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

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

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 Overview

• Status: Completed
• Conditions: Onychomycosis
• Intervention / Treatment: Drug: HTS-519 Insert

Detailed Description

Open label, single-site

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Mesa, Arizona, United States, 85206
      • OrthoArizona - East Valley Foot & Ankle Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: HTS-519 Insert; Active treatment	Drug: HTS-519 Insert; Maximum feasible dose of HTS-519 Insert per diseased nail; Other Names: HTS-519 Biodegradable Micro Insert

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Related Adverse Events	Frequency and severity of Treatment Related Adverse Events	Up to 48 weeks

Collaborators and Investigators

• Sponsor: Hallux, Inc.
• Investigators: Study Director: Thomas Tremblay, RN, BSN, Hallux, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2016
• Primary Completion (ACTUAL): October 1, 2018
• Study Completion (ACTUAL): October 1, 2018

Study Registration Dates

• First Submitted: June 5, 2016
• First Submitted That Met QC Criteria: June 8, 2016
• First Posted (ESTIMATE): June 14, 2016

Study Record Updates

• Last Update Posted (ACTUAL): November 2, 2021
• Last Update Submitted That Met QC Criteria: October 25, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Tinea; Dermatomycoses; Nail Diseases; Onychomycosis
• Other Study ID Numbers: HTS-002B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO