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Aditya K Gupta - One of the best experts on this subject based on the ideXlab platform.
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efficacy of lasers for the management of dermatophyte Toenail Onychomycosis
Journal of the American Podiatric Medical Association, 2021Co-Authors: Aditya K Gupta, Maanasa Venkataraman, Emma M QuinlanAbstract: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.
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one size does not fit all the need for individualized treatment based on factors that may affect the therapeutic outcome of efinaconazole 10 solution for the treatment of Toenail Onychomycosis
International Journal of Dermatology, 2021Co-Authors: Aditya K Gupta, Maanasa Venkataraman, Naveen Anbalagan, Eric GueninAbstract:Successful management of Onychomycosis is a challenge because cure rates with most antifungals are relatively low and recurrence rates are high. A drug-based approach by treating the nail alone may not suffice. There are several host-related factors (age, sex, body mass index [BMI], and patient's quality of life), disease-related factors (disease severity, duration, and the number of Toenails affected), and comorbidities (tinea pedis and diabetes) that may affect treatment efficacy. Here, we review the post hoc analyses of the phase III trials of efinaconazole 10% solution that have investigated the impact of these factors on topical therapy for Toenail Onychomycosis. The significant clinical variables that may affect the efficacy of efinaconazole include sex, BMI, disease severity, disease duration, and tinea pedis. As older patients may have slower Toenail growth and more severe, longstanding disease compared with younger patients, they may require longer treatment duration, beyond the 48-week standard regimen. Treatment compliance may need to be discussed for an improved health outcome. Therefore, these prognostic factors need to be carefully evaluated, which may aid in formulating individualized therapy to maximize treatment success.
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monotherapy for Toenail Onychomycosis a systematic review and network meta analysis
British Journal of Dermatology, 2020Co-Authors: Aditya K Gupta, Neil H Shear, Kelly A Foley, Rachel R Mays, Vincent PiguetAbstract:Background Onychomycosis is a fungal infection of the nail caused by dermatophytes, yeasts and nondermatophyte moulds that accounts for approximately 50% of all nail-related disease. Objectives This study aims to assess the effectiveness and safety of monotherapy and combination treatments for Toenail Onychomycosis using a network meta-analysis (NMA). Methods Quality of evidence was assessed using Cochrane-compliant rules and the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach. Efficacy and safety outcomes were compared using a random-effects NMA to estimate pooled odds ratios (ORs) of direct and indirect comparisons among oral and topical treatments (PROSPERO 2015: CRD42018086912). There were not enough eligible combination and device-based therapy trials to include in the NMA. Results Of 77 randomized controlled trials, 26 were included in the ORs (8136 patients). There were no significant inconsistencies between the direct and indirect evidence. Relative effects show that the odds of mycological cure with continuous terbinafine 250 mg or continuous itraconazole 200 mg are significantly greater than topical treatments. Fluconazole, pulse regimens of terbinafine and itraconazole, and topical treatments did not differ significantly in the odds of achieving mycological cure. The ORs of adverse events occurring with oral or topical treatments were not significantly different from each other. For mycological cure, evidence was of moderate or high quality while evidence ranged from very low to high quality for adverse events. Conclusions Our review suggests that oral and topical treatments for Toenail Onychomycosis are safe and effective in producing mycological cure. What's already known about this topic? Topical treatments traditionally have lower success rates than oral treatments. Oral treatments have the advantage of shorter treatment durations, but also present challenges in cases of drug-drug interactions or immunosuppression. A network meta-analysis (NMA) gathers data from indirect evidence to gain confidence about all treatment comparisons and allows for estimation of comparative effects that have not been investigated in head-to-head randomized clinical trials (RCTs). What does this study add? This NMA of efficacy and safety includes all RCTs of oral, topical, combination and device-based treatments for Toenail Onychomycosis, adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement for NMA. The odds of achieving mycological cure with continuous terbinafine 250 mg or continuous itraconazole 200 mg were significantly greater than topical treatments. Fluconazole, pulse regimens of terbinafine and itraconazole, and topical treatments did not differ significantly in the odds of achieving mycological cure.
