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Marlis Sarkany - One of the best experts on this subject based on the ideXlab platform.
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A pilot, layerwise, ex vivo evaluation of the antifungal efficacy of Amorolfine 5% nail lacquer vs other topical antifungal nail formulations in healthy toenails.
Mycoses, 2019Co-Authors: Mahmoud A. Ghannoum, Lisa Long, Gernot Kunze, Marlis Sarkany, Hanan Osman-ponchetAbstract:Background Studies investigating the penetration of Amorolfine through the nail have shown the highest concentration in the uppermost layer and measurable antifungal activity even in the lower layers of the nail. Objectives This pilot, ex vivo study compared the penetration of antifungal concentrations of Amorolfine 5% nail lacquer in different layers of healthy, human cadaver toenails with that of terbinafine 10% nail solution, ciclopirox 8% nail lacquer and naftifine 1% nail solution. Moreover, the effect of nail filing prior to application on the penetration of Amorolfine 5% was assessed. Methods Unfiled (n = 3) and filed (n = 3) nails were used for each antimycotic agent and Amorolfine 5% nail lacquer, respectively. Twenty-four hours after topical application, the nails were sliced (10 μm), solubilised and added to agar plates seeded with Trichophyton rubrum. Zones of growth inhibition were measured. Results Only Amorolfine penetrated the nails at sufficient concentrations to inhibit growth of T rubrum at different nail depths. In contrast, the comparators did not show antifungal efficacy. Nail filing resulted in larger zones of inhibition for Amorolfine compared with those of intact nails. Conclusions Unlike its comparators, a single application of Amorolfine 5% nail lacquer resulted in antifungal efficacy within the nail plate. Nail filing increased the antifungal efficacy of Amorolfine 5% nail lacquer.
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Patient-reported outcomes from two randomised studies comparing once-weekly application of Amorolfine 5% nail lacquer to other methods of topical treatment in distal and lateral subungual onychomycosis.
Mycoses, 2017Co-Authors: Martin Schaller, Bardur Sigurgeirsson, Marlis SarkanyAbstract:Summary Patient adherence is a key consideration in the choice of a topical regimen for the treatment of onychomycosis. The objective of this study was to investigate patient-reported outcomes (treatment utilisation, adherence and satisfaction) in onychomycosis treated with once-weekly Amorolfine 5% nail lacquer versus once-daily ciclopirox 8% nail lacquer (Study A) or once-daily urea 40% ointment/bifonazole 1% cream combination regimen (Study B). Study A: Subjects received Amorolfine and ciclopirox on opposite feet for 12 weeks. Study B: Subjects received Amorolfine and urea/bifonazole on opposite feet for 6-7 weeks. Assessments included subject adherence as per label, treatment preference and questionnaire. Study A: More subjects adhered to Amorolfine (85%) than to ciclopirox (60%) (P = .025). Overall, subjects were satisfied (95% vs 100%, respectively) and the treatments were balanced in terms of preference (50% vs 45%) at week 12. Study B: More subjects adhered to Amorolfine dosage (81.8%) than to the dosage of the urea/bifonazole combination regimen (59.1%) (P = .096). At the end of study, 85.7% of subjects preferred Amorolfine versus 14.3% for urea/bifonazole. Fewer subjects experienced local side effects with Amorolfine (4.5%) compared to urea (27.3%) and bifonazole (15%). Amorolfine 5% nail lacquer offers a simple and convenient treatment option, which may result in improved patient adherence and consequently lead to improved efficacy and patient satisfaction.
