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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2012

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Safety Population

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tinea Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor

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