Trial Outcomes & Findings for Early Feasibility Study to Evaluate the Efficacy of the RenewalNail™ Plasma Treatment System in Patients With Onychomycosis (Fungal Nail) (NCT NCT03216200)

Last Updated: 2019-10-11

Results Overview

number of participants with mycological cure defined as two consecutive negative cultures per FDA guideline

Recruitment status

COMPLETED

Study phase

Target enrollment

5 participants

Primary outcome timeframe

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

Results posted on

2019-10-11

Participant milestones
Measure	Experimental 5 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. plasma treatment: application of cold atmospheric plasma to a fungal infected toenail
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Withdrawal data not reported

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

Baseline characteristics by cohort
Measure	Experimental n=5 Participants 5 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. plasma treatment: application of cold atmospheric plasma to a fungal infected toenail
Age, Continuous	54 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	5 Participants n=5 Participants

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

number of participants with mycological cure defined as two consecutive negative cultures per FDA guideline

Outcome measures
Measure	Experimental n=5 Participants 5 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. plasma treatment: application of cold atmospheric plasma to a fungal infected toenail
Mycological Cure	2 Participants

Timeframe: 5 months after the first treatment

Number of patients with photographic evidence of increased clear nail growth

Outcome measures
Measure	Experimental n=5 Participants 5 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. plasma treatment: application of cold atmospheric plasma to a fungal infected toenail
Clear Nail Growth	3 Participants

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Experimental n=5 participants at risk 5 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. plasma treatment: application of cold atmospheric plasma to a fungal infected toenail
Skin and subcutaneous tissue disorders Erythema	20.0% 1/5 • Number of events 2 • 5 months

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