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Amorolfine 5% Nail Lacquer Exhibits Potent Antifungal Activity Compared to Three Acid-Based Devices Indicated for the Treatment of Onychomycosis: An In Vitro Nail Penetration Assay
Dermatology and Therapy, 2016Co-Authors: Mahmoud Ghannoum, Karine Sevin, Marlis SarkanyAbstract:Introduction Onychomycosis is the most common infectious disease involving nails. The aim of this study was to evaluate the antifungal activity of Amorolfine 5% nail lacquer and three different acid-based medical devices indicated in the treatment of onychomycosis using an in vitro nail penetration assay. Methods Four products were tested in vitro: (a) Amorolfine 5% nail lacquer; (b) ethyl lactate and acetic acid; (c) citric acid and urea; (d) ethyl lactate, glycerin, lactic acid, and citric acid. Test products were applied to healthy human cadaver nails and allowed to dry. Disks were cut from each piece of nail and placed on seeded agar plates of Trichophyton rubrum. Following incubation at 30 °C, zones of inhibition were measured. Results Amorolfine-treated nails exhibited inhibitory activity against T. rubrum with a mean zone of inhibition of 59.2 mm in diameter. In contrast, all three acid-based medical devices and the untreated controls showed no zones of inhibition (mean effective zones of 0 mm). Conclusion In this in vitro nail penetration model, head-on, comparative study, we showed that Amorolfine 5% nail lacquer possesses potent antifungal activity, whereas no antifungal activity was detected for three commercially available acid-based medical devices under identical assay conditions. Funding Galderma.
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Amorolfine 5% Nail Lacquer Exhibits Potent Antifungal Activity Compared to Three Acid-Based Devices Indicated for the Treatment of Onychomycosis: An In Vitro Nail Penetration Assay
Dermatology and therapy, 2016Co-Authors: Mahmoud A. Ghannoum, Karine Sevin, Marlis SarkanyAbstract:Onychomycosis is the most common infectious disease involving nails. The aim of this study was to evaluate the antifungal activity of Amorolfine 5% nail lacquer and three different acid-based medical devices indicated in the treatment of onychomycosis using an in vitro nail penetration assay. Four products were tested in vitro: (a) Amorolfine 5% nail lacquer; (b) ethyl lactate and acetic acid; (c) citric acid and urea; (d) ethyl lactate, glycerin, lactic acid, and citric acid. Test products were applied to healthy human cadaver nails and allowed to dry. Disks were cut from each piece of nail and placed on seeded agar plates of Trichophyton rubrum. Following incubation at 30 °C, zones of inhibition were measured. Amorolfine-treated nails exhibited inhibitory activity against T. rubrum with a mean zone of inhibition of 59.2 mm in diameter. In contrast, all three acid-based medical devices and the untreated controls showed no zones of inhibition (mean effective zones of 0 mm). In this in vitro nail penetration model, head-on, comparative study, we showed that Amorolfine 5% nail lacquer possesses potent antifungal activity, whereas no antifungal activity was detected for three commercially available acid-based medical devices under identical assay conditions. Galderma.
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Amorolfine 5 nail lacquer exhibits potent antifungal activity compared to three acid based devices indicated for the treatment of onychomycosis an in vitro nail penetration assay
Dermatologic Therapy, 2016Co-Authors: Mahmoud A. Ghannoum, Karine Sevin, Marlis SarkanyAbstract:Introduction Onychomycosis is the most common infectious disease involving nails. The aim of this study was to evaluate the antifungal activity of Amorolfine 5% nail lacquer and three different acid-based medical devices indicated in the treatment of onychomycosis using an in vitro nail penetration assay.
Wenying Cai - One of the best experts on this subject based on the ideXlab platform.
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Comparison of a fractional 2940-nm Er:YAG laser and 5% Amorolfine lacquer combination therapy versus a 5% Amorolfine lacquer monotherapy for the treatment of onychomycosis: a randomized controlled trial.
Lasers in medical science, 2020Co-Authors: Jing Zhang, Yunqing Zhang, Jinglin Qin, Wenying Cai, Huaiqiu Huang, Sulian YangAbstract:Onychomycosis is a fungal infection of the nail. The aim of this randomized controlled clinical trial was to compare the efficacy of 2940-nm Er:YAG laser treatment combined with a 5% Amorolfine lacquer versus Amorolfine monotherapy for treating onychomycosis. In this study, patients with onychomycosis of the great toenail were randomly assigned to a combination therapy group and a monotherapy group. In the combination therapy group, the included toenails were treated with a fractional 2940-nm Er:YAG laser at weeks 1, 2, 3, 4, 8, and 12, combined with a 5% Amorolfine lacquer twice a week for 12 weeks, while in the monotherapy group, the included toenails were treated with only a 5% Amorolfine lacquer twice a week for 12 weeks. The onychomycosis severity index (OSI) score and the mycological clearance rate (MCR) of the included toenails were assessed at baseline, week 12, and week 24. At weeks 12 and 24, the great toenails with mild and moderate onychomycosis in the combination therapy group showed obvious improvement and a greater decrease in OSI than those in the monotherapy group. At week 24, the toenails with mild and moderate onychomycosis in the combination therapy group also showed a better MCR. For the toenails with severe onychomycosis, little improvement was observed in either group at week 12 or week 24. In conclusion, fractional 2940-nm Er:YAG laser treatment combined with a 5% Amorolfine lacquer is more effective than Amorolfine monotherapy in short-term improvement of onychomycosis.
