What side effects are associated with this type of intervention?

Common treatments for toenail fungus, such as terbinafine (including Hallux Terbinafine Subungual Gel), often have side effects. Topical terbinafine can cause local irritation, redness, and itching. Systemic terbinafine, taken orally, may lead to gastrointestinal issues (nausea, diarrhea), headache, and, in rare cases, liver toxicity. Other topical antifungals like clotrimazole and miconazole may also cause local skin reactions. It is important to monitor for these side effects and consult a healthcare provider if they occur.

What prior FDA approvals exist?

The FDA has approved several treatments for toenail fungus (onychomycosis) that inhibit squalene epoxidase, thereby disrupting fungal cell membrane synthesis. Terbinafine, an oral antifungal, is one of the most well-known drugs in this category. It works by inhibiting the enzyme squalene epoxidase, leading to a deficiency in ergosterol and an accumulation of squalene, which disrupts the fungal cell membrane. Other FDA-approved treatments include topical formulations like efinaconazole and tavaborole, which also target fungal cell membrane synthesis but through different mechanisms. These treatments have been shown to be effective in clinical trials and are commonly used in practice.

What other types of research exist?

Promising alternatives to Hallux Terbinafine Subungual Gel for toenail fungus treatment include topical efinaconazole and tavaborole, both of which have shown efficacy in clinical trials. Efinaconazole inhibits fungal lanosterol 14α-demethylase, while tavaborole inhibits fungal leucyl-tRNA synthetase. These alternatives offer different mechanisms of action and have been effective in treating onychomycosis.

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Antifungal

Terbinafine Gel for Toenail Fungus

Phase 2

Waitlist Available

Led By Lewis H. Freed, DPM

Research Sponsored by Hallux, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with DLSO of at least one great toe

Patients with DLSO in the target toe confirmed by positive KOH and positive fungal culture for dermatophytes

Must not have

No severe psoriasis or severe atopic dermatitis

No uncontrolled diabetes mellitus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 52

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a special gel for treating toenail fungus in patients with a specific type of infection. The gel works by stopping the fungus from growing.

Who is the study for?

This trial is for men and women aged 18-75 with toenail fungus, specifically on the big toe. Participants must not use other nail treatments during the study and should have a confirmed fungal infection by lab tests. Those with uncontrolled diabetes, recent participation in other drug trials, or who used antifungal treatments recently cannot join.

What is being tested?

The trial is testing Hallux Terbinafine Subungual Gel (HSG) to treat toenail fungus over a period of 44 weeks. It aims to assess how effective and safe HSG is when applied directly under the toenail, as well as understanding how the body processes it.

What are the potential side effects?

While specific side effects are not listed here, common side effects of topical antifungal treatments like HSG can include skin irritation, redness, itching or burning at the application site. Systemic side effects are less common but may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a fungal infection in at least one of my big toes.

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My toe fungus was confirmed by lab tests.

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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe skin conditions like psoriasis or atopic dermatitis.

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My diabetes is under control.

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I have not had a serious fungal infection or a condition that weakens my immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete Cure at Week 52 in the Target Toe

Secondary study objectives

Clinical Cure in the Target Toe

Mycological Cure in the Target Toe

Positive Response in the Target Toe

Other study objectives

Nail Pharmacokinetics

Patient Global Assessment

Plasma Pharmacokinetics

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: HSGExperimental Treatment1 Intervention

Hallux terbinafine subungual gel

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Terbinafine, the active ingredient in Hallux Terbinafine Subungual Gel, works by inhibiting the enzyme squalene epoxidase, which is crucial for the synthesis of ergosterol, a key component of fungal cell membranes. By disrupting ergosterol production, terbinafine compromises the integrity of the fungal cell membrane, leading to cell death. This mechanism is particularly important for toenail fungus patients because it directly targets and eradicates the fungal cells responsible for the infection, promoting effective and sustained treatment outcomes.