Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety and preliminary efficacy of using electrical plasma to treat toenail fungus.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Plasma treatment using Plasma delivery system A 3 treatments/week for 2 weeks, then monthly |
|
| Group 2 | Experimental | Plasma treatment using Plasma delivery system A 2 treatments/week for 2 weeks, then monthly |
|
| Group 3 | Experimental | Plasma treatment using Plasma delivery system B 3 treatments/week for 2 weeks, then monthly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MOE Plasma Delivery System A | Device | Plasma treatment |
| |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
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:
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;
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sin Park, PhD | Contact | 914-594-1985 | allsra@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MOE Medical Devices Site 5 | Recruiting | Quincy | Massachusetts | 02169 | United States | |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| MOE Plasma Delivery System B |
| Device |
Plasma treatment |
|
| MOE Medical Devices Site 4 |
| Terminated |
| Philadelphia |
| Pennsylvania |
| 19103 |
| United States |
| MOE Medical Devices Investigational Site 3 | Terminated | Pittsburgh | Pennsylvania | 15222 | United States |
| MOE Medical Devices Site 6 | Not yet recruiting | Austin | Texas | 78759 | United States |
|
| MOE Medical Devices Investigational Site 1 | Recruiting | College Station | Texas | 77802 | United States |
| MOE Medical Devices Investigational Site 2 | Recruiting | McAllen | Texas | 78501 | United States |
| MOE Medical Devices Site 7 | Not yet recruiting | San Antonio | Texas | 78229 | United States |
|
| ID | Term |
|---|---|
| D014009 | Onychomycosis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D009260 | Nail Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided