1. To begin, what are the advantages of the Erchonia Lunula onychomycosis laser device?

This device is unique in that it is the only true, dual diode, Class 2 laser that offers multiple benefits. The Lunula combines the anti-fungal effects of the 405 nm wavelength with the regenerative outcomes of a 635 nm wavelength.

The Lunula produces two wavelengths, 635 nm and 405 nm, both of which have been enriched by a proprietary rotating line-generated laser beam. The Lunula’s specially designed delivery mechanism maximizes both photon concentration and treatment surface area.

The Lunula’s patented delivery system ensures that all infected tissue, nail bed and most importantly, the proximal germinal/matrix tissue are properly targeted and treated.

2. Are all laser wavelengths the same?

No. The higher wavelengths produce more heat. Wavelengths of 900nm or higher are considered Class 4 devices and produce an increase in temperature in the tissue being treated.

The lower wavelength lasers, Class 2, do not rely on heat production. Cold lasers initiate true physiologic responses, photo modulation. The Class 2 lasers have wavelengths 700 nm or lower.

3. Is the tissue response the same with the lower wavelengths?

No, the lower the wavelength the greater the anti-microbial/antifungal effect and as the wavelength decreases the power increases.

4. Do you feel there is an advantage utilizing a multiple diode approach in the treatment of onychomycosis?

Yes. The 635 nm wavelength stimulates endogenous mechanisms, which enhances the immunological function of resident neutrophil and macrophage function to further degrade the infectious agent. This wavelength also induces tissue rejuvenation, increased vascularization, which enables the dual diode approach to accelerate the growth of a clearer, healthier nail.

The 405 nm wavelength provides anti-microbial, antibacterial and anti-fungal effects.

The dual diode approach provided by the Lunula Onychomycosis Device provides symbiotic wavelengths that enhance the eradication of the infectious agent.

5. What kind of response have you seen when utilizing the dual diode lower wavelength approach in the treatment of onychomycosis?

I have participated in a preliminary study involving over 100 patients and we had an average clearance of 73.89% in as little as 3.5 months following two treatments. In this study neither concurrent systemic nor topical therapy was utilized.

I am currently involved in a multi-site study which includes four treatments over a four-week period, again with no adjunct systemic or topical therapy. It appears that the increased number of treatments, four treatments as opposed to two treatments, will result in a significantly increased success rate.

6. Have you seen any complications with this form of therapy?

No complications have been reported.

7. Why do you feel that cold laser therapy for onychomycosis is gaining acceptance in both the medical community and patient community?

Laser therapy is gaining in popularity because mainstay onychomycosis therapies have continuously provided inconsistent outcomes combined with potentially significant adverse events while low-level laser therapy provides a safe and subtle, yet effective approach to the treatment of onychomycosis.

Whether it is the clinical validation, the effectiveness or the safety, the Lunula is providing patients with a non-invasive and painless treatment solution for their fungal toenails. This therapy has emerged as the alternative treatment of choice.

8. What is your feeling regarding obtaining fungal cultures prior to low-level laser therapy?

Onychomycosis can be a clinical impression. Fungal cultures can be utilized however false negatives are often present. I used to obtain cultures prior to systemic therapy because of the risks of liver toxicity and therefore definitive diagnosis was necessary prior to treatment. Because of the high percentage of false negative culture results, many patients were not treated. I now provide treatment based on clinical evaluation as low-level laser therapy is without risks and the worst thing that can happen is essentially nothing. This is explained in full to the patient.

9. Overall the Lunula is an effective device, providing a painless treatment option for the treatment of onychomycosis.

Pinpoint and other Class IV heat-based lasers can be an issue in patients with peripheral neuropathy or sensation issues as pain may not be sensed and heat damage can be incurred. The heat generating lasers are also unable to treat to germinal matrix area where fungi are often harbored. Please comment.

I believe this is significant. The heat based and spot delivery systems cannot treat the germinal/matrix layer and in my opinion present other concerns. The Lunula laser treats the entire nail complex: nail plate, nail bed and germinal/matrix complex. The Lunula leaves no area untreated, not so with the other lasers. Safety is another issue. The heat-based lasers have the potential to burn tissue and thereby create areas of sub-ungual necrosis, a significant issue in a patient with medical co-morbidities such as diabetes and peripheral vascular disease.

10. Do you have any other concerns regarding the heat-based lasers as opposed to a true cold laser?

Another concern would be the fact that the heat based lasers create a foul smelling plume which places the patient, the treating physician and any ancillary staff in the room at risk for inhaling active mycosis, potentially exposing any individual in the room at risk for pulmonary ingestion and infection. In my opinion heat based lasers should have a sophisticated air evacuation system and adequate masks for filtration for all people in the room and in fact should have an air filtration system that purifies the air to help prevent the risk of airborne transmitted infection. Common remarks from all users of the heat based laser systems are that they ask their patients to tell them when they feel pain, that’s already too late. They also state that they can smell laser plume, again too late.

11. You mentioned laser plume. What is it?

The Class IV and higher wavelength heat generating lasers are used to
increase temperature, vaporize, coagulate and cut tissue. The vapors, smoke and
particulate debris produced during the procedures are laser plumes.

12. What does laser plume contain?

It’s my understanding that laser plume can contain carcinogens, irritants, mutagens and dust. Plumes may also contain viruses, bacteria, fungal spores, blood fragments and even cancer cells. The contents may also contain carbon monoxide, hydrocarbons and various toxic gases. Plumes may also contain chemicals such as formaldehyde, hydrogen cyanide and benzene, especially if nail polish and nail polish removers have been utilized.

