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

Hallux, Inc.

Status and phase

Completed

Phase 2

Conditions

Onychomycosis

Treatments

Drug: HTS-519 Insert

Study type

Interventional

Funder types

Industry

Identifiers

NCT02798380

HTS-002B

Details and patient eligibility

About

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.

Full description

Open label, single-site

Enrollment

30 patients

Sex

All

Ages

18 to 74 years old

Volunteers

No Healthy Volunteers

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