OnychomycosisNCT01819051
Pilot Study to Evaluate Plasma Treatment of Onychomycosis
A study testing MOE Antimicrobial Plasma Treatment System in people with Onychomycosis, run by Moe Medical Devices at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- MOE Antimicrobial Plasma Treatment System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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);
- Subject known to have received treatment with investigational drugs within 30 days prior to enrollment into this study;
- Subject who is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function
- Subjects who may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse (no testing required), or subjects who are unable to return for scheduled follow-up visits
- Woman who is breastfeeding, pregnant, or intends to become pregnant;
- Subject who is part of the staff personnel directly involved with this study;
- Subject who is a family member of the investigational study staff.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10065
About this study
Official title: A Single Center, Pilot Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of the Plasma Treatment System in Treating Onychomycosis
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
- Being tested
- MOE Antimicrobial Plasma Treatment System
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOE Antimicrobial Plasma Treatment SystemDevice
Plasma applied to great toenail 1X/week for three weeks
| Study group | Role | What they receive |
|---|---|---|
| Plasma | Experimental | Apply plasma to great toenail for up to 20 minutes, 1X/week for 3 weeks Receives: Device: MOE Antimicrobial Plasma Treatment System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of reported adverse events
Measured: Change from Baseline to 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OnychomycosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moe Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819051
- Sponsor's protocol ID
- MOE - 131
- Status last verified
- Sep 2017
- First submitted
- 22 Mar 2013
- Last updated
- 14 Sep 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Pilot Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of the Plasma Treatment System in Treating Onychomycosis
- ClinicalTrials.gov ID
- NCT01819051
- Acronym / sponsor ID
- MOE - 131
- Conditions
- Onychomycosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Moe Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 27 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Plasma | Experimental | Device: MOE Antimicrobial Plasma Treatment SystemApply plasma to great toenail for up to 20 minutes, 1X/week for 3 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (21 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOE Antimicrobial Plasma Treatment SystemPlasma applied to great toenail 1X/week for three weeks | Device | Plasma |
Primary outcome
Change in number of reported adverse events
Time frame: Change from Baseline to 6 months post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOE Antimicrobial Plasma Treatment System in people with Onychomycosis, run by Moe Medical Devices at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of reported adverse events (time frame: Change from Baseline to 6 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2017.