OnychomycosisNCT02242019
Study of Erchonia Low Level Laser Light Therapy to Treat Toenail Fungus
A study testing Erchonia LUNULA in people with Onychomycosis, run by Erchonia Corporation at 1 site in Ireland.
Trial summary
The purpose of this study is to determine whether low level laser light therapy is effective in the treatment of toenail onychomycosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Onychomycosis
- What is being tested?
- Erchonia LUNULA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteIreland
- Study dates
- Feb 2013to Feb 2014
- 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
- Onychomycosis present in at least one great toenail, identified as current bacterial/fungal infection classified by the investigator as onychomycosis, with the nail presenting positive on visual inspection for somewhat thickened nail plate with a cloudy appearance and some discoloration (white to yellow to brown).
- 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
- Spikes of disease extending to nail matrix in the affected great toenail(s).
- Infection involving lunula of the affected toenail(s), e.g., genetic nail disorders, primentary disorders.
- Affected great toenail(s) has less than 2mm clear (unaffected) nail plate length beyond the proximal fold.
- Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the affected great toenail(s).
- Chronic plantar (moccasin) tinea pedis.
- History of current or past psoriasis of the skin and/or nails.
Show all 29Show fewer
- Concurrent lichen planus.
- Onychogryphosis.
- Any of the following conditions of the affected great toenail(s) is present: proximal subungual onychomycosis; white superficial onychomycosis; dermatophytoma or "yellow spike/streak"; exclusively lateral disease
- Confounding problems/abnormalities of the great toenail(s).
- Any abnormality of the affected great toenail(s) that could prevent a normal appearing nail if clearing of infection is achieved.
- Inability for the affected great toenail(s) to become normal in the opinion of the investigator.
- History of multiple repeated failures with previous therapies for onychomycosis.
- Trauma to the affected great toenail(s).
- Use of oral antifungal agents in the past 6 months.
- Use of topical antifungal agents in the past 1 month.
- Prior surgical treatment of the affected great toe(s).
- Subject is unwilling or unable to refrain from employing other (non-study) treatments (traditional and alternative) for his or her toenail onychomycosis throughout study participation.
- Subject is 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.
- Cancer and/or treatment of any type of cancer within the last six months.
- Peripheral vascular disease or peripheral circulatory impairment.
- History of uncontrolled diabetes mellitus.
- Known immunodeficiency.
- Known sensitivity, or contraindication, to light therapy.
- Pregnant, breast feeding, 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 LUNULA on Treating Toenail Onychomycosis
The purpose of this study is to determine whether low level laser light therapy is effective in the treatment of toenail onychomycosis.
Read the detailed description
An infection of toenail fungus, or onychomycosis, typically occurs when fungi (most commonly dermatophytes) infect the nail, but may also be caused by yeasts and molds. The nail fungal infection usually begins as a white or yellow spot under the tip of the toenail and then spreads deeper into the nail causing discoloration, thickening and the development of crumbling edges to the nail which can be unsightly and painful and may produce serious physical and occupational limitations. Onychomycosis can also have a detrimental effect on an individual's quality of life, affecting their psychosocial and emotional wellbeing.
Onychomycosis can be difficult to treat, and infections recur easily. Toenail fungus affects approximately 23 million adults (about 10%) in the United States. It is more common among older adults and tends to affect men more than women. Potential complications of onychomycosis include pain, permanent damage to the nails and serious infections that can spread beyond the feet.
Currently available treatments for onychomycosis include oral antifungal medications (Lamisil, Sporanox); antifungal nail polish (Penlac); topical over-the-counter antifungal creams; photodynamic therapy and in more severe cases, surgery to remove the nail. However, there is no perfect cure for toenail fungus. Even the most effective oral medications are only successful about half of the time, and topical medications are successful less than 10% of the time. In addition, clearance of the infection and growth of new clear nail can be slow, and the rate of recurrence of infection is high. Antifungal drugs may also cause side effects ranging from skin rashes to liver damage.
Therefore, the need for a more effective and lasting cure is evident. Recently, research has found laser therapy to show promise as a novel alternative treatment for toenail onychomycosis. Unlike medication-driven treatments, laser therapy presents minimal risk of side effects. Laser therapy is applied to toenail onychomycosis by shining a laser light through the toenail. The laser light vaporizes the fungus while leaving the skin and surrounding tissue unharmed.
Low level laser light 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 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 onychomycosis without the onset of any adverse events.
- Conditions
- Onychomycosis
- Being tested
- Erchonia LUNULA
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erchonia LUNULADevice
The Erchonia LUNULA is administered to the infected toes for 12 minutes per treatment for 4 treatments, each treatment one week apart.
| Study group | Role | What they receive |
|---|---|---|
| Erchonia LUNULA | Experimental | The Erchonia LUNULA 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 LUNULA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Toenails Attaining 3 Millimeters (mm) or More of Clear Nail Growth
Individual toenail success criteria was defined as 3 millimeter (mm) or more of clear nail growth at 36 weeks post-procedure administration as evaluated relative to baseline. Overall study success criteria was defined as an 60% or more of treated toenails meeting the individual success criteria.
Measured: Baseline and 36 Weeks
Change in Millimeters (mm) of Clear Nail Bed
Millimeter (mm) of clear nail from the base of the toenail was determined from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 36 weeks after the end of the procedure administration phase. An increase in mm of clear nail between the two measurement points indicates that the toenail has improved and is positive for study success. A decrease in mm of clear nail between the two measurement points indicates that the toenail has worsened and is negative for study success.