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Combination therapy for onychomycosis using a fractional 2940-nm Er:YAG laser and 5 % Amorolfine lacquer.
Lasers in medical science, 2016Co-Authors: Jing Zhang, Huaiqiu Huang, Wenying CaiAbstract:Onychomycosis remains difficult to cure by traditional methods. The aim of this study was to evaluate the efficacy of combination therapy with a fractional erbium yttrium aluminum garnet (Er:YAG) laser and 5 % Amorolfine lacquer on onychomycosis. Nine patients with bilateral nails affected by distal and lateral subungual onychomycosis were included. The bilateral nails of each patient were divided into two groups. The 20 affected nails on one side of each patient as group 1 were treated with a fractional Er:YAG laser once a week and 5 % Amorolfine lacquer twice weekly, while the 20 nails on the symmetrical side of each patient as group 2 were treated with Amorolfine lacquer only. The laser treatment was conducted at weeks 1, 2, 3, 4, 8, and 12 in group 1. The clinical improvement, onychomycosis severity index (OSI), maximum linear clear nail growth (MLCNG), and mycological cure rate were evaluated. At week 24, 18 of 20 (90 %) nails in group 1 had achieved obvious clinical responses. The mean OSI score showed a significant decrease (5.24) and the average MLCNG was 3.1 mm in group 1. At week 24, 15 of 20 (75 %) nails achieved a negative mycological examination in group 1, compared with four of 20 (20 %) nails in group 2. The treatments were well-tolerated by most patients. This clinical study suggests that combination therapy of a fractional 2940-nm Er:YAG laser and 5 % Amorolfine lacquer is an effective, safe, and convenient treatment method for onychomycosis.
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combination therapy for onychomycosis using a fractional 2940 nm er yag laser and 5 Amorolfine lacquer
Lasers in Medical Science, 2016Co-Authors: Jing Zhang, Huaiqiu Huang, Wenying CaiAbstract:Onychomycosis remains difficult to cure by traditional methods. The aim of this study was to evaluate the efficacy of combination therapy with a fractional erbium yttrium aluminum garnet (Er:YAG) laser and 5 % Amorolfine lacquer on onychomycosis. Nine patients with bilateral nails affected by distal and lateral subungual onychomycosis were included. The bilateral nails of each patient were divided into two groups. The 20 affected nails on one side of each patient as group 1 were treated with a fractional Er:YAG laser once a week and 5 % Amorolfine lacquer twice weekly, while the 20 nails on the symmetrical side of each patient as group 2 were treated with Amorolfine lacquer only. The laser treatment was conducted at weeks 1, 2, 3, 4, 8, and 12 in group 1. The clinical improvement, onychomycosis severity index (OSI), maximum linear clear nail growth (MLCNG), and mycological cure rate were evaluated. At week 24, 18 of 20 (90 %) nails in group 1 had achieved obvious clinical responses. The mean OSI score showed a significant decrease (5.24) and the average MLCNG was 3.1 mm in group 1. At week 24, 15 of 20 (75 %) nails achieved a negative mycological examination in group 1, compared with four of 20 (20 %) nails in group 2. The treatments were well-tolerated by most patients. This clinical study suggests that combination therapy of a fractional 2940-nm Er:YAG laser and 5 % Amorolfine lacquer is an effective, safe, and convenient treatment method for onychomycosis.
Mahmoud A. Ghannoum - One of the best experts on this subject based on the ideXlab platform.
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A pilot, layerwise, ex vivo evaluation of the antifungal efficacy of Amorolfine 5% nail lacquer vs other topical antifungal nail formulations in healthy toenails.
