Pilot Study to Evaluate Plasma Treatment of Onychomycosis

NCT01819051 | Completed

• 1 other identifier: MOE - 131
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety of treating human toenails with atmospheric plasma (MOE Antimicrobial Plasma Treatment System) and get an initial evaluation of the efficacy of this treatment for toenail fungus (onychomycosis).

Conditions

Onychomycosis

Outcome Measures

Primary Outcomes (1)

• Change in number of reported adverse events

  Change from Baseline to 6 months post-treatment

Study Arms (1)

Plasma

EXPERIMENTAL

Apply plasma to great toenail for up to 20 minutes, 1X/week for 3 weeks

Device: MOE Antimicrobial Plasma Treatment System

Interventions

MOE Antimicrobial Plasma Treatment System DEVICE

Plasma applied to great toenail 1X/week for three weeks

Plasma

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be between 18 and 75 years of age inclusive, of either sex, and of any race;
• Subject must have distal subungual infection that affects approximately 25% to 50% of at least one great toenail, both clinically and mycologically diagnosed;
• Subject must have at least 2 mm of 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;
• Woman of childbearing potential who is 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 medication. 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 child-bearing potential who is not currently sexually active must agree to use a medically accepted method of contraception should she become sexually active while participating in the study.
• Woman of childbearing potential must have a negative serum pregnancy test within 72 hours prior to start of study drug.

You may not qualify if:

• Subject with one or more of the following conditions on the target toenail:
• proximal subungual onychomycosis,
• white superficial onychomycosis,
• dermatophytoma or "yellow spike/streak",
• exclusively lateral disease,
• inability to become normal in the opinion of the investigator.
• Subject with psoriasis, 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 history of uncontrolled diabetes mellitus;
• Subject with known chronic or active liver disease;
• 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 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);

Sponsors & Collaborators

• Moe Medical Devices: lead

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Onychomycosis

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2013
• First Posted: March 27, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: September 14, 2017

Record last verified: 2017-09

Locations

US (1)