Measured: Baseline and 36 Weeks
Secondary outcomes (1)
Change in Percent (%) of Onychomycosis Disease Involvement
The percent (%) of the toenail that had onychomycosis disease involvement was determined. Change in the % of toenail onychomycosis disease involvement was calculated as the difference in the % of toenail onychomycosis disease involvement from baseline measurement to the measurement at 36 weeks after the end of the procedure administration phase. A decrease in the % of toenail onychomycosis disease involvement between the two measurement points indicates that the toenail onychomycosis involvement has decreased and is positive for study success. An increase in the % of toenail onychomycosis disease involvement between the two measurement points indicates that the toenail onychomycosis involvement has increased and is negative for study success.
Measured: Baseline and 36 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startFeb 2013
- Primary completionFeb 2014
- Study completionFeb 2014
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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erchonia Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Sullivan, Podiatry, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02242019
- Sponsor's protocol ID
- EC_TFRS_004
- Status last verified
- Apr 2016
- First submitted
- 12 Sep 2014
- Last updated
- 17 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Effect of the Erchonia LUNULA on Treating Toenail Onychomycosis
- ClinicalTrials.gov ID
- NCT02242019
- Acronym / sponsor ID
- EC_TFRS_004
- Conditions
- Onychomycosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Erchonia CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 16 Sep 2014 (estimated)
- Results
- Posted 10 Aug 2015
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 light therapy is effective in the treatment of toenail onychomycosis.
Detailed description
An infection of toenail fungus, or onychomycosis, typically occurs when fungi (most commonly dermatophytes) infect the nail, but may also be caused by yeasts and molds. The nail fungal infection usually begins as a white or yellow spot under the tip of the toenail and then spreads deeper into the nail causing discoloration, thickening and the development of crumbling edges to the nail which can be unsightly and painful and may produce serious physical and occupational limitations. Onychomycosis can also have a detrimental effect on an individual's quality of life, affecting their psychosocial and emotional wellbeing.
Onychomycosis can be difficult to treat, and infections recur easily. Toenail fungus affects approximately 23 million adults (about 10%) in the United States. It is more common among older adults and tends to affect men more than women. Potential complications of onychomycosis include pain, permanent damage to the nails and serious infections that can spread beyond the feet.
Currently available treatments for onychomycosis include oral antifungal medications (Lamisil, Sporanox); antifungal nail polish (Penlac); topical over-the-counter antifungal creams; photodynamic therapy and in more severe cases, surgery to remove the nail. However, there is no perfect cure for toenail fungus. Even the most effective oral medications are only successful about half of the time, and topical medications are successful less than 10% of the time. In addition, clearance of the infection and growth of new clear nail can be slow, and the rate of recurrence of infection is high. Antifungal drugs may also cause side effects ranging from skin rashes to liver damage.
Therefore, the need for a more effective and lasting cure is evident. Recently, research has found laser therapy to show promise as a novel alternative treatment for toenail onychomycosis. Unlike medication-driven treatments, laser therapy presents minimal risk of side effects. Laser therapy is applied to toenail onychomycosis by shining a laser light through the toenail. The laser light vaporizes the fungus while leaving the skin and surrounding tissue unharmed.
Low level laser light 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 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 onychomycosis 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 LUNULA | Experimental | Device: Erchonia LUNULAThe Erchonia LUNULA 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 (3 listed)
- Onychomycosis present in at least one great toenail, identified as current bacterial/fungal infection classified by the investigator as onychomycosis, with the nail presenting positive on visual inspection for somewhat thickened nail plate with a cloudy appearance and some discoloration (white to yellow to brown).
- 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.
Key exclusion criteria (29 listed)
- Spikes of disease extending to nail matrix in the affected great toenail(s).
- Infection involving lunula of the affected toenail(s), e.g., genetic nail disorders, primentary disorders.
- Affected great toenail(s) has less than 2mm clear (unaffected) nail plate length beyond the proximal fold.
- Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the affected great toenail(s).
- Chronic plantar (moccasin) tinea pedis.
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 LUNULAThe Erchonia LUNULA is administered to the infected toes for 12 minutes per treatment for 4 treatments, each treatment one week apart. | Device | Erchonia LUNULA |
Primary outcome
Number of Toenails Attaining 3 Millimeters (mm) or More of Clear Nail Growth
Time frame: Baseline and 36 Weeks
Individual toenail success criteria was defined as 3 millimeter (mm) or more of clear nail growth at 36 weeks post-procedure administration as evaluated relative to baseline. Overall study success criteria was defined as an 60% or more of treated toenails meeting the individual success criteria.
Change in Millimeters (mm) of Clear Nail Bed
Time frame: Baseline and 36 Weeks
Millimeter (mm) of clear nail from the base of the toenail was determined from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 36 weeks after the end of the procedure administration phase. An increase in mm of clear nail between the two measurement points indicates that the toenail has improved and is positive for study success. A decrease in mm of clear nail between the two measurement points indicates that the toenail has worsened and is negative for study success.
1 secondary outcome
Change in Percent (%) of Onychomycosis Disease Involvement
Time frame: Baseline and 36 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
- 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.
Robert Sullivan, Podiatry principal investigator
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 LUNULA in people with Onychomycosis, run by Erchonia Corporation at 1 site in Ireland.
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 3 inclusion and 29 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 17 May 2016. 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 Ireland. 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 10 Aug 2015). 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?
Number of Toenails Attaining 3 Millimeters (mm) or More of Clear Nail Growth (time frame: Baseline and 36 Weeks). The study lists 2 primary outcomes in all. 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 17 May 2016.