NCT03072550

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

A Multi 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: 26 (actual)
• Sponsor: DeviceFarm, Inc. · Industry
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Early feasibility 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 Sponsor has developed the RenewalNail™ plasma treatment system to topically treat fungal infected toenails. The goal of the RenewalNail™ therapy is to overcome the shortcomings of both topical and oral therapies by combining the safety of a topical treatment with the efficacy of an oral treatment. The primary objective of this early feasibility study is to evaluate the efficacy and safety of the RenewalNail™ plasma treatment system and Protocol in achieving mycological cure for the patient. 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. Two consecutive negative results will confirm the elimination of fungus causing onychomycosis infection, as recommended by recent FDA guidance. There will be no placebo arm in the study. Secondary objectives include assessing if the treatment protocol results in clear nail growth for the patient over a 5-month interval.

Conditions

• Onychomycosis Due to Trichophyton Rubrum
• Onychomycosis Due to Trichophyton Mentagrophytes

Interventions

Type	Name	Description
DEVICE	RenewalNail™ Plasma Treatment System	application of cold atmospheric plasma to a fungal infected toenail

Timeline

• Start date: 2017-03-01
• Primary completion: 2018-04-01
• Completion: 2018-06-30
• First posted: 2017-03-07
• Last updated: 2019-09-16
• Results posted: 2019-08-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study