Treating onychomycosis with the short‐pulsed 1064‐nm‐Nd:<scp>YAG</scp> laser: results of a prospective randomized controlled trial

Karsai, Syrus; Jäger, Michael W.; Oesterhelt, A.; Weiss, Carey I.; Schneider, Stefan W.; Jünger, Michael; Raulin, Christian

doi:10.1111/jdv.13798

Cited by 31 publications

(28 citation statements)

References 17 publications

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“…Mycological cure, as evaluated by microscopy and/or culture, was assessed in 67% (14 of 21) of studies (for lasers in monotherapy see Figs and ). In many studies, results were found to be not significant from control (active comparator, no treatment) or reported only descriptive statistics . Two studies examined mycological cure (negative culture and negative microscopy) using patients as the unit of analysis, with 11% of patients achieving mycological cure ( N = 18) .…”

Section: Resultsmentioning

confidence: 99%

“…In many studies, results were found to be not significant from control (active comparator, no treatment) or reported only descriptive statistics . Two studies examined mycological cure (negative culture and negative microscopy) using patients as the unit of analysis, with 11% of patients achieving mycological cure ( N = 18) . Mycological cure, defined as negative culture alone, was observed in 60% of patients ( N = 52) …”

Section: Resultsmentioning

confidence: 99%

“…Nine randomized controlled trials (RCTs) were incorporated in this review; untreated patients or sham‐treated patients were used in seven studies, and comparators were used in two studies (e.g. oral treatment, broadband light) .…”

Section: Resultsmentioning

confidence: 99%

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A critical review of improvement rates for laser therapy used to treat toenail onychomycosis

Gupta

Versteeg

2017

Acad Dermatol Venereol

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Onychomycosis is a nail infection that is primary caused by dermatophytes. Alternative treatments are needed as current therapies (oral and topical antifungals) have limited effectiveness. Lasers are currently approved by the FDA to temporarily increase the amount of clear nail in onychomycosis patients. Lasers can theoretically elicit fungicidal effects but in practice produce mixed results. This review compared laser-induced improvement rates to FDA-approved indications and traditional onychomycosis treatments. A review of the literature (PubMed, Clinicaltrials.gov, Medline and Embase) was used to locate articles for this review. RCTs, non-randomized, uncontrolled and retrospective studies that included at least one of the following measures were eligible; complete cure, mycological cure, clinical improvement and clinical cure. Mycological cure (negative culture and negative microscopy) was evaluated in two studies using patients as the unit of analysis with an average rate of 11%, increasing to 63% when nails were used as the unit of analysis (three studies). Clinical cure (100% clear nail) was evaluated in six studies with a rate of 13% using nails as the unit of analysis and 13% when patients were used as the unit of analysis (two studies). Clinical improvement (at any time point) was found in 36% of patients (five studies) and 67% of nails (nine studies). Nail clarity as measured by clear nail growth and/or nail plate/bed clearance at 12 weeks was found to be 2.6 mm across onychomycotic nails. Laser studies, to date, provide preliminary evidence of clinical improvement and clear nail growth in toenail onychomycosis, consistent with the FDA clearance for aesthetic endpoints. Laser studies however do not provide efficacy rates for medical endpoints that equate or exceed those found with traditional therapies (oral and topical treatments).

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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A critical review of improvement rates for laser therapy used to treat toenail onychomycosis

Gupta

Versteeg

2017

Acad Dermatol Venereol

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“…When summarizing all of the results of the randomized controlled trials on the laser treatment of onychomycosis published to date [12,17,[20][21][22][23][24][25][26], there are hardly any correlating endpoints that allow for a comparison of the wide range of findings. Thus, no valid conclusions for practical application can be found, in particular because the findings of numerous studies entailed a short follow-up period of 3-6 months [21,22], mycological diagnostics that were inadequate or lacking altogether [12,[21][22][23], an insufficient number of treatment sessions [12] or a study population with inhomogeneous clinical involvement [20] and varying fungal species (dermatophytes, moulds, and yeasts) [12,20], laser apparatuses, treatment parameters [24][25][26], units of analysis (using nails or patients as the unit of analysis), and criteria of efficacy [22,[27][28][29].…”

