NCT01519752

A Therapeutic Equivalence Study of Two Oxiconazole Nitrate Topical Cream Treatments for Patients With Tinea Pedis

A Randomized, Double-Blind, Placebo Controlled, Parallel Design, Multiple-Site, Study Comparing Oxiconazole Nitrate Cream 1% (Taro Pharmaceuticals,Inc) to Oxistat® (Oxiconazole Nitrate Cream) Cream 1% (PharmaDerma) in the Treatment of Tinea Pedis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 661 (actual)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to demonstrate that Oxiconazole nitrate 1% topical cream is effective for the treatment of patients with moderate to severe Tinea pedis.

Conditions

• Tinea Pedis

Interventions

Type	Name	Description
DRUG	Oxiconazole Nitrate Cream 1%	Oxiconazole Nitrate Cream 1% applied to affected area once a day for 28 days
DRUG	Oxiconazole Nitrate Cream 1% (Oxistat®)	Oxiconazole Nitrate Cream 1%(Oxistat®)applied to affected area once a day for 28 days
DRUG	Placebo	Placebo applied to affected area once a day for 28 days

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-08-01
• Completion: 2012-11-01
• First posted: 2012-01-27
• Last updated: 2014-01-22