Lunula LASER Studies
FDA And Health Canada cleared laser device for the temporary increase of clear nail for patients with Onychomycosis (fungal toenail infection).
- 67% of all study treated toenails showed an improvement after 3 months.
- 89% of treated toenails demonstrated an increase in clear nail after 6 months.
- No adverse events were reported. Conclusion: Non-thermal laser therapy is safe and
effective for increasing the extent of clear nail in onychomycosis-infected toenails
- Lunula LASER has been used in Europe for over 5 years and in clinical studies for over 7 years
Mechanism of Action
The Lunula Laser® 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 Lunula Laser 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.
Powerful Photochemical Effects
405nm Possesses antimicrobial effects to target 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 target the symptoms of Onychomycosis.
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.
No treatment is guaranteed to permanently cure your fungal toenails especially if your feet come into contact with fungus and if you are prone to infections. The environment of your toenails, shoes, socks and shower both during and after treatment is important to prevent re-infection and involves specialized shoe sprays, anti-fungal foot products and regularly cleaning your shower with anti-bacterial/mold products.