Onychomycosis of ToenailPhase 2NCT07382427
A Phase 2 Study to Assess the Effectiveness of Topical Terbinafine in Participants With Mild to Moderate Onychomycosis of the Toenails
A Phase 2 study testing 2.4% Topical Terbinafine and 10% Topical Efinaconazole in people with Onychomycosis of Toenail, run by Onyx Axiom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Onychomycosis of Toenail
- What is being tested?
- 2.4% Topical Terbinafine and 10% Topical Efinaconazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to Feb 2028
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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 oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. Postmenopausal status will be confirmed through testing of follicle-stimulating hormone (FSH) levels ≥40 IU/L at Screening for amenorrheic female participants.
- Agree to avoid the use of toenail polish, cosmetic toenail products, and pedicures during the trial period.
- Written informed consent from the participant prior to any trial procedures.
- Willing and able to comply with the scheduled visits, confinement period, treatment plan, laboratory tests, and other trial procedures and requirements.
Who cannot join
- Presence of any toenail infection other than or in addition to dermatophytes, such as Scytalidium as determined by the Investigator (candidal onychomycosis infection, concurrent with a positive dermatophyte culture, is acceptable).
- Presence of any of the following: dermatophytoma, fungal "spikes" within 3 mm of the proximal toenail fold on the target great toenail, infection extending to the matrix, or only lateral toenail disease in the target great toenail.
- Presence of severe moccasin tinea pedis at the Screening or Baseline visits, as determined by the Investigator. If the participant has interdigital tinea pedis that requires treatment, the participant must agree to use only an Investigator-approved topical antifungal therapy .
- Presence of any disease/condition that might cause toenail abnormalities or may interfere with the evaluation of the investigational medicinal product (IMP), as determined by the Investigator (e.g., open sore or ulceration on the toes of affected toenails, psoriasis, immune dysfunction immunocompromised, collagen-vascular diseases, lichen planus, peripheral vascular disease, recurrent cellulitis, lymphatic insufficiency, or traumatic onychodystrophy due to chronic physical stimuli).
- Any previous surgery on the target great toenail.
- Presence of onychomycosis of the fingernail or fingernail dermatophytosis.
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- Target great toenail (including the toenail plate and any subungual debris) thicker than 3 mm at the Screening and Baseline visit - Day 1s.
- Presence of onychodystrophy that could interfere with clinical assessments, as determined by the Investigator.
- Presence of any underlying disease or dermatological condition that, in the opinion of the Investigator, could present a safety concern for the participant or that could interfere with clinical evaluations.
- Use of the following topical preparations within the indicated time prior to the Baseline visit (Day 1) or need for concurrent use of any of the following topical preparations during the trial; Toenail polish or cosmetic toenail products: 1 day; Other topical prescription or over-the-counter medications to the toenails (with the exception of bland emollients): 2 weeks; Topical prescription or over-the-counter antifungal therapy for the toenails, including devices to treat onychomycosis: 4 weeks
- Use of the following systemic medications within the indicated time prior to the Baseline visit or need for concurrent use of any of the following systemic medications during the trial; Systemic antifungal therapy: 4 weeks; Systemic immunosuppressive agents: 6 months; History of oral antifungal with known activity against dermatophytes within twelve months prior to Screening.
- Known human immunodeficiency virus (HIV) infection self-reported or as determined by the Investigator.
- Received treatment for any type of cancer in the previous 6 months, with the exception of nonmelanoma skin cancer (e.g., basal cell carcinoma or nonmetastatic squamous cell carcinoma) that was treated successfully .
- Diagnosis of diabetes mellitus.
- History of hypersensitivity or allergic reactions to any of the IMP constituents.
- Females who are pregnant, lactating, or planning a pregnancy during the trial period.
- History of immunosuppression and/or clinical signs indicative of possible immunosuppression, as determined by the Investigator.
- History of drug abuse or addiction in the last 12 months of enrolment that, in the opinion of the Investigator, could affect the participant's safety and/or compliance with the trial .
