Laser Therapy for the Treatment of Onychomycosis: Best Evidence Based Practice or Not?

NewsBot · Dec 3, 2016

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Laser Therapy for the Treatment of Onychomycosis: Best Evidence Based
Practice or Not?
Nadia Dembskey and Heidi Abrahamse
Clin Res Foot Ankle 2016, 4:4

Onychomycosis is a very common condition that accounts for 50% of all nail pathologies. Currently 2–5% of the
world population suffers from this disorder. It is primarily caused by dermatophytes, but the infection can also be
caused by yeasts and non-dermatophyte moulds. Onychomycosis is a therapeutic challenge and recently there has
been an increase in resistance to oral and topical antifungal agents, leading to 20–25% relapse and/or reinfection
rate. During the past 5 years, the emergence of laser therapy has been the topic of discussion as a newer, safer
modality of treatment.
Nail clippings and scrapings are the most common methods of sampling for suspected onychomycosis. The
simplest method for detecting fungi is by way of 20% potassium hydroxide (KOH) preparations, but lately show
insufficient sensitivity in onychomycosis – as much as 40–68%. Fungi can also be grown in culture form; however a
70% sensitivity detection failure rate is seen. Recently, histological fungal detection – in the form of Periodic AcidSchiff
(PAS) stain – has shown high sensitivity at 92% in the detection of fungal elements.
The exact mechanism of action of laser is unknown but it is believed that heat disintegrates fungal structures.
One of the most appealing characteristics of laser therapy is its ability to deliver energy to the target tissue and avoid
systemic side effects at the same time. In 2009 the United Kingdom (UK) Podiatry magazine Podiatry Now published
a letter suggesting laser treatment was “possibly the most radical development in the treatment of onychomycosis
our profession has ever seen”, although concerns were raised over the unproven efficacy and investment costs
involved.
Papers have been published investigating the efficacy of lasers for the treatment of onychomycosis. Even though
laser therapy provides an alternative option with rapid procedure duration, conflicting evidence is shown in a variety
of papers and studies with longer follow-up periods suggest onychomycosis relapse in those treated with laser,
which warrants further investigation.
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Admin2 · Dec 3, 2016

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Other threads tagged with: onychomycosis

NewsBot · Mar 9, 2017

The Effect of Long-Pulsed Nd:YAG Laser for the Treatment of Onychomycosis.
Gökhan Okan, MD, Nagehan Tarikci, MD, Gonca Gokdemir, MD
Journal of the American Podiatric Medical Association: January 2017, Vol. 107, No. 1, pp. 54-59.

Background: Topical onychomycosis therapies are usually inadequate, and patient compliance to systemic therapies is poor. Recently, interest in laser therapy for the treatment of onychomycosis has increased. We sought to investigate the efficacy of long-pulsed Nd:YAG laser therapy for onychomycosis.

Methods: Thirty patients with mycologically confirmed onychomycosis received long-pulsed 1064-nm Nd:YAG laser therapy, moving the beam in a spiral pattern over the whole nail plate two times, with a 1-minute pause between passes. Laser therapy was performed with a spot diameter of 4 mm at a speed of 25 mm/sec once weekly for 4 weeks using fluencies ranging from 40 to 60 J/cm2, depending on the thickness of the nail plate. Patients were evaluated in terms of clinical improvement and mycologic cure.

Results: Thirty patients started and 15 completed the study. Mycologic cure was achieved in nine patients (60%), of whom eight (89%) were infected with Trichophyton sp. Complete clinical improvement was achieved in seven patients (47%), all of whom were infected with Trichophyton sp. Mycologic cure was not achieved in one of two patients infected with Epidermophyton or in either patient in whom the agent was Candida or Aspergillus; complete clinical improvement did not occur in any of these patients. No serious adverse events were observed.

