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
Background Terbinafine nail solution (TNS) was developed for the treatment of onychomycosis. Objective To assess the efficacy of TNS vs. vehicle and amorolfine 5% nail lacquer. Methods Subjects with mild‐to‐moderate toe onychomycosis (25% to ≤75% nail‐involvement, matrix uninvolved) were randomiz...
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| Published in | Journal of the European Academy of Dermatology and Venereology Vol. 27; no. 3; pp. 287 - 294 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Oxford, UK
Blackwell Publishing Ltd
01.03.2013
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| Subjects | |
| Online Access | Get full text |
| ISSN | 0926-9959 1468-3083 1468-3083 |
| DOI | 10.1111/j.1468-3083.2011.04373.x |
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| Abstract | Background Terbinafine nail solution (TNS) was developed for the treatment of onychomycosis.
Objective To assess the efficacy of TNS vs. vehicle and amorolfine 5% nail lacquer.
Methods 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.
Results 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.
Conclusion 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. |
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| AbstractList | Background Terbinafine nail solution (TNS) was developed for the treatment of onychomycosis.
Objective To assess the efficacy of TNS vs. vehicle and amorolfine 5% nail lacquer.
Methods 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.
Results 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.
Conclusion 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. Background Terbinafine nail solution (TNS) was developed for the treatment of onychomycosis. Objective To assess the efficacy of TNS vs. vehicle and amorolfine 5% nail lacquer. Methods 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. Results 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. Conclusion 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. Background Terbinafine nail solution (TNS) was developed for the treatment of onychomycosis. Objective To assess the efficacy of TNS vs. vehicle and amorolfine 5% nail lacquer. Methods Subjects with mild-to-moderate toe onychomycosis (25% to less than or equal 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 ( less than or equal to 10% residual-involvement and negative mycology) at week 52. Results 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 6months of treatment regimen while complete cure and clinical effectiveness may be achievable only after 10months. A simulation study suggests that longer treatment duration would have resulted in higher complete cure with TNS vs. vehicle. Study treatments were well-tolerated. Conclusion 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. Terbinafine nail solution (TNS) was developed for the treatment of onychomycosis.BACKGROUNDTerbinafine nail solution (TNS) was developed for the treatment of onychomycosis.To assess the efficacy of TNS vs. vehicle and amorolfine 5% nail lacquer.OBJECTIVETo 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.METHODSSubjects 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.RESULTSComplete 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.CONCLUSIONPrimary 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. 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. |
| Author | Elewski, B.E. Nyirady, J. Korting, H.-C. Shouey, R.J. Hugot, S. Sigurgeirsson, B. Parneix-Spake, A. Baker, D.R. Rich, P.A. Thangavelu, K. Damaj, B. Ghannoum, M.A. Ling, M. Mayser, P. Gupta, A.K. Notter, M. |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/22181693$$D View this record in MEDLINE/PubMed |