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a retrospective study comparing k101 nail solution as a monotherapy and in combination with oral terbinafine or itraconazole for the treatment of Toenail Onychomycosis
Skin Appendage Disorders, 2018Co-Authors: Avner Shemer, Aditya K Gupta, Meir Babaev, Renata Farhi, Ralph C Daniel, Aviv BarzilaiAbstract:Background Onychomycosis is a difficult-to-treat fungal infection of the nails. The efficacy of monotherapy is not ideal, and combination therapies provide an alternative that may increase treatment efficacy. Method A retrospective analysis of data from 91 patients was undertaken. Treatment for Toenail Onychomycosis occurred between 2014 and 2016 and consisted of combination therapy with oral terbinafine (250 mg/day for 12 weeks) or itraconazole (3 pulses, 400 mg/day for 7 days) + K101 nail solution daily, or K101 nail solution monotherapy. Efficacy outcomes at 12 and 15 months were analyzed. Results At 12 months, the clinical cure rate for combination of terbinafine + K101 solution was significantly higher than that for K101 monotherapy (p = 0.008). Patients receiving this combination also showed significant improvement in percent of affected nail at 3 months (p = 0.029), while patients receiving itraconazole + K101 solution demonstrated improvement in percent of affected nail at 6 months (p = 0.037). At 15 months, there was no significant difference between treatments for complete, clinical, and mycological cure. Conclusion Combination therapy with oral terbinafine or itraconazole and K101 nail solution results in clearance of infected nail earlier than that with topical K101 alone. These combinations may encourage compliance and be effective for patients with moderate Onychomycosis.
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topical antifungal treatment prevents recurrence of Toenail Onychomycosis following cure
Dermatologic Therapy, 2017Co-Authors: Avner Shemer, Aditya K Gupta, Adaia Kamshov, Meir Babaev, Renata Farhi, Ralph C Daniel, Kelly A FoleyAbstract:Recurrence rates are high for Onychomycosis, with prophylactic topical antifungal use proposed to counter recurrence. Although this is a reasonable action for many clinicians, few studies have been conducted on the efficacy of topical prophylaxis. A retrospective chart review (2010-2015) was conducted in patients receiving oral terbinafine or itraconazole for Toenail Onychomycosis. Following complete cure, a topical antifungal (amorolfine, bifonazole, ciclopirox olamine, or terbinafine spray) was used weekly as prophylaxis. Recurrence was recorded along with patient characteristics including demographics and concomitant medical conditions. Data from 320 patients were collected. Recurrence was significantly lower in patients receiving topical antifungal prophylaxis than in no prophylactic treatment following oral terbinafine (p < .001), but not itraconazole (p = .185). Regardless of oral treatment, the use of topical antifungals as prophylaxis (p < .001) decreased, and the number of affected Toenails (p = .048) and family history of fungal infections (p < .001) increased the likelihood that recurrence would occur. This study supports the use of topical antifungal medications as prophylactic treatment to help prevent recurrence of Toenail Onychomycosis and suggests that those with a family history of fungal infections should be closely monitored.
Kelly A Foley - One of the best experts on this subject based on the ideXlab platform.
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monotherapy for Toenail Onychomycosis a systematic review and network meta analysis
British Journal of Dermatology, 2020Co-Authors: Aditya K Gupta, Neil H Shear, Kelly A Foley, Rachel R Mays, Vincent PiguetAbstract:Background Onychomycosis is a fungal infection of the nail caused by dermatophytes, yeasts and nondermatophyte moulds that accounts for approximately 50% of all nail-related disease. Objectives This study aims to assess the effectiveness and safety of monotherapy and combination treatments for Toenail Onychomycosis using a network meta-analysis (NMA). Methods Quality of evidence was assessed using Cochrane-compliant rules and the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach. Efficacy and safety outcomes were compared using a random-effects NMA to estimate pooled odds ratios (ORs) of direct and indirect comparisons among oral and topical treatments (PROSPERO 2015: CRD42018086912). There were not enough eligible combination and device-based therapy trials to include in the NMA. Results Of 77 randomized controlled trials, 26 were included in the ORs (8136 patients). There were no significant inconsistencies between the direct and indirect evidence. Relative effects show that the odds of mycological cure with continuous terbinafine 250 mg or continuous itraconazole 200 mg are significantly greater than topical treatments. Fluconazole, pulse regimens of terbinafine and itraconazole, and topical treatments did not differ significantly in the odds of achieving mycological cure. The ORs of adverse events occurring with oral or topical treatments were not significantly different from each other. For mycological cure, evidence was of moderate or high quality while evidence ranged from very low to high quality for adverse events. Conclusions Our review suggests that oral and topical treatments for Toenail Onychomycosis are safe and effective in producing mycological cure. What's already known about this topic? Topical treatments traditionally have lower success rates than oral treatments. Oral treatments have the advantage of shorter treatment durations, but also present challenges in cases of drug-drug interactions or immunosuppression. A network meta-analysis (NMA) gathers data from indirect evidence to gain confidence about all treatment comparisons and allows for estimation of comparative effects that have not been investigated in head-to-head randomized clinical trials (RCTs). What does this study add? This NMA of efficacy and safety includes all RCTs of oral, topical, combination and device-based treatments for Toenail Onychomycosis, adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement for NMA. The odds of achieving mycological cure with continuous terbinafine 250 mg or continuous itraconazole 200 mg were significantly greater than topical treatments. Fluconazole, pulse regimens of terbinafine and itraconazole, and topical treatments did not differ significantly in the odds of achieving mycological cure.
