Topical Tolnaftate Stick for Tinea Pedis: An Open-Label Interventional Study
Clinical Study to Assess Tolnaftate 1% With a Novel Vehicle for the Treatment of Tinea Pedis
Propedix, Inc.
150 participants
Dec 30, 2024
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Inclusion Criteria5
- 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 Criteria10
- 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
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Interventions
Topical antifungal stick containing 1% tolnaftate in the Formula A base. Applied twice daily for 4 weeks.
Topical antifungal stick containing 1% tolnaftate in the Formula B base. Applied twice daily for 4 weeks.
Topical antifungal stick containing 1% tolnaftate in the PP2C-2003 base formulation. Applied twice daily for 30 days.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07245667