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| Notes | ark:/67375/WNG-FZ954DRX-5 ArticleID:JDV4373 istex:A88F6E0A739D4C8FFC2ACCC77B02A85F63368899 Conflict of interest H.C. Korting has previously collaborated with Novartis in the development of topicals containing terbinafine, and with Galderma concerning amorolfin‐containing preparations. Drs’. P. Mayser, R. Shouey, A. Gupta and B. Sigurgeirsson have no conflict of interests. S. Hugot, M. Notter, K. Thangavelu, A. Parneix‐Spake and J. Nyirady are employees of Novartis. Drs’ B.E. Elewski, P. Rich and M. Ling have received research grant fund from Novartis for the performing of the study. Dr B. Damaj is an employee of NexMed (USA), Inc. Dr D. Baker was a principal investigator at one of the research sites. Dr M. Ghannoum has accepted as a consultant for Novartis Pharmaceuticals. Funding sources Novartis Pharma AG, Basel, Switzerland. ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 23 ObjectType-Article-1 ObjectType-Feature-2 |
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| PublicationTitle | Journal of the European Academy of Dermatology and Venereology |
| PublicationTitleAlternate | J Eur Acad Dermatol Venereol |
| PublicationYear | 2013 |
| Publisher | Blackwell Publishing Ltd |
| Publisher_xml | – name: Blackwell Publishing Ltd |
| References | Ghannoum MA, Chaturvedi V, Espinel-Ingroff A et al. Intra- and interlaboratory study of a method for testing the antifungal susceptibilities of dermatophytes. J Clin Microbiol 2004; 42: 2977-2979. CLSI. Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi; Approved Standard, 2nd edn. CLSI, Wayne, PA, 2008. CLSI document M38-A2 [ISBN 1-56238-668-9]. Schwartz RA, Janniger CK. Onychomycosis. Cutis 1996; 57: 67-74. Gupta AK, Konnikov N, MacDonald P et al. Prevalence and epidemiology of toenail onychomycosis in diabetic subjects: a multicentre survey. Br J Dermatol 1998; 139: 665-671. Roberts DT. Prevalence of dermatophyte onychomycosis in the United Kingdom: results of an omnibus survey. Br J Dermatol 1992; 126(Suppl 39): 23-27. Sais G, Jucglà A, Peyrí J. Prevalence of dermatophyte onychomycosis in Spain: a cross-sectional study. Br J Dermatol 1995; 132: 758-761. Elewski BE. A full "cure" for onychomycosis is not always possible. Arch Dermatol 1999; 135: 852-853. Gupta AK, Ryder JE, Johnson AM. Cumulative meta-analysis of systemic antifungal agents for the treatment of onychomycosis. Br J Dermatol 2004; 150: 537-544. Werschler WP, Bondar G, Armstrong D. Assessing treatment outcomes in toenail onychomycosis clinical trials. Am J Clin Dermatol 2004; 5: 145-152. Elewski BE, Charif MA. Prevalence of onychomycosis in patients attending a dermatology clinic in northeastern Ohio for other conditions. Arch Dermatol 1997; 133: 1172-1173. Gupta AK, Jain HC, Lynde CW, Watteel GN, Summerbell RC. Prevalence and epidemiology of unsuspected onychomycosis in patients visiting dermatologists' offices in Ontario, Canada - a multicenter survey of 2001 patients. Int J Dermatol 1997; 36: 783-787. Gupta AK, Lynch LE, Kogan N, Cooper EA. The use of an intermittent terbinafine regimen for the treatment of dermatophyte toenail onychomycosis. J Eur Acad Dermatol Venereol 2009; 23: 256-262. Sigurgeirsson B. Prognostic factors for cure following treatment of onychomycosis. J Eur Acad Dermatol Venereol 2010; 24: 679-684. Finch JJ, Warshaw EM. Toenail onychomycosis: current and future treatment options. Dermatol Ther 2007; 20: 31-46. Gupta AK, Baran R. Ciclopirox nail lacquer solution 8% in the 21st century. J Am Acad Dermatol 2000; 43: S96-S102. Lauharanta J. Comparative efficacy and safety of amorolfine nail lacquer 2% versus 5% once weekly. Clin Exp Dermatol 1992; 17(Suppl 1): 41-43. Gupta AK, Fleckman P, Baran R. Ciclopirox nail lacquer topical solution 