Comparison of visual assessments versus planimetry assessments in a large-scale clinical trial of onychomycosis

Gupta, Aditya K.; Cooper, Elizabeth A.

doi:10.3109/09546634.2012.697990

Cited by 4 publications

(3 citation statements)

References 7 publications

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“…9,11,14 Also, from our experience, our patients would not have tolerated higher fluence because of significant discomfort at the fluences used (6-8 J/cm 2 ). The absence of planimetry to measure the primary outcome is also a limitation but, as evaluated in the study by Gupta and Cooper, 15 comparison showed good statistical agreement of visual and planimetry measures.…”

Section: Discussionmentioning

confidence: 99%

A Randomized, Double-Blind, Controlled Trial Evaluating the Efficacy of Nd:YAG 1064 nm Short-Pulse Laser Compared With Placebo in the Treatment of Toenail Onychomycosis

et al. 2019

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Introduction: Laser and light-based therapies have emerged as interesting treatment options with minimal side effects or contraindications to treat onychomycosis. Although increasing reports of successful treatment exist, few randomized, controlled, prospective studies have evaluated their true efficacy. We conducted a prospective, randomized, double-blind, controlled trial to evaluate the cure rate of onychomycosis treated by laser. Methods: Fifty-one patients were randomized to receive 3 treatments (0, 12, 24 weeks) of 1064 Nd:YAG short-pulse (Cutera GenesisPlus) laser or placebo sham laser. The primary efficacy end point is the proportion of patients with a complete cure rate of the target great toenail at week 52. The secondary efficacy end points, at week 52, were treatment success defined as almost clear nail (≤ 10%) and negative mycology, completely or almost clear nail of the great toenail, negative mycology, improvement from one OSI severity class to another of the target toenail, and the difference in proximal nail plate clearance between baseline and week 52. Results: No patient (0%) in the laser group and 2 patients (7.7%) in the placebo group reached the primary outcome. One patient (4.8%) in the laser group reached treatment success vs 2 (7.7%) in the placebo group. Only 6 patients (33%) had negative cultures in the laser group vs 11 (50%) in the placebo group. None of the secondary end points were met. Conclusions: This study demonstrated that 3 treatments of Nd:YAG 1064 nm laser at 3-month intervals were not effective to treat onychomycosis.

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Section: Discussionmentioning

confidence: 99%

A Randomized, Double-Blind, Controlled Trial Evaluating the Efficacy of Nd:YAG 1064 nm Short-Pulse Laser Compared With Placebo in the Treatment of Toenail Onychomycosis

et al. 2019

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“…In this study, onychomycosis severity and follow‐up of clinical evolution of in treated patients could be quantified using an image analysis program. To reduce errors using the visual estimation when determining onychomycosis treatment efficacy, 17‐19 several methods have been previously described 20,21 . However, they are time consuming or require access to sophisticated software, rarely available for dermatologists who deal with onychomycosis in routine.…”

Section: Discussionmentioning

confidence: 99%

Severe onychomycosis management with oral terbinafine in a kidney transplantation setting: Clinical follow‐up by image analysis

Moreno-Sabater

Ouali

Chasset

et al. 2020

Mycoses

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Background Severe onychomycosis treatment in kidney transplant recipients (KTR) is challenging because of drug interactions and adverse events. Tacrolimus remains the antirejection treatment (ART) of choice in kidney transplantation but tolerance with systemic terbinafine for the management of severe onychomycosis has not been studied. Objective This study illustrates severe onychomycosis management in a kidney transplantation setting and investigates systemic terbinafine tolerance profile in KTR. Patients/Methods We retrospective analysed clinical data of KTR with a confirmed diagnosis of severe onychomycosis. Results We retrieved a total of 29 KTR with severe onychomycosis needing an oral treatment to manage onychomycosis. In 55.1% (16/29) KTR, altered renal biological parameters or lack of guidelines to manage severe onychomycosis were the main reasons to deterring clinicians from prescribing oral treatments. 13 patients received an oral terbinafine treatment (9, 3 and 1 with a tacrolimus, cyclosporine and everolimus‐based ART, respectively). Clinical and biological follow‐up did not reveal severe drug interactions. ART blood levels showed significant variations in 2 patients without clinical consequences in renal graft. Two patients reported mild adverse events but after only one dose of terbinafine. Using an open‐source image analysis program, clinical evolution of onychomycosis could be retrospectively quantified and followed up. Conclusions The results presented here suggest that oral terbinafine can be proposed to treat severe onychomycosis with an acceptable tolerance profile in KTR with different ART such as tacrolimus and highlight the need of multicentric studies to establish guidelines for onychomycosis treatment in KTR.

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“…History and clinical evaluation are not sufficient to make the diagnosis of onychomycosis, and empiric treatment of presumed onychomycosis may lead to lower than expected cure rates and missed diagnoses. A diagnosis based solely on physical examination/clinical signs can be incorrect, and various laboratory assessments would be useful for confirmation …”

Section: Differential Diagnosis Of Onychomycosismentioning

confidence: 99%

Examining the importance of laboratory and diagnostic testing when treating and diagnosing onychomycosis

et al. 2017

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Onychomycosis is a fungal nail infection caused primarily by dermatophytes. Several other nail disorders, including psoriasis, can simulate onychomycosis. Accurate diagnosis is therefore vital for the ongoing treatment and management of onychomycosis and to avoid misdiagnosis and treatment delay, which can be both lengthy and costly. Often, a combination of histologic and laboratory techniques is used to obtain an accurate diagnosis. The potential diagnostic challenges associated with the differential diagnosis of onychomycosis caused by dermatophytes and the most common techniques used to confirm the diagnosis are discussed.

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Comparison of visual assessments versus planimetry assessments in a large-scale clinical trial of onychomycosis

Abstract: The results suggest that objective measures such as planimetry will reduce the impact of visual assessment errors, and techniques to increase the standardization of onychomycosis assessment are warranted.

Cited by 4 publications

References 7 publications

A Randomized, Double-Blind, Controlled Trial Evaluating the Efficacy of Nd:YAG 1064 nm Short-Pulse Laser Compared With Placebo in the Treatment of Toenail Onychomycosis

A Randomized, Double-Blind, Controlled Trial Evaluating the Efficacy of Nd:YAG 1064 nm Short-Pulse Laser Compared With Placebo in the Treatment of Toenail Onychomycosis

Severe onychomycosis management with oral terbinafine in a kidney transplantation setting: Clinical follow‐up by image analysis

Examining the importance of laboratory and diagnostic testing when treating and diagnosing onychomycosis

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