Safety of a Topical Antifungal Treatment for Tinea Cruris, Tinea Pedis and Tinea Corporis
Phase 3
Completed
- Conditions
- Tinea PedisTinea CrurisTinea Corporis
- Interventions
- Drug: Product 33525
- Registration Number
- NCT01349998
- Lead Sponsor
- Tinea Pharmaceuticals
- Brief Summary
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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 604
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Safety Population Product 33525 -
- Primary Outcome Measures
Name Time Method Number of Subjects with Adverse Events 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 Outcome Measures
Name Time Method Clinical Cure and Mycological Cure 1 week Post Treatment, 2 weeks Post Treatment, and 3 weeks Post Treatment Proportion of patients achieving effective treatment