OnychomycosisNCT02724384
Evaluating the Safety, Tolerability and Preliminary Efficacy of Plasma in Improving the Appearance of Onychomycosis
A study testing MOE Plasma Delivery System A and MOE Plasma Delivery System B in people with Onychomycosis, run by Moe Medical Devices at 7 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and preliminary efficacy of using electrical plasma to treat toenail fungus. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- MOE Plasma Delivery System A and MOE Plasma Delivery System B
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 7 sitesUnited States
- Study dates
- Mar 2016to Feb 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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
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- 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;
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites, 5 recruiting
- Not yet recruiting
MOE Medical Devices Site 6
Austin, Texas, 78759
Janet DuBois
- Recruiting
MOE Medical Devices Investigational Site 1
College Station, Texas, 77802
- Recruiting
MOE Medical Devices Investigational Site 2
McAllen, Texas, 78501
- Terminated
MOE Medical Devices Site 4
Philadelphia, Pennsylvania, 19103
- Terminated
MOE Medical Devices Investigational Site 3
Pittsburgh, Pennsylvania, 15222
- Recruiting
MOE Medical Devices Site 5
Quincy, Massachusetts, 02169
- Not yet recruiting
MOE Medical Devices Site 7
San Antonio, Texas, 78229
Richard Pollak
About this study
Official title: A Multi-Center Pilot Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of the Plasma Treatment System in Improving the Appearance of Onychomycosis
The purpose of this study is to evaluate the safety and preliminary efficacy of using electrical plasma to treat toenail fungus.
Read the 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.
- Conditions
- Onychomycosis
- Being tested
- MOE Plasma Delivery System A, MOE Plasma Delivery System B
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOE Plasma Delivery System ADevice
Plasma treatment
MOE Plasma Delivery System BDevice
Plasma treatment
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Plasma treatment using Plasma delivery system A 3 treatments/week for 2 weeks, then monthly Receives: Device: MOE Plasma Delivery System A |
| Group 2 | Experimental | Plasma treatment using Plasma delivery system A 2 treatments/week for 2 weeks, then monthly Receives: Device: MOE Plasma Delivery System A |
| Group 3 | Experimental | Plasma treatment using Plasma delivery system B 3 treatments/week for 2 weeks, then monthly Receives: Device: MOE Plasma Delivery System B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2018 (estimated)
- Study completionFeb 2019 (estimated)
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moe Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02724384
- Sponsor's protocol ID
- OM-0030
- Status last verified
- Sep 2017
- First submitted
- 22 Mar 2016
- 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 Multi-Center Pilot Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of the Plasma Treatment System in Improving the Appearance of Onychomycosis
- ClinicalTrials.gov ID
- NCT02724384
- Acronym / sponsor ID
- OM-0030
- Conditions
- Onychomycosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Moe Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 31 Mar 2016 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: MOE Plasma Delivery System APlasma treatment using Plasma delivery system A 3 treatments/week for 2 weeks, then monthly |
| Group 2 | Experimental | Device: MOE Plasma Delivery System APlasma treatment using Plasma delivery system A 2 treatments/week for 2 weeks, then monthly |
| Group 3 | Experimental | Device: MOE Plasma Delivery System BPlasma treatment using Plasma delivery system B 3 treatments/week for 2 weeks, then monthly |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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);
Key exclusion criteria (20 listed)
- 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;
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 Plasma Delivery System APlasma treatment | Device | Group 1, Group 2 |
| MOE Plasma Delivery System BPlasma treatment | Device | Group 3 |
Primary outcome
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.
1 secondary outcome
Efficacy as assessed by Clinical, Mycological and Complete Cure Rates assessed in accordance with FDA Guidance for onychomycosis trials issued March 7, 2016
Time frame: 12 months
Results and safety
Results are not available in the source record.
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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOE Plasma Delivery System A and MOE Plasma Delivery System B in people with Onychomycosis, run by Moe Medical Devices at 7 sites 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 9 inclusion and 20 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: status not confirmed, 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 7 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sin Park, PhD (914-594-1985, allsra@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: 12 months). 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.