8% in the treatment of toenail onychomycosis. J Am Acad Dermatol 2000; 43: S70-S80. Burkhart CN, Burkhart CG, Gupta AK. Dermatophytoma: recalcitrance to treatment because of existence of fungal biofilm. J Am Acad Dermatol 2002; 47: 629-631. Schafer-Korting M, Schoellmann C, Korting HC. Fungicidal activity plus reservoir effect allow short treatment courses with terbinafine in tinea pedis. Skin Pharmacol Physiol 2008; 21: 203-210. De Cuyper C, Hindryckx PH. Long-term outcomes in the treatment of toenail onychomycosis. Br J Dermatol 1999; 141(Suppl 56): 15-20. Svejgaard EL, Nilsson J. Onychomycosis in Denmark: prevalence of fungal nailinfection in general practice. Mycoses 2004; 47: 131-135. Ghannoum MA, Wraith LA, Cai B, Nyirady J, Isham N. Susceptibility of dermatophyte isolates obtained from a large worldwide terbinafine tinea capitis clinical trial. Br J Dermatol 2008; 159: 711-713. Paus RPS, Sundberg JP. In Bonognia JL, Jorizzo JL eds. Biology of Hair and Nails. Dermatology, 2nd edn. Elsevier, Amsterdam, 2008: 965-986. Baran R, Sigurgeirsson B, de Berker D et al. A multicentre, randomized, controlled study of the efficacy, safety and cost-effectiveness of a combination therapy with amorolfine nail lacquer and oral terbinafine compared with oral terbinafine alone for the treatment of onychomycosis with matrix involvement. Br J Dermatol 2007; 157: 149-157. Hay RJ. The future of onychomycosis therapy may involve a combination of approaches. Br J Dermatol 2001; 145(Suppl 60): 3-8. Poulin Y, Thomas R, Gupta AK. Brief treatment guide for onychomycosis. J Cutan Med Surg 2006; 10(Suppl 2): S39-S43. Prescrire R. Fungal nail infections: diagnosis and management. Prescrire Int 2009; 18: 26-30. Roberts DT. Onychomycosis: current treatment and future challenges. Br J Dermatol 1999; 141(Suppl 56): 1-4. Jaiswal A, Sharma RP, Garg AP. An open randomized comparative study to test the efficacy and safety of oral terbinafine pulse as a monotherapy and in combination with topical ciclopirox olamine 8% or topical amorolfine hydrochloride 5% in the treatment of onychomycosis. Indian J Dermatol Venereol Leprol 2007; 73: 393-396. Roberts DT. Prevalence of derm atophyte onychomycosis in the United Kingdom: results of an omnibus survey. Br J Dermatol 1992; 126: 23-27. Baran R, Kaoukhov A. Topical antifungal drugs for the treatment of onychomycosis: an overview of current strategies for monotherapy and combination therapy. J Eur Acad Dermatol Venereol 2005; 19: 21-29. Sigurgeirsson B, Elewski BE, Rich PA et al. Intermittent versus continuous terbinafine in the treatment of toenail onychomycosis: a randomized, double-blind comparison. J Dermatolog Treat 2006; 17: 38-44. Pierard GE, Pierard-Franchimont C. The nail under fungal siege in patients with type II diabetes mellitus. Mycoses 2005; 48: 339-342. Heikkilä H, Stubb S. The prevalence of onychomycosis in Finland. Br J Dermatol 1995; 133: 699-703. Epstein E. How often does oral treatment of toenail onychomycosis produce a disease-free nail? An analysis of published data. Arch Dermatol 1998; 134: 1551-1554. Sigurgeirsson B, Steingrímsson O, Sveinsdóttir S. Prevalence of onychomycosis in Iceland: a population-based study. Acta Derm Venereol 2002; 82: 467-469. Kumar S, Kimball AB. New antifungal therapies for the treatment of onychomycosis. Expert Opin Investig Drugs 2009; 18: 727-734. Gupta AK, De Doncker P, Scher RK et al. Itraconazole for the treatment of onychomycosis. Int J Dermatol 1998; 37: 303-308. Drake LA, Scher RK, Smith EB et al. Effect of onychomycosis on quality of life. J Am Acad Dermatol 1998; 38: 702-704. Elewski BE. Onychomycosis treatment, quality of life, and economic issues. Am J Clin Dermatol 2000; 1: 19-26. Reinel D. Topical treatment of onychomycosis with amorolfine 