Onychomycosis
Conditions
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
Interventions
DRUGHTS-519 Insert
Maximum feasible dose of HTS-519 Insert per diseased nail
Sponsors
Hallux, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Related Adverse Events | Up to 48 weeks | Frequency and severity of Treatment Related Adverse Events |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HTS-519 Insert Active treatment
HTS-519 Insert: Maximum feasible dose of HTS-519 Insert per diseased nail | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | HTS-519 Insert |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Age, Continuous | 59.9 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 28 Participants |
| Region of Enrollment United States | 30 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 28 / 30 |
| serious Total, serious adverse events | 2 / 30 |
Outcome results
Primary
Treatment Related Adverse Events
Frequency and severity of Treatment Related Adverse Events
Time frame: Up to 48 weeks
Population: Safety Population: All Enrolled
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Safety Population: All Enrolled | Treatment Related Adverse Events | No. of Subjects with Treatment-related AE | 22 Participants |
| Safety Population: All Enrolled | Treatment Related Adverse Events | No. of Subjects with no Treatment-related AE | 8 Participants |