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topical antifungal treatment prevents recurrence of Toenail Onychomycosis following cure
Dermatologic Therapy, 2017Co-Authors: Avner Shemer, Aditya K Gupta, Adaia Kamshov, Meir Babaev, Renata Farhi, Ralph C Daniel, Kelly A FoleyAbstract:Recurrence rates are high for Onychomycosis, with prophylactic topical antifungal use proposed to counter recurrence. Although this is a reasonable action for many clinicians, few studies have been conducted on the efficacy of topical prophylaxis. A retrospective chart review (2010-2015) was conducted in patients receiving oral terbinafine or itraconazole for Toenail Onychomycosis. Following complete cure, a topical antifungal (amorolfine, bifonazole, ciclopirox olamine, or terbinafine spray) was used weekly as prophylaxis. Recurrence was recorded along with patient characteristics including demographics and concomitant medical conditions. Data from 320 patients were collected. Recurrence was significantly lower in patients receiving topical antifungal prophylaxis than in no prophylactic treatment following oral terbinafine (p < .001), but not itraconazole (p = .185). Regardless of oral treatment, the use of topical antifungals as prophylaxis (p < .001) decreased, and the number of affected Toenails (p = .048) and family history of fungal infections (p < .001) increased the likelihood that recurrence would occur. This study supports the use of topical antifungal medications as prophylactic treatment to help prevent recurrence of Toenail Onychomycosis and suggests that those with a family history of fungal infections should be closely monitored.
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the prevalence of unsuspected Onychomycosis and its causative organisms in a multicentre canadian sample of 30 000 patients visiting physicians offices
Journal of The European Academy of Dermatology and Venereology, 2016Co-Authors: Aditya K Gupta, Elizabeth A Cooper, Hem C Jain, Deanne Daigle, Kelly A Foley, Gita Gupta, Charles Lynde, Richard C. SummerbellAbstract:Background Onychomycosis is difficult to treat and a concern for many patients. Prevalence estimates of Onychomycosis in North American clinic samples have been higher than what has been reported for general populations. Objective A large, multicentre study was conducted to estimate the prevalence of Toenail Onychomycosis in the Canadian population. Methods Patients were recruited from the offices of three dermatologists and one family physician in Ontario, Canada. Nail samples for mycological testing were obtained from normal and abnormal-looking nails. This sample of 32 193 patients includes our previous published study of 15 000 patients. Results Abnormal nails were observed in 4350 patients. Of these, the prevalence of culture-confirmed Toenail Onychomycosis was estimated to be 6.7% (95% CI, 6.41–6.96%). Following sex and age adjustments for the general population, the estimated prevalence of Toenail Onychomycosis in Canada was 6.4% (95% CI, 6.12%–6.65%). The distribution of fungal organisms in culture-confirmed Onychomycosis was 71.9% dermatophytes, 20.4% non-dermatophyte moulds and 7.6% yeasts. Toenail Onychomycosis was four times more prevalent in those over the age of 60 years than below the age of 60 years. Conclusion The present data highlights that Onychomycosis may be a growing medical concern among ageing patients.