Conclusions: Based on these results, long-pulsed Nd:YAG laser can be used as an effective treatment for onychomycosis, but further studies are needed to draw firmer conclusions.
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NewsBot · Apr 2, 2017

Clinical clearing of moderate and severe onychomycosis with the Nd:YAG 1064nm laser and post treatment prevention with tolnaftate
Myron A. Bodman DPM et al
The Foot and Ankle Online Journal 10 (1): 3

Background: Many patients prefer local treatment to systemic therapy for onychomycosis but efficacy rates, especially in moderate and severe cases have been poor. The aim of this study was to assess laser therapy clearing in all degrees of severity.
Methods: Thirty-two patients with mycologically proven onychomycosis received three laser treatments with a long pulse ND:YAG 1064nm laser. The proximal clear zones (PCZ), onychomycosis severity index (OSI) and responses to standardized nail quality of life (Nail Q of L) questions were recorded. The patients were followed for one year at 9 week intervals while using a tolnaftate in oil topical antifungal after the laser treatments were completed.
Results: The PCZ improved an average of 3.46mms (p<.05), OSI improved an average of 54.6% (p<.05) while the 15.8% improvement in the Nail Q of L responses was found to be not statistically significant.
Conclusions: Severe total dystrophic type of onychomycosis improves significantly with laser therapy. Clinically measuring the onychomycosis severity index and proximal clear zone can help to guide management of an infection that can only improve one mm per month over 9-12 months. Satisfaction surveys should not be performed frequently but may yield significant results if limited to baseline and after one complete nail growth cycle. This study found improvement in both PCZ and OSI with the 1064 YAG laser and it encourages further research combining the laser and either pulsed oral or continuous topical antifungal therapies.
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NewsBot · Apr 6, 2017

Clinical laser treatment of toenail onychomycoses.
Zalacain A et al
Lasers Med Sci. 2017 Apr 4. doi: 10.1007/s10103-017-2198-6.

Onychomycoses are fungal infections of the fingernails or toenails having a prevalence of 3% among adults and accounts for 50% of nail infections. It is caused by dermatophytes, non-dermatophyte filamentous fungi, and yeasts. Compressions and microtraumas significantly contribute to onychomycosis. Laser and photodynamic therapies are being proposed to treat onychomycosis. Laser light (1064 nm) was used to treat onychomycosis in 156 affected toenails. Patients were clinically followed up for 9 months after treatment. Microbiological detection of fungal presence in lesions was accomplished. A total of 116 samples allowed the isolation of at least a fungus. Most of nails were affected in more than two thirds surface (some of them in the full surface). In 85% of cases, after 18 months of the onset of treatment, culture turned negative. After 3 months months, only five patients were completely symptom-free with negative culture. In 25 patients, only after 6 months, the absence of symptoms was achieved and the cultures negativized; in 29 patients, 9 months were required. No noticeable adverse effects were reported. This study reinforces previous works suggesting the applicability of laser therapies to treat toenail onychomycosis.
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NewsBot · Jul 4, 2017

A Retrospective Study of Non-thermal Laser Therapy for the Treatment of Toenail Onychomycosis.
Zang K et al
J Clin Aesthet Dermatol. 2017 May;10(5):24-30

Objective: The objective of this study was to assess the efficacy of non-thermal laser therapy for treating toenail onychomycosis. Design: This retrospective study analyzed the results of three nonrandomized, open-label studies. The device used was a 635nm/405nm dual-diode laser. Affected toenails were treated for 12 minutes weekly for 2 or 4 weeks. Setting: Treatments occurred in clinic and private office settings. Participants: Subjects with onychomycosis-infected toenails were enrolled. Measurements: Fifty great toenails were included in the analysis based on visually identifiable onychomycosis; thickened, discolored nail plate; and confirmed etiology of onychomycosis. Changes in the extent of clear nail bed was measured using multi-platform image manipulation software. The primary outcome measure was the percent of toenails attaining ≥3mm of clear nail growth during the six-month post-treatment period. Overall study success was defined as ≥60 percent of treated toenails meeting the individual success criteria. The secondary outcome measure was change in the length of clear nail bed. Results: Most treated toenails (67%) achieved individual treatment success. The extent of clear nail at baseline increased by a mean of 5.18 (4.76) mm after 6 months (p<0.0001). In addition, 89 percent of treated toenails demonstrated an increase in clear nail across the six-month study period. 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 following one weekly treatment for four week
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NewsBot · Oct 19, 2017

Clinical trials of lasers for toenail onychomycosis: The implications of new regulatory guidance.
Gupta AK et al
J Dermatolog Treat. 2017 May;28(3):264-270. doi: 10.1080/09546634.2016.1214670.

