Phase 2
Completed N=30
Efficacy, Safety, and Tolerability of HTS-519 Insert in Patients With Toenail Fungus of the Big Toenail
Onychomycosis
Source: ClinicalTrials.gov NCT02798380 ↗
Enrolled (actual)
30
Serious AEs
6.7%
Results posted
Sep 2019
Primary outcomePrimary: Treatment Related Adverse Events — 22; 8 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Related Adverse Events |
22; 8 | — |
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
Data sourced from ClinicalTrials.gov (NCT02798380). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.