Mycoses, 2019Co-Authors: Mahmoud A. Ghannoum, Lisa Long, Gernot Kunze, Marlis Sarkany, Hanan Osman-ponchetAbstract:Background Studies investigating the penetration of Amorolfine through the nail have shown the highest concentration in the uppermost layer and measurable antifungal activity even in the lower layers of the nail. Objectives This pilot, ex vivo study compared the penetration of antifungal concentrations of Amorolfine 5% nail lacquer in different layers of healthy, human cadaver toenails with that of terbinafine 10% nail solution, ciclopirox 8% nail lacquer and naftifine 1% nail solution. Moreover, the effect of nail filing prior to application on the penetration of Amorolfine 5% was assessed. Methods Unfiled (n = 3) and filed (n = 3) nails were used for each antimycotic agent and Amorolfine 5% nail lacquer, respectively. Twenty-four hours after topical application, the nails were sliced (10 μm), solubilised and added to agar plates seeded with Trichophyton rubrum. Zones of growth inhibition were measured. Results Only Amorolfine penetrated the nails at sufficient concentrations to inhibit growth of T rubrum at different nail depths. In contrast, the comparators did not show antifungal efficacy. Nail filing resulted in larger zones of inhibition for Amorolfine compared with those of intact nails. Conclusions Unlike its comparators, a single application of Amorolfine 5% nail lacquer resulted in antifungal efficacy within the nail plate. Nail filing increased the antifungal efficacy of Amorolfine 5% nail lacquer.
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Application of cosmetic nail varnish does not affect the antifungal efficacy of Amorolfine 5% nail lacquer in the treatment of distal subungual toenail onychomycosis: Results of a randomised active-controlled study and in vitro assays
Mycoses, 2016Co-Authors: Bardur Sigurgeirsson, Hanan Osman-ponchet, Mahmoud A. Ghannoum, N. Kerrouche, F SidouAbstract:As onychomycosis is unsightly, this study clinically evaluated whether the antifungal efficacy of Amorolfine 5% nail lacquer (NL) was affected by a masking, natural-coloured, cosmetic nail varnish applied 24 h later; in vitro investigations were also performed. Subjects with mild-to-moderate distal subungual toenail onychomycosis were randomised to receive Amorolfine 5% NL once weekly with or without cosmetic nail varnish applied 24 h later. After 12-week treatment, antifungal activity of affected toenail clippings was assessed by measurement of zones of inhibition (ZOIs) on Trichophyton mentagrophytes seeded agar plates. Mean diameters were 53.5 mm for the Amorolfine 5% NL-alone group (n = 23) and 53.6 mm for Amorolfine 5% NL plus cosmetic nail varnish group (n = 25). Also, mycological cultures of subungual debris at week 12 were negative for all subjects in both groups. Most subjects (88%) reported that cosmetic nail varnish masked their infected toenails. Additionally, cadaver human nails coated in vitro with or without cosmetic nail varnish 10 min or 24 h post Amorolfine NL application all gave ZOIs on Trichophyton rubrum agar plates representing potent antifungal activity. In conclusion, cosmetic nail varnish applied post Amorolfine had no effect on the subungual antifungal activity of Amorolfine 5% NL or its penetration through toenails.
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Amorolfine 5% Nail Lacquer Exhibits Potent Antifungal Activity Compared to Three Acid-Based Devices Indicated for the Treatment of Onychomycosis: An In Vitro Nail Penetration Assay
Dermatology and therapy, 2016Co-Authors: Mahmoud A. Ghannoum, Karine Sevin, Marlis SarkanyAbstract:Onychomycosis is the most common infectious disease involving nails. The aim of this study was to evaluate the antifungal activity of Amorolfine 5% nail lacquer and three different acid-based medical devices indicated in the treatment of onychomycosis using an in vitro nail penetration assay. Four products were tested in vitro: (a) Amorolfine 5% nail lacquer; (b) ethyl lactate and acetic acid; (c) citric acid and urea; (d) ethyl lactate, glycerin, lactic acid, and citric acid. Test products were applied to healthy human cadaver nails and allowed to dry. Disks were cut from each piece of nail and placed on seeded agar plates of Trichophyton rubrum. Following incubation at 30 °C, zones of inhibition were measured. Amorolfine-treated nails exhibited inhibitory activity against T. rubrum with a mean zone of inhibition of 59.2 mm in diameter. In contrast, all three acid-based medical devices and the untreated controls showed no zones of inhibition (mean effective zones of 0 mm). In this in vitro nail penetration model, head-on, comparative study, we showed that Amorolfine 5% nail lacquer possesses potent antifungal activity, whereas no antifungal activity was detected for three commercially available acid-based medical devices under identical assay conditions. Galderma.