BACKGROUND:
Despite the fact that lasers are presently indicated for the cosmetic outcome "temporary increase in clear nail", these devices are increasingly used to treat onychomycosis and particularly in patients who are unwilling or unable to take oral antifungal medication. The US Food and Drug Administration (FDA) recently issued draft guidance for medical device trials for onychomycosis.
OBJECTIVE:
This review evaluates the quality of laser trials for onychomycosis and compares the design guidelines for medical devices and antifungal drugs.
METHOD:
The PubMed database up to 29 May 2015 was searched for clinical studies of laser treatment for onychomycosis.
RESULTS:
The evidence demonstrating that lasers eradicate pathogenic fungi is limited and published laser trials suffer from limitations such as incomplete reporting of randomization and lack of stratified analyzes for fingernail/toenail data and infecting organisms. Differences in inclusion criteria and efficacy outcomes between drug and device guidelines may prevent the comparison of results from device and drug trials.
CONCLUSION:
We propose the standardization of device guidelines to match those of antifungal drug trials. Patients and physicians need to be aware of the capabilities and limitations of laser treatment for onychomycosis.
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NewsBot · Oct 19, 2017

Real-World Efficacy of 1064-nm Nd:YAG Laser for the Treatment of Onychomycosis.
Rivers JK et al
J Cutan Med Surg. 2017 Mar/Apr;21(2):108-113. doi: 10.1177/1203475416676804

BACKGROUND:
Onychomycosis is a cosmetic and, at times, medical concern; therefore, effective and safe alternatives to treatment are needed.
OBJECTIVE:
To determine the efficacy of a 1064-nm Nd:YAG laser for the treatment of onychomycosis in a real-world setting.
METHODS:
A single-centre retrospective chart review was conducted between 2012 and 2013. One hundred consecutive patients with a culture- and/or potassium hydroxide-confirmed diagnosis of onychomycosis were treated at least twice. Baseline and follow-up photographs were taken, and the change in degree of clinical nail involvement of the subject's great toenail was determined by a blinded reviewer using validated planimetry measurement.
RESULTS:
A total of 199 hallux nails from 100 subjects were assessed. The mean infected area decreased from 53.2% at baseline to 50.8% at the end of the study (paired t test, P = .054; Wilcoxon signed rank test, P = .006). Degree of nail involvement was statistically significantly associated with amount of improvement; subjects who had the greatest degree of nail involvement improved the most, while those with less severe disease showed a worsening of nail appearance (Kruskal-Wallis test, P < .001). Three-quarters (72.6%) of nails that had more than 67% nail involvement showed statistically significant improvement (χ2 test, P = .001). Adverse events were limited to mild to moderate pain at the time of therapy. A total of 76 subjects were assessed for treatment satisfaction: 60% were very satisfied with treatment despite limited clinical improvement in some cases.
CONCLUSIONS:
Laser therapy has a very limited positive clinical effect on the appearance of onychomycosis after 2 treatment sessions.
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NewsBot · Jun 18, 2018

Clinical laser treatment of toenail onychomycoses.
Zalacain A et al
Lasers Med Sci. 2018 May;33(4):927-933.

Onychomycoses are fungal infections of the fingernails or toenails having a prevalence of 3% among adults and accounts for 50% of nail infections. It is caused by dermatophytes, non-dermatophyte filamentous fungi, and yeasts. Compressions and microtraumas significantly contribute to onychomycosis. Laser and photodynamic therapies are being proposed to treat onychomycosis. Laser light (1064 nm) was used to treat onychomycosis in 156 affected toenails. Patients were clinically followed up for 9 months after treatment. Microbiological detection of fungal presence in lesions was accomplished. A total of 116 samples allowed the isolation of at least a fungus. Most of nails were affected in more than two thirds surface (some of them in the full surface). In 85% of cases, after 18 months of the onset of treatment, culture turned negative. After 3 months months, only five patients were completely symptom-free with negative culture. In 25 patients, only after 6 months, the absence of symptoms was achieved and the cultures negativized; in 29 patients, 9 months were required. No noticeable adverse effects were reported. This study reinforces previous works suggesting the applicability of laser therapies to treat toenail onychomycosis.
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NewsBot · Jun 22, 2018

From Podiatry Today:
Revisiting Laser Treatment: Does It Have A Viable Role In Onychomycosis Treatment?