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the prevalence of culture confirmed Toenail Onychomycosis in at risk patient populations
Journal of The European Academy of Dermatology and Venereology, 2015Co-Authors: Aditya K Gupta, Deanne Daigle, Kelly A FoleyAbstract:Onychomycosis is a fungal infection of the nail and is the most common nail affliction in the general population. Certain patient populations are at greater risk of infection and the prevalence of Onychomycosis reported in the literature has yet to be summarized across these at-risk groups. We performed a systematic review of the literature and calculated pooled prevalence estimates of Onychomycosis in at-risk patient populations. The prevalence of dermatophyte Toenail Onychomycosis was as follows: general population 3.22% (3.07, 3.38), children 0.14% (0.11, 0.18), the elderly 10.28% (8.63, 12.18), diabetic patients 8.75% (7.48, 10.21), psoriatic patients 10.22% (8.61, 12.09), HIV positive patients 10.40% (8.02, 13.38), dialysis patients 11.93% (7.11, 19.35) and renal transplant patients 5.17% (1.77, 14.14). Dialysis patients had the highest prevalence of Onychomycosis caused by dermatophytes, elderly individuals had the highest prevalence of Onychomycosis caused by yeasts (6.07%; 95% CI = 3.58, 10.11) and psoriatic patients had the highest prevalence of Onychomycosis caused by non-dermatophyte moulds (2.49%; 95% CI = 1.74, 3.55). An increased prevalence of Onychomycosis in certain patient populations may be attributed to impaired immunity, reduced peripheral circulation and alterations to the nail plate which render these patients more susceptible to infection.
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topical therapy for Toenail Onychomycosis an evidence based review
American Journal of Clinical Dermatology, 2014Co-Authors: Aditya K Gupta, Deanne Daigle, Kelly A FoleyAbstract:Managing Toenail Onychomycosis with topical treatments is challenging. It is difficult for topical medication to penetrate the nail plate, and this is reflected in lower cure rates with topical treatment than with oral treatment. However, oral medications may not be suitable for some patients, because of drug interactions; therefore, topical treatments are critical in managing the disease in certain patient populations. This paper reviews the quality and content of the scientific literature on topical treatments for Toenail Onychomycosis. PubMed, Ovid (Medline and Embase), Scopus, Cochrane library, and clinicaltrials.gov databases were searched for original clinical reports of topical monotherapy for microscopy and/or culture-confirmed Toenail Onychomycosis in adults. Studies were evaluated using an Onychomycosis study quality scale, which was based on the CONSORT guidelines. Twenty-five publications (28 studies) were identified and met the inclusion criteria. Thirteen studies scored high ratings on the quality scale. These were randomized controlled trials or randomized comparative trials. Low-quality studies were nonrandomized, open studies that prevented statistical analysis. Most studies reported clinical and mycological cure. The most variation was observed with reporting outcomes of clinical improvement. Amorolfine, ciclopirox, tavaborole, and efinaconazole produced clinical and mycological cure in patients with mild to moderate Toenail Onychomycosis (<50–65 % nail involvement), with efinaconazole showing the highest rates. Treatments were generally applied daily for 24–48 weeks, with longer treatment and follow-up showing better outcomes. Topical treatment with amorolfine, ciclopirox, tavaborole, or efinaconazole is appropriate for cases of mild to moderate Toenail Onychomycosis due to dermatophyte or mixed dermatophyte/Candida infection.
Vincent Piguet - One of the best experts on this subject based on the ideXlab platform.
