Tinea Corporis, Tinea Cruris, Tinea Pedis
Conditions
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.
Interventions
DRUGProduct 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
Sponsors
Tinea Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical Cure and Mycological Cure | 1 week Post Treatment, 2 weeks Post Treatment, and 3 weeks Post Treatment | Proportion of patients achieving effective treatment |
Countries
Belize, El Salvador, Honduras, Puerto Rico, United States
Outcome results
None listed