NewsBot · Dec 3, 2019

Laser treatment for onychomycosis
A systematic review and meta-analysis
Ma, Weiwei MD, MMed, (Derm); Si, Chenchen MD, MMed, (Derm); Kasyanju Carrero, Lorna Martin MD, MMed, (Derm); Liu, Hou-Fang MD, MMed, (Derm); Yin, Xu-Feng MD, MMed, (Derm); Liu, Juan MD, MMed, (Derm); Xu, Yang MD, PhD; Zhou, Bingrong MD, PhD
Medicine: November 2019 - Volume 98 - Issue 48 - p e17948

Background: Laser systems are a common treatment choice for onychomycosis. They exert their effects on inhibiting the growth of the fungus by selective photothermolysis but efficacy is dependent on the specific type of apparatus used. To systematically review the available published literature on the curative effects and safety of laser treatment for onychomycosis.

Methods: Databases including PubMed, web of science, China National Knowledge Internet (CNKI), WanFang Database and VIP were searched systematically to identify relevant articles published up to July 2018. Potentially relevant articles were sourced, assessed against eligibility criteria by 2 researchers independently and data were extracted from included studies. A meta-analysis was performed using R software.

Results: Thirty-five articles involving 1723 patients and 4278 infected nails were included. Meta-analysis of data extracted from these studies revealed that: the overall mycological cure rate was 63.0% (95%CI 0.53-0.73); the mycological cure rate associated with the 1064-nm Nd: YAG laser was 63.0% (95%CI 0.51-0.74); and that of CO2 lasers was 74.0% (95%CI 0.37-0.98). The published data indicate that laser treatment is relatively safe, but can cause tolerable pain and occasionally lead to bleeding after treatment.

Conclusion: Laser treatment of onychomycosis is effective and safe. The cumulative cure rate of laser treatment was significantly higher for CO2 lasers than other types of laser. Laser practitioners should be made aware of potential adverse effects such as pain and bleeding.
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NewsBot · Apr 26, 2020

Laser therapy for onychomycosis in patients with diabetes at risk for foot ulcers: a randomized, quadruple-blind, sham-controlled trial (LASER-1).
Nijenhuis-Rosien L et al
J Eur Acad Dermatol Venereol. 2019 Nov;33(11):2143-2150

BACKGROUND:
Patients with diabetes mellitus are at high risk for onychomycosis, which is related to the development of foot ulcers.

OBJECTIVE:
The aim of this study was to evaluate the safety and efficacy of the treatment of onychomycosis with local laser therapy.

METHODS:
In a single-centre, randomized (1:1), quadruple-blind, sham-controlled trial, patients and microbiological confirmation with diabetes mellitus, at risk for developing diabetic foot ulcers (Sims classification score 1, 2) and a clinical suspicion on onychomycosis, were randomized to either four sessions neodymium-doped yttrium aluminium garnet (Nd-YAG) 1064 nm laser or sham treatment. The primary outcome was clinical and microbiological cure of onychomycosis after 1-year follow-up.

RESULTS:
From March 2015 to July 2016, 64 patients were randomized; 63 could be analysed. Trichophyton rubrum was the most detected pathogen. There was no difference in the primary outcome between laser and sham treatment. With the exception of a subungual haematoma in the fifth toenail occurring 2 weeks after laser treatment, the results suggested that treatment with Nd-YAG 1064 nm laser is safe.

CONCLUSION:
At this moment, there is no evidence of any effect of laser treatment for onychomycosis in patients with diabetes at increased risk for foot ulcers, at least not within 1 year after treatment.
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