- History of alcohol abuse that, in the opinion of the Investigator, could affect the participant's safety and/or compliance with the trial. As per Australian Alcohol Guidelines, Australian Government it is recommended regular consumption of more than 10 standard drinks/week and/or no more than 4 standard drinks on any single day, where 1 standard drink is 10 g of pure alcohol and is equivalent to 285mL beer (4.9% alcohol/volume), 100 mL wine (12% alcohol/volume) or 30 mL spirit (40% alcohol/volume).
- Use of any investigational drug or device within 30 days of 5 half-lives (whichever is longer) prior to the Screening visit or concurrent participation in another clinical trial with an investigational drug or device.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 2, Randomized, Single-blind, Active- and Vehicle-controlled Study to Assess the Safety, Tolerability, and Efficacy of 2.4% Terbinafine Hydrochloride Topical Solution (AP4500) in Participants With Mild to Moderate Onychomycosis of the Toenails
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.
Read more
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
- Conditions
- Onychomycosis of Toenail
- Being tested
- 2.4% Topical Terbinafine, 10% Topical Efinaconazole, Vehicle Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2.4% Topical TerbinafineDrug
Novel topical terbinafine product designed to increase terbinafine absorption through the nail to the site of infection
10% Topical EfinaconazoleDrug
Commercial topical efinaconazole formulation approved for the treatment of onychomycosis
Vehicle ControlOther
Vehicle control formulation to act as a control for the experimental product
| Study group | Role | What they receive |
|---|---|---|
| 2.4% Topical Terbinafine once per day | Experimental | Novel topical terbinafine formulation developed to increase drug absorption through the nail. Applied once per day. Receives: Drug: 2.4% Topical Terbinafine |
| 2.4% Topical Terbinafine twice per day | Experimental | Novel topical terbinafine formulation developed to increase drug absorption through the nail. Applied twice per day. Receives: Drug: 2.4% Topical Terbinafine |
| 10% Topical Efinaconazole once per day | Active comparator | Commercial comparator product approved for the treatment of onychomycosis. Applied once per day, as per labelled instructions. Receives: Drug: 10% Topical Efinaconazole |
| Topical Vehicle once per day | Placebo comparator | Vehicle formulation without drug to act as control group for the experimental product. Applied once per day. Receives: Other: Vehicle Control |
| Topical Vehicle twice per day | Placebo comparator | Vehicle formulation without drug to act as control group for the experimental product. Applied twice per day. Receives: Other: Vehicle Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Complete Cure at Weeks 12, 24, 36, 48, and 52
Complete Cure is defined as 0% visible onychomycosis of the target great toenail upon examination and negative potassium hydroxide [KOH] fungal culture
Measured: 52 weeks
Secondary outcomes (3)
Number of participants with Almost Complete Cure at Weeks 12, 24, 36, 48 and 52
Almost Complete Cure defined as onychomycosis affecting a maximum of 5% toenail after visual examination and negative KOH examination and fungal culture
Measured: 52 weeks
Incidence, severity, and relationship to treatment of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events (AEs) as coded by MedDRA
A by participate adverse event data listing, including verbatim term, preferred term, system organ class, severity, and relationship to the investigational medicinal product are to be provided.
