Onychomycosis of ToenailNCT03066336
A Study to See if Low Level Laser Light Can Help to Treat Toenail Fungus
A study testing Erchonia LunulaLaser in people with Onychomycosis of Toenail, run by Erchonia Corporation at 1 site in United States.
Trial summary
The purpose of this study is to determine whether low level laser therapy (LLLT) using the Erchonia LunulaLaser device is effective in clearing toenails with onychomycosis. 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2017to 1 Nov 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 up to 60%
- 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 or C. albicans or mixed dermatophyte/Candida infection. In the event of the KOH stain and the fungal culture provide conflicting results, i.e., one is positive and the other negative, resolution may be obtained by a second negative fungal culture finding from a nail clipping from the same nail
- 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
Who cannot join
- 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 proximal subungual onychomycosis (PSO); superficial white onychomycosis (SWO); complete dystrophy; other nail changes.
- Identification through fungal culture of the growth of a rare fungal species (i.e. not Trichophyton rubrum (T. rubrum) or other common dermatophyte or C. albicans or mixed dermatophyte/Candida infection) or non-fungal organisms such as mold or bacteria
- 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
Show all 27Show fewer
- 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 immuno-suppressive 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.
United States1 site
University Of Miami Department of Dermatology
Miami, Florida, 33146
About this study
Official title: A Pilot Evaluation of the Effect of the Erchonia LunulaLaser for the Treatment of Toenail Onychomycosis
The purpose of this study is to determine whether low level laser therapy (LLLT) using the Erchonia LunulaLaser device is effective in clearing toenails with onychomycosis.
Read the detailed description
Nail onychomycosis, or fungus infection, is typically caused by a fungus called dermatophytes, but may also be caused by yeasts and molds. These microscopic organisms invade the skin through tiny invisible cuts or through a small separation between the nail and the nail bed. Under conditions of warmth and moisture, the fungi grow and spread. The infection begins as a white or yellow spot under the tip of the nail, and as it spreads deeper into the nail, causes unsightly and potentially painful nail discoloration, thickening and the development of crumbling edges. Onychomycosis occurs more commonly in toenails than in fingernails because toenails are often confined in a dark, warm, moist environment inside shoes where fungi can thrive. Toenail fungus affects approximately 23 million people in the US - about 10% of all adults.
Potential complications of onychomycosis include pain in the nails, permanent damage to the nails, development of other serious infections that can spread beyond the feet for individuals with a suppressed immune system due to medication, diabetes or other conditions, such as leukemia and AIDS.
Nail fungus can be difficult to treat, and repeated infections are common. Currently available treatments for onychomycosis include oral antifungal medications, antifungal lacquer, and topical medications, surgical nail removal and photodynamic therapy. There is no perfect cure for toenail fungus. Even the most effective oral medications are successful only about half of the time, and topical medications are successful less than 10% of the time. Recently, research has found laser therapy to show promise as a novel alternative treatment for toenail onychomycosis. Unlike medication-driven treatments for toenail fungus which can have many side effects including serious ones such as liver toxicity, laser therapy presents minimal to no risk of side effects. Laser therapy is applied to toenail onychomycosis by shining a laser light through the toenail into the tissue below. The laser light vaporizes the fungus while leaving the skin and surrounding healthy tissue unharmed.
Low level laser therapy operates under the principle of photochemistry with a photoacceptor molecule absorbing the emitted photons and inducing a biological cascade. Like our eukaryotic cell, fungi contain the highly complex organelle the mitochondria, which is responsible for the manufacturing of the energy molecule adenosine triphosphate (ATP). Within the inner mitochondrial membrane is cytochrome c oxidase, an identified photoacceptor molecule. It is believed that laser therapy could perhaps provide a means to photo-destroy the fungi responsible for onychomycosis (OM) by inducing the release of highly reactive superoxides. Moreover, laser therapy has been shown to promote superoxide dismutase (SOD), a process responsible for the destruction of foreign invaders. Extracellular release of low levels of mediators associated with SOD can increase the expression of chemokines, cytokines, and endothelial leukocyte adhesion molecules, amplifying the cascade that elicits the inflammatory response. The physiologic function of hydrogen peroxide, superoxide anion, and hydroxyl free radical is to destroy phagocytosed microbes. By enhancing the natural processes of the immune system and impacting the structural integrity of the fungi strain, it is believed that laser therapy may provide a means for clinicians to effectively treat OM without the onset of any adverse events.
