Back to resultsEfficacy, Safety, and Tolerability of HTS-519 Insert in Patients With Toenail Fungus of the Big Toenail
Primary Purpose
Onychomycosis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
HTS-519 Insert
Sponsored by
About this trial
This is an interventional treatment trial for Onychomycosis
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- OrthoArizona - East Valley Foot & Ankle Specialists
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HTS-519 Insert
Arm Description
Active treatment
Outcomes
Primary Outcome Measures
Treatment Related Adverse Events
Frequency and severity of Treatment Related Adverse Events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02798380
Brief Title
Efficacy, Safety, and Tolerability of HTS-519 Insert in Patients With Toenail Fungus of the Big Toenail
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hallux, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
Open label, single-site
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HTS-519 Insert
Arm Type
Experimental
Arm Description
Active treatment
Intervention Type
Drug
Intervention Name(s)
HTS-519 Insert
Other Intervention Name(s)
HTS-519 Biodegradable Micro Insert
Intervention Description
Maximum feasible dose of HTS-519 Insert per diseased nail
Primary Outcome Measure Information:
Title
Treatment Related Adverse Events
Description
Frequency and severity of Treatment Related Adverse Events
Time Frame
Up to 48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Tremblay, RN, BSN
Organizational Affiliation
Hallux, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
OrthoArizona - East Valley Foot & Ankle Specialists
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy, Safety, and Tolerability of HTS-519 Insert in Patients With Toenail Fungus of the Big Toenail
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