Onychomycosis of ToenailNCT06006455
Effect of the Erchonia® LunulaLaser™ for the Treatment of Toenail Onychomycosis
A study testing Erchonia LunulaLaser in people with Onychomycosis of Toenail, run by Erchonia Corporation at 1 site in United Kingdom.
Trial summary
The purpose of this clinical study is to demonstrate the efficacy of the Erchonia LunulaLaser™, for the treatment of onychomycosis of the toenail. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Onychomycosis of Toenail
- What is being tested?
- Erchonia LunulaLaser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jun 2020to 10 Sep 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmation of the presence of fungal infection through a positive KOH stain finding and a positive fungal culture finding
- Identification through fungal culture of the growth of Trichophyton rubrum (T. rubrum) or other common dermatophyte
- Visual clinical presentation of onychomycosis in the target great toenail is distal subungual onychomycosis (DSO), visualized as a nail with normal surface texture and thickness but variable "bays" of white nail that extend from the distal nail tip proximally into the area of the nail bed
- Clinical involvement of onychomycosis in the target toenail is between 20%-50%
- Subject is willing and able to refrain from employing other (non-study) treatments (traditional or alternative) for his or her toenail onychomycosis throughout study participation.
- Subject is willing and able to refrain from the use of nail cosmetics such as clear and/or colored nail lacquers throughout study participation
- Male or female
- 18 years of age or older
Who cannot join
- Lack of confirmation of the presence of fungal infection through a negative KOH stain finding and/or a negative fungal culture finding
- Visual clinical presentations of onychomycosis in the target great toenail that are inconsistent with the clinical presentation of distal subungual onychomycosis (DSO), in whole or in part (i.e. indicative of mixed etiology); specifically visual clinical presentations consistent with one or more of the following:
- Proximal subungual onychomycosis (PSO): visualized as a white discoloration below the nail plate at the base of the nail, near the lunula. The distal nail retains normal appearance and texture. PSO involves infection near the matrix, deep to the nail. It may be associated with trauma to the nail or to immune compromise
- Superficial white onychomycosis (SWO): visualized by the appearance of a white coating on the nail surface that can be eliminated by filing or buffing the surface of the affected portion of the nail
- Complete dystrophy: Nails which are 100% dystrophic are manifested by yellowing and thickening of the entire nail unit
- Other nail changes: Nails that visually present with changes that appear as parallel lines, small pinpoint depressions, brown spots, black or brown linear streaks, complete yellowing of all nails without textural change, green debris below the nail, or notches in the nail margin
Show all 31Show fewer
- Less than 2mm clear (unaffected) nail plate length beyond the proximal fold
- Presence of dermatophytoma (thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed)
- Infection involving lunula e.g., genetic nail disorders, primentary disorders
- Severe plantar (moccasin) tinea pedis
- Psoriasis of the skin and/or nails, lichen planus, or other medical conditions known to induce nail changes
- Onychogryphosis
- Trauma from ill-fitting shoes, running, or overly-aggressive nail care
- Previous toenail surgery
- Uncontrolled diabetes mellitus
- Peripheral vascular disease
- Recurrent cellulitis
- Lymphatic insufficiency
- Immune compromise (whether due to underlying medical disorders or immunosuppressive treatments)
- Other compromised states of health
- Known photosensitivity disorder
- Use of oral antifungal drugs in the prior 6 months
- Use of topical treatment of the skin or nails within the prior 2 months
- Any abnormality of the toenail that could prevent a normal appearing nail from occurring if clearing of infection is achieved.
- Current trauma, open wound on or about the treatment area
- Deformity of the target toe/toenail secondary to fungal infection/onychomycosis due to prior injury, surgical procedures or another medical condition
- Pregnant or planning pregnancy prior to the end of study participation
- Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years
- Developmental disability or cognitive impairment that would preclude adequate comprehension of the informed consent form and/or ability to follow study subject requirements and/or record the necessary study measurements
- Involvement in litigation and/or receiving disability benefits related in any way to the parameters of the study
- Participation in a clinical study or other type of research in the past 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of the Effect of the Erchonia® LunulaLaser™ for the Treatment of Toenail Onychomycosis
The purpose of this clinical study is to demonstrate the efficacy of the Erchonia LunulaLaser™, for the treatment of onychomycosis of the toenail.
Read the detailed description
This active test treatment group only study will evaluate the effectiveness of the Erchonia LunulaLaser™ manufactured by Erchonia Corporation (the Sponsor) for the treatment of onychomycosis of the toenail.
- Conditions
- Onychomycosis of Toenail
- Being tested
- Erchonia LunulaLaser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erchonia LunulaLaserDevice
405nm violet and 635nm red laser light therapy.
| Study group | Role | What they receive |
|---|---|---|
| Erchonia LunulaLaser | Experimental | The Erchonia LunulaLaser emits red light (635 nm) and violet light (405 nm) to the affected toenail for 12 minutes per treatment. The treatment phase involves an initial weekly treatment administration phase, 1 treatment a week for 4 weeks, followed by an every two-month maintenance treatment administration phase, months 3, 5, 7, 9, and 11. Receives: Device: Erchonia LunulaLaser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Toenails Attaining Complete Cure
Complete Cure criteria is defined as a subject/toenail satisfying both the 'Clinical Cure' and the 'Mycological Cure' criteria in order to be considered a study responder, defined as follows:
(i) Clinical Cure: Measurement of clear nail increase as the following:
- at least 12 mm increase in clear nail of the great toenail, with evidence of distal growth of the affected area, 12 months after the first treatment; or
- complete clearance 12 months after the first treatment if less than 12 mm distal nail was involved prior to treatment.
