A Phase 2 Study to Assess the Effectiveness of Topical Terbinafine in Participants With Mild to M… (NCT07382427) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Phase 2 Study to Assess the Effectiveness of Topical Terbinafine in Participants With Mild to Moderate Onychomycosis of the Toenails
200 participantsStarted 2026-03
Plain-language summary
Onychomycosis is a fungal infection of the toenail caused by a range of organisms, including dermophytes, non-dermophyte molds, and yeasts. Topical antifungals are often used for mild to moderate onychomycosis, especially when oral therapy is contraindicated. Generally, topical antifungal agents are well-tolerated with minimal side effects, but they are less effective than oral antifungal therapies due to poor nail penetration. Consequently, the current treatment period for topical onychomycosis products is \~12 months.
Terbinafine is an antifungal drug approved by the FDA for the treatment of topical skin infections. A new formulation (AP4500) has been developed to increase terbinafine absorption through the nail in order to directly kill fungi at the site of onychomycosis infection.
The goal of this clinical trial is to learn if AP4500 works to treat mild to moderate toenail fungus in adults. The main questions the study aims to answer are:
Does AP4500 work to treat onychomycosis? Does AP4500 work best when applied once or twice per day? Does AP4500 treat onychomycosis faster than current treatments? Is AP4500 more effective than current treatments?
Researchers will compare AP4500 to a vehicle control (a look-alike substance that contains no drug) and a commercial comparator product (Jublia) that has already been commercialized for the treatment of toenail fungus.
Participants will:
Apply topical formulations once or twice a day to an infected toenail for a period of 48 weeks Visit the clinic 4 times over this period for checkups and tests, with a subsequent follow up visit 4 weeks after treatment is completed
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female participants aged 18 to 70 years, inclusive at the time of informed consent.
* In general, good health, as assessed by the Investigator, as determined by medical history, safety laboratory tests, and other tests.
* At least 1 great toenail (the "target great toenail") with clinically diagnosed distal lateral subungual onychomycosis involving 20% to 50% of the affected great toenail but with no more than 6 toenails and no fingernails involved, and without dermatophytomas or lanula (matrix) involvement.
* Target great toenail must have an uninfected length of at least 3 mm from the proximal nailfold and a thickness of no more than 3 mm.
* Target great toenail must have evidence of toenail growth per the participant's report that monthly clipping is required.
* Within 42 days prior to Baseline (Day 1), must have a positive potassium hydroxide (KOH) examination of the target great toenail.
* Within 42 days prior to Baseline (Day 1), must have a positive dermatophyte culture for Trichophyton rubrum or Trichophyton mentagrophytes from the target great toenail.
* Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening and prior to dosing and be willing to have additional pregnancy tests as required throughout the trial. Women not of childbearing potential are women who are either permanent sterile or postmenopausal. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophor…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of patients with Complete Cure at Weeks 12, 24, 36, 48, and 52