5% nail lacquer: comparative efficacy and tolerability of once and twice weekly use. Dermatology 1992; 184(Suppl 1): 21-24. Turner RR. Testa MA. Measuring the impact of onychomycosis on patient quality of life. Qual Life Res 2000; 9: 39-53. Ghannoum MA, Long L, Pfister WR. Determination of the efficacy of terbinafine hydrochloride nail solution in the topical treatment of dermatophytosis in a guinea pig model. Mycoses 2009; 52: 35-43. Bauer P, Rohmel J. An adaptive method for establishing a dose-response relationship. Stat Med 1995; 14: 1595-1607. Claveau J, Vender RB, Gupta AK. Multitherapy approach to onychomycosis therapy. J Cutan Med Surg 2006; 10(Suppl 2): S44-S47. Petranyi G, Ryder NS, Stutz A. Allylamine derivatives: new class of synthetic antifungal agents inhibiting fungal squalene epoxidase. Science 1984; 224: 1239-1241. Scher RK, Tavakkol A, Sigurgeirsson B et al. Onychomycosis: diagnosis and definition of cure. J Am Acad Dermatol 2007; 56: 939-944. 2009; 23 2004; 42 2001; 145 1992; 184 1984; 224 2006; 10 1995; 14 2004; 47 2000; 43 2000; 9 2006; 17 1997; 133 1992; 126 1992; 17 2008 1999; 141 2004; 5 2002; 82 2000; 1 1995; 133 1998; 139 2007; 73 2005; 48 1995; 132 1996; 57 2007; 56 1998; 134 1998; 38 1998; 37 2002; 47 2007; 157 2005; 19 2009; 52 2010; 24 1997; 36 2004; 150 2008; 21 1999; 135 2008; 159 2007; 20 2009; 18 e_1_2_8_27_2 e_1_2_8_28_2 e_1_2_8_49_2 e_1_2_8_29_2 e_1_2_8_23_2 e_1_2_8_46_2 e_1_2_8_24_2 e_1_2_8_45_2 e_1_2_8_25_2 e_1_2_8_48_2 e_1_2_8_26_2 e_1_2_8_47_2 Schwartz RA (e_1_2_8_22_2) 1996; 57 e_1_2_8_9_2 e_1_2_8_2_2 e_1_2_8_4_2 e_1_2_8_3_2 e_1_2_8_6_2 e_1_2_8_5_2 e_1_2_8_8_2 e_1_2_8_7_2 e_1_2_8_42_2 e_1_2_8_20_2 e_1_2_8_41_2 e_1_2_8_21_2 e_1_2_8_44_2 e_1_2_8_43_2 e_1_2_8_40_2 CLSI (e_1_2_8_33_2) 2008 e_1_2_8_39_2 e_1_2_8_17_2 e_1_2_8_38_2 e_1_2_8_18_2 e_1_2_8_12_2 e_1_2_8_35_2 e_1_2_8_13_2 e_1_2_8_34_2 e_1_2_8_14_2 e_1_2_8_37_2 e_1_2_8_15_2 e_1_2_8_36_2 Prescrire R (e_1_2_8_16_2) 2009; 18 e_1_2_8_31_2 e_1_2_8_30_2 e_1_2_8_10_2 e_1_2_8_11_2 e_1_2_8_32_2 Paus RPS (e_1_2_8_19_2) 2008 |
| References_xml | – reference: Drake LA, Scher RK, Smith EB et al. Effect of onychomycosis on quality of life. J Am Acad Dermatol 1998; 38: 702-704. – reference: Gupta AK, Ryder JE, Johnson AM. Cumulative meta-analysis of systemic antifungal agents for the treatment of onychomycosis. Br J Dermatol 2004; 150: 537-544. – reference: Elewski BE. A full "cure" for onychomycosis is not always possible. Arch Dermatol 1999; 135: 852-853. – reference: Epstein E. How often does oral treatment of toenail onychomycosis produce a disease-free nail? An analysis of published data. Arch Dermatol 1998; 134: 1551-1554. – reference: Ghannoum MA, Long L, Pfister WR. Determination of the efficacy of terbinafine hydrochloride nail solution in the topical treatment of dermatophytosis in a guinea pig model. Mycoses 2009; 52: 35-43. – reference: Schwartz RA, Janniger CK. Onychomycosis. Cutis 1996; 57: 67-74. – reference: Roberts DT. Onychomycosis: current treatment and future challenges. Br J Dermatol 1999; 141(Suppl 56): 1-4. – reference: Elewski BE. Onychomycosis treatment, quality of life, and economic issues. Am J Clin Dermatol 2000; 1: 19-26. – reference: Jaiswal A, Sharma RP, Garg AP. An open randomized comparative study to test the efficacy and safety of oral terbinafine pulse as a monotherapy and in combination with topical ciclopirox olamine 8% or topical amorolfine hydrochloride 5% in the treatment of onychomycosis. Indian J Dermatol Venereol Leprol 2007; 73: 393-396. – reference: Sigurgeirsson B. Prognostic factors for cure following treatment of onychomycosis. J Eur Acad Dermatol Venereol 2010; 24: 679-684. – reference: Baran R, Kaoukhov A. Topical antifungal drugs for the treatment of onychomycosis: an overview of current