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

NCT02798380 | Completed Phase 2 Results

• 1 other identifier: HTS-002B
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Onychomycosis

Outcome Measures

Primary Outcomes (1)

• Treatment Related Adverse Events

  Frequency and severity of Treatment Related Adverse Events

  Up to 48 weeks

Study Arms (1)

HTS-519 Insert

EXPERIMENTAL

Active treatment

Drug: HTS-519 Insert

Interventions

HTS-519 Insert DRUG

Maximum feasible dose of HTS-519 Insert per diseased nail

Also known as: HTS-519 Biodegradable Micro Insert

HTS-519 Insert

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hallux, Inc.: lead

Study Sites (1)

OrthoArizona - East Valley Foot & Ankle Specialists

Mesa, Arizona, 85206, United States

Location

MeSH Terms

Conditions

Onychomycosis

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Thomas M Tremblay, RN BSN, Vice President of Clinical Affairs
• Organization: Hallux, Inc.

ttremblay@halluxinc.com

(415) 305-3491

Study Officials

• Thomas Tremblay, RN, BSN

  Hallux, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2016
• First Posted: June 14, 2016
• Study Start: July 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: November 2, 2021
• Results First Posted: September 24, 2019

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)