Evaluating the Safety, Tolerability and Preliminary Efficacy of Plasma in Improving the Appearance of Onychomycosis

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

Detailed Description
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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.

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

Conditions
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Onychomycosis

Intervention / Treatment
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* Device: MOE Plasma Delivery System A
* Device: MOE Plasma Delivery System B


Participation Criteria
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Eligibility Criteria
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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; Subject with uncontrolled diabetes mellitus, subjects with diabetes controlled by insulin or with known diabetic peripheral neuropathy Subject with any known immunodeficiency; Any pacemakers, or any metallic implants or prostheses in the vicinity of the treatment site (such as ankle, foot, etc.); Subject with any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with study evaluations or optimal participation in the study; Subject who has received systemic antifungal therapy within 6 months (except single diflucan tablet for vaginal candida) or topical antifungal therapy applied to the foot or toenails within 1 month of study entry; Subject who has received radiation therapy, chemotherapy, and/or immunosuppressive drugs within 6 months of study, and/or oral corticosteroids for >1 month within the 6 months of study (exception: inhaled steroids); Subject known to have received treatment with investigational drugs or devices within 30 days prior to enrollment into this study; Subject who is unwilling to abstain from any cosmetic nail or foot treatments outside those provided by the study clinic, beyond basic nail trimming (i.e. no spa foot treatments, no pedicures/toenail polish use, no other topical prescription toenail medication); Woman who is breastfeeding, pregnant, or intends to become pregnant (check via urine test only); Subject who is part of the staff personnel directly involved with this study or a family member of the investigational study staff;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Plasma treatment using Plasma delivery system A 3 treatments/week for 2 weeks, then monthly | Device: MOE Plasma Delivery System A<br>* Plasma treatment<br>|
| Experimental: Group 2<br>Plasma treatment using Plasma delivery system A 2 treatments/week for 2 weeks, then monthly | Device: MOE Plasma Delivery System A<br>* Plasma treatment<br>|
| Experimental: Group 3<br>Plasma treatment using Plasma delivery system B 3 treatments/week for 2 weeks, then monthly | Device: MOE Plasma Delivery System B<br>* Plasma treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects with treatment-related adverse events as assessed by CTCAE v4.0 | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy as assessed by Clinical, Mycological and Complete Cure Rates assessed in accordance with FDA Guidance for onychomycosis trials issued March 7, 2016 | The secondary objective of this study is to evaluate the preliminary efficacy of non-ablative electrical plasma in improving the appearance and treatment of onychomycosis. | 12 months |