Onychomycosis Due to Trichophyton RubrumNCT03072550
Early Feasibility Study to Evaluate the Efficacy and Safety of the RenewalNail™ Plasma Treatment System in Patients With Mild to Moderate Onychomycosis (Fungal Nail)
A study testing RenewalNail™ Plasma Treatment System in people with Onychomycosis Due to Trichophyton Rubrum and Onychomycosis Due to Trichophyton Mentagrophytes, run by DeviceFarm, Inc. at 2 sites in United States.
Trial summary
Early feasibility 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 Due to Trichophyton Rubrum, Onychomycosis Due to Trichophyton Mentagrophytes
- What is being tested?
- RenewalNail™ Plasma Treatment System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2017to 30 Jun 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 male or female and of any race;
- 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 or both big toe nails involved with 20-75% infection;
- Subjects with both positive KOH and culture for onychomycosis dermatophytes in screening of nail samples;
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- Subjects whose infection is confirmed to be caused by T. rubrum or T. mentagrophytes;
- 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 throughout study participation;
- 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) 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), 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 presence of dermatophytoma (defined as demarcated and localized thick masses) of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail;
- Subjects with onychomycosis infection involving lunula of the affected toenail(s) or spikes of disease extending to nail matrix in the affected big toenail(s);
- Subjects with conditions other than distal subungual onychomycosis known to cause abnormal nail appearance such as 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;
- 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 with a history of multiple repeated failures with previous therapies for onychomycosis;
- Subjects whose affected big toenails cannot become normal in the opinion of the investigator;
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- Subjects with abnormality of the affected big toenail(s) that could prevent a normal appearing nail if clearing of infection is achieved;
- Subjects with trauma to the affected big toenail(s) as identified by the study doctor;
- 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;
- Subjects with dementia or psychic condition that might interfere with the ability to understand the study and thus give written informed consent;
- Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding treatment;
- Subjects who are unwilling or unable to refrain from employing other (non-study) treatments (traditional and alternative) for their toenail onychomycosis throughout study participation;
- Subjects who are unwilling or unable to refrain from the use of nail cosmetics such as clear and/or colored nail lacquers until the end of study participation;
- Subjects who are immunocompromised (e.g. adrenal insufficiency, diabetes mellitus, febrile neutropenia, and the human immunodeficiency virus infected);
- Subjects who underwent treatment of any type of cancer within the last six months;
- 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 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;
- 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;
- Subjects who are family members of the investigational study staff;
- Subjects with a history or signs of peripheral circulatory insufficiency and/or diabetic neuropathy;
- 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
2 sites in 1 country.
United States2 sites
Center for Dermatology Clinical Research, Inc.
Fremont, California, 94538
Center For Clinical Research Inc.
San Francisco, California, 94115
About this study
Official title: A Multi 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.
Early feasibility 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 Sponsor has developed the RenewalNail™ plasma treatment system to topically treat fungal infected toenails. The goal of the RenewalNail™ therapy is to overcome the shortcomings of both topical and oral therapies by combining the safety of a topical treatment with the efficacy of an oral treatment.
The primary objective of this early feasibility study is to evaluate the efficacy and safety of the RenewalNail™ plasma treatment system and Protocol in achieving mycological cure for the patient. 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. Two consecutive negative results will confirm the elimination of fungus causing onychomycosis infection, as recommended by recent FDA guidance. There will be no placebo arm in the study.
Secondary objectives include assessing if the treatment protocol results in clear nail growth for the patient over a 5-month interval.
- Conditions
- Onychomycosis Due to Trichophyton Rubrum, Onychomycosis Due to Trichophyton Mentagrophytes
- Being tested
- RenewalNail™ Plasma Treatment System
- Keywords
- fungal nail, toenail fungus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RenewalNail™ Plasma Treatment SystemDevice
Also called cold atmospheric plasma treatment
application of cold atmospheric plasma to a fungal infected toenail
| Study group | Role | What they receive |
|---|---|---|
| Multi-center open label | Experimental | Thirty 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: RenewalNail™ Plasma Treatment System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mycological Cure
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start1 Mar 2017
- Primary completion1 Apr 2018
- Study completion30 Jun 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 Due to Trichophyton RubrumStudies 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
- multi-center open-label study
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- DeviceFarm, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Symbio, LLC, Center for Dermatology Clinical Research, Inc.
- Responsible party
- Sponsor
- Investigators
- Jeffrey N Roe, PhD, Principal investigator, DeviceFarm, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072550
- Sponsor's protocol ID
- DFCR-0002
- Status last verified
- Aug 2019
- First submitted
- 2 Mar 2017
- Last updated
- 16 Sep 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 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi 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
- NCT03072550
- Acronym / sponsor ID
- DFCR-0002
- Conditions
- Onychomycosis Due to Trichophyton Rubrum, Onychomycosis Due to Trichophyton Mentagrophytes
- Keywords
- fungal nail, toenail fungus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- DeviceFarm, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Symbio, LLC, Center for Dermatology Clinical Research, Inc.
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 7 Mar 2017 (actual)
- Results
- Posted 29 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Early feasibility 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 Sponsor has developed the RenewalNail™ plasma treatment system to topically treat fungal infected toenails. The goal of the RenewalNail™ therapy is to overcome the shortcomings of both topical and oral therapies by combining the safety of a topical treatment with the efficacy of an oral treatment.
The primary objective of this early feasibility study is to evaluate the efficacy and safety of the RenewalNail™ plasma treatment system and Protocol in achieving mycological cure for the patient. 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. Two consecutive negative results will confirm the elimination of fungus causing onychomycosis infection, as recommended by recent FDA guidance. There will be no placebo arm in the study.
Secondary objectives include assessing if the treatment protocol results in clear nail growth for the patient over a 5-month interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- multi-center open-label study
| Arm | Type | Receives |
|---|---|---|
| Multi-center open label | Experimental | Device: RenewalNail™ Plasma Treatment SystemThirty 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 (13 listed)
- Subjects who are between 21 to 75 years (inclusive) of age;
- Subjects male or female and of any race;
- 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 or both big toe nails involved with 20-75% infection;
Key exclusion criteria (25 listed)
- Subjects with presence of dermatophytoma (defined as demarcated and localized thick masses) of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail;
- Subjects with onychomycosis infection involving lunula of the affected toenail(s) or spikes of disease extending to nail matrix in the affected big toenail(s);
- Subjects with conditions other than distal subungual onychomycosis known to cause abnormal nail appearance such as 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;
- 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 with a history of multiple repeated failures with previous therapies for onychomycosis;
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 |
|---|---|---|
| RenewalNail™ Plasma Treatment SystemAlso: cold atmospheric plasma treatmentapplication of cold atmospheric plasma to a fungal infected toenail | Device | Multi-center open label |
Primary outcome
Mycological Cure
Time frame: 2 cultures taken a week apart within 2 weeks after the first treatment
mycological cure defined as two consecutive negative cultures per FDA guideline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RenewalNail™ Plasma Treatment System in people with Onychomycosis Due to Trichophyton Rubrum and Onychomycosis Due to Trichophyton Mentagrophytes, run by DeviceFarm, Inc. at 2 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 13 inclusion and 25 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 16 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 29 Aug 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 16 Sep 2019.