The last decade has seen a significant increase in medical tools designed to treat fungal nail infections. Onychomycosis presents a large frustration to both patients and practitioners due to the limited availability of treatment options paired with the persistent and very obvious nature of the infection. As such, clinics now have numerous options for antifungal treatments more effective than the laboursome daily topical ointments with efficacy rates as low as between 5.5% and 17.8%,4 or oral prescription medication with complete cure rates of only between 14-38%,9 despite having mycological cure rates as high as 54-70% in the same studies and with many podiatric patients not meeting the inclusion criteria for systemically safe use.
With significant increases in the efficacy, efficiency and safety profiles of modern innovations in fungal nail treatments comes a significant investment decision for clinics. This means it’s important for practitioners to know what their options are, the pros and cons of each, and how they work practically inside the clinic, to see if it would be a good fit for their team and practice, and worth the investment.
Here is a deep dive into four of the most recent innovative treatments for fungal nail infections being used in podiatry clinics across the world.
Clearanail
How it works
Clearanail is a patented device that works through micro-penetration of the nail plate paired with topical terbinafine application. It comes in the form of a hand-held device that is used by the practitioner to drill very small holes of approximately 0.4mm all throughout the nail plate. While the concept of nail fenestration is not new, with “partial results” having shown an increase in areas of the nail plate that are free of disease,1 this approach had a major flaw: the devices used to penetrate the nail plate did not know when to stop. This meant that the holes would extend further than the nail and into the healthy, living tissue of the patient.
Clearanail overcomes this system by using a manual drill (as opposed to laser fenestration) that intuitively knows when to stop by detecting changes in the density of the material that it is drilling through. Next, the terbinafine is applied topically to act on the fungus.
Does nail fenestration for fungal nails work?
Studies have shown that nail fenestration can improve drug delivery by three or four times, though this study did not examine the Clearanail device specifically.2 Another study that compared nail fenestration with terbinafine with terbinafine alone found that nail fenestration did produce higher mycological cure rates, but not as high as where the device use was also paired with oral antifungal use, which still remains unsuitable for many podiatric patients.3
As the treating practitioner, after initial debridement and nail preparation, your responsibility is to apply the device over the nail, hold it in place, and let the drilling action happen at approximately 5 seconds per hole. This must be done over the entire nail in order for effective penetration of the antifungal. This means the success of the treatment is linked to the number of holes applied by the practitioner and their spacing, especially among different levels of infection throughout the nail. The holes will remain in the nail provided that the patient does not wear any polish or other lacquers, something that many wish to do to mask the current appearance of their nails – with aesthetic concerns often being the primary motivating factor for seeking treatment. The total appointment time is one hour, and terbinafine may be applied for up to three months following the treatment, after which a review to check progress should be conducted.
PACT: Photodynamic Antimicrobial Therapy
PACT is a registered device that uses photodynamic therapy to help kill nail fungus. Specifically, it combines the use of a certain wavelength of light administered by the PACT lamp with a special blue dye that increases the sensitivity of the fungal cells in the area to which it is applied. Through the interaction of photosensitising agents, light and oxygen, photochemical reactions occur that act on the fungal cells to destroy them.
As the treating practitioner, after debridement and nail preparation, you must apply the blue dye carefully over each toenail and leave the dye on for a minimum of ten minutes. Then you must position the PACT lamp over the toenails and apply for ten minutes. The radius of the light will not cover both feet – it may successfully cover two lesser digits, or a single hallux, depending on the size of your toes. While PACT guidelines recommend treating the affected nails, given the likely presence of fungal spores over the other toes, for best outcomes it is best to apply to all of the toes to help reduce the risk of reinfection, as with any antifungal treatment. As such, treatment time can exceed one hour if only a single PACT lamp is used.
Three initial PACT sessions are recommended within one month regardless of the severity of the onychomycosis. A repeat session is required either after one or two months depending on infection severity. Reviews should then be carried out either monthly or bi-monthly, with repeat sessions carried out as needed. Like any antifungal treatment, nails must grow out to see results of a clear nail base. No adverse events have been reported, but the nail will be stained blue for a temporary period immediately after the treatment application.
Does photodynamic therapy for fungal nails work?
We could not find any studies that evaluated the efficacy of the marketed PACT lamp and protocol specifically, but did find a limited selection of others that evaluated photodynamic antimicrobial chemotherapy. One study was completed in vitro, showing it could inhibit fungal growth in the microdilution assay with strains of T. rubrum. It was concluded to be an effective onychomycosis treatment in vitro, but these promising results needed validation from clinical trials. Another study found that this therapy could significantly reduce cell growth and biofilm formation in Candida albicans species.4
Hot Laser
There are a variety of hot lasers available on the market, with the Pinpointe laser one of the best known. Hot lasers use different wavelengths of light that produce a heating effect on the nail and any surface it comes into contact with. The nails are heated to approximately 46-48 degrees which creates a fungicidal effect and damages the fungal cells.
