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)

Completed NA Results posted Last updated 16 September 2019

What this trial tests

NA trial testing RenewalNail™ Plasma Treatment System in Onychomycosis Due to Trichophyton Rubrum in 26 participants. Completed in 30 June 2018.

Timeline

1 March 2017

Primary endpoint
1 April 2018

30 June 2018

Quick facts

Lead sponsor	DeviceFarm, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	26
Start date	1 March 2017
Primary completion	1 April 2018
Estimated completion	30 June 2018
Sites	2 locations across United States

Drugs / interventions tested

• RenewalNail™ Plasma Treatment System

Conditions studied

• Onychomycosis Due to Trichophyton Rubrum — all drugs for Onychomycosis Due to Trichophyton Rubrum →
• Onychomycosis Due to Trichophyton Mentagrophytes — all drugs for Onychomycosis Due to Trichophyton Mentagrophytes →

Sponsor

DeviceFarm, Inc.

Who can join

Adults 21 to 75, any sex, with Onychomycosis Due to Trichophyton Rubrum or Onychomycosis Due to Trichophyton Mentagrophytes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mycological Cure Primary · 2 cultures taken a week apart within 2 weeks after the first treatment

mycological cure defined as two consecutive negative cultures per FDA guideline

Group	Value	95% CI
Multi-center Open Label	12

Adverse events — posted to ClinicalTrials.gov

Time frame: 5 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Multi-center Open Label

Serious: 1/26 (4%)

Deaths: 0/26

Serious adverse events (1 terms)

Reaction	System	Multi-center Open Label
Staphylococcal infection	Infections and infestations	—

Other adverse events (3 terms — click to expand)

Reaction	System	Multi-center Open Label
erythema	Skin and subcutaneous tissue disorders	—
edema	Skin and subcutaneous tissue disorders	—
exfoliation	Skin and subcutaneous tissue disorders	—

Most-reported serious reactions: Staphylococcal infection.

Data from ClinicalTrials.gov NCT03072550 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. ROS from Physical Plasmas: Redox Chemistry for Biomedical Therapy.
   Privat-Maldonado A, Schmidt A, Lin A, Weltmann KD, et al · · 2019 · cited 155× · PMID 31687089 · DOI 10.1155/2019/9062098