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

January 22, 2013 updated by: Tinea Pharmaceuticals

An Open-Label Study to Evaluate the Safety of Long-Term Administration of Product 33525 in Subjects With Tinea Pedis, Tinea Corporis, or Tinea Cruris

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

604

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

  • Belize
      • Belize City, Belize
  • El Salvador
      • San Salvador, El Salvador
  • Honduras
    • Sula
      • San Pedro, Sula, Honduras
  • Puerto Rico
      • Cidra, Puerto Rico
  • United States
    • California
      • Fremont, California, United States
      • Los Angeles, California, United States
    • Florida
      • Miami, Florida, United States
      • Miramar, Florida, United States
      • St. Petersburg, Florida, United States
    • Georgia
      • Augusta, Georgia, United States
    • Indiana
      • Evansville, Indiana, United States
    • Michigan
      • Warren, Michigan, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • New Jersey
      • Paramus, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • Ohio
      • Cincinatti, Ohio, United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
    • Tennessee
      • Goodletsville, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • College Station, Texas, United States
      • Plano, Texas, United States
      • San Antonio, Texas, United States
    • Virginia
      • Lynchburg, Virginia, 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:

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

Exclusion Criteria:

  • Pregnancy and allergies. Additional criteria listed in protocol

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

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Safety Population
Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects with Adverse Events
Time Frame: One Year
To examine the long-term safety of treating tinea pedis, tinea corporis or tinea cruris, treatment-emergent adverse events occurring during the study will be recorded. Adverse events will be summarized by the number of subjects reporting events, system organ class, preferred term, severity, relationship to study drug, and seriousness. Baseline and end of study laboratory assessments will be conducted.
One Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Cure and Mycological Cure
Time Frame: 1 week Post Treatment, 2 weeks Post Treatment, and 3 weeks Post Treatment
Proportion of patients achieving effective treatment
1 week Post Treatment, 2 weeks Post Treatment, and 3 weeks Post Treatment

Collaborators and Investigators

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

Sponsor

Tinea Pharmaceuticals

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

May 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

May 3, 2011

First Submitted That Met QC Criteria

May 6, 2011

First Posted (Estimate)

May 9, 2011

Study Record Updates

Last Update Posted (Estimate)

January 23, 2013

Last Update Submitted That Met QC Criteria

January 22, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-1005

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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