MedTrace Logo

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

NCT03072550 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2019-09-16

Study results available
· View outcomes & findings →

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.

Conditions

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

Interventions

DEVICE

RenewalNail™ Plasma Treatment System

application of cold atmospheric plasma to a fungal infected toenail

Sponsors & Collaborators

  • Symbio, LLC

    collaborator INDUSTRY

  • Center for Dermatology Clinical Research, Inc.

    collaborator UNKNOWN

  • DeviceFarm, Inc.

    lead INDUSTRY

Principal Investigators

  • Jeffrey N Roe, PhD · DeviceFarm, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2018-04-01
Completion
2018-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03072550 on ClinicalTrials.gov