Tinea PedisPhase 2NCT07245667
Topical Tolnaftate Stick for Tinea Pedis: An Open-Label Interventional Study
A Phase 2 study testing 1% Tolnaftate Stick Formula A, 1% Tolnaftate Stick Formula B and 1% Tolnaftate Stick Formula C in people with Tinea Pedis, run by Propedix, Inc. at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tinea Pedis
- What is being tested?
- 1% Tolnaftate Stick Formula A, 1% Tolnaftate Stick Formula B and 1% Tolnaftate Stick Formula C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Dec 2024to Feb 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Kuchnir Dermatology and Dermatological Surgery
Framingham, Massachusetts, 01701
Prinicipal Investigator, 508-872-2220, clinicalresearch@propedix.com
- Recruiting
Kuchnir Dermatology and Dermatological Surgery
Milford, Massachusetts, 01757
Prinicipal Investigator, 508-478-2610, clinicalresearch@propedix.com
About this study
Official title: Clinical Study to Assess Tolnaftate 1% With a Novel Vehicle for the Treatment of Tinea Pedis
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).
Read the detailed 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.
- Conditions
- Tinea Pedis
- Being tested
- 1% Tolnaftate Stick Formula A, 1% Tolnaftate Stick Formula B, 1% Tolnaftate Stick Formula C
- Keywords
- tinea pedis, athletes foot
- Medical subject headings
- Tinea Pedis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% Tolnaftate Stick Formula ADrug
Topical antifungal stick containing 1% tolnaftate in the Formula A base. Applied twice daily for 4 weeks.
1% Tolnaftate Stick Formula BDrug
Topical antifungal stick containing 1% tolnaftate in the Formula B base. Applied twice daily for 4 weeks.
1% Tolnaftate Stick Formula CDrug
Topical antifungal stick containing 1% tolnaftate in the PP2C-2003 base formulation. Applied twice daily for 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Tolnaftate Stick Formula A | Experimental | Participants will receive Formula A, a topical 1% tolnaftate formulation delivered through a stick-based applicator. The product is applied twice daily for four weeks. Receives: Drug: 1% Tolnaftate Stick Formula A |
| Tolnaftate Stick Formula B | Experimental | Participants will receive Formula B, a topical 1% tolnaftate formulation delivered through a stick-based applicator. The product is applied twice daily for four weeks. Receives: Drug: 1% Tolnaftate Stick Formula B |
| Tolnaftate Stick Formula C | Experimental | Topical antifungal stick containing 1% tolnaftate in the Formula C base. Applied twice daily for 4 weeks. Receives: Drug: 1% Tolnaftate Stick Formula C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects with a Complete Cure at Week 4
Primary Efficacy Endpoint: Effective treatment, defined as mycological cure, based on a negative potassium hydroxide (KOH) test at week 4.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start30 Dec 2024
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinea PedisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Propedix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245667
- Sponsor's protocol ID
- PRO-TP-001
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared outside the study team because this is a small study designed for internal evaluation of formulation performance and tolerability. Data will be presented only in aggregated, de-identified form in any publications or presentations.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Assess Tolnaftate 1% With a Novel Vehicle for the Treatment of Tinea Pedis
- ClinicalTrials.gov ID
- NCT07245667
- Acronym / sponsor ID
- PRO-TP-001
- Conditions
- Tinea Pedis
- Keywords
- tinea pedis, athletes foot
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Propedix, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tolnaftate Stick Formula A | Experimental | Drug: 1% Tolnaftate Stick Formula AParticipants will receive Formula A, a topical 1% tolnaftate formulation delivered through a stick-based applicator. The product is applied twice daily for four weeks. |
| Tolnaftate Stick Formula B | Experimental | Drug: 1% Tolnaftate Stick Formula BParticipants will receive Formula B, a topical 1% tolnaftate formulation delivered through a stick-based applicator. The product is applied twice daily for four weeks. |
| Tolnaftate Stick Formula C | Experimental | Drug: 1% Tolnaftate Stick Formula CTopical antifungal stick containing 1% tolnaftate in the Formula C base. Applied twice daily for 4 weeks. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1% Tolnaftate Stick Formula ATopical antifungal stick containing 1% tolnaftate in the Formula A base. Applied twice daily for 4 weeks. | Drug | Tolnaftate Stick Formula A |
| 1% Tolnaftate Stick Formula BTopical antifungal stick containing 1% tolnaftate in the Formula B base. Applied twice daily for 4 weeks. | Drug | Tolnaftate Stick Formula B |
| 1% Tolnaftate Stick Formula CTopical antifungal stick containing 1% tolnaftate in the PP2C-2003 base formulation. Applied twice daily for 30 days. | Drug | Tolnaftate Stick Formula C |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared outside the study team because this is a small study designed for internal evaluation of formulation performance and tolerability. Data will be presented only in aggregated, de-identified form in any publications or presentations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 1% Tolnaftate Stick Formula A, 1% Tolnaftate Stick Formula B and 1% Tolnaftate Stick Formula C in people with Tinea Pedis, run by Propedix, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prinicipal Investigator (617-869-0126, cschanbacher@propedix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects with a Complete Cure at Week 4 (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.