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monotherapy for Toenail Onychomycosis a systematic review and network meta analysis
British Journal of Dermatology, 2020Co-Authors: Aditya K Gupta, Neil H Shear, Kelly A Foley, Rachel R Mays, Vincent PiguetAbstract:Background Onychomycosis is a fungal infection of the nail caused by dermatophytes, yeasts and nondermatophyte moulds that accounts for approximately 50% of all nail-related disease. Objectives This study aims to assess the effectiveness and safety of monotherapy and combination treatments for Toenail Onychomycosis using a network meta-analysis (NMA). Methods Quality of evidence was assessed using Cochrane-compliant rules and the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach. Efficacy and safety outcomes were compared using a random-effects NMA to estimate pooled odds ratios (ORs) of direct and indirect comparisons among oral and topical treatments (PROSPERO 2015: CRD42018086912). There were not enough eligible combination and device-based therapy trials to include in the NMA. Results Of 77 randomized controlled trials, 26 were included in the ORs (8136 patients). There were no significant inconsistencies between the direct and indirect evidence. Relative effects show that the odds of mycological cure with continuous terbinafine 250 mg or continuous itraconazole 200 mg are significantly greater than topical treatments. Fluconazole, pulse regimens of terbinafine and itraconazole, and topical treatments did not differ significantly in the odds of achieving mycological cure. The ORs of adverse events occurring with oral or topical treatments were not significantly different from each other. For mycological cure, evidence was of moderate or high quality while evidence ranged from very low to high quality for adverse events. Conclusions Our review suggests that oral and topical treatments for Toenail Onychomycosis are safe and effective in producing mycological cure. What's already known about this topic? Topical treatments traditionally have lower success rates than oral treatments. Oral treatments have the advantage of shorter treatment durations, but also present challenges in cases of drug-drug interactions or immunosuppression. A network meta-analysis (NMA) gathers data from indirect evidence to gain confidence about all treatment comparisons and allows for estimation of comparative effects that have not been investigated in head-to-head randomized clinical trials (RCTs). What does this study add? This NMA of efficacy and safety includes all RCTs of oral, topical, combination and device-based treatments for Toenail Onychomycosis, adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement for NMA. The odds of achieving mycological cure with continuous terbinafine 250 mg or continuous itraconazole 200 mg were significantly greater than topical treatments. Fluconazole, pulse regimens of terbinafine and itraconazole, and topical treatments did not differ significantly in the odds of achieving mycological cure.
Sally E M Bellsyer - One of the best experts on this subject based on the ideXlab platform.
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oral antifungal medication for Toenail Onychomycosis
Cochrane Database of Systematic Reviews, 2017Co-Authors: Sanne Kreijkampkaspers, Kate Hawke, Linda Guo, George Kerin, Sally E M Bellsyer, Parker Magin, Mieke L Van DrielAbstract:Background Fungal infection of the Toenails, also called Onychomycosis, is a common problem that causes damage to the nail's structure and physical appearance. For those severely affected, it can interfere with normal daily activities. Treatment is taken orally or applied topically; however, traditionally topical treatments have low success rates due to the nail's physical properties. Oral treatments also appear to have shorter treatment times and better cure rates. Our review will assist those needing to make an evidence-based choice for treatment. Objectives To assess the effects of oral antifungal treatments for Toenail Onychomycosis. Search methods We searched the following databases up to October 2016: the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We also searched five trials registers and checked the reference lists of included and excluded studies for further references to relevant randomised controlled trials (RCTs). We sought to identify unpublished and ongoing trials by correspondence with authors and by contacting relevant pharmaceutical companies. Selection criteria RCTs comparing oral antifungal treatment to placebo or another oral antifungal treatment in participants with Toenail Onychomycosis, confirmed by one or more positive cultures, direct microscopy of fungal elements, or histological examination of the nail. Data collection and analysis We used standard methodological procedures expected by Cochrane. Main results We included 48 studies involving 10,200 participants. Half the studies took place in more than one centre and were conducted in outpatient dermatology settings. The participants mainly had subungual fungal infection of the Toenails. Study duration ranged from 4 months to 2 years. We assessed one study as being at low risk of bias in all domains and 18 studies as being at high