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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
604
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
Unnamed facility
Fremont, California, United States
Unnamed facility
Los Angeles, California, United States
Number of Subjects with Adverse Events
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.
Time frame: One Year
Clinical Cure and Mycological Cure
Proportion of patients achieving effective treatment
Time frame: 1 week Post Treatment, 2 weeks Post Treatment, and 3 weeks Post Treatment
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Unnamed facility
Miami, Florida, United States
Unnamed facility
Miramar, Florida, United States
Unnamed facility
St. Petersburg, Florida, United States
Unnamed facility
Augusta, Georgia, United States
Unnamed facility
Evansville, Indiana, United States
Unnamed facility
Warren, Michigan, United States
Unnamed facility
Omaha, Nebraska, United States
Unnamed facility
Paramus, New Jersey, United States
...and 14 more locations