Section: Discussionmentioning

confidence: 99%

The Energy Density and Treatment Times Are the Main Factors That Affect the Efficacy of Long-Pulsed 1,064-nm Nd:YAG Laser Treatment for Onychomycosis Caused by Trichophyton rubrum

Liu¹,

Zhang²,

Zeng³

et al. 2018

Dermatology

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Background: No optimal regimen exists for the LPNYL (long-pulsed 1,064-nm neodymium:yttrium-aluminum-garnet laser) for treating onychomycosis. Objective: To establish an optimal LPNYL treatment regimen for onychomycosis caused by Trichophyton rubrum (OCTr). Patients and Methods: First, 511 infected nails of 177 patients were treated using LPNYL with orthogonally designed regimens according to various energy densities, spot sizes, pulse widths, and treatment times. The optimal treatment regimen was established by multivariate analysis. Next, 69 patients with 221 infected nails were randomized to receive oral itraconazole (drug group) and the optimal regimen of LPNYL treatment (laser group). The clinical efficacy (CE) and mycological efficacy (ME) were evaluated at 6 and 12 months following the start of treatment, and adverse reactions were recorded in both groups. Results: Both CE and ME were significantly correlated with the energy density (p < 0.05) and treatment times (p < 0.05), but not with the spot size (0.071 0.05), and no significant difference was observed in CE at 12 months between the two groups (p > 0.05). At 6 months, the CE in the laser group was significantly higher than that in the drug group (p < 0.001). Conclusions: LPNYL is effective and safe for treating OCTr. The energy density and treatment times are the main factors that affect the efficacy. The optimal regimen for LPNYL is an energy density of 45 J/cm², pulse width of 35 ms, spot size of 4 mm, frequency of 1 Hz, and 6 treatments with 1-week intervals. Laser treatment has rapid clinical recovery.

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“…It is apparent that a standardized treatment protocol is lacking amongst studies using shorter pulse widths of 0.1 to 0.3 milliseconds, and there are no obvious indications as to the most efficacious combination of treatment parameters. A study ( n = 30) using a 1064 nm Nd:YAG pulsed laser at a pulse width of 0.1 milliseconds and fluence of 25 J/cm 2 achieved an 80% mycological cure rate with 67% complete cure , while a study ( n = 20) using comparable laser parameters (0.1‐millisecond pulse width, 20 J/cm 2 fluence) achieved 0% mycological cure with increased clinical severity . Studies that treated with 0.3‐millisecond pulse widths and 14 to 16 J/cm 2 irradiation similarly show variability in clinical cures ranging from 0% to 51%, with mediocre mycological cures of up to 58% .…”

Section: Photothermal and Photoablative Therapymentioning

confidence: 99%

Light treatments of nail fungal infections

Houang

Perrone

Mawad

et al. 2018

Journal of Biophotonics

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Nail fungal infections are notoriously persistent and difficult to treat which can lead to severe health impacts, particularly in the immunocompromized. Current antifungal treatments, including systemic and topical drugs, are prolonged and do not effectively provide a complete cure. Severe side effects are also associated with systemic antifungals, such as hepatotoxicity. Light treatments of onychomycosis are an emerging therapy that has localized photodynamic, photothermal or photoablative action. These treatments have shown to be an effective alternative to traditional antifungal remedies with comparable or better cure rates achieved in shorter times and without systemic side effects. This report reviews significant clinical and experimental studies in the field, highlighting mechanisms of action and major effects related to light therapy; in particular, the impact of light on fungal genetics.

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Treating onychomycosis with the short‐pulsed 1064‐nm‐Nd:YAG laser: results of a prospective randomized controlled trial

Abstract: The short-pulsed 1064-nm-Nd:YAG laser shows no long-term efficacy as a monotherapy. Its role as an adjuvant therapy should be investigated in upcoming trials.

Cited by 31 publications

References 17 publications

A critical review of improvement rates for laser therapy used to treat toenail onychomycosis

A critical review of improvement rates for laser therapy used to treat toenail onychomycosis

The Energy Density and Treatment Times Are the Main Factors That Affect the Efficacy of Long-Pulsed 1,064-nm Nd:YAG Laser Treatment for Onychomycosis Caused by <b><i>Trichophyton rubrum</i></b>

Light treatments of nail fungal infections

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