Trial Outcomes & Findings for Early Feasibility Study to Evaluate the Efficacy and Safety of the RenewalNail™ Plasma Treatment System in Patients With Mild to Moderate Onychomycosis (Fungal Nail) (NCT NCT03072550)

NCT ID: NCT03072550

Last Updated: 2019-09-16

Results Overview

mycological cure defined as two consecutive negative cultures per FDA guideline

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 26 participants
• Primary outcome timeframe: 2 cultures taken a week apart within 2 weeks after the first treatment
• Results posted on: 2019-09-16

Participant Flow

Participant milestones

Measure	Multi-center Open Label 26 Subjects with 20-75% Distal Subungual Onychomycosis (mild to moderate DSO) infection of their big toe (hallux) nail infected by the dermatophytes Trichophyton (T.) rubrum or T. mentagrophytes will be enrolled. All Subjects will receive three 45-minute plasma treatments performed over a week. RenewalNail™ Plasma Treatment System: application of cold atmospheric plasma to a fungal infected toenail
Overall Study STARTED	26
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Multi-center Open Label n=26 Participants Thirty Subjects with 20-75% Distal Subungual Onychomycosis (mild to moderate DSO) infection of their big toe (hallux) nail infected by the dermatophytes Trichophyton (T.) rubrum or T. mentagrophytes will be enrolled. All Subjects will receive three 45-minute plasma treatments performed over a week. RenewalNail™ Plasma Treatment System: application of cold atmospheric plasma to a fungal infected toenail
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	57 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants
Positive KOH and fungal culture for T. rubrum or T. mentagrophytes	26 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 cultures taken a week apart within 2 weeks after the first treatment

mycological cure defined as two consecutive negative cultures per FDA guideline

Outcome measures

Measure

Multi-center Open Label n=24 Participants 26 Subjects with 20-75% Distal Subungual Onychomycosis (mild to moderate DSO) infection of their big toe (hallux) nail infected by the dermatophytes Trichophyton (T.) rubrum or T. mentagrophytes will be enrolled. All Subjects will receive three 45-minute plasma treatments performed over a week. RenewalNail™ Plasma Treatment System: application of cold atmospheric plasma to a fungal infected toenail

Mycological Cure

12 Participants

Adverse Events

Multi-center Open Label

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure

Multi-center Open Label n=26 participants at risk 26 Subjects with 20-75% Distal Subungual Onychomycosis (mild to moderate DSO) infection of their big toe (hallux) nail infected by the dermatophytes Trichophyton (T.) rubrum or T. mentagrophytes will be enrolled. All Subjects will receive three 45-minute plasma treatments performed over a week. RenewalNail™ Plasma Treatment System: application of cold atmospheric plasma to a fungal infected toenail

Infections and infestations Staphylococcal infection

3.8% 1/26 • Number of events 1 • 5 months

Other adverse events

Measure	Multi-center Open Label n=26 participants at risk 26 Subjects with 20-75% Distal Subungual Onychomycosis (mild to moderate DSO) infection of their big toe (hallux) nail infected by the dermatophytes Trichophyton (T.) rubrum or T. mentagrophytes will be enrolled. All Subjects will receive three 45-minute plasma treatments performed over a week. RenewalNail™ Plasma Treatment System: application of cold atmospheric plasma to a fungal infected toenail
Skin and subcutaneous tissue disorders erythema	19.2% 5/26 • Number of events 5 • 5 months
Skin and subcutaneous tissue disorders edema	15.4% 4/26 • Number of events 4 • 5 months
Skin and subcutaneous tissue disorders exfoliation	3.8% 1/26 • Number of events 1 • 5 months

Additional Information

Jeffrey N Roe

DeviceFarm

Phone: 925-895-1584

Email: jeffnroe1@devicefarmtech.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place