risk of bias in at least one domain. The most common high-risk domain was 'blinding of personnel and participants'. We found high-quality evidence that terbinafine is more effective than placebo for achieving clinical cure (risk ratio (RR) 6.00, 95% confidence interval (CI) 3.96 to 9.08, 8 studies, 1006 participants) and mycological cure (RR 4.53, 95% CI 2.47 to 8.33, 8 studies, 1006 participants). Adverse events amongst terbinafine-treated participants included gastrointestinal symptoms, infections, and headache, but there was probably no significant difference in their risk between the groups (RR 1.13, 95% CI 0.87 to 1.47, 4 studies, 399 participants, moderate-quality evidence). There was high-quality evidence that azoles were more effective than placebo for achieving clinical cure (RR 22.18, 95% CI 12.63 to 38.95, 9 studies, 3440 participants) and mycological cure (RR 5.86, 95% CI 3.23 to 10.62, 9 studies, 3440 participants). There were slightly more adverse events in the azole group (the most common being headache, flu-like symptoms, and nausea), but the difference was probably not significant (RR 1.04, 95% CI 0.97 to 1.12; 9 studies, 3441 participants, moderate-quality evidence). Terbinafine and azoles may lower the recurrence rate when compared, individually, to placebo (RR 0.05, 95% CI 0.01 to 0.38, 1 study, 35 participants; RR 0.55, 95% CI 0.29 to 1.07, 1 study, 26 participants, respectively; both low-quality evidence). There is moderate-quality evidence that terbinafine was probably more effective than azoles for achieving clinical cure (RR 0.82, 95% CI 0.72 to 0.95, 15 studies, 2168 participants) and mycological cure (RR 0.77, 95% CI 0.68 to 0.88, 17 studies, 2544 participants). There was probably no difference in the risk of adverse events (RR 1.00, 95% CI 0.86 to 1.17; 9 studies, 1762 participants, moderate-quality evidence) between the two groups, and there may be no difference in recurrence rate (RR 1.11, 95% CI 0.68 to 1.79, 5 studies, 282 participants, low-quality evidence). Common adverse events in both groups included headache, viral infection, and nausea. Moderate-quality evidence shows that azoles and griseofulvin probably had similar efficacy for achieving clinical cure (RR 0.94, 95% CI 0.45 to 1.96, 5 studies, 222 participants) and mycological cure (RR 0.87, 95% CI 0.50 to 1.51, 5 studies, 222 participants). However, the risk of adverse events was probably higher in the griseofulvin group (RR 2.41, 95% CI 1.56 to 3.73, 2 studies, 143 participants, moderate-quality evidence), with the most common being gastrointestinal disturbance and allergic reaction (in griseofulvin-treated participants) along with nausea and vomiting (in azole-treated participants). Very low-quality evidence means we are uncertain about this comparison's impact on recurrence rate (RR 4.00, 0.26 to 61.76, 1 study, 7 participants). There is low-quality evidence that terbinafine may be more effective than griseofulvin in terms of clinical cure (RR 0.32, 95% CI 0.14 to 0.72, 4 studies, 270 participants) and mycological cure (RR 0.64, 95% CI 0.46 to 0.90, 5 studies, 465 participants), and griseofulvin was associated with a higher risk of adverse events, although this was based on low-quality evidence (RR 2.09, 95% CI 1.15 to 3.82, 2 studies, 100 participants). Common adverse events included headache and stomach problems (in griseofulvin-treated participants) as well as taste loss and nausea (in terbinafine-treated participants). No studies addressed recurrence rate for this comparison. No study addressed quality of life. Authors' conclusions We found high-quality evidence that compared to placebo, terbinafine and azoles are effective treatments for the mycological and clinical cure of Onychomycosis, with moderate-quality evidence of excess harm. However, terbinafine probably leads to better cure rates than azoles with the same risk of adverse events (moderate-quality evidence). Azole and griseofulvin were shown to probably have a similar effect on cure, but more adverse events appeared to occur with the latter (moderate-quality evidence). Terbinafine may improve cure and be associated with fewer adverse effects when compared to griseofulvin (low-quality evidence). Only four comparisons assessed recurrence rate: low-quality evidence found that terbinafine or azoles may lower the recurrence rate when compared to placebo, but there may be no difference between them. Only a limited number of studies reported adverse events, and the severity of the events was not taken into account. Overall, the quality of the evidence varied widely from high to very low depending on the outcome and comparison. The main reasons to downgrade evidence were limitations in study design, such as unclear allocation concealment and randomisation as well as lack of blinding.
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oral antifungal medication for Toenail Onychomycosis protocol
Cochrane Database of Systematic Reviews, 2012Co-Authors: Sanne Kreijkampkaspers, Sally E M Bellsyer, Parker Magin, Mieke L Van DrielAbstract:This is the protocol for a review and there is no abstract. The objectives are as follows: To compare the benefits and harms of oral antifungal treatments for Toenail Onychomycosis.
