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

Phase 2

Completed

• Conditions: Onychomycosis
• Interventions: Drug: HTS-519 Insert

• Registration Number: NCT02798380
• Lead Sponsor: Hallux, Inc.

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

Study Timeline

• Study First Submitted: 2016-06-05
• Study First Submitted QC: 2016-06-08
• Study First Posted: 2016-06-14
• Study Start: 2016-07
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Results First Submitted: 2019-07-23
• Results First Submitted QC: 2019-09-05
• Results First Posted: 2019-09-24
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-25
• Last Update Posted: 2021-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HTS-519 Insert	HTS-519 Insert	Active treatment

Primary Outcome Measures

Name	Time	Method
Treatment Related Adverse Events	Up to 48 weeks	Frequency and severity of Treatment Related Adverse Events

Trial Locations

Locations (1)

OrthoArizona - East Valley Foot & Ankle Specialists; 🇺🇸 Mesa, Arizona, United States