Onychomycosis of ToenailPhase 2NCT05135910
To Evaluate Hallux Terbinafine Subungual Gel (HSG) in the Treatment of Onychomycosis
A Phase 2 study testing Hallux Terbinafine Subungual Gel in people with Onychomycosis of Toenail, run by Hallux, Inc. at 4 sites in United States.
Trial summary
The key objective is to establish the efficacy, safety, tolerability, and pharmacokinetics of investigational drug Hallux Terbinafine Subungual Gel (HSG) administered over 44 weeks to patients with distal-lateral subungual onychomycosis (DLSO). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Onychomycosis of Toenail
- What is being tested?
- Hallux Terbinafine Subungual Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 4 sitesUnited States
- Study dates
- 13 Jan 2022to 30 Sep 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and females 18 - 75 years of age inclusive
- 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
- Willingness to abstain from pedicures, nail clipping, or application of nail polish or nail cosmetics to their toenails over the study period
Who cannot join
- History of any significant chronic fungal disease other than onychomycosis or an immunocompromised condition
- Any previous surgery to or abnormalities of the target toe that in the investigator's opinion could prevent the toenail surface area from clearing even if eradication of the DLSO infection is achieved
- Participation in another clinical study of an investigational drug or device within 3 months of screening
- No administration of oral terbinafine or another oral antifungal within 6 months of screening
- No topical antifungal used for onychomycosis or a dermatophyte infection (i.e. tinea pedis) within 3 months of screening
- No uncontrolled diabetes mellitus
- No severe psoriasis or severe atopic dermatitis
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
4 sites in 1 country.
United States4 sites
J&S Studies
College Station, Texas, 77845
OrthoArizona - East Valley Foot & Ankle Specialists
Mesa, Arizona, 85206
Front Range Foot and Ankle Clinic
Parker, Colorado, 80134
Oregon Dermatology & Research Center
Portland, Oregon, 97210
About this study
Official title: An Open Label Phase 2a Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Hallux Terbinafine Subungual Gel Administered to the Toenail Bed of Patients With Distal-Lateral Subungual Onychomycosis
The key objective is to establish the efficacy, safety, tolerability, and pharmacokinetics of investigational drug Hallux Terbinafine Subungual Gel (HSG) administered over 44 weeks to patients with distal-lateral subungual onychomycosis (DLSO).
Read the detailed description
Primary Efficacy: To identify patients achieving Complete Cure in the target toenail at Week 52.
Secondary Efficacy: To identify patients that have achieved 1) Clinical Cure, 2) Mycological Cure, and/or 3) Positive Response in the target toenail at Week 52.
Plasma Pharmacokinetics: To characterize concentrations of terbinafine and major metabolite in a subpopulation of patients over the study period.
Nail Pharmacokinetics: To characterize concentrations of terbinafine and major metabolite in distal nail clippings in patients over the study period.
HSG Safety and Tolerability Profile: To establish from plasma pharmacokinetics, related adverse events, treatment site reactions, pain, clinically significant changes in medical condition and/or medications, and clinically significant changes in liver function, serum chemistry, urinalysis, and complete blood count over the study period.
Subungual Topical Procedure: To establish the ease and durability of once monthly and once bi-monthly HSG subungual topical treatments, the Investigator will record at selected time points 1) nail measurements indicating progressive clearing, 2) the ease and depth of each topical administration, 3) the investigational drug volume administered each treatment, and 4) patient tolerability.
- Conditions
- Onychomycosis of Toenail
- Being tested
- Hallux Terbinafine Subungual Gel
- Keywords
- Onychomycosis
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hallux Terbinafine Subungual GelDrug
Also called HSG
Hallux Terbinafine Subungual Gel (HSG) administered every 1 to 2 months over 44 weeks.
| Study group | Role | What they receive |
|---|---|---|
| HSG | Experimental | Hallux terbinafine subungual gel Receives: Drug: Hallux Terbinafine Subungual Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Cure at Week 52 in the Target Toe
Complete Cure is defined as 1) 100% healthy, clear nail, and 2) negative mycology. Healthy, clear nail is absent any disease involvement attributable to DLSO and is determined by Investigator Global Assessment (IGA). Negative mycology is defined as zero visualization of septate hyphae by KOH microscopy (negative KOH) combined with a fungal culture negative for causal dermatophytes (negative fungal culture).
Measured: Week 52
Secondary outcomes (3)
Clinical Cure in the Target Toe
100% healthy, clear nail
Measured: Week 52
Mycological Cure in the Target Toe
Negative KOH, negative fungal culture
Measured: Week 52
Positive Response in the Target Toe
≥ 80% decrease in disease involvement
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start13 Jan 2022
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hallux, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lewis H. Freed, DPM, Principal investigator, OrthoArizona, East Valley Foot & Ankle SpecialistsTerry M. Jones, MD, Principal investigator, J&S StudiesDaniel P. Mallett, DPM, Principal investigator, Front Range Foot and Ankle ClinicPhoebe Rich, MD, Principal investigator, Oregon Dermatology and Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135910
- Sponsor's protocol ID
- HSG-201
- Status last verified
- Aug 2023
- First submitted
- 28 Oct 2021
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: This is a phase II study. Individual participant data (IPD) of this study will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Phase 2a Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Hallux Terbinafine Subungual Gel Administered to the Toenail Bed of Patients With Distal-Lateral Subungual Onychomycosis
- ClinicalTrials.gov ID
- NCT05135910
- Acronym / sponsor ID
- HSG-201
- Conditions
- Onychomycosis of Toenail
- Keywords
- Onychomycosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Hallux, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 26 Nov 2021 (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.