As the treating practitioner, the hot laser treatment process is entirely hands on. Following nail debridement and preparation, the laser is applied over the entire nail, extending to the outer nail and skin edges. The length of time that the laser can stay on the nail will vary depending on each patient’s heat sensitivity as the nail will often warm even after a few seconds, making it a stop-start procedure. This is also why this treatment is contraindicated in those with diabetes, neuropathy and some other conditions, as they may be at a greater risk of burns due to not being able to detect the heat effectively. A well-known case study highlighted these risks, with a 64 year old female developing necrotic lesions and underwent amputation of her two big toes one month after treatment with hot laser.5 Treatment times vary depending on the number of toes treated and the patient’s response, but typically range between 30-60 minutes, and are typically 60 minutes if all ten toes are treated. Patients should be advised of the risk of burns, discomfort and pain.
Does hot laser treatment for fungal nails work?
Hot laser has had its efficacy evaluated over a limited range of primarily small scale studies with variable results that promisingly all follow a “trend towards improvement”.6 Results range from cure rates of 33%7, to “good treatment outcomes” in 72% of nails treated, where the actual cure rate was 9.3%8. The largest efficacy review of hot lasers included 4278 infected nails, and produced a total cure rate of 63%.9 Recent studies have shown a visual improvement rate as high as 86.7% if treatment protocols are amended and standardised.10 Other studies have reported a 0% mycological cure after 12 months, which may be attributed to a high rate of re-infection during this time.11
As ‘hot laser’ includes a variety of devices operating at different wavelengths, it’s important to look into the research behind the specific hot laser device you are considering investing in. The Pinpointe laser, for example, has found mycological cure rates of between 51% and 53%.12 Additionally, be sure to examine the treatment protocol within the efficacy studies. In multiple studies with high efficacy findings, hot laser was only one part of a multi-faceted approach, which may impact on the replicability of the results in a clinical setting.
Lunula Cold Laser
Lunula cold laser uses cool wavelengths of light to produce its fungicidal effects. This box-like device utilises a dual-diode approach, where two heat-free laser beams of 405nm and 635nm respectively operate in unison to target the fungal cells while fortifying the body’s natural defence mechanisms, each with their own specific mechanism of action. The blue wavelength (405nm) significantly weakens the outer wall of the fungal cells by causing irreversible damage while the red (635nm) wavelength strengthens the body’s immune cells to act on the fungus, which improving blood flow to the area to accelerate the treatment process.
As the treating practitioner, after nail debridement and preparation, the treatment process is entirely automated and hands off, aside from placing each foot in the Lunula laser and activating the device. The rotating lasers run for 12 minutes per foot, acting on the entire foot and all toenails. There is no intervention by a podiatrist during the time, aside from assisting the patient to switch feet and checking on them. The patient is free to sit back and relax. The podiatrist may leverage this time to provide education or re-infection prevention. The total appointment time is 30 minutes, the entire process is painless, and there are no contraindications, side effects or risks for adverse reactions.
Does cold laser treatment for fungal nails work?
Efficacy results for cold laser range from demonstrating an 89% clear nail increase with a 67% treatment success rate,13 to clinical cure and mycological cure rates of 70% and 95% respectively. These figures rise to 90% and 95% by 12 months, with 100% of study participants having new unaffected nail growth.14 Studies conducted using strict protocols by the laser manufacturers have confirmed individual success rates to be as high as 86% at week 12, extending to 99% by week 48.15
When examining any laser results, it’s important to differentiate between the degree of severity of nails affected, as many patients will present with extreme fungal severities, and some hot laser studies we observed excluded heavily affected nails. One Lunula study, where on average 81% of the toenail was affected by fungus (denoting a severe infection), showed that 63.6% of toenails reached full clearance.16 Two audits completed by clinics using the cold laser in patient management have reported success rates of 84-87%17 and 89%18 over 12-18 months. Cold laser also demonstrated excellent patient satisfaction rates, including in a study of 320 patients using the laser that resulted in a 93% satisfaction rate.19
Oral Antifungal Medications Are Changing, Too
During our review of the available evidence, we came across studies examining new oral medications for nail fungus that have proven to overcome the potential systemic adverse events while being potent enough to be taken weekly, not daily. Unfortunately, these medications have yielded low 48-week success rates of between 32% and 42%.20
So, What Is The Best Investment For Your Clinic
