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

• Status: Completed
• Trial end date: 2018-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hallux, Inc.

Criteria

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