OnychomycosisPhase 2NCT02798380
Efficacy, Safety, and Tolerability of HTS-519 Insert in Patients With Toenail Fungus of the Big Toenail
A Phase 2 study testing HTS-519 Insert in people with Onychomycosis, run by Hallux, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to assess the efficacy, safety and tolerability of HTS-519 Inserts in the treatment of mild to moderate toenail fungus disease of the big toenail. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- HTS-519 Insert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Oct 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and females 18 - 74 years of age inclusive
- Fungal toenail infection of one or both of the large (great) toenails
- The nail infection must be due to a dermatophyte, (mixed infections [dermatophyte and non-dermatophyte] are not allowed)
- Willingness not to have professional pedicures or application of any nail polish product or nail cosmetics to the toenails after the screening visit
Who cannot join
- History of any significant chronic fungal disease other than onychomycosis or immunocompromised condition
- Any abnormalities of the nail or previous surgery of the toenail that could prevent a normal appearing nail if clearing of infection is achieved
- Significant confounding conditions as assessed by the study doctor
- Participation in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
- No administration of systemic antifungal medications within 6 months prior to screening visit
- No application of prescription topical antifungal medications for toenail fungus within 3 months or other commercially available topical medications for toenail fungus applied directly to the toenails within 1 month prior to screening visit
- Tinea pedis (athlete's foot) that would require systemic treatment
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
United States1 site
OrthoArizona - East Valley Foot & Ankle Specialists
Mesa, Arizona, 85206
About this study
Official title: An Open-Label Phase 2 Study to Investigate the Efficacy, Tolerability, and Safety of the HTS-519 Insert in the Treatment of Subjects With Distal Lateral Subungual Onychomycosis of the Great Toenail
The purpose of this study is to assess the efficacy, safety and tolerability of HTS-519 Inserts in the treatment of mild to moderate toenail fungus disease of the big toenail.
Read the detailed description
Open label, single-site
- Conditions
- Onychomycosis
- Being tested
- HTS-519 Insert
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTS-519 InsertDrug
Also called HTS-519 Biodegradable Micro Insert
Maximum feasible dose of HTS-519 Insert per diseased nail
| Study group | Role | What they receive |
|---|---|---|
| HTS-519 Insert | Experimental | Active treatment Receives: Drug: HTS-519 Insert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Related Adverse Events
Frequency and severity of Treatment Related Adverse Events
Measured: Up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OnychomycosisStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hallux, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Tremblay, RN, BSN, Study director, Hallux, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798380
- Sponsor's protocol ID
- HTS-002B
- Status last verified
- Oct 2021
- First submitted
- 5 Jun 2016
- Last updated
- 2 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase 2 Study to Investigate the Efficacy, Tolerability, and Safety of the HTS-519 Insert in the Treatment of Subjects With Distal Lateral Subungual Onychomycosis of the Great Toenail
- ClinicalTrials.gov ID
- NCT02798380
- Acronym / sponsor ID
- HTS-002B
- Conditions
- Onychomycosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hallux, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2016 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 14 Jun 2016 (estimated)
- Results
- Posted 24 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy, safety and tolerability of HTS-519 Inserts in the treatment of mild to moderate toenail fungus disease of the big toenail.
Detailed description
Open label, single-site
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HTS-519 Insert | Experimental | Drug: HTS-519 InsertActive treatment |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and females 18 - 74 years of age inclusive
- Fungal toenail infection of one or both of the large (great) toenails
- The nail infection must be due to a dermatophyte, (mixed infections [dermatophyte and non-dermatophyte] are not allowed)
- Willingness not to have professional pedicures or application of any nail polish product or nail cosmetics to the toenails after the screening visit
Key exclusion criteria (8 listed)
- History of any significant chronic fungal disease other than onychomycosis or immunocompromised condition
- Any abnormalities of the nail or previous surgery of the toenail that could prevent a normal appearing nail if clearing of infection is achieved
- Significant confounding conditions as assessed by the study doctor
- Participation in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
- No administration of systemic antifungal medications within 6 months prior to screening visit
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 |
|---|---|---|
| HTS-519 InsertAlso: HTS-519 Biodegradable Micro InsertMaximum feasible dose of HTS-519 Insert per diseased nail | Drug | HTS-519 Insert |
Primary outcome
Treatment Related Adverse Events
Time frame: Up to 48 weeks
Frequency and severity of Treatment Related Adverse Events
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Onychomycosis
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URGO MICKAEL Filmogel, Topical Treatment of Onychomycosis
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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. This study is not recruiting at the moment.
Thomas Tremblay, RN, BSN study director
Hallux, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HTS-519 Insert in people with Onychomycosis, run by Hallux, Inc. at 1 site 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: finished, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 24 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Treatment Related Adverse Events (time frame: Up to 48 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 2 Nov 2021.