifine Hydrochloride Gel 2% applied once daily for fourteen consecutive days to affected areas plus a 1/2 inch margin of healthy surrounding skin.
DRUG	Naftin® Gel 2%	Naftin® Gel 2% applied once daily for fourteen consecutive days to affected areas plus a 1/2 inch margin of healthy surrounding skin.
DRUG	Placebo Topical Gel	Placebo Topical Gel applied once daily for fourteen consecutive days to affected areas plus a 1/2 inch margin of healthy surrounding skin.

Timeline

• Start date: 2014-06-27
• Primary completion: 2018-05-15
• Completion: 2018-05-15
• First posted: 2015-01-09
• Last updated: 2018-09-06