BridgeMD
New treatment option for Tinea Pedis
Official title Topical Tolnaftate Stick for Tinea Pedis: An Open-Label Interventional Study
ClinicalTrials.gov ID: NCT07245667
What this study is testing
What is 1% Tolnaftate Stick Formula A?
1% Tolnaftate Stick Formula A is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for tinea pedis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Framingham, Massachusetts, United States
- Milford, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Framingham, Massachusetts, United States; Milford, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.