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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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

Brief 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 Summary:

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.


Sponsor: DeviceFarm, Inc.

Current Primary Outcome: mycological cure [ Time Frame: 2 cultures taken a week apart within 2 weeks after the first treatment ]

mycological cure defined as two consecutive negative cultures per FDA guideline


Original Primary Outcome: Same as current

Current Secondary Outcome: clear nail growth [ Time Frame: 5 months after the first treatment ]

photographic evidence of increased clear nail growth


Original Secondary Outcome: Same as current

Information By: DeviceFarm, Inc.

Dates:
Date Received: March 2, 2017
Date Started: March 1, 2017
Date Completion: July 2018
Last Updated: March 6, 2017
Last Verified: March 2017