Safety of a Topical Antifungal Treatment for Tinea Cruris, Tinea Pedis and Tinea Corporis
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 Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||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|
- Number of Subjects with Adverse Events [ Time Frame: One Year ] [ Designated as safety issue: No ]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.
- Clinical Cure and Mycological Cure [ Time Frame: 1 week Post Treatment, 2 weeks Post Treatment, and 3 weeks Post Treatment ] [ Designated as safety issue: No ]Proportion of patients achieving effective treatment
|Study Start Date:||May 2011|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
|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
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