Overview
This study is designed to evaluate the safety and effectiveness of multiple 1% tolnaftate formulations delivered through novel stick-based vehicles in individuals with tinea pedis (athlete's foot).
Description
To evaluate the efficacy and safety of 1% tolnaftate formulations delivered through novel stick-based vehicles in the treatment of subjects with potassium hydroxide (KOH)-positive tinea pedis.
Eligibility
Inclusion Criteria:
- Male or female, aged 16 or above
- Clinical diagnosis of tinea pedis (For Cohort 4, positive symptomology is acceptable)
- Confirmation of diagnosis with positive potassium hydroxide (KOH) microscopy (For Cohort 4, a negative KOH test is acceptable)
- Signed and dated informed consent form
- Willingness to comply with study protocol and availability for the duration of the study
Exclusion Criteria:
- Diagnosis of moccasin-type tinea pedis
- Presence of serous exudate or pus
- Treatment with a topical antifungal in the past 2 weeks
- Treatment with a systemic antifungal in the past 4 weeks
- Concurrent immunosuppressive or antimicrobial therapy
- Liver disease
- Pregnancy or breastfeeding
- Use any other antifungal therapy during trial or within three months of starting the trial
- Known hypersensitivity to any ingredients of trial agents
- Patients with a current diagnosis of diabetes or neuropathy