Measured: 52 weeks
Time to Clinical Efficacy in participants over 48 weeks
Affected toenails will be visually assessed at 12, 24, 36, 48 and 52 weeks for Clinical Efficacy (defined as a maximum of 10% of the nail demonstrating onychomycosis)
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Onychomycosis of ToenailStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Onyx Axiom
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382427
- Sponsor's protocol ID
- ONX-001
- Status last verified
- Feb 2026
- First submitted
- 20 Nov 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is an industry sponsored trial using a proprietary formulation. Results will be commercially confidential.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Single-blind, Active- and Vehicle-controlled Study to Assess the Safety, Tolerability, and Efficacy of 2.4% Terbinafine Hydrochloride Topical Solution (AP4500) in Participants With Mild to Moderate Onychomycosis of the Toenails
- ClinicalTrials.gov ID
- NCT07382427
- Acronym / sponsor ID
- ONX-001
- Conditions
- Onychomycosis of Toenail
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Onyx AxiomIndustry (pharma, biotech, devices)
- Study start
- Mar 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 2 Feb 2026 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 2.4% Topical Terbinafine once per day | Experimental | Drug: 2.4% Topical TerbinafineNovel topical terbinafine formulation developed to increase drug absorption through the nail. Applied once per day. |
| 2.4% Topical Terbinafine twice per day | Experimental | Drug: 2.4% Topical TerbinafineNovel topical terbinafine formulation developed to increase drug absorption through the nail. Applied twice per day. |
| 10% Topical Efinaconazole once per day | Active comparator | Drug: 10% Topical EfinaconazoleCommercial comparator product approved for the treatment of onychomycosis. Applied once per day, as per labelled instructions. |
| Topical Vehicle once per day | Placebo comparator | Other: Vehicle ControlVehicle formulation without drug to act as control group for the experimental product. Applied once per day. |
| Topical Vehicle twice per day | Placebo comparator | Other: Vehicle ControlVehicle formulation without drug to act as control group for the experimental product. Applied twice per day. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (20 listed)
- Presence of any toenail infection other than or in addition to dermatophytes, such as Scytalidium as determined by the Investigator (candidal onychomycosis infection, concurrent with a positive dermatophyte culture, is acceptable).
- Presence of any of the following: dermatophytoma, fungal "spikes" within 3 mm of the proximal toenail fold on the target great toenail, infection extending to the matrix, or only lateral toenail disease in the target great toenail.
- Presence of severe moccasin tinea pedis at the Screening or Baseline visits, as determined by the Investigator. If the participant has interdigital tinea pedis that requires treatment, the participant must agree to use only an Investigator-approved topical antifungal therapy .
- Presence of any disease/condition that might cause toenail abnormalities or may interfere with the evaluation of the investigational medicinal product (IMP), as determined by the Investigator (e.g., open sore or ulceration on the toes of affected toenails, psoriasis, immune dysfunction immunocompromised, collagen-vascular diseases, lichen planus, peripheral vascular disease, recurrent cellulitis, lymphatic insufficiency, or traumatic onychodystrophy due to chronic physical stimuli).
- Any previous surgery on the target great toenail.
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 |
|---|---|---|
| 2.4% Topical TerbinafineNovel topical terbinafine product designed to increase terbinafine absorption through the nail to the site of infection | Drug | 2.4% Topical Terbinafine once per day, 2.4% Topical Terbinafine twice per day |
| 10% Topical EfinaconazoleCommercial topical efinaconazole formulation approved for the treatment of onychomycosis | Drug | 10% Topical Efinaconazole once per day |
| Vehicle ControlVehicle control formulation to act as a control for the experimental product | Other | Topical Vehicle once per day, Topical Vehicle twice per day |
Primary outcome
Number of patients with Complete Cure at Weeks 12, 24, 36, 48, and 52
Time frame: 52 weeks
Complete Cure is defined as 0% visible onychomycosis of the target great toenail upon examination and negative potassium hydroxide [KOH] fungal culture
3 secondary outcomes
Number of participants with Almost Complete Cure at Weeks 12, 24, 36, 48 and 52
Time frame: 52 weeks
Incidence, severity, and relationship to treatment of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events (AEs) as coded by MedDRA
Time frame: 52 weeks
Time to Clinical Efficacy in participants over 48 weeks
Time frame: 52 weeks
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 4 Feb 2026.
- Individual participant dataSharing planned: No. This is an industry sponsored trial using a proprietary formulation. Results will be commercially confidential.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 2.4% Topical Terbinafine and 10% Topical Efinaconazole in people with Onychomycosis of Toenail, run by Onyx Axiom.
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 11 inclusion and 20 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: opening soon, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Dianne Pepper (+61426762990, dianne.pepper@alithialifesciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with Complete Cure at Weeks 12, 24, 36, 48, and 52 (time frame: 52 weeks). 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 4 Feb 2026.