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Amorolfine 5 nail lacquer exhibits potent antifungal activity compared to three acid based devices indicated for the treatment of onychomycosis an in vitro nail penetration assay
Dermatologic Therapy, 2016Co-Authors: Mahmoud A. Ghannoum, Karine Sevin, Marlis SarkanyAbstract:Introduction Onychomycosis is the most common infectious disease involving nails. The aim of this study was to evaluate the antifungal activity of Amorolfine 5% nail lacquer and three different acid-based medical devices indicated in the treatment of onychomycosis using an in vitro nail penetration assay.
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Efficacy, safety and tolerability of topical terbinafine nail solution in patients with mild‐to‐moderate toenail onychomycosis: results from three randomized studies using double‐blind vehicle‐controlled and open‐label active‐controlled designs
Journal of the European Academy of Dermatology and Venereology : JEADV, 2011Co-Authors: Boni E. Elewski, Mahmoud A. Ghannoum, P. Mayser, Aditya K. Gupta, Hans Christian Korting, R. J. Shouey, Diane Baker, Phoebe Rich, M. Ling, S. HugotAbstract:Terbinafine nail solution (TNS) was developed for the treatment of onychomycosis. To assess the efficacy of TNS vs. vehicle and Amorolfine 5% nail lacquer. Subjects with mild-to-moderate toe onychomycosis (25% to ≤75% nail-involvement, matrix uninvolved) were randomized to receive either TNS or vehicle in two double-blind studies, and to TNS or Amorolfine in an active-controlled, open-label study. Primary endpoint was complete cure (no residual clinical involvement and negative mycology) at week 52. Secondary endpoints were mycological cure (negative mycology defined as negative KOH microscopy and negative culture) and clinical effectiveness (≤10% residual-involvement and negative mycology) at week 52. Complete cure was not different between TNS vs. vehicle and Amorolfine. Mycological cure was higher with TNS vs. vehicle, as was clinical effectiveness with TNS vs. vehicle, and TNS and Amorolfine were not different for secondary efficacy endpoints. Patients achieving mycological cure had a better clinical outcome, and efficacy was improved in subjects with milder disease. Post hoc analysis suggests that nail thickness is an important prognostic factor. Moreover, mycological cure may require 6 months of treatment regimen while complete cure and clinical effectiveness may be achievable only after 10 months. A simulation study suggests that longer treatment duration would have resulted in higher complete cure with TNS vs. vehicle. Study treatments were well-tolerated. Primary efficacy objectives were not met in the studies reported herein. Possible reasons for failure to achieve significant outcomes include insufficient length of treatment; stringency of primary endpoint and severity of nail involvement of study population. © 2011 The Authors. Journal of the European Academy of Dermatology and Venereology © 2011 European Academy of Dermatology and Venereology.
Jing Zhang - One of the best experts on this subject based on the ideXlab platform.
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Comparison of a fractional 2940-nm Er:YAG laser and 5% Amorolfine lacquer combination therapy versus a 5% Amorolfine lacquer monotherapy for the treatment of onychomycosis: a randomized controlled trial.
