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Antifungal
Terbinafine Gel for Toenail Fungus
Phase 2
Waitlist Available
Led By Terry M. Jones, MD
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 belowSelect...
I have a fungal infection in at least one of my big toes.
Select...
My toe fungus was confirmed by lab tests.
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I am between 18 and 75 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
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 moreTrial 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
Terry M. Jones, MDPrincipal InvestigatorJ&S Studies
Daniel P. Mallett, DPMPrincipal InvestigatorFront Range Foot and Ankle Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a fungal infection in at least one of my big toes.I am willing to not get pedicures, clip my nails, or use nail products on my toenails during the study.I haven't used antifungal treatments for nail or skin fungus in the last 3 months.My toe fungus was confirmed by lab tests.I do not have severe skin conditions like psoriasis or atopic dermatitis.My toe's condition or past surgeries might not allow full healing from a nail infection.My diabetes is under control.I am between 18 and 75 years old.I haven't taken oral antifungal medication in the last 6 months.I have not had a serious fungal infection or a condition that weakens my immune system.
Research Study Groups:
This trial has the following groups:- Group 1: HSG
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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