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Topical Antifungal Treatment for Tinea Pedis

Primary Purpose

Tinea Pedis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
33525
Placebo
Sponsored by
Medicis Global Service Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinea Pedis focused on measuring Tinea Pedis, Antifungal

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Moderate erythema, moderate scaling, and mild pruritus

Exclusion Criteria:

  • Pregnancy and allergies

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

Product 33525

Product 33525 Placebo

Outcomes

Primary Outcome Measures

Proportion of patients achieving complete clearance
Signs and Symptoms Severity Score and negative Potassium Hydroxide (KOH) and Culture

Secondary Outcome Measures

Proportion of patients achieving effective treatment
Clinical Cure and Mycologic Cure

Full Information

First Posted
July 15, 2011
Last Updated
August 20, 2013
Sponsor
Medicis Global Service Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01396811
Brief Title
Topical Antifungal Treatment for Tinea Pedis
Official Title
A Randomized, Multi-Center, Double-Blind, Vehicle-Controlled Study Evaluating the Efficacy and Safety of Product 33525 in Subjects With Tinea Pedis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medicis Global Service Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinea Pedis
Keywords
Tinea Pedis, Antifungal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
322 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
Product 33525
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Product 33525 Placebo
Intervention Type
Drug
Intervention Name(s)
33525
Intervention Description
Daily for 14 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Daily for 14 days
Primary Outcome Measure Information:
Title
Proportion of patients achieving complete clearance
Description
Signs and Symptoms Severity Score and negative Potassium Hydroxide (KOH) and Culture
Time Frame
Day 42
Secondary Outcome Measure Information:
Title
Proportion of patients achieving effective treatment
Description
Clinical Cure and Mycologic Cure
Time Frame
Day 42

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Moderate erythema, moderate scaling, and mild pruritus Exclusion Criteria: Pregnancy and allergies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ron Staugaard
Organizational Affiliation
Medicis Pharmaceutical
Official's Role
Study Director
Facility Information:
City
Miami
State/Province
Florida
Country
United States
City
Miramar
State/Province
Florida
Country
United States
City
Augusta
State/Province
Georgia
Country
United States
City
Evansville
State/Province
Indiana
Country
United States
City
Warren
State/Province
Michigan
Country
United States
City
Hackensack
State/Province
New Jersey
Country
United States
City
High Point
State/Province
North Carolina
Country
United States
City
Cinncinnati
State/Province
Ohio
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Belize City
Country
Belize

12. IPD Sharing Statement

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Topical Antifungal Treatment for Tinea Pedis

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