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- Author or Editor: Maanasa Venkataraman x
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Background: Onychomycosis is a chronic fungal nail infection caused predominantly by dermatophytes, and less commonly by nondermatophyte molds and Candida species. Onychomycosis treatment includes oral and topical antifungals, the efficacy of which is evaluated through randomized, double-blind, controlled trials for US Food and Drug Administration approval. The primary efficacy measure is complete cure (complete mycologic and clinical cure). The secondary measures are clinical cure (usually ≤10% involvement of target nail) and mycologic cure (negative microscopy and culture). Some lasers are US Food and Drug Administration approved for the mild temporary increase in clear nail; however, some practitioners attempt to use lasers to treat and cure onychomycosis.
Methods: A systematic review of the literature was performed in July of 2020 to evaluate the efficacy rates demonstrated by randomized controlled trials of laser monotherapy for dermatophyte onychomycosis of the great toenail.
Results: Randomized controlled trials assessing the efficacy of laser monotherapy for dermatophyte toenail onychomycosis are limited. Many studies measured cure rates by means of nails instead of patients, and performed only microscopy or culture, not both. Only one included study reported mycologic cure rate in patients as negative light microscopy and culture (0%). The combined clinical cure rates in short- and long-pulsed laser studies were 13.0%–16.7% and 25.9%, respectively. There was no study that reported the complete cure rate; however, one did report treatment success (mycologic cure [negative microscopy and culture] and ≤10% clinical involvement) in nails as 16.7%.
Conclusions: The effectiveness of lasers as a therapeutic intervention for dermatophyte toenail onychomycosis is limited based on complete, mycologic, and clinical cure rates. However, it may be possible to use different treatment parameters or lasers with a different wavelength to increase the efficacy. Lasers could be a potential management option for older patients and onychomycosis patients with coexisting conditions such as diabetes, liver, and/or kidney diseases for whom systemic antifungal agents are contraindicated or have failed.
Background: Onychomycosis is a chronic fungal nail infection caused predominantly by dermatophytes, and less commonly by non-dermatophyte molds (NDMs) and Candida species. Onychomycosis treatment includes oral and topical antifungals, the efficacy of which is evaluated through randomized, double-blinded, controlled trials (RCTs) for USA FDA approval. The primary efficacy measure is complete cure (complete mycological and clinical cure). The secondary measures are clinical cure (usually {less than or equal to}10 % involvement of target nail) and mycological cure (negative microscopy and culture). Some lasers are FDA-approved for the mild temporary increase in clear nail; however, some practitioners attempt to use lasers to treat and cure onychomycosis. Methods: A systematic review of the literature was performed in July 2020 to evaluate the efficacy rates demonstrated by RCTs of laser monotherapy for dermatophyte onychomycosis of the great toenail. Results: RCTs assessing the efficacy of laser monotherapy for dermatophyte toenail onychomycosis are limited. Many studies measured cure rates via nails instead of patients, and performed only microscopy or culture, not both. Only one included study reported mycological cure rate in patients as negative light microscopy and culture (0%). The combined clinical cure rates in short- and long-pulsed laser studies were (13.0-16.7% and 25.9%, respectively). There was no study that reported the complete cure rate, however, one did report treatment success (mycological cure (negative microscopy and culture) and {less than or equal to}10% clinical involvement) in nails as 16.7%. Conclusions: The effectiveness of lasers as a therapeutic intervention for dermatophyte toenail onychomycosis is limited based on complete, mycological, and clinical cure rates. However, it may be possible to use different treatment parameters or lasers with a different wavelength to increase the efficacy. Lasers could be a potential management option for older patients and onychomycosis patients with coexisting conditions such as diabetes, liver and/or kidney diseases for whom systemic antifungal agents are contraindicated or have failed.
Cure Rates of Control Interventions in Randomized Trials of Onychomycosis Treatments
A Systematic Review and Meta-Analysis
Background: The efficacy of antifungals for onychomycosis has been determined in randomized controlled trials (RCTs); interestingly, their control arms have demonstrated some therapeutic effects. These controls constitute either placebos (inert pills) or vehicles (all but the antifungal component of the creams). We sought to determine whether RCT controls exhibited statistically relevant efficacy rates (ie, beyond the placebo effect), whether oral and topical controls differed in their efficacies, and whether the efficacy rates of the controls correlated with those of the active comparator associated with that control.
Methods: All RCTs of oral and topical monotherapies for dermatophyte toenail onychomycosis were identified through a systematic literature search. For the meta-analyses of cure rates, the double arcsine transformation was used. The N – 1 χ2 test was used to determine whether the cure rates significantly differed between topical and oral controls. Correlation was investigated using Kendall rank correlation tests.
Results: The pooled mycological, complete, and clinical cure rates of the control interventions (19 trials) were 9%, 1%, and 6%, respectively. The pooled efficacy rates for oral and topical controls were as follows: mycological cure rate, 7% and 12% (P = .0016); complete cure rate, 1% for both; and clinical cure rate, 4% and 8%, respectively (P = .0033). For oral RCTs, the respective cure rates of the active therapies were not correlated with controls. However, for topical RCTs, as the mycological and clinical cure rates of the active therapy increased, so did those of the topical vehicle associated with the active therapy in question, and vice versa.
Conclusions: The topical vehicle cure rates were often higher than the oral placebo cure rates, likely due to the presence of nonantifungal chemicals (eg, moisturizers, urea) with antifungal and debriding properties, which are not present in oral controls.
