Science

The Science – how effective is it?

The Science behind the Lunula Laser Technology at Achilles-Centre for clinically effective treatment of Fungal Nail Infection of feet and hands.

before after strong nail recovery

These are the before and after images showing strong recovery of normal nail at 10 months

Below we present details of how and why the system we use is so effective based on research results drawn up in the early stages of the development of the system. As more case studies are carried out the level of effectiveness of Lunula Laser is showing a high success rate – upto 90% + of nails are showing improvement:

Lunula’s clinical use for the treatment of onychomycosis has been substantiated by two independent clinical investigations. It is important to mention that neither nail debridement nor topical/oral antifungals were administered during the studies (to create a unified consistent approach).

The first study evaluated 168 toes with an average baseline disease involvement of 81.15%. After a single Lunula treatment, disease involvement was reduced to 31.32% at study endpoint, an improvement in nail clarity of 63.58%. The second study, which was a FDA directed study, evaluated 105 toes, or 75 subjects, after four Lunula treatments separated by a single week. Subjects reported an average clear nail of 73.79% and 79.75% at post-procedure months 3 and 6, respectively.

This was a statistically significant change compared with the average 43.4% clear nail measured at baseline. Equally important, the clinical responses observed in both trials were achieved without a single adverse event.

DID YOU KNOW? Patients in a 168-toe study reported a 73.89% improvement in nail clarity in 3.5 months

Lunula’s Proven Approach

Lunula combines two therapeutically beneficial wavelengths: 405 and 635 nm. Each wavelength is capable of stimulating a specific cell and tissue response in the nail bed to effectively and safely treat onychomycosis. Both wavelengths are enhanced in their effectiveness by a proprietary, rotating line-generated beam; a unique delivery mechanism that maximizes photon concentration and treatment surface area – ensuring that all infected toes are properly treated. As a result, the Lunula provides a treatment absent of any adverse events while effectively addressing unsightly onychomycosis.

The 635 nm wavelength stimulates nitric oxide (NO) production and reactive oxygen species (ROS). 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.

The 405 nm 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. When applied concurrently, the two wavelengths represent a truly multifaceted treatment.

ros generation laser therapy 405 nm red laser

FIGURE 1. ROS generation following laser therapy at ~405 nm and Red Laser Courtesy of Lavi et al.

FIRST – By increasing the production of ROS to damage the fungi and increase its susceptibility to an immune attack.

SECOND – By increasing ATP and ROS to increase immune response by increasing blood flow and improving immune cell function. The application of 405 nm has been reported to significantly increase the production of ROS and activate key secondary cascades to weaken fungi defense against the body’s immune response, which in turn, kills the fungus. When compared to other wavelengths, 405 nm yields the highest production of ROS (Figure 1)

Peripheral blood flow impairment due to tight shoes or poor circulation can affect the body’s own immune response to the colonizing fungus. Without the infiltration of leukocytes, monocytes, and macrophages which are carried in the blood supply, the infectious agent is able to spread along the nail plate and bed. Healthy blood flow must be achieved  and encouraged by following all advice given as the Lunula Laser alone will not cure.

The 635 nm wavelength has been proven to increase peripheral blood supply by stimulating key pathways responsible for angiogenesis (new blood vessel formation). Increased blood flow provides greater nutrient delivery to tissues / cells for rejuvenation and enables immune cells to infiltrate the tissue to destroy the fungus.

improved blood flow benefit

These images demonstrate the improved blood flow benefit of the 635 nm wavelength

STUDIES PUBLISHED ON BENEFITS OF 635 NM WAVELENGTH

Author Reported outcome
Zheng H et al (1992) Activation of immune cells (macrophage) by increasing concentration of ROS with laser.
Dolgushin et al (2010) Stimulation of neutrophil function by increasing ROS production following laser.
Schindl et al (1999) Activation PI3 kinase/eNOS signaling following 632.8 nm laser.
MacMicking et (al(1997) Nitric oxide (NO) reveals antimicrobial effects against infectious agents.
Gasparyan et al (2006) Laser at 632.8 nm increases new blood vessel formation (angiogenesis).

STUDIES PUBLISHED ON BENEFITS OF 405 NM WAVELENGTH

Author Reported outcome
Emmons et al (1939) Fungal damage reported following stimulation with near-UV. light (~405 nm).
Klebanov et al (2005) Membrane degradation reported as a result of increased ROS levels following laser at ~405 nm.
Eichler M et al (2005) Increased ROS production following stimulation of NOX receptor with ~405 nm laser.
Lavi R et al (2012) Increased level of ROS following stimulation with ~405 nm.

The Commitment to Research

Lunula has been studied – from the early in-vitro analysis to the extensive in-vivo studies – and its clinical use to treat painful and unsightly toenail infections has been substantiated. The unique dual-diode approach of Lunula effectively targets the causative infectious agent while fortifying the body’s natural defense mechanisms. This multifaceted approach is the first of its kind, providing patients with a truly effective, yet safe, treatment for onychomycosis.

Lunula is supported by a clinical foundation of both histological and clinical evidence that upholds the viability of this approach and ensures an effective treatment for patients suffering with onychomycosis.

DID YOU KNOW? Lunula has been studied both in-vitro and in-vivo.

Source: www.lunula.com (precised version)

Foot Fungus Before & After images