|
Treatment |
Evidence for Efficacy |
Practitioner Satisfaction |
Patient Satisfaction |
|---|---|---|---|
| Clearanail | Limited. This device has not specifically been studied or evaluated. Nail fenestration (generally) shows evidence of improvement of topical drug delivery, but with lower results than oral medications. | Moderate. One hour treatment time, manual application with positioning device over the area of the nail for drilling. Success of treatment may be influenced by practitioner and treatment spacing. | Moderate. One hour treatment time, manual application with positioning device over the area of the nail for drilling. Success of treatment may be influenced by practitioner and treatment spacing. |
| PACT | Limited, but promising. This device has not specifically been studied or evaluated. Photodynamic therapy (generally) shows promising results in inhibiting fungal growth in vitro, but this needs validation from clinical trials, especially using the specific marketed device. | Low. Treatment success is highly dependent on the steps and care taken by the treating practitioner. After nail debridement, blue dye must be applied to each nail and dried for a minimum of 10 mins. The PACT lamp must then be carefully positioned over the nails. Light radius does not cover all toes, must do different areas/toes separately. Recommended guidance to only treat affected toes – much higher risk of recurrence. Three sessions mandatory, with repeat sessions to follow based on symptom severity. | Moderate. No patient self-treatment at home required. Nails may stain blue for a short period. Long treatment sessions. |
| Hot Lasers | Good. Studies into the use of heat-based lasers for onychomycosis shows good treatment outcomes, as high as 72% in some studies. Visual improvement rates of 86% also reported. Low mycological cure rates reported in the same studies, often below 10%. | Low. Very time intensive, stop-start process, efficacy greatly dependent on individual practitioner protocol and treatment time exhausted. Treatment tolerance is greatly variable, dependent on individual heat tolerance. Greater risk of patient complications from the hot laser treatment to then manage. | Low. Notable risk of burns and complications. Discomfort during treatment. Long treatment time. Case studies reporting the development of necrotic lesions following treatment. Unsuitable for those with circulation or neuropathic issues relating to the feet, and other exclusions. |
| Lunula Cold Laser | Great. Both treatment success rates and mycological cure rates range between 70% and 95%. The specific Lunula device has been extensively studied with proven results, as opposed to evaluating low level laser generally, which shows similar results. Evidence for strong efficacy in both severe and mild infections. | High. Hands-off treatment is not dependent on the practitioner for success. 12-minutes per foot. Time available for strong focus on re-infection prevention and at home care. | High. 93% patient satisfaction rate in a trial of 320 patients. No pain, discomfort or side effects. Fast treatment time. |
Based on its efficacy, patient satisfaction, safety and ease of use for the practitioner, the Lunula cold laser is best positioned to deliver superior outcomes for patients and elegantly solve the highly frustrating problem of onychomycosis, while also streamlining your clinic’s processes, time management and safety protocols.
You can learn more about cold laser, including expected profitability and complimentary marketing plans to promote bookings, by contacting our Lunula Laser Australia Customer Service on 1300 653 522 or at info@lunula.com.au.
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1 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3798374/
2 https://pubmed.ncbi.nlm.nih.gov/30646496/
3 https://pubmed.ncbi.nlm.nih.gov/27032812/
4 https://www.sciencedirect.com/science/article/abs/pii/S1572100019300468
5 https://www.academia.edu/42352851/Diabetic_neuropathy_and_Nd_YAG_1064_nm_laser_for_onychomycosis_be_careful
6 https://www.karger.com/article/FullText/492526
7 https://jfootankleres.biomedcentral.com/articles/10.1186/1757-1146-7-34
8 https://pubmed.ncbi.nlm.nih.gov/24693870/
9 https://journals.lww.com/md-journal/Fulltext/2019/11290/Laser_treatment_for_onychomycosis__A_systematic.11.aspx
10 https://www.mdpi.com/2304-6732/8/9/350
11 https://www.hmpgloballearningnetwork.com/site/podiatry/blogged/recent-research-shows-failure-laser-therapy-monotherapy-onychomycosis
12 Long-pulse Nd:YAG 1064-nm laser treatment for onychomycosis. Zhang RN, Wang DK, Zhuo FL, Duan XH, Zhang XY, Zhao JY Chin Med J (Engl). 2012 Sep; 125(18):3288-91.
13 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5479474
14 https://www.peertechzpublications.com/articles/IJDCR-7-140.php
15 https://www.coldlasernailclinic.nz/wp-content/uploads/2018/03/ERCHONIA-LUNULA-Toenail-Onychomycosis-Clinical-Study-Results-Report-FDA-3.docx
16 https://www.podiatrym.com/pdf/2017/1/Tumolo117web.pdf
17 https://www.compleetfeet.co.uk/lunula-laser-fungal-nail-audit-201617/
18 https://www.podiatrym.com/pdf/2017/1/Tumolo117web.pdf
19 https://www.opnassociation.ca/wp-content/uploads/2019/09/Sullivan_Erchonia-Laser-Therapy-in-the-Treatment-of-Onychomycosis-Preliminary-Report_Podiatry-Review-Vol-71.2_03_14.pdf
20 https://onlinelibrary.wiley.com/doi/10.1111/bjd.19732