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oral treatments for Toenail Onychomycosis a systematic review
Archives of Dermatology, 2002Co-Authors: Fay Crawford, Sally E M Bellsyer, Philip Young, Christine Godfrey, R Hart, Elizabeth Brunt, Ian RussellAbstract:Objective To identify and synthesize the evidence for the efficacy of oral treatments for fungal infections of the Toenails. Design Systematic review of randomized controlled trials. Interventions Oral treatments for dermatophyte infections of the Toenails. Main Outcome Measures Cure confirmed by microscopy and culture results in patients with clinically diagnosed fungal infections. Data relating to the clinical cure rates were also extracted from the trials. Results A pooled analysis of 2 trials comparing mycological cure rates from continuous treatment with terbinafine (250 mg/d for 12 weeks) and continuous treatment with itraconazole (200 mg/d for 12 weeks) found a statistically significant difference in 11- and 12-month outcomes in favor of terbinafine (risk difference, −0.23 [95% confidence interval, −0.32 to −0.15]; number needed to treat, 5 [95% confidence interval, 4 to 8]). An analysis of clinical cure rates was not possible because of the diversity of definitions used in researching the effectiveness of oral antifungal drugs for Onychomycosis. Only 3 trials gave a clear definition of clinical cure and presented data for these outcomes. Conclusions There is good evidence that a continuous regimen of terbinafine (250 mg/d) for 3 months is the most effective oral treatment for fungally infected Toenails. Consensus among researchers evaluating oral antifungal drugs for Onychomycosis is needed to establish meaningful definitions of clinical cure. Most trials were funded by the pharmaceutical industry; we found little independent research, and this may have introduced bias to the review.
Jacek C. Szepietowski - One of the best experts on this subject based on the ideXlab platform.
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Factors Influencing Coexistence of Toenail Onychomycosis With Tinea Pedis and Other Dermatomycoses
2013Co-Authors: Jacek C. Szepietowski, Adam Reich, Emilia Garlowska, Marzena Kulig, Eugeniusz BaranAbstract:tions were fingernail Onychomycosis (7.4%), tinea cruris (4.2%), tinea corporis (2.1%), tinea manuum (1.6%), and tinea capitis (0.5%). The presence of concomitant fungal skin infections depended on number of involved Toenails; duration of Onychomycosis; sex, age, and education level; area of residence; and type of isolated fungus. Conclusions: The coexistence of Toenail Onychomycosis with other types of fungal skin infections is a frequent phenomenon. It could be hypothesized that infected Toenails may be a site from which the fungal infections could spread to other body areas. Effective therapy for Onychomycosis might therefore be essential not only to treat the lesional Toenails but also to prevent spreading the infection to other sites of the skin.
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efficacy safety and tolerability of an optimized avulsion technique with onyster 40 urea ointment with plastic dressing ointment compared to bifonazole urea ointment for removal of the clinically infected nail in Toenail Onychomycosis a randomized evaluator blinded controlled study
Dermatology, 2013Co-Authors: M Lahfa, Jacek C. Szepietowski, Antonella Tosti, Bianca Maria Piraccini, C Bulailivideanu, Robert Baran, Jean Paul Ortonne, Bertrand Richert, Vincent Sibaud, H CoubeterguesAbstract:Background: Toenail Onychomycosis is highly prevalent, with 14-28% of people aged 60 or over suffering from the disease. Use of a topical antifungal alone in Toenail Onychomycosis is associated with low cure rates. This may be due to limited penetration of the topical antifungal through the diseased nail. The objective of the present study was to compare two treatment modalities to obtain diseased nail chemical avulsion in Toenail Onychomycosis. Methods: In this European, multicenter, randomized, parallel-group, open-label, active-controlled study, male or female adult patients with distal-lateral or lateral subungual dermatophyte Onychomycosis on at least 12.5% of the great Toenail were randomized either to a 40% urea ointment with plastic dressing group (n = 53) or to a bifonazole-urea ointment group (n = 52). The ointments were applied daily for a maximum of 3 weeks according to the summary of product characteristics. After assessment of infected nail debridement, topical antifungal treatment with bifonazole cream was applied daily in both groups for 8 weeks. 102 patients were evaluated, i.e. 51 in the 40% urea ointment with plastic dressing group and 51 in the bifonazole-urea group. The primary end point was complete removal of the nail plate at day 21 (D21). Secondary end points were: complete cure and mycological cure evaluated at D105. Ease of use and local tolerability were also assessed. Results: Complete removal of the clinically infected target nail plate area, assessed by blinded evaluators, was significantly higher in the 40% urea ointment with plastic dressing group (61.2%) than in the control group (39.2%), showing the superiority of 40% urea ointment with plastic dressing (p = 0.028). The same results were observed in the per-protocol population (63.0 vs. 36.6%; p = 0.014). Complete removal of the infected area assessed by the investigator at D21 showed a significantly higher success rate in patients treated with 40% urea ointment with plastic dressing (86.3%) as compared to patients treated with bifonazole-urea (60.8%), confirming the superiority of 40% urea ointment with plastic dressing (p = 0.004). At D105, the complete cure of Onychomycosis, a criterion combining clinical and mycological assessments, showed a success rate of 27.7% for 40% urea ointment with plastic dressing versus 20.8% for the control group. No statistical difference was observed between the two treatment groups. The number of patients with at least one adverse event was twice as high in the bifonazole-urea group in comparison to the 40% urea ointment with plastic dressing group. Overall assessment of local tolerability by the investigator was considered good/very good in 98.0% of the 40% urea ointment with plastic dressing patients versus 90.4% of the bifonazole-urea patients, at D21, with no significant difference between both groups. Conclusion: This study shows the superiority of 40% urea ointment with plastic dressing to bifonazole-urea ointment for complete removal of the infected target nail assessed by blinded evaluators and by the investigators. Further studies are needed to assess the impact of preliminary chemical nail avulsion on the efficacy of topical treatment of Onychomycosis as assessed by complete cure at 1 year.
