Topical Antifungal Treatment for Tinea Pedis

August 20, 2013 updated by: Medicis Global Service Corporation

A Randomized, Multi-Center, Double-Blind, Vehicle-Controlled Study Evaluating the Efficacy and Safety of Product 33525 in Subjects With Tinea Pedis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

321

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Cidra, Puerto Rico
  • United States
    • California
      • Los Angeles, California, United States
    • New Jersey
      • Paramus, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States
    • Texas
      • Austin, Texas, United States
      • College Station, Texas, United States
      • Plano, Texas, United States
      • San Antonio, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Moderate erythema, moderate scaling, and mild pruritus

Exclusion Criteria:

  • Pregnancy and allergies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active
Product 33525
Drug: 33525
Daily for 14 days
Placebo Comparator: Placebo
Product 33525 Placebo
Drug: Placebo
Daily for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients achieving complete clearance
Time Frame: Day 42
Signs and Symptoms Severity Score and negative Potassium Hydroxide (KOH) and Culture
Day 42

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients achieving effective treatment
Time Frame: Day 42
Clinical Cure and Mycologic Cure
Day 42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medicis Global Service Corporation

Investigators

  • Study Director: Ron Staugaard, Medicis Pharmaceutical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

July 15, 2011

First Submitted That Met QC Criteria

July 18, 2011

First Posted (Estimate)

July 19, 2011

Study Record Updates

Last Update Posted (Estimate)

August 28, 2013

Last Update Submitted That Met QC Criteria

August 20, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-1000-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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