At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 30 enrolled
Drug / intervention
HTS-519 Insertdrug
Likely dose
Maximum feasible dose of HTS-519 Insert per diseased nailAI-extracted
Key inclusion· 3
- ✓Age 18–74 years
- ✓Fungal toenail infection of one or both great toenails confirmed to be dermatophyte (not mixed infection)
- ✓Willing to avoid professional pedicures and nail polish/cosmetics on toenails after screening
Key exclusion· 7
- ✕History of significant chronic fungal disease other than onychomycosis or immunocompromised condition
- ✕Nail abnormalities or previous toenail surgery that would prevent normal nail appearance even if infection clears
- ✕Significant confounding conditions as assessed by study physician
- ✕Concurrent participation in another investigational drug/device trial
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating HTS-519 Insert for Onychomycosis. Completed, enrolled 30 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOnychomycosis
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 2016
Enrollment StartJul 2016
Primary CompletionOct 2018
TodayJul 2026
First PostedJun 14, 2016
Enrollment StartJul 1, 2016
Primary CompletionOct 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 10.0 years ago
Interventions
HTS-519 Insertdrug
Maximum feasible dose of HTS-519 Insert per diseased nail