13. You seem concerned about laser plume, why?

Both patients and medical staff can be at risk from exposure to laser plumes.

14. What do you feel are the risks with using a heat-based Class 4 laser as opposed to a true cold laser?

The heat-based lasers are not without risk. When using heat-based lasers to treat nail fungus, there are risks: thermal burning, necrosis, pain, threat of airborne mycosis with the potential of pulmonary ingestion with resultant long-term infection and disease.

When utilizing true cold laser therapy, such as the Lunula device, there is virtually no risk, either to the patient or the treating physician. The worst thing that can happen with true cold laser therapy for onychomycosis is nothing.

15. Is debridement of the toenail necessary when utilizing laser therapy to treat onychomycosis?

In my practice no debridement is being performed except on extremely hypertrophic and thickened nails. Occasionally it may be necessary to completely remove the nail plate and then directly irradiate the nail bed. This preserves the nail matrix to allow the nail to regrow. Removal of the nail plate is generally reserved for severe cases were conventional treatments have been ineffective. The Lunula generally yields very good results.

16. Can you comment as to whether or not there is a difference in response when treating Candida versus Dermatophytes?

The response to clinical onychomycosis appears to be the same for both Candida and Dermatophytes. I am not aware of any specific study that has been done to show a differentiation in response to treatment. I am currently involved in a study whereby we have taken cultures of all patients and we will be able to see if there is any difference in response to treatment. That information should be available in approximately five months. However, I might add that the cultures were only positive in 60% of the patients.

17. It is my understanding that you have modified your treatment protocol that now employs four treatments over four weeks. Please comment.

I do believe that the four treatment protocol will be the most effective protocol that we will use. Again this treatment is noninvasive and painless and is administered without risk. The current study that we are employing indicates that the results will be significantly superior to the prior two treatment protocol. This is because this therapy increases microcirculation which results in accelerated nail growth and increased nutrition to the nail.

18. Have you noticed a clinical advantage of the four treatment protocol as opposed to the two treatment protocol?

Yes and I believe this advantage to be most significant. With preliminary studies we know that with treatment from the low- level laser, it increases the vascular supply to the toe. However the effects last for a short period of time. With repeated treatments such as once a week for four weeks the results remain for the long-term and an increase in vascularity promotes more rapid nail growth and growth of healthier nail tissue.

19. The Lunula appears to be an effective solution to onychomycosis in the vast majority of individuals (~75%) however in some situations or where faster results are sought then there are alternative options such as the four treatment protocol or complete nail avulsion. What are your thoughts?

Our success rate with two treatments was approximately 73%. It is becoming clear that the success rate will be significantly greater with four treatments. I will have a clearer picture in six months. Again, there are no alternative treatments that offer any measure of success that do not have negative effects.

20. What are the Advantages of Lunula Low Level Laser for the Treatment of Onychomycosis?

no chance of developing microbial resistance to this form of treatment
does not interfere nor interact with any systemic medicine
no chance for liver toxicity
treatment protocol is painless, ensuring good patient compliance
no pain during treatment

21. What are your thoughts regarding the mechanism of action in the destruction of the invading fungal organism?

Peroxynitrite is a compound that has potent anti-microbial effects. This compound is formed when Nitric Oxide (NO) reacts with Reactive Oxygen Species (ROS). The Lunula Laser by Erchonia, the only true Low Level Laser used to treat onychomycosis, uniquely has two different laser diodes; a 635nm and a 405nm. This combination of wavelengths is crucial in that the 635nm diode produces NO and the 405nm diode is the best producer of ROS, both within the visible light spectrum. Cell destruction is triggered by the cytotoxic effects of peroxynitrite.
*NO + ROS = peroxynitrite destroys fungal pathogens*
The 635nm laser enhances mitochondrial energy metabolism, which generates NO, and this is combined with the 405nm laser, which generates ROS, produces peroxynitrite. This by-product is cytotoxic and destroys pathogenic bacteria, fungi and protozoa.

22. As we wind down the questioning it occurred to me that we have not spoken about the chance for re-infection. Is this a concern and if so how do you deal with the risk?

Yes, this is a real concern. People that have had nail fungus are always susceptible to re-infection. However I have a post treatment regimen that can minimize the risk.

I ask all patients before treatment if their spouse or significant other has nail fungus. If so, I will not administer Lunula laser treatment without treating their partner and treatment is postponed until it can be administered at the same time.
The patient is advised to spray the shower with an anti-microbial agent before using after their laser treatment.

All closed toe shoes are to be sanitized. I have a gas sterilizing device that is used to “treat” the patient’s shoes. This devise is located in the same room as the Lunula so patients can be treated at the same time as their shoes. They can see that we are serious about reducing their risk for recurrence.

All patients are sent home with an antifungal spray and they are advised to get into the habit of spraying their shoes every time they take them off so that they remain fungus free and ready for the next use.

Patients are asked to scrub their toes daily while showering.
I also advise patients that when they get a pedicure they should seek out a reputable salon or spa that uses sterile instruments. They are further advised to bring their own nail polish and remover, both of which should be newly purchased after the Lunula treatment. I inform the patients that at a nail salon when they are picking out a color they are really picking out a fungus.

In conclusion I remind patients that fungus is everywhere in our environment and that their risk of re-infection is ever present. In order to control fungus, they must practice daily foot hygiene.

What kind of clinical results have you experienced with the Lunula Laser?
The results have been quite impressive. I will share some of the results of our study. The results that you will see are the state of the toenail on the day of the first treatment and again at six moths. Each on of the following patients was given four treatments, one week apart. No other adjunctive therapies were used in any of theses patients.