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

Onychomycosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02798380
• Other study ID #: HTS-002B
• Status: Completed
• Phase: Phase 2
• Start date: July 2016
• Est. completion date: October 2018

Study information

• Verified date: October 2021
• Source: Hallux, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Open label, single-site

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Onychomycosis

Intervention

Drug:
• HTS-519 Insert
Maximum feasible dose of HTS-519 Insert per diseased nail

Locations

Country	Name	City	State
United States	OrthoArizona - East Valley Foot & Ankle Specialists	Mesa	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Hallux, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Related Adverse Events	Frequency and severity of Treatment Related Adverse Events	Up to 48 weeks