Topical Tolnaftate Stick for Tinea Pedis: An Open-Label Interventional Study (NCT07245667) | Clinical Trial Compass
RecruitingPhase 2
Topical Tolnaftate Stick for Tinea Pedis: An Open-Label Interventional Study
United States150 participantsStarted 2024-12-30
Plain-language 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).
Who can participate
Age range16 Years
SexALL
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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
What they're measuring
1
Percentage of Subjects with a Complete Cure at Week 4