OnychomycosisNCT02588599
A Retrospective Analysis of the Effects of Low Level Laser Therapy on Toenail Onychomycosis
A study testing Erchonia LUNULA in people with Onychomycosis, run by Erchonia Corporation.
Trial summary
The purpose of this study is to determine whether low level laser therapy (LLLT) using the Erchonia LUNULA device is effective in increasing clear nail in toenails with 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
- 54 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Oct 2015
- 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
- Great toenail presents with clearly visually identifiable and photographically documentable onychomycosis of the great toenail, or no visible onychomycosis (1 great toenail)
- Onychomycosis has been identified as due to 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)
- Onychomycosis etiology has been confirmed through positive fungal potassium hydroxide preparation (KOH) testing results
Who cannot join
- Spikes of disease extending to nail matrix in the great toenail
- Infection involving lunula of the great toenail, e.g. genetic nail disorders, primentary disorders
- Great toenail has less than 2mm clear (unaffected) nail plate length beyond the proximal fold
- Dermatophytoma or "yellow spike/streak" (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the great toenail
- Onychogryphosis
- Proximal subungual onychomycosis
- White superficial onychomycosis
About this study
Official title: A Retrospective Evaluation of the Effect of the Erchonia LUNULA™ on the Increase of Clear Nail in Patients With Toenail Onychomycosis
The purpose of this study is to determine whether low level laser therapy (LLLT) using the Erchonia LUNULA device is effective in increasing clear nail in 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
- 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
Active low level laser light therapy
| 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.
Percent (%) 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 6 months 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: 6 Months
Secondary outcomes (1)
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 6 months 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 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2015
- Study completionOct 2015
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erchonia Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kerry Zang, DPM, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588599
- Sponsor's protocol ID
- EC_LUNULA_RETRO
- Status last verified
- Aug 2016
- First submitted
- 25 Oct 2015
- Last updated
- 28 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Zang K, Sullivan R, Shanks S. A Retrospective Study of Non-thermal Laser Therapy for the Treatment of Toenail Onychomycosis. J Clin Aesthet Dermatol. 2017 May;10(5):24-30. Epub 2017 May 1.
PubMed 28670355
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Evaluation of the Effect of the Erchonia LUNULA™ on the Increase of Clear Nail in Patients With Toenail Onychomycosis
- ClinicalTrials.gov ID
- NCT02588599
- Acronym / sponsor ID
- EC_LUNULA_RETRO
- Conditions
- Onychomycosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Erchonia CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 28 Oct 2015 (estimated)
- Results
- Posted 21 Jul 2016
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 LUNULA device is effective in increasing clear nail in 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 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)
- Great toenail presents with clearly visually identifiable and photographically documentable onychomycosis of the great toenail, or no visible onychomycosis (1 great toenail)
- Onychomycosis has been identified as due to 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)
- Onychomycosis etiology has been confirmed through positive fungal potassium hydroxide preparation (KOH) testing results
Key exclusion criteria (7 listed)
- Spikes of disease extending to nail matrix in the great toenail
- Infection involving lunula of the great toenail, e.g. genetic nail disorders, primentary disorders
- Great toenail has less than 2mm clear (unaffected) nail plate length beyond the proximal fold
- Dermatophytoma or "yellow spike/streak" (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the great toenail
- Onychogryphosis
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 LUNULAActive low level laser light therapy | Device | Erchonia LUNULA |
Primary outcome
Percent (%) of Toenails Attaining 3 Millimeters (mm) or More of Clear Nail Growth
Time frame: 6 Months
Individual toenail success criteria was defined as 3 millimeter (mm) or more of clear nail growth at 6 months 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.
1 secondary outcome
Change in Millimeters (mm) of Clear Nail Bed
Time frame: Baseline and 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28670355Zang K, Sullivan R, Shanks S. A Retrospective Study of Non-thermal Laser Therapy for the Treatment of Toenail Onychomycosis. J Clin Aesthet Dermatol. 2017 May;10(5):24-30. Epub 2017 May 1.
- Individual participant dataSharing planned: No
Related trials for Onychomycosis
RecruitingObservational study
In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
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Not yet recruiting
Systemic Antifungal Plus Q-Switched Nd:YAG Laser for Onychomycosis
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Photodynamic Therapy For Onychomycosis
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URGO MICKAEL Filmogel, Topical Treatment of Onychomycosis
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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.
Kerry Zang, DPM principal investigator
Questions about this trial
What is this clinical trial studying?
A study testing Erchonia LUNULA in people with Onychomycosis, run by Erchonia Corporation.
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 7 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 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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 21 Jul 2016). 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?
Percent (%) of Toenails Attaining 3 Millimeters (mm) or More of Clear Nail Growth (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02588599, which also lists 1 linked publication.
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 28 Sep 2016.