Trial Outcomes & Findings for Efficacy, Safety, and Tolerability of HTS-519 Insert in Patients With Toenail Fungus of the Big Toenail (NCT NCT02798380)

Last Updated: 2021-11-02

Results Overview

Frequency and severity of Treatment Related Adverse Events

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

Up to 48 weeks

Results posted on

2021-11-02

Participant milestones
Measure	HTS-519 Insert Active treatment HTS-519 Insert: Maximum feasible dose of HTS-519 Insert per diseased nail
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Efficacy, Safety, and Tolerability of HTS-519 Insert in Patients With Toenail Fungus of the Big Toenail

Baseline characteristics by cohort
Measure	HTS-519 Insert n=30 Participants Active treatment HTS-519 Insert: Maximum feasible dose of HTS-519 Insert per diseased nail
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants
Age, Continuous	59.9 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	30 Participants n=5 Participants

Timeframe: Up to 48 weeks

Population: Safety Population: All Enrolled

Frequency and severity of Treatment Related Adverse Events

Outcome measures
Measure	Safety Population: All Enrolled n=30 Participants Active treatment HTS-519 Insert: Maximum feasible dose of HTS-519 Insert per diseased nail
Treatment Related Adverse Events No. of Subjects with Treatment-related AE	22 Participants
Treatment Related Adverse Events No. of Subjects with no Treatment-related AE	8 Participants

Serious events: 2 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events
Measure	HTS-519 Insert n=30 participants at risk Active treatment HTS-519 Insert: Maximum feasible dose of HTS-519 Insert per diseased nail
Investigations Leg edema	3.3% 1/30 • Number of events 1 • 48 weeks
Surgical and medical procedures Spinal Fusion Surgery	3.3% 1/30 • Number of events 1 • 48 weeks

Other adverse events
Measure	HTS-519 Insert n=30 participants at risk Active treatment HTS-519 Insert: Maximum feasible dose of HTS-519 Insert per diseased nail
General disorders Mild Punctate Bleeding	13.3% 4/30 • 48 weeks
General disorders Mild Subungual Hematoma	56.7% 17/30 • 48 weeks
Investigations Mild Pain in Toe	6.7% 2/30 • 48 weeks
Skin and subcutaneous tissue disorders Mild Onycholysis	16.7% 5/30 • 48 weeks

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