NCT03216200

Early Feasibility Study to Evaluate the Efficacy of the RenewalNail™ Plasma Treatment System in Patients With Onychomycosis (Fungal Nail)

A Single Center Open Label Early Feasibility Study to Evaluate the Efficacy and Safety of the RenewalNail™ Plasma Treatment System in Patients With Mild to Moderate Onychomycosis (Fungal Nail) of the Hallux Caused by Trichophyton Rubrum or Trichophyton Mentagrophytes.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: DeviceFarm, Inc. · Industry
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A study to determine if a three-treatment protocol with the RenewalNail™ plasma treatment system over a week will result in mycological cure and/or clear nail growth on the treated hallux toe.

Detailed description

The purpose of this study is to assess the clinical feasibility of DeviceFarm, Inc.'s RenewalNail™ system and the treatment protocol that was developed based on extensive laboratory testing on human cadaver nails. The Protocol calls for three 45-minute treatments performed over a week to achieve mycological cure. Mycological cure will be assessed with two consecutive mycological culture tests done over a week following the third treatment. Two consecutive negative mycology culture results confirm the elimination of fungus causing onychomycosis infection, as recommended by recent FDA guidance. There will be no placebo arm in the study. Clear nail growth will be documented and assessed by photography for 5 months after treatment.

Conditions

• Onychomycosis of Toenail
• Onychomycosis

Interventions

Type	Name	Description
DEVICE	plasma treatment	application of cold atmospheric plasma to a fungal infected toenail

Timeline

• Start date: 2017-07-07
• Primary completion: 2018-06-30
• Completion: 2018-07-10
• First posted: 2017-07-13
• Last updated: 2019-10-11
• Results posted: 2019-10-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study