A Multi-Center Pilot Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of the Plasma Treatment System in Improving the Appearance of Onychomycosis

Moe Medical Devices7 sites in 1 country75 target enrollmentMarch 2016

ConditionsOnychomycosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Onychomycosis
Sponsor: Moe Medical Devices
Enrollment: 75
Locations: 7
Primary Endpoint: Number of Subjects with treatment-related adverse events as assessed by CTCAE v4.0
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety and preliminary efficacy of using electrical plasma to treat toenail fungus.

Detailed Description

75 patients will be recruited at several sites. Patients will be split into 3 groups that have different treatment doses. Patient participation in the study will last 12 months.

Registry

clinicaltrials.gov

Start Date

March 2016

End Date

February 2019

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Moe Medical Devices

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject must be between 18 and 70 years of age inclusive, of either sex, and of any race;
•Subject must have distal subungual infection that affects approximately 25% to 60% of at least one great toenail
•Dermatophyte infection or infection with C. Albicans in the target great toenail confirmed by identification of a dermatophyte organism in culture;
•Subject must have at least 3 mm from the proximal end of the target toenail free of infection;
•Subject must have a target toenail that is assessed as capable of growing approximately 1 mm/month, (e.g., the subject needs to report cutting his or her toenails at least once per month);
•Subject must be willing to give written informed consent and able to adhere to procedures and visit schedules;
•Subject must consent to having the toenails photographed during the study period;
•Woman of childbearing potential: If currently sexually active, must agree to use a medically accepted method of contraception while receiving protocol-specified medication and for 30 days after stopping the study treatments; If not currently active, must agree to use medically accepted method of contraception should she become sexually active during study participation. Methods include condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed intrauterine device, oral or systemic hormonal contraceptive (plus an additional reliable barrier method), and surgical sterilization (e.g., hysterectomy or tubal ligation);
•Woman of childbearing potential must have a negative serum or urine pregnancy test prior to start of study.

Exclusion Criteria

•Subject with more than 6 infected toenails
•Subject with fingernail onychomycosis
•Subject with one or more of the following conditions on the primary target toenail:
•white superficial onychomycosis
•dermatophytoma or "yellow spike/streak"
•primarily lateral or bi-lateral disease
•toenail thickness greater than 3 mm
•inability to become normal in the opinion of the investigator
•Subject with psoriasis, pincer nail, prior nail surgery, severe moccasin-type tinea pedis requiring treatment, symptomatic interdigital tinea pedis, lichen planus, or other abnormalities that could result in a clinically abnormal nail;
•Subject with peripheral vascular disease or peripheral circulatory impairment;

Outcomes

Primary Outcomes

Number of Subjects with treatment-related adverse events as assessed by CTCAE v4.0

Time Frame: 12 months

The primary objective of this study is to compare the short-term safety and tolerability of application of non-ablative electrical plasma to human nails among the different dosing regimes.

Secondary Outcomes

Efficacy as assessed by Clinical, Mycological and Complete Cure Rates assessed in accordance with FDA Guidance for onychomycosis trials issued March 7, 2016(12 months)