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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights

Study Summary

This trial is testing a new gel to treat a type of fungal nail infection. The goal is to see if the gel is effective, safe, and well tolerated.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete Cure at Week 52 in the Target Toe
Secondary outcome measures
Clinical Cure in the Target Toe
Mycological Cure in the Target Toe
Positive Response in the Target Toe
Other outcome measures
Nail Pharmacokinetics
Patient Global Assessment
Plasma Pharmacokinetics
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: HSGExperimental Treatment1 Intervention
Hallux terbinafine subungual gel

Find a Location

Who is running the clinical trial?

Hallux, Inc.Lead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
Lewis H. Freed, DPMPrincipal InvestigatorOrthoArizona, East Valley Foot & Ankle Specialists
Daniel P. Mallett, DPMPrincipal InvestigatorFront Range Foot and Ankle Clinic

Media Library

Hallux Terbinafine Subungual Gel (Antifungal) Clinical Trial Eligibility Overview. Trial Name: NCT05135910 — Phase 2
Toenail Fungus Research Study Groups: HSG
Toenail Fungus Clinical Trial 2023: Hallux Terbinafine Subungual Gel Highlights & Side Effects. Trial Name: NCT05135910 — Phase 2
Hallux Terbinafine Subungual Gel (Antifungal) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05135910 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the patient recruitment for this investigation restricted to those under 75 years of age?

"This medical trial is open to individuals aged 18 years or older and younger than 75."

Answered by AI

Do I meet the criteria necessary to participate in this experiment?

"This clinical trial is looking for 35 male and female participants aged 18-75 who have been clinically diagnosed with onychomycosis. As part of their inclusion criteria, these patients need to present with a distal lateral subungual involvement in at least one great toe as confirmed by KOH testing and fungal culture; they should also abstain from any pedicure, nail clipping or cosmetic treatments during the study period."

Answered by AI

Has Hallux Terbinafine Subungual Gel been approved by the Food and Drug Administration?

"Hallux Terbinafine Subungual Gel is believed to be relatively safe, with a score of 2 assigned based on the Phase 2 trial's safety findings but lack of efficacy data."

Answered by AI

Are there any ongoing enrollment opportunities for this experiment?

"Affirmative. Clinicaltrials.gov details that this scientific investigation, published on January 13th 2022, is presently recruiting participants. 35 individuals must be recruited from 3 different sites."

Answered by AI

What is the current participation rate of this research project?

"This trial necessitates the enrolment of 35 eligible patients. For their convenience, they may choose to join at OrthoArizona - East Valley Foot & Ankle Specialists in Mesa, Arizona or J&S Studies in College Station, Texas."

Answered by AI

Could you elucidate on prior investigations concerning Hallux Terbinafine Subungual Gel?

"Hallux Terbinafine Subungual Gel was first investigated during 2021 at Oregon Health & Science University. 25 studies have since been completed and presently, three trials are still in progress, with various sites located in Mesa, Arizona."

Answered by AI

What diseases or conditions is Hallux Terbinafine Subungual Gel generally prescribed for?

"Hallux Terbinafine Subungual Gel is meant to manage fungal infections such as onychomycosis, severe tinea pedis and sporotrichosis."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
To Evaluate Hallux Terbinafine Subungual Gel (HSG) in the Treatment of Onychomycosis
2022. "To Evaluate Hallux Terbinafine Subungual Gel (HSG) in the Treatment of Onychomycosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05135910.
~5 spots leftby Sep 2024
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