NCT07245667 Topical Tolnaftate Stick for Tinea Pedis: An Open-Label Interventional Study
| NCT ID | NCT07245667 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Propedix, Inc. |
| Condition | Tinea Pedis |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-12-30 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 150 participants in total. It began in 2024-12-30 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07245667 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Tinea Pedis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07245667 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07245667 currently recruiting?
Yes, NCT07245667 is actively recruiting participants. Contact the research team at cschanbacher@propedix.com for enrollment information.
Where is the NCT07245667 trial being conducted?
This trial is being conducted at Framingham, United States, Milford, United States.
Who is sponsoring the NCT07245667 clinical trial?
NCT07245667 is sponsored by Propedix, Inc.. The trial plans to enroll 150 participants.