NCT01580891

Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis

Randomized, Double-Blind, Placebo-Controlled, Multiple-Site, Parallel Design Study to Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1,053 (actual)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the efficacy and safety of the test formulation of Naftifine HCl Cream 1% (Taro Pharmaceuticals Inc.) as compared to the already marketed formulation Naftin® (Naftifine HCl) 1% Cream (Merz Pharmaceuticals) and placebo in patients with tinea pedis and to show the superiority of the active treatments over placebo when dosed once a day for 28 days.

Conditions

• Tinea Pedis

Interventions

Type	Name	Description
DRUG	Naftifine HCl Cream 1%	Naftifine HCl Cream 1% applied topically once a day for 28 days.
DRUG	Naftin® (Naftifine HCl) Cream 1%	Naftin® (Naftifine HCl) Cream 1% applied topically once a day for 28 days.
DRUG	Placebo topical cream	Placebo topical cream applied topically once a day for 28 days.

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-03-01
• Completion: 2013-07-01
• First posted: 2012-04-19
• Last updated: 2014-05-06