Tolnaftate Stick for Athlete's Foot
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method of using tolnaftate, a common antifungal, in stick form to treat athlete's foot. The goal is to determine if these stick formulations are safe and effective. Participants will apply one of three different tolnaftate stick formulas twice daily for four weeks. Individuals with athlete's foot who haven't recently used antifungal treatments and don't have pus or severe symptoms might be suitable candidates for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.
Will I have to stop taking my current medications?
You will need to stop using any antifungal treatments before joining the trial, and you cannot use any other antifungal therapy during the trial or within three months before starting it. If you are on immunosuppressive or antimicrobial therapy, you cannot participate in the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that tolnaftate, the main ingredient in the stick treatments under testing, is usually safe for treating skin infections like athlete's foot. Studies indicate that tolnaftate effectively fights fungus on the skin when used as a cream or ointment. Most people experience no serious side effects. Some might have mild skin irritation, such as redness or itching, but these effects typically don't last long. Tolnaftate is already in many over-the-counter products for similar issues, suggesting it is safe to use. However, it should not be used on children under two years old unless a doctor approves.12345
Why are researchers excited about this trial's treatments?
Unlike standard athlete's foot treatments, like creams and sprays that can be messy and inconvenient, this new approach uses a stick-based applicator to deliver tolnaftate, a proven antifungal agent, directly to the affected area. Researchers are excited because this delivery method could be easier to use and may ensure more consistent application. Plus, with three different formulas being tested, each stick might offer unique benefits in terms of absorption and effectiveness, potentially raising the bar for athlete's foot care.
What evidence suggests that this trial's treatments could be effective for athlete's foot?
Studies have shown that creams and ointments for fungal infections, like tolnaftate, effectively treat athlete's foot. Tolnaftate stops the fungus from growing. Research indicates that these treatments cure athlete's foot in 70% to 75% of people, compared to only 20% to 30% who improve with a placebo. In this trial, participants will receive one of the experimental tolnaftate stick formulations, such as Formula A, B, or C, which are likely effective, especially with regular use. The stick allows easy application directly to the affected area.24678
Are You a Good Fit for This Trial?
This trial is for adults over 18 with athlete's foot, who can follow the study rules and be available throughout. They must have a clinical diagnosis confirmed by microscopy (except Cohort 4). People using antifungals recently, on immunosuppressants or antibiotics, allergic to ingredients in the test products, with liver disease, pregnant/breastfeeding women, diabetics or those with neuropathy cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a topical 1% tolnaftate formulation applied twice daily for four weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Tolnaftate Stick
Trial Overview
The study tests three different stick-based formulas of 1% Tolnaftate against athlete's foot. It aims to see which formula is safest and most effective at treating this condition.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Topical antifungal stick containing 1% tolnaftate in the Formula C base. Applied twice daily for 4 weeks.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Propedix, Inc.
Lead Sponsor
Citations
Topical Tolnaftate Stick for Tinea Pedis: An Open-Label ...
This study is designed to evaluate the safety and effectiveness of multiple 1% tolnaftate formulations delivered through novel stick-based ...
Topical management of tinea pedis - PMC
Bottom line. Tinea pedis is successfully treated with topical antifungals in 70% to 75% of patients compared with 20% to 30% using placebo. Tea tree oil is ...
Tolnaftate (topical route) - Side effects & dosage
It is used to treat some types of fungus infections. It may also be used together with medicines taken by mouth for fungus infections.
Consensus for the Treatment of Tinea Pedis: A Systematic ...
The likelihood of resolving tinea pedis infection in the study participants treated with terbinafine was 3.9 (95% CI: 2.0–7.8) times those ...
Propedix Launches Dryello™, the First-Ever Dry Stick ...
Dryello applies dry, stays dry, and delivers powerful dual-action relief—treatment and prevention – all in a convenient stick." The Tinea pedis ...
Tolnaftate topical Uses, Side Effects & Warnings
Tolnaftate topical (for the skin) is used to treat infections such as athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).
Label: EQUATE ATHLETES FOOT- tolnaftate cream - DailyMed
For external use only - Do not use - on children under 2 years of age unless directed by a doctor - When using this product avoid contact with eyes - Stop ...
Tinactin, Aftate (tolnaftate) dosing, indications, interactions, ...
tolnaftate (Rx) ; Contraindications. Hypersensitivity ; Cautions. For external use only. Not for use on children under 2 years of age unless directed by a doctor.
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