Onychomycosis of ToenailNCT03216200
Early Feasibility Study to Evaluate the Efficacy of the RenewalNail™ Plasma Treatment System in Patients With Onychomycosis (Fungal Nail)
A study testing plasma treatment in people with Onychomycosis of Toenail and Onychomycosis, run by DeviceFarm, Inc. at 1 site in United States.
Trial summary
A study to determine if a three-treatment protocol with the RenewalNail™ plasma treatment system over a week will result in mycological cure and/or clear nail growth on the treated hallux toe. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Onychomycosis of Toenail, Onychomycosis
- What is being tested?
- plasma treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2017to 10 Jul 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are between 21 to 75 years (inclusive) of age;
- Subjects who are in good general health and free from any clinically significant disease that might interfere with the study evaluations;
- Subjects with established clinical diagnosis of distal subungual onychomycosis;
- Subjects with at least one big toe nail involved with 20-75% infection;
- Subjects with both positive KOH and culture for onychomycosis dermatophytes in screening of nail samples;
- Subjects whose infection is confirmed to be caused by T. rubrum or T. mentagrophytes;
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- Subjects who are willing and able to refrain from employing other (non-study) treatments (traditional or alternative) for his or her toenail onychomycosis throughout study participation;
- Subjects who are willing and able to refrain from the use of nail cosmetics such as clear and/or colored nail lacquers during the week of treatment (from Study Visits 1 through 3);
- Subjects who are willing and able to give written informed consent and able to adhere to procedures and visit schedules;
- Women of childbearing potential who are currently sexually active must agree to use a medically accepted method of contraception while receiving protocol specified treatment. Methods include condoms (male or female), diaphragm or cervical cap with spermicide, medically prescribed intrauterine device, oral or systemic hormonal contraceptive, surgical sterilization (e.g., hysterectomy or tubal ligation);
- Women of childbearing potential who are not currently sexually active must agree to use a medically accepted method of contraception should they become sexually active while participating in the study;
- Women of childbearing potential must have a negative pregnancy test prior to start of study.
Who cannot join
- Subjects with onychomycosis infection involving lunula of the affected toenail(s) or spikes of disease extending to nail matrix in the affected big toenail;
- Subjects whose foot is too large (larger than US men's size 13) or too small (smaller than US women's size 3) to properly fit into the plasma treatment device;
- Subjects whose affected big toenail cannot become normal in the opinion of the investigator;
- Subjects who received topical antifungal treatment of the nails within 2 weeks before study initiation;
- Subjects who received systemic antifungal treatment within 3 months before study initiation;
- Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding treatment;
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- Subjects who are immunocompromised (e.g. adrenal insufficiency, diabetes mellitus, febrile neutropenia, and the human immunodeficiency virus infected);
- Subjects with any pacemakers, or any metallic implants or prostheses in the vicinity of the treatment site (such as ankle, foot, etc.);
- Subjects 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;
- Subjects who feel they cannot sit for 45 minutes at a time during the treatment;
- Subjects who are part of the staff personnel directly involved with this study or who are family members of the investigational study staff;
- Subjects with known allergy to any of the tested treatment products [i.e. perfluorocarbons and plastic polycarbonate];
- Women who are pregnant, breastfeeding, or planning pregnancy prior to the end of study participation;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center Open Label Early Feasibility Study to Evaluate the Efficacy and Safety of the RenewalNail™ Plasma Treatment System in Patients With Mild to Moderate Onychomycosis (Fungal Nail) of the Hallux Caused by Trichophyton Rubrum or Trichophyton Mentagrophytes.
A study to determine if a three-treatment protocol with the RenewalNail™ plasma treatment system over a week will result in mycological cure and/or clear nail growth on the treated hallux toe.
Read the detailed description
The purpose of this study is to assess the clinical feasibility of DeviceFarm, Inc.'s RenewalNail™ system and the treatment protocol that was developed based on extensive laboratory testing on human cadaver nails. The Protocol calls for three 45-minute treatments performed over a week to achieve mycological cure. Mycological cure will be assessed with two consecutive mycological culture tests done over a week following the third treatment. Two consecutive negative mycology culture results confirm the elimination of fungus causing onychomycosis infection, as recommended by recent FDA guidance. There will be no placebo arm in the study. Clear nail growth will be documented and assessed by photography for 5 months after treatment.