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evaluation of quality of life in patients with Toenail Onychomycosis by polish version of an international Onychomycosis specific questionnaire
Journal of The European Academy of Dermatology and Venereology, 2007Co-Authors: Jacek C. Szepietowski, Adam Reich, Emilia Garlowska, Przemyslaw Pacan, Eugeniusz BaranAbstract:Background Onychomycosis is the most frequent nail disease, which could impair the patient's quality of life. Objective The present study was undertaken to evaluate the impact of Toenail Onychomycosis on quality of life among Polish population. Patients and methods Three thousand nine-hundred and four (3904: 2269 females and 1635 males) individuals fulfilled an international Onychomycosis-specific quality-of-life questionnaire consisting of statements regarding social, emotional and symptoms problems. All patients had Toenail Onychomycosis confirmed by the positive direct microscopic examination and/or by the positive mycologic culture. Seven hundred and sixty-seven patients simultaneously had fingernail Onychomycosis. All patients were divided into subgroups according to sex, age, education level, place of living, type of Onychomycosis, number of involved Toenails, fingernails involvement, duration of illness and previously used antimycotic therapy. Results Most of the patients demonstrated significantly reduced quality of life. The degree of life impairment varied between analysed subgroups. Patients with more advanced Toenail Onychomycosis and with fingernail involvement were more seriously affected. Both social and emotional impairments were more pronounced in female than in male patients, although there were no differences according to symptoms. Moreover, patients with better educational level and people living in towns or cities were more emotionally and socially affected by Onychomycosis, although people living in the country or with poorer education level presented with significantly more severe symptoms. Conclusions Toenail Onychomycosis is still a serious medical problem, which can significantly reduce the patient's quality of life.
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Factors Influencing Coexistence of Toenail Onychomycosis With Tinea Pedis and Other Dermatomycoses: A Survey of 2761 Patients
Archives of dermatology, 2006Co-Authors: Jacek C. Szepietowski, Adam Reich, Emilia Garlowska, Marzena Kulig, Eugeniusz BaranAbstract:Objective To evaluate the prevalence and factors influencing the presence of concomitant dermatomycoses in patients with Toenail Onychomycosis. Design Prospective study based on a specially designed questionnaire completed by dermatologists. Patients A total of 2761 patients with Toenail Onychomycosis. Main Outcome Measures The diagnosis of fungal skin infections was confirmed by direct microscopic examination or by culture. Results In 1181 patients (42.8%) with Toenail Onychomycosis, concomitant fungal skin infections were noted. Tinea pedis was the most common and was found in 933 patients (33.8%). Other concomitant fungal skin infections were fingernail Onychomycosis (7.4%), tinea cruris (4.2%), tinea corporis (2.1%), tinea manuum (1.6%), and tinea capitis (0.5%). The presence of concomitant fungal skin infections depended on number of involved Toenails; duration of Onychomycosis; sex, age, and education level; area of residence; and type of isolated fungus. Conclusions The coexistence of Toenail Onychomycosis with other types of fungal skin infections is a frequent phenomenon. It could be hypothesized that infected Toenails may be a site from which the fungal infections could spread to other body areas. Effective therapy for Onychomycosis might therefore be essential not only to treat the lesional Toenails but also to prevent spreading the infection to other sites of the skin.