Mechanism of Action
The LunulaLaser® by Erchonia is a dual-diode low-level laser device that administers two therapeutic wavelengths: 405 nm (violet) and 635 nm (red) as a line-generated beam to maximize the treatment surface area. The device targets fungus that lives in and under the toenail without causing damage to it or the surrounding skin. This photochemical mechanism enables LunulaLaser to give a direct, non-contact treatment using photonic energy to modulate secondary cellular reactions without the patient feeling the device working.
The fungal pathogen may not only affect multiple toes, but also may be found deep within a dystrophic nail or along the nail bed and root. The line-generated beam ensures that, regardless of where the fungal pathogen resides, an effective treatment will be administered.
Peripheral blood flow impairment can affect the body’s endogenous immune response to the colonising fungus.
Powerful Photochemical Effects
405nm Possesses antimicrobial effects to treat onychomycosis causing fungus
The 405nm wavelength targets NADPH oxidase (NOX), a membrane bound enzyme, and increases NOX’s production of ROS, which can be converted into H2O2. As H2O2 starts to degrade the fungal cell wall and membrane fungi function and behavior will be greatly impaired. This can result in fungal death. Additionally, degradation of the fungi membrane and cell wall will increase fungal susceptibility to the body’s immune attack.
635nm Supports local immune cells to fight onychomycosis causing fungus.
The 635nm wavelength stimulates cytochrome c oxidsase (CCO), an important enzyme necessary for the production of adenosine triphosphate (ATP) and reactive oxygen species (ROS). Increased ATP activates PI3 kinase/eNOS signaling pathways, which increases nitric oxide (NO) production. NO is critical for new blood vessel formation increasing nutrient delivery and infiltration of immunological cells. Additionally, NO is a powerful antimicrobial agent, and will help destroy the infectious agent. For resident macrophages and neutrophils, two types of immune cells, the increased production of ROS is quickly converted into cytotoxic hydrogen peroxide (H2O2), which is used by the immune cells to destroy onychomycosis-causing fungus.
Built On A Solid Foundation Of
Histological And Clinical Research
Lunula is supported by an unwavering clinical foundation of both histological and clinical evidence that upholds the viability of this approach and ensures an effective treatment for your patients suffering with onychomycosis.
United States Clinical Study
The purpose of this study was to demonstrate through retrospective analysis the efficacy of the Erchonia LunulaLaser, manufactured by Erchonia Corporation, for the increase of clear nail in patients with toenail onychomycosis, when applying the LunulaLaser to the toenail for 12 minutes one time per week for a total of 4 procedure administrations.
This study was a retrospective analysis of a compilation of pre-procedure and six-month post procedure pholographs of fifty-four (54) great toenails with varying degrees of onychomycosis disease involvement selected from amongst an existing pool of photographs taken during three prior Erchonia Corporation research studies wherein 4 sequential weekly 12-minute procedures with the LunulaLaser were administered. The evaluating investigator was blinded to corresponding pre and post-procedure photographs through application of a randomized numeric coding methodology.
The linear measurement of millimeter (mm) of clear nail from the proximal nail fold to the most proximal area of nail dystrophy was objectively measured from unmarked digital photographic images using the validated GNU Image Manipulation Program (GIMP 2.8) software system, a multi-platform image/photo manipulation software system, at baseline evaluation (prior to LunulaLaser procedure administration) and at 6 months following completion of the LunulaLaser procedure administration protocol.
Primary Outcome Measure: Change in mm of Clear Nail from Baseline to Study Endpoint: The primary efficacy outcome measure in this study was the mm of clear nail growth at 6 months post procedure administration end relative to Baseline (pre-procedure administration). Individual toenail success was defined as 3 mm or more of clear nail growth at 6 months post-procedure end relative to baseline. Overall study success was defined as an anticipated 60% of treated toenails meeting the individual toenail success criteria.
Sixty seven per cent (67%) of all study treated toenails evaluated in this study met the study individual toenail success criteria, exceeding the pre-established overall study success goal of 60% by 7%. The magnitude of the mean change in mm of clear nail from baseline to 6 months post-procedure for all treated toenails was an increase of 5.18 mm, 2.18 mm in excess of the pre-established 3 mm increase success criteria. A t-test for paired samples found this mean change of +5.18 mm in clear nail to be statistically significant (t=-8.0; df=53; p<0.0001).
The Erchonia LunulaLaser is an effective tool for increasing clear nail in toenails infected with onychomycosis, significantly increasing mm of clear nail over a 6 month period following completion of the 4-week procedure administration phase.
The Limitations And Risks
Treatment of the body’s most distal region — the toes — with an oral anti-fungal medication is often greeted with non-response or high rate of recurrence due to limited drug bioavailability routinely caused by insufficient blood flow. Next, the infectious agent is a eukaryote, and therefore, shares structural and biochemical similarities with our body’s eukaryotic cell. As a result, our own important biochemical pathways can be negatively affected by oral anti-fungals. Although quite rare, hepatotoxicity has been reported in patients taking oral anti-fungal medication. To mitigate the risk of liver complications, patients with specific pre-existing medical conditions cannot be prescribed oral anti-fungal medications, but for those patients who are taking anti-fungals, they must undergo routine liver function tests throughout the treatment course.
Non-response, high-rate of recurrence, limited to certain patients, and serious risk of adverse events — these represent the drawback of oral anti-fungal medications.