Safety of a Topical Antifungal Treatment for Tinea Cruris, Tinea Pedis and Tinea Corporis

NCT ID: NCT01349998

Last Updated: 2013-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

604 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-09-30

Brief Summary

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The purpose of this study is to examine the long-term safety of treating recurrent episodes of tinea pedis for 14 days for each recurrence and recurrent episodes of tinea corporis or tinea cruris for 7 days for each recurrence with Product 33525.

Detailed Description

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Conditions

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Tinea Pedis Tinea Cruris Tinea Corporis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Safety Population

Group Type EXPERIMENTAL

Product 33525

Intervention Type DRUG

Daily dosing for 2 weeks each recurrence for patients with tinea pedis and Daily dosing for 1 week each recurrence for patients with tinea cruris and tinea corporis

Interventions

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Product 33525

Daily dosing for 2 weeks each recurrence for patients with tinea pedis and Daily dosing for 1 week each recurrence for patients with tinea cruris and tinea corporis

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Evidence of tinea cruris, tinea pedis, or tinea corporis. Additional criteria listed in protocol

Exclusion Criteria

* Pregnancy and allergies. Additional criteria listed in protocol
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tinea Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fremont, California, United States

Site Status

Los Angeles, California, United States

Site Status

Miami, Florida, United States

Site Status

Miramar, Florida, United States

Site Status

St. Petersburg, Florida, United States

Site Status

Augusta, Georgia, United States

Site Status

Evansville, Indiana, United States

Site Status

Warren, Michigan, United States

Site Status

Omaha, Nebraska, United States

Site Status

Paramus, New Jersey, United States

Site Status

Albuquerque, New Mexico, United States

Site Status

Cincinnati, Ohio, United States

Site Status

Hershey, Pennsylvania, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Goodletsville, Tennessee, United States

Site Status

Austin, Texas, United States

Site Status

College Station, Texas, United States

Site Status

Plano, Texas, United States

Site Status

San Antonio, Texas, United States

Site Status

Lynchburg, Virginia, United States

Site Status

Belize City, Belize District, Belize

Site Status

San Salvador, , El Salvador

Site Status

San Pedro, Sula, Honduras

Site Status

Cidra, , Puerto Rico

Site Status

Countries

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United States Belize El Salvador Honduras Puerto Rico

Other Identifiers

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MP-1005

Identifier Type: -

Identifier Source: org_study_id

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