Lasers in medical science, 2020Co-Authors: Jing Zhang, Yunqing Zhang, Jinglin Qin, Wenying Cai, Huaiqiu Huang, Sulian YangAbstract:Onychomycosis is a fungal infection of the nail. The aim of this randomized controlled clinical trial was to compare the efficacy of 2940-nm Er:YAG laser treatment combined with a 5% Amorolfine lacquer versus Amorolfine monotherapy for treating onychomycosis. In this study, patients with onychomycosis of the great toenail were randomly assigned to a combination therapy group and a monotherapy group. In the combination therapy group, the included toenails were treated with a fractional 2940-nm Er:YAG laser at weeks 1, 2, 3, 4, 8, and 12, combined with a 5% Amorolfine lacquer twice a week for 12 weeks, while in the monotherapy group, the included toenails were treated with only a 5% Amorolfine lacquer twice a week for 12 weeks. The onychomycosis severity index (OSI) score and the mycological clearance rate (MCR) of the included toenails were assessed at baseline, week 12, and week 24. At weeks 12 and 24, the great toenails with mild and moderate onychomycosis in the combination therapy group showed obvious improvement and a greater decrease in OSI than those in the monotherapy group. At week 24, the toenails with mild and moderate onychomycosis in the combination therapy group also showed a better MCR. For the toenails with severe onychomycosis, little improvement was observed in either group at week 12 or week 24. In conclusion, fractional 2940-nm Er:YAG laser treatment combined with a 5% Amorolfine lacquer is more effective than Amorolfine monotherapy in short-term improvement of onychomycosis.
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Combination therapy for onychomycosis using a fractional 2940-nm Er:YAG laser and 5 % Amorolfine lacquer.
Lasers in medical science, 2016Co-Authors: Jing Zhang, Huaiqiu Huang, Wenying CaiAbstract:Onychomycosis remains difficult to cure by traditional methods. The aim of this study was to evaluate the efficacy of combination therapy with a fractional erbium yttrium aluminum garnet (Er:YAG) laser and 5 % Amorolfine lacquer on onychomycosis. Nine patients with bilateral nails affected by distal and lateral subungual onychomycosis were included. The bilateral nails of each patient were divided into two groups. The 20 affected nails on one side of each patient as group 1 were treated with a fractional Er:YAG laser once a week and 5 % Amorolfine lacquer twice weekly, while the 20 nails on the symmetrical side of each patient as group 2 were treated with Amorolfine lacquer only. The laser treatment was conducted at weeks 1, 2, 3, 4, 8, and 12 in group 1. The clinical improvement, onychomycosis severity index (OSI), maximum linear clear nail growth (MLCNG), and mycological cure rate were evaluated. At week 24, 18 of 20 (90 %) nails in group 1 had achieved obvious clinical responses. The mean OSI score showed a significant decrease (5.24) and the average MLCNG was 3.1 mm in group 1. At week 24, 15 of 20 (75 %) nails achieved a negative mycological examination in group 1, compared with four of 20 (20 %) nails in group 2. The treatments were well-tolerated by most patients. This clinical study suggests that combination therapy of a fractional 2940-nm Er:YAG laser and 5 % Amorolfine lacquer is an effective, safe, and convenient treatment method for onychomycosis.
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combination therapy for onychomycosis using a fractional 2940 nm er yag laser and 5 Amorolfine lacquer
Lasers in Medical Science, 2016Co-Authors: Jing Zhang, Huaiqiu Huang, Wenying CaiAbstract:Onychomycosis remains difficult to cure by traditional methods. The aim of this study was to evaluate the efficacy of combination therapy with a fractional erbium yttrium aluminum garnet (Er:YAG) laser and 5 % Amorolfine lacquer on onychomycosis. Nine patients with bilateral nails affected by distal and lateral subungual onychomycosis were included. The bilateral nails of each patient were divided into two groups. The 20 affected nails on one side of each patient as group 1 were treated with a fractional Er:YAG laser once a week and 5 % Amorolfine lacquer twice weekly, while the 20 nails on the symmetrical side of each patient as group 2 were treated with Amorolfine lacquer only. The laser treatment was conducted at weeks 1, 2, 3, 4, 8, and 12 in group 1. The clinical improvement, onychomycosis severity index (OSI), maximum linear clear nail growth (MLCNG), and mycological cure rate were evaluated. At week 24, 18 of 20 (90 %) nails in group 1 had achieved obvious clinical responses. The mean OSI score showed a significant decrease (5.24) and the average MLCNG was 3.1 mm in group 1. At week 24, 15 of 20 (75 %) nails achieved a negative mycological examination in group 1, compared with four of 20 (20 %) nails in group 2. The treatments were well-tolerated by most patients. This clinical study suggests that combination therapy of a fractional 2940-nm Er:YAG laser and 5 % Amorolfine lacquer is an effective, safe, and convenient treatment method for onychomycosis.
Janne J. Jokinen - One of the best experts on this subject based on the ideXlab platform.