- 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
Active Low Level Laser Light Therapy
| Study group | Role | What they receive |
|---|---|---|
| Erchonia LunulaLaser | Experimental | The Erchonia LunulaLaser emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart. Receives: Device: Erchonia LunulaLaser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent (%) of toenails attaining mycologic cure at study endpoint
Mycologic cure is defined as both negative Potassium Hydroxide (KOH) and negative Fungal Culture results, or two serial negative Fungal Culture results.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start10 Apr 2017
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Why it stopped: Difficulty recruiting subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erchonia Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Antonella Tosti, MD, Principal investigatorTed Rosen, MD, Principal investigator, unaffilliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03066336
- Sponsor's protocol ID
- EC_LL_MYC_PS
- Status last verified
- Aug 2023
- First submitted
- 23 Feb 2017
- Last updated
- 21 Aug 2023
- Results posted
- No
- 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 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Evaluation of the Effect of the Erchonia LunulaLaser for the Treatment of Toenail Onychomycosis
- ClinicalTrials.gov ID
- NCT03066336
- Acronym / sponsor ID
- EC_LL_MYC_PS
- Conditions
- Onychomycosis of Toenail
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty recruiting subjects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Erchonia CorporationIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 28 Feb 2017 (actual)
- 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 determine whether low level laser therapy (LLLT) using the Erchonia LunulaLaser device is effective in clearing toenails with onychomycosis.
Detailed description
Nail onychomycosis, or fungus infection, is typically caused by a fungus called dermatophytes, but may also be caused by yeasts and molds. These microscopic organisms invade the skin through tiny invisible cuts or through a small separation between the nail and the nail bed. Under conditions of warmth and moisture, the fungi grow and spread. The infection begins as a white or yellow spot under the tip of the nail, and as it spreads deeper into the nail, causes unsightly and potentially painful nail discoloration, thickening and the development of crumbling edges. Onychomycosis occurs more commonly in toenails than in fingernails because toenails are often confined in a dark, warm, moist environment inside shoes where fungi can thrive. Toenail fungus affects approximately 23 million people in the US - about 10% of all adults.
Potential complications of onychomycosis include pain in the nails, permanent damage to the nails, development of other serious infections that can spread beyond the feet for individuals with a suppressed immune system due to medication, diabetes or other conditions, such as leukemia and AIDS.
Nail fungus can be difficult to treat, and repeated infections are common. Currently available treatments for onychomycosis include oral antifungal medications, antifungal lacquer, and topical medications, surgical nail removal and photodynamic therapy. There is no perfect cure for toenail fungus. Even the most effective oral medications are successful only about half of the time, and topical medications are successful less than 10% of the time. Recently, research has found laser therapy to show promise as a novel alternative treatment for toenail onychomycosis. Unlike medication-driven treatments for toenail fungus which can have many side effects including serious ones such as liver toxicity, laser therapy presents minimal to no risk of side effects. Laser therapy is applied to toenail onychomycosis by shining a laser light through the toenail into the tissue below. The laser light vaporizes the fungus while leaving the skin and surrounding healthy tissue unharmed.
Low level laser therapy operates under the principle of photochemistry with a photoacceptor molecule absorbing the emitted photons and inducing a biological cascade. Like our eukaryotic cell, fungi contain the highly complex organelle the mitochondria, which is responsible for the manufacturing of the energy molecule adenosine triphosphate (ATP). Within the inner mitochondrial membrane is cytochrome c oxidase, an identified photoacceptor molecule. It is believed that laser therapy could perhaps provide a means to photo-destroy the fungi responsible for onychomycosis (OM) by inducing the release of highly reactive superoxides. Moreover, laser therapy has been shown to promote superoxide dismutase (SOD), a process responsible for the destruction of foreign invaders. Extracellular release of low levels of mediators associated with SOD can increase the expression of chemokines, cytokines, and endothelial leukocyte adhesion molecules, amplifying the cascade that elicits the inflammatory response. The physiologic function of hydrogen peroxide, superoxide anion, and hydroxyl free radical is to destroy phagocytosed microbes. By enhancing the natural processes of the immune system and impacting the structural integrity of the fungi strain, it is believed that laser therapy may provide a means for clinicians to effectively treat OM without the onset of any adverse events.
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 both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 up to 60%
- 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 or C. albicans or mixed dermatophyte/Candida infection. In the event of the KOH stain and the fungal culture provide conflicting results, i.e., one is positive and the other negative, resolution may be obtained by a second negative fungal culture finding from a nail clipping from the same nail
- 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 (27 listed)
- 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 proximal subungual onychomycosis (PSO); superficial white onychomycosis (SWO); complete dystrophy; other nail changes.
- Identification through fungal culture of the growth of a rare fungal species (i.e. not Trichophyton rubrum (T. rubrum) or other common dermatophyte or C. albicans or mixed dermatophyte/Candida infection) or non-fungal organisms such as mold or bacteria
- 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 LunulaLaserActive Low Level Laser Light Therapy | Device | Erchonia LunulaLaser |
Primary outcome
Percent (%) of toenails attaining mycologic cure at study endpoint
Time frame: 3 months
Mycologic cure is defined as both negative Potassium Hydroxide (KOH) and negative Fungal Culture results, or two serial negative Fungal Culture results.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- 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.
Antonella Tosti, MD principal investigator
Ted Rosen, MD principal investigator
unaffilliated
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 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 6 inclusion and 27 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: withdrawn, as of the sponsor's last update on 21 Aug 2023. 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 was withdrawn before enrolling participants, so there are no results.
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?
Percent (%) of toenails attaining mycologic cure at study endpoint (time frame: 3 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 21 Aug 2023.