NCT07245667 · Propedix, Inc.
Topical Tolnaftate Stick for Tinea Pedis: An Open-Label Interventional Study
What this study is about
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).
View original scientific description
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).
Interventions
DRUG
1% Tolnaftate Stick Formula A
Topical antifungal stick containing 1% tolnaftate in the Formula A base. Applied twice daily for 4 weeks.
DRUG
1% Tolnaftate Stick Formula B
Topical antifungal stick containing 1% tolnaftate in the Formula B base. Applied twice daily for 4 weeks.
DRUG
1% Tolnaftate Stick Formula C
Topical antifungal stick containing 1% tolnaftate in the PP2C-2003 base formulation. Applied twice daily for 30 days.
Primary outcome measures
Percentage of Subjects with a Complete Cure at Week 4
Time frame: Week 4
Primary Efficacy Endpoint: Effective treatment, defined as mycological cure, based on a negative potassium hydroxide (KOH) test at week 4.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Framingham, Massachusetts
- Milford, Massachusetts
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 28, 2025 · Source of record for eligibility and locations