The response should be progressive in at least 2 sequential timepoints that are at least 3 months apart, with projected increase of at least 1 mm per month.
(ii) Mycologic Cure: both negative KOH and negative Fungal Culture results (or two serial negative Fungal Culture results)
Measured: 12 months
Secondary outcomes (1)
Mycologic Cure
Mycological cure is defined as negative culture for dermatophytes using the BioMed InTray™ DM Culture
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start15 Jun 2020
- Primary completion16 Jul 2024
- Study completion10 Sep 2024
Why it stopped: The study was terminated early by the sponsor for business reasons unrelated to safety. No data analysis was performed.
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
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erchonia Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robin Stones, MB.ChB, Principal investigator, Blemish Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006455
- Sponsor's protocol ID
- R-TOT
- Status last verified
- Jul 2025
- First submitted
- 17 Aug 2023
- Last updated
- 1 Aug 2025
- 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 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Effect of the Erchonia® LunulaLaser™ for the Treatment of Toenail Onychomycosis
- ClinicalTrials.gov ID
- NCT06006455
- Acronym / sponsor ID
- R-TOT
- Conditions
- Onychomycosis of Toenail
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early by the sponsor for business reasons unrelated to safety. No data analysis was performed.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Erchonia CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 16 Jul 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 23 Aug 2023 (actual)
- Results
- Posted 1 Aug 2025
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 clinical study is to demonstrate the efficacy of the Erchonia LunulaLaser™, for the treatment of onychomycosis of the toenail.
Detailed description
This active test treatment group only study will evaluate the effectiveness of the Erchonia LunulaLaser™ manufactured by Erchonia Corporation (the Sponsor) for the treatment of onychomycosis of the toenail.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erchonia LunulaLaser | Experimental | Device: Erchonia LunulaLaserThe Erchonia LunulaLaser emits red light (635 nm) and violet light (405 nm) to the affected toenail for 12 minutes per treatment. The treatment phase involves an initial weekly treatment administration phase, 1 treatment a week for 4 weeks, followed by an every two-month maintenance treatment administration phase, months 3, 5, 7, 9, and 11. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Confirmation of the presence of fungal infection through a positive KOH stain finding and a positive fungal culture finding
- Identification through fungal culture of the growth of Trichophyton rubrum (T. rubrum) or other common dermatophyte
- Visual clinical presentation of onychomycosis in the target great toenail is distal subungual onychomycosis (DSO), visualized as a nail with normal surface texture and thickness but variable "bays" of white nail that extend from the distal nail tip proximally into the area of the nail bed
- Clinical involvement of onychomycosis in the target toenail is between 20%-50%
- Subject is willing and able to refrain from employing other (non-study) treatments (traditional or alternative) for his or her toenail onychomycosis throughout study participation.
Key exclusion criteria (31 listed)
- Lack of confirmation of the presence of fungal infection through a negative KOH stain finding and/or a negative fungal culture finding
- Visual clinical presentations of onychomycosis in the target great toenail that are inconsistent with the clinical presentation of distal subungual onychomycosis (DSO), in whole or in part (i.e. indicative of mixed etiology); specifically visual clinical presentations consistent with one or more of the following:
- Less than 2mm clear (unaffected) nail plate length beyond the proximal fold
- Presence of dermatophytoma (thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed)
- Infection involving lunula e.g., genetic nail disorders, primentary disorders
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 |
|---|---|---|
| Erchonia LunulaLaser405nm violet and 635nm red laser light therapy. | Device | Erchonia LunulaLaser |
Primary outcome
Percentage of Participants With Toenails Attaining Complete Cure
Time frame: 12 months
Complete Cure criteria is defined as a subject/toenail satisfying both the 'Clinical Cure' and the 'Mycological Cure' criteria in order to be considered a study responder, defined as follows: (i) Clinical Cure: Measurement of clear nail increase as the following: * at least 12 mm increase in clear nail of the great toenail, with evidence of distal growth of the affected area, 12 months after the first treatment; or * complete clearance 12 months after the first treatment if less than 12 mm distal nail was involved prior to treatment. The response should be progressive in at least 2 sequential timepoints that are at least 3 months apart, with projected increase of at least 1 mm per month. (ii) Mycologic Cure: both negative KOH and negative Fungal Culture results (or two serial negative Fungal Culture results)
1 secondary outcome
Mycologic Cure
Time frame: 14 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- 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.
Robin Stones, MB.ChB principal investigator
Blemish Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erchonia LunulaLaser in people with Onychomycosis of Toenail, run by Erchonia Corporation at 1 site in United Kingdom.
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 31 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: stopped early, as of the sponsor's last update on 1 Aug 2025. 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 Kingdom. 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 1 Aug 2025). 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?
Percentage of Participants With Toenails Attaining Complete Cure (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 1 Aug 2025.