- Conditions
- Onychomycosis of Toenail, Onychomycosis
- Being tested
- plasma treatment
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plasma treatmentDevice
Also called RenewalNail™ plasma treatment system
application of cold atmospheric plasma to a fungal infected toenail
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | 5 Subjects with 20-75% Distal Subungual Onychomycosis (mild to moderate DSO) infection of their big toe (hallux) nail infected by the dermatophytes Trichophyton (T.) rubrum or T. mentagrophytes will be enrolled. All Subjects will receive three 45-minute plasma treatments performed over a week. Receives: Device: plasma treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mycological Cure
number of participants with mycological cure defined as two consecutive negative cultures per FDA guideline
Measured: 2 cultures taken a week apart within 2 weeks after the first treatment
Secondary outcomes (1)
Clear Nail Growth
Number of patients with photographic evidence of increased clear nail growth
Measured: 5 months after the first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start7 Jul 2017
- Primary completion30 Jun 2018
- Study completion10 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Onychomycosis of ToenailStudies 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
- Model description
- single center open-label study
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- DeviceFarm, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey N Roe, PhD, Principal investigator, DeviceFarm, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03216200
- Sponsor's protocol ID
- DFCR-0003
- Status last verified
- Sep 2019
- First submitted
- 11 Jul 2017
- Last updated
- 11 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Open Label Early Feasibility Study to Evaluate the Efficacy and Safety of the RenewalNail™ Plasma Treatment System in Patients With Mild to Moderate Onychomycosis (Fungal Nail) of the Hallux Caused by Trichophyton Rubrum or Trichophyton Mentagrophytes.
- ClinicalTrials.gov ID
- NCT03216200
- Acronym / sponsor ID
- DFCR-0003
- Conditions
- Onychomycosis of Toenail, Onychomycosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- DeviceFarm, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Jul 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 10 Jul 2018 (actual)
- First posted
- 13 Jul 2017 (actual)
- Results
- Posted 11 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to determine if a three-treatment protocol with the RenewalNail™ plasma treatment system over a week will result in mycological cure and/or clear nail growth on the treated hallux toe.
Detailed description
The purpose of this study is to assess the clinical feasibility of DeviceFarm, Inc.'s RenewalNail™ system and the treatment protocol that was developed based on extensive laboratory testing on human cadaver nails. The Protocol calls for three 45-minute treatments performed over a week to achieve mycological cure. Mycological cure will be assessed with two consecutive mycological culture tests done over a week following the third treatment. Two consecutive negative mycology culture results confirm the elimination of fungus causing onychomycosis infection, as recommended by recent FDA guidance. There will be no placebo arm in the study. Clear nail growth will be documented and assessed by photography for 5 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single center open-label study
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: plasma treatment5 Subjects with 20-75% Distal Subungual Onychomycosis (mild to moderate DSO) infection of their big toe (hallux) nail infected by the dermatophytes Trichophyton (T.) rubrum or T. mentagrophytes will be enrolled. All Subjects will receive three 45-minute plasma treatments performed over a week. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects who are between 21 to 75 years (inclusive) of age;
- Subjects who are in good general health and free from any clinically significant disease that might interfere with the study evaluations;
- Subjects with established clinical diagnosis of distal subungual onychomycosis;
- Subjects with at least one big toe nail involved with 20-75% infection;
- Subjects with both positive KOH and culture for onychomycosis dermatophytes in screening of nail samples;
Key exclusion criteria (13 listed)
- Subjects with onychomycosis infection involving lunula of the affected toenail(s) or spikes of disease extending to nail matrix in the affected big toenail;
- Subjects whose foot is too large (larger than US men's size 13) or too small (smaller than US women's size 3) to properly fit into the plasma treatment device;
- Subjects whose affected big toenail cannot become normal in the opinion of the investigator;
- Subjects who received topical antifungal treatment of the nails within 2 weeks before study initiation;
- Subjects who received systemic antifungal treatment within 3 months before study initiation;
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 |
|---|---|---|
| plasma treatmentAlso: RenewalNail™ plasma treatment systemapplication of cold atmospheric plasma to a fungal infected toenail | Device | Experimental |
Primary outcome
Mycological Cure
Time frame: 2 cultures taken a week apart within 2 weeks after the first treatment
number of participants with mycological cure defined as two consecutive negative cultures per FDA guideline
1 secondary outcome
Clear Nail Growth
Time frame: 5 months after the first treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Jeffrey N Roe, PhD principal investigator
DeviceFarm, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing plasma treatment in people with Onychomycosis of Toenail and Onychomycosis, run by DeviceFarm, Inc. 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 12 inclusion and 13 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 11 Oct 2019. 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?
Yes. Results are posted in the registry (first posted 11 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mycological Cure (time frame: 2 cultures taken a week apart within 2 weeks after the first 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 11 Oct 2019.