strategies for monotherapy and combination therapy. J Eur Acad Dermatol Venereol 2005; 19: 21-29. – reference: Svejgaard EL, Nilsson J. Onychomycosis in Denmark: prevalence of fungal nailinfection in general practice. Mycoses 2004; 47: 131-135. – reference: Petranyi G, Ryder NS, Stutz A. Allylamine derivatives: new class of synthetic antifungal agents inhibiting fungal squalene epoxidase. Science 1984; 224: 1239-1241. – reference: De Cuyper C, Hindryckx PH. Long-term outcomes in the treatment of toenail onychomycosis. Br J Dermatol 1999; 141(Suppl 56): 15-20. – reference: Heikkilä H, Stubb S. The prevalence of onychomycosis in Finland. Br J Dermatol 1995; 133: 699-703. – reference: Gupta AK, Konnikov N, MacDonald P et al. Prevalence and epidemiology of toenail onychomycosis in diabetic subjects: a multicentre survey. Br J Dermatol 1998; 139: 665-671. – reference: Roberts DT. Prevalence of derm atophyte onychomycosis in the United Kingdom: results of an omnibus survey. Br J Dermatol 1992; 126: 23-27. – reference: Burkhart CN, Burkhart CG, Gupta AK. Dermatophytoma: recalcitrance to treatment because of existence of fungal biofilm. J Am Acad Dermatol 2002; 47: 629-631. – reference: Hay RJ. The future of onychomycosis therapy may involve a combination of approaches. Br J Dermatol 2001; 145(Suppl 60): 3-8. – reference: Reinel D. Topical treatment of onychomycosis with amorolfine 5% nail lacquer: comparative efficacy and tolerability of once and twice weekly use. Dermatology 1992; 184(Suppl 1): 21-24. – reference: Pierard GE, Pierard-Franchimont C. The nail under fungal siege in patients with type II diabetes mellitus. Mycoses 2005; 48: 339-342. – reference: Lauharanta J. Comparative efficacy and safety of amorolfine nail lacquer 2% versus 5% once weekly. Clin Exp Dermatol 1992; 17(Suppl 1): 41-43. – reference: Baran R, Sigurgeirsson B, de Berker D et al. A multicentre, randomized, controlled study of the efficacy, safety and cost-effectiveness of a combination therapy with amorolfine nail lacquer and oral terbinafine compared with oral terbinafine alone for the treatment of onychomycosis with matrix involvement. Br J Dermatol 2007; 157: 149-157. – reference: Sigurgeirsson B, Elewski BE, Rich PA et al. Intermittent versus continuous terbinafine in the treatment of toenail onychomycosis: a randomized, double-blind comparison. J Dermatolog Treat 2006; 17: 38-44. – reference: Prescrire R. Fungal nail infections: diagnosis and management. Prescrire Int 2009; 18: 26-30. – reference: Bauer P, Rohmel J. An adaptive method for establishing a dose-response relationship. Stat Med 1995; 14: 1595-1607. – reference: Kumar S, Kimball AB. New antifungal therapies for the treatment of onychomycosis. Expert Opin Investig Drugs 2009; 18: 727-734. – reference: Roberts DT. Prevalence of dermatophyte onychomycosis in the United Kingdom: results of an omnibus survey. Br J Dermatol 1992; 126(Suppl 39): 23-27. – reference: Gupta AK, Baran R. Ciclopirox nail lacquer solution 8% in the 21st century. J Am Acad Dermatol 2000; 43: S96-S102. – reference: Werschler WP, Bondar G, Armstrong D. Assessing treatment outcomes in toenail onychomycosis clinical trials. Am J Clin Dermatol 2004; 5: 145-152. – reference: Paus RPS, Sundberg JP. In Bonognia JL, Jorizzo JL eds. Biology of Hair and Nails. Dermatology, 2nd edn. Elsevier, Amsterdam, 2008: 965-986. – reference: Schafer-Korting M, Schoellmann C, Korting HC. Fungicidal activity plus reservoir effect allow short treatment courses with terbinafine in tinea pedis. Skin Pharmacol Physiol 2008; 21: 203-210. – reference: CLSI. Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi; Approved Standard, 2nd edn. CLSI, Wayne, PA, 2008. CLSI document M38-A2 [ISBN 1-56238-668-9]. – reference: Scher RK, Tavakkol A, Sigurgeirsson B et al. Onychomycosis: diagnosis and definition of cure. J Am Acad Dermatol 2007; 56: 939-944. – reference: Elewski BE, Charif MA. Prevalence of onychomycosis in patients attending a dermatology clinic in northeastern Ohio for other conditions. Arch Dermatol 1997; 133: 1172-1173. – reference: Turner RR. Testa MA. Measuring the impact of onychomycosis on patient quality of life. Qual Life Res 2000; 9: 39-53. – reference: Finch JJ, Warshaw EM. Toenail onychomycosis: current and future treatment options. Dermatol Ther 2007; 20: 31-46. – reference: Gupta AK, Lynch LE, Kogan N, Cooper EA. The use of an intermittent terbinafine regimen for the treatment of dermatophyte toenail onychomycosis. J Eur Acad Dermatol Venereol 2009; 23: 256-262. – reference: Ghannoum MA, Chaturvedi V, Espinel-Ingroff A et al. Intra- and interlaboratory study of a method for testing the antifungal susceptibilities of dermatophytes. J Clin Microbiol 2004; 42: 2977-2979. – reference: Sigurgeirsson B, Steingrímsson O, Sveinsdóttir S. Prevalence of onychomycosis in Iceland: a population-based study. Acta Derm Venereol 2002; 82: 467-469. – reference: Gupta AK, Jain HC, Lynde CW, Watteel GN, Summerbell RC. Prevalence and epidemiology of unsuspected onychomycosis in patients visiting dermatologists' offices in Ontario, Canada - a multicenter survey of 2001 patients. Int J Dermatol 1997; 36: 783-787. – reference: Poulin Y, Thomas R, Gupta AK. Brief treatment guide for onychomycosis. J Cutan Med Surg 2006; 10(Suppl 2): S39-S43. – reference: Ghannoum MA, Wraith LA, Cai B, Nyirady J, Isham N. Susceptibility of dermatophyte isolates obtained from a large worldwide terbinafine tinea capitis clinical trial. Br J Dermatol 2008; 159: 711-713. – reference: Claveau J, Vender RB, Gupta AK. Multitherapy approach to onychomycosis therapy. J Cutan Med Surg 2006; 10(Suppl 2): S44-S47. – reference: Gupta AK, De Doncker P, Scher RK et al. Itraconazole for the treatment of onychomycosis. Int J Dermatol 1998; 37: 303-308. – reference: Sais G, Jucglà A, Peyrí J. Prevalence of dermatophyte onychomycosis in Spain: a cross-sectional study. Br J Dermatol 1995; 132: 758-761. – reference: Gupta AK, Fleckman P, Baran R. Ciclopirox nail lacquer topical solution 8% in the treatment of toenail onychomycosis. 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| Snippet | Background Terbinafine nail solution (TNS) was developed for the treatment of onychomycosis.
Objective To assess the efficacy of TNS vs. vehicle and... Background Terbinafine nail solution (TNS) was developed for the treatment of onychomycosis. Objective To assess the efficacy of TNS vs. vehicle and... Terbinafine nail solution (TNS) was developed for the treatment of onychomycosis. To assess the efficacy of TNS vs. vehicle and amorolfine 5% nail lacquer.... Background Terbinafine nail solution (TNS) was developed for the treatment of onychomycosis. Objective To assess the efficacy of TNS vs. vehicle and amorolfine... Terbinafine nail solution (TNS) was developed for the treatment of onychomycosis.BACKGROUNDTerbinafine nail solution (TNS) was developed for the treatment of... |
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| SubjectTerms | Administration, Topical Adolescent Adult Aged Amorolfine Antifungal Agents - administration & dosage Antifungal Agents - adverse effects Antifungal Agents - therapeutic use Child Double-Blind Method Female Humans Male Middle Aged Nail Diseases - drug therapy Naphthalenes - administration & dosage Naphthalenes - adverse effects Naphthalenes - therapeutic use Onychomycosis - drug therapy Randomized Controlled Trials as Topic Young Adult |
| Title | 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 |
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