Topical Antifungal Treatment for Tinea Pedis

Phase 3

Completed

• Conditions: Tinea Pedis
• Interventions: Drug: Placebo; Drug: 33525

• Registration Number: NCT01396811
• Lead Sponsor: Medicis Global Service Corporation

Brief Summary

The purpose of this study is to determine if a topical antifungal cream is safe and effective for the treatment of tinea pedis.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-15
• Study First Submitted QC: 2011-07-18
• Study First Posted: 2011-07-19
• Primary Completion: 2012-01
• Study Completion: 2012-03
• Disposition First Submitted: 2013-01-22
• Disposition First Submitted QC: 2013-01-22
• Disposition First Posted: 2013-01-23
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-20
• Last Update Posted: 2013-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 322

Inclusion Criteria

• Moderate erythema, moderate scaling, and mild pruritus

Exclusion Criteria

• Pregnancy and allergies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Product 33525 Placebo
Active	33525	Product 33525

Primary Outcome Measures

Name	Time	Method
Proportion of patients achieving complete clearance	Day 42	Signs and Symptoms Severity Score and negative Potassium Hydroxide (KOH) and Culture

Secondary Outcome Measures

Name	Time	Method
Proportion of patients achieving effective treatment	Day 42	Clinical Cure and Mycologic Cure