The key objective is to establish the efficacy, safety, tolerability, and pharmacokinetics of investigational drug Hallux Terbinafine Subungual Gel (HSG) administered over 44 weeks to patients with distal-lateral subungual onychomycosis (DLSO).
Detailed description
Primary Efficacy: To identify patients achieving Complete Cure in the target toenail at Week 52.
Secondary Efficacy: To identify patients that have achieved 1) Clinical Cure, 2) Mycological Cure, and/or 3) Positive Response in the target toenail at Week 52.
Plasma Pharmacokinetics: To characterize concentrations of terbinafine and major metabolite in a subpopulation of patients over the study period.
Nail Pharmacokinetics: To characterize concentrations of terbinafine and major metabolite in distal nail clippings in patients over the study period.
HSG Safety and Tolerability Profile: To establish from plasma pharmacokinetics, related adverse events, treatment site reactions, pain, clinically significant changes in medical condition and/or medications, and clinically significant changes in liver function, serum chemistry, urinalysis, and complete blood count over the study period.
Subungual Topical Procedure: To establish the ease and durability of once monthly and once bi-monthly HSG subungual topical treatments, the Investigator will record at selected time points 1) nail measurements indicating progressive clearing, 2) the ease and depth of each topical administration, 3) the investigational drug volume administered each treatment, and 4) patient tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HSG | Experimental | Drug: Hallux Terbinafine Subungual GelHallux terbinafine subungual gel |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and females 18 - 75 years of age inclusive
- 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
- Willingness to abstain from pedicures, nail clipping, or application of nail polish or nail cosmetics to their toenails over the study period
Key exclusion criteria (8 listed)
- History of any significant chronic fungal disease other than onychomycosis or an immunocompromised condition
- Any previous surgery to or abnormalities of the target toe that in the investigator's opinion could prevent the toenail surface area from clearing even if eradication of the DLSO infection is achieved
- Participation in another clinical study of an investigational drug or device within 3 months of screening
- No administration of oral terbinafine or another oral antifungal within 6 months of screening
- No topical antifungal used for onychomycosis or a dermatophyte infection (i.e. tinea pedis) within 3 months of screening
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 |
|---|---|---|
| Hallux Terbinafine Subungual GelAlso: HSGHallux Terbinafine Subungual Gel (HSG) administered every 1 to 2 months over 44 weeks. | Drug | HSG |
Primary outcome
Complete Cure at Week 52 in the Target Toe
Time frame: Week 52
Complete Cure is defined as 1) 100% healthy, clear nail, and 2) negative mycology. Healthy, clear nail is absent any disease involvement attributable to DLSO and is determined by Investigator Global Assessment (IGA). Negative mycology is defined as zero visualization of septate hyphae by KOH microscopy (negative KOH) combined with a fungal culture negative for causal dermatophytes (negative fungal culture).
3 secondary outcomes
Clinical Cure in the Target Toe
Time frame: Week 52
Mycological Cure in the Target Toe
Time frame: Week 52
Positive Response in the Target Toe
Time frame: Week 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Individual participant dataSharing planned: No. This is a phase II study. Individual participant data (IPD) of this study will not be shared.
Related trials for Onychomycosis of Toenail
Active, not recruitingPhase 1
Photodynamic Therapy For Onychomycosis
Onychomycosis of Toenail
Recruiting
URGO MICKAEL Filmogel, Topical Treatment of Onychomycosis
Onychomycosis of Toenail
Active, not recruiting
Exploring Different Dose-frequency Home Photodynamic Therapy Protocols Using a Novel Home-targeted LED Device for Onychomycosis
Onychomycosis of Toenails, Onychomycosis of Fingernail
Active, not recruitingPhase 2
Safety, Tolerability and Efficacy of Trichostatin A in Patients With Mild to Severe Onychomycosis
Onychomycosis of Toenail
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
Onychomycosis of Toenail
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. This study is not recruiting at the moment.
Lewis H. Freed, DPM principal investigator
OrthoArizona, East Valley Foot & Ankle Specialists
Terry M. Jones, MD principal investigator
J&S Studies
Daniel P. Mallett, DPM principal investigator
Front Range Foot and Ankle Clinic
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hallux Terbinafine Subungual Gel in people with Onychomycosis of Toenail, run by Hallux, Inc. at 4 sites in United States.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Cure at Week 52 in the Target Toe (time frame: Week 52). 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 7 Aug 2023.