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Efficacy of topical resin lacquer, Amorolfine and oral terbinafine for treating toenail onychomycosis: a prospective, randomized, controlled, investigator‐blinded, parallel‐group clinical trial
The British journal of dermatology, 2015Co-Authors: Tommi Auvinen, Raine Tiihonen, M. Soini, M. Wangel, Arno Sipponen, Janne J. JokinenAbstract:Norway spruce (Picea abies) produces resin to protect against decomposition by microbial pathogens. In vitro tests have shown that spruce resin has antifungal properties against dermatophytes known to cause nearly 90% of onychomycosis in humans. To confirm previous in vivo observations that a topical resin lacquer provides mycological and clinical efficacy, and to compare this lacquer with topical Amorolfine hydrochloride lacquer and systemic terbinafine for treating dermatophyte toenail onychomycosis. In this prospective, randomized, controlled, investigator-blinded study, 73 patients with onychomycosis were randomized to receive topical 30% resin lacquer once daily for 9 months, topical 5% Amorolfine lacquer once weekly for 9 months, or 250 mg oral terbinafine once daily for 3 months. The primary outcome measure was complete mycological cure at 10 months. Secondary outcomes were clinical efficacy, cost-effectiveness and patient compliance. At 10 months, complete mycological cure rates with the resin, Amorolfine and terbinafine treatments were 13% [95% confidence interval (CI) 0-28], 8% (95% CI 0-19) and 56% (95% CI 35-77), respectively (P ≤ 0·002). At 10 months, clinical responses were complete in four patients (16%) treated with terbinafine, and partial in seven (30%), seven (28%) and nine (36%) patients treated with resin, Amorolfine and terbinafine, respectively (P < 0·05). Resin, Amorolfine and terbinafine treatments cost €41·6, €56·3 and €52·1, respectively, per patient (P < 0·001). Topical 30% resin lacquer and topical 5% Amorolfine lacquer provided similar efficacy for treating dermatophyte toenail onychomycosis. However, orally administered terbinafine was significantly more effective in terms of mycological cure and clinical outcome than either topical therapy at the 10-month follow-up. © 2015 British Association of Dermatologists.
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efficacy of topical resin lacquer Amorolfine and oral terbinafine for treating toenail onychomycosis a prospective randomized controlled investigator blinded parallel group clinical trial
British Journal of Dermatology, 2015Co-Authors: Tommi Auvinen, Raine Tiihonen, M. Soini, M. Wangel, Arno Sipponen, Janne J. JokinenAbstract:Summary Background Norway spruce (Picea abies) produces resin to protect against decomposition by microbial pathogens. In vitro tests have shown that spruce resin has antifungal properties against dermatophytes known to cause nearly 90% of onychomycosis in humans. Objectives To confirm previous in vivo observations that a topical resin lacquer provides mycological and clinical efficacy, and to compare this lacquer with topical Amorolfine hydrochloride lacquer and systemic terbinafine for treating dermatophyte toenail onychomycosis. Methods In this prospective, randomized, controlled, investigator-blinded study, 73 patients with onychomycosis were randomized to receive topical 30% resin lacquer once daily for 9 months, topical 5% Amorolfine lacquer once weekly for 9 months, or 250 mg oral terbinafine once daily for 3 months. The primary outcome measure was complete mycological cure at 10 months. Secondary outcomes were clinical efficacy, cost-effectiveness and patient compliance. Results At 10 months, complete mycological cure rates with the resin, Amorolfine and terbinafine treatments were 13% [95% confidence interval (CI) 0–28], 8% (95% CI 0–19) and 56% (95% CI 35–77), respectively (P ≤ 0·002). At 10 months, clinical responses were complete in four patients (16%) treated with terbinafine, and partial in seven (30%), seven (28%) and nine (36%) patients treated with resin, Amorolfine and terbinafine, respectively (P < 0·05). Resin, Amorolfine and terbinafine treatments cost €41·6, €56·3 and €52·1, respectively, per patient (P < 0·001). Conclusions Topical 30% resin lacquer and topical 5% Amorolfine lacquer provided similar efficacy for treating dermatophyte toenail onychomycosis. However, orally administered terbinafine was significantly more effective in terms of mycological cure and clinical outcome than either topical therapy at the 10-month follow-up.
