Assessment of Dermatophytosis Treatment Studies: Interpreting the Data

October 2015 | Volume 14 | Issue 10 | Supplement Individual Articles | 48 | Copyright © October 2015

Theodore Rosen MD

Department of Dermatology, Baylor College of Medicine, Houston, TX

patients must be warned about the tenacious nature of some dermatomycoses.


Theodore Rosen MD has received honoraria from the following pharmaceutical companies with respect to participation in advisory board meetings: Anacor, Galderma, Merz, and Valeant.


  1. Borgers M, Degreef H, Cauwenbergh G. Fungal infections of the skin: infection process and antimycotic therapy. Curr Drug Targets. 2005;6(8):849-862.
  2. Watanabe S. Dermatomycosis--classification, etiology, pathogenesis, and treatment. [Article in Japanese]. Nihon Rinsho. 2008;66(12):2285-2289.
  3. Havlickova B, Czaika VA, Friedrich M. Epidemiological trends in skin mycoses worldwide. Mycoses. 2008;51(suppl 4):s2-s15.
  4. Charles AJ. Superficial cutaneous fungal infections in tropical countries. Dermatol Ther. 2009;22(6):550-559.
  5. Panackal AA, Halpern EF, Watson AJ. Cutaneous fungal infections in the United States: Analysis of the National Ambulatory Medical Care Survey (NAMCS) and National Hospital Ambulatory Medical Care Survey (NHAMCS), 1995-2004. Int J Dermatol. 2009;48:704-712.
  6. Pires CA, Cruz NF, Lobato AM, Sousa PO, Carneiro FR, Mendes AM. Clinical, epidemiological, and therapeutic profile of dermatophytosis. An Bras Dermatol. 2014;89(2):259-264.
  7. Seebacher C1, Bouchara JP, Mignon B. Updates on the epidemiology of dermatophyte infections. Mycopathologia. 2008;166(5-6):335-352.
  8. Gupta AK, Daigle D, Foley KA. The prevalence of culture-confirmed toenail onychomycosis in at-risk patient populations. J Eur Acad Dermatol Venereol. 2015;29(6):1039-1044.
  9. Onalan O, Adar A, Keles H, et al. Onychomycosis is associated with subclinical atherosclerosis in patients with diabetes. Vasa. 2015;44(1):59-64.
  10. Rosen T, Friedlander SF, Kircik L, et al. Onychomycosis: epidemiology, diagnosis, and treatment in a changing landscape. J Drugs Dermatol. 2015;14(3):223-233.
  11. Zaias N, Rebell G. Chronic dermatophytosis syndrome due to Trichophyton rubrum. Int J Dermatol. 1996;35(9):614-617.
  12. Scher RK, Rich P, Pariser D, Elewski B. The epidemiology, etiology, and pathophysiology of onychomycosis. Semin Cutan Med Surg. 2013;32(2 suppl 1):s2-s4.
  13. Al Hasan M, Fitzgerald SM, Saoudian M, et al. Dermatology for the practicing allergist: Tinea pedis and its complications. Clin Mol Allergy. 2004;2:5.
  14. Schwinn A, Ebert J, Bröcker EB. Frequency of Trichophytonrubrum in tinea capitis. Mycoses. 1995;38(1-2):1-7.
  15. Yasuda SU, Zhang L, Huang SM. The role of ethnicity in variability in response to drugs: focus on clinical pharmacology studies. Clin Pharmacol Ther. 2008;84(3):417-423.
  16. Gupta AK, Ryder JE, Johnson AM. Cumulative meta-analysis of systemic antifungal agents for the treatment of onychomycosis. Br J Dermatol. 2004;150(3):537-544.
  17. Rotta I, Sanchez A, Gonçalves PR, Otuki MF, Correr CJ. Efficacy and safety of topical antifungals in the treatment of dermatomycosis: a systematic review. Br J Dermatol. 2012;166(5):927-933.
  18. Cohen AD, Medvesovsky E, Shalev R, et al. An independent comparison of terbinafine and itraconazole in the treatment of toenail onychomycosis. J Dermatolog Treat. 2003;14(4):237-242.
  19. Evans EG, Sigurgeirsson B. Double blind, randomised study of continuous terbinafine compared with intermittent itraconazole in treatment of toenail onychomycosis. The LION Study Group. BMJ. 1999;318:1031-1035.
  20. Rotta I, Ziegelmann PK, Otuki MF, Riveros BS, Bernardo NL, Correr CJ. Efficacy of topical antifungals in the treatment of dermatophytosis: a mixed-treatment comparison meta-analysis involving 14 treatments. JAMA Dermatol. 2013;149(3):341-349.
  21. Jarratt M, Jones T, Adelglass J, et al. Efficacy and safety of once-daily luliconazole 1% cream in patients ≥12 years of age with interdigital tinea pedis: a phase 3, randomized, double-blind,vehicle-controlled study. J Drugs Dermatol. 2014;13(7):838-846.
  22. Savin R, Jorizzo J. The safety and efficacy of sertaconazole nitrate cream 2% for tinea pedis. Cutis. 2006;78(4):268-274.
  23. Elewski BE, Vlahovic TC. Econazole nitrate foam 1% for the treatment of tinea pedis: results from two double-blind, vehicle-controlled, phase 3 clinical trials. J Drugs Dermatol. 2014;13(7):803-808.
  24. Stein Gold LF, Parish LC, Vlahovic T, et al. Efficacy and safety of naftifine HCl Gel 2% in the treatment of interdigital and moccasin type tinea pedis: pooled results from two multicenter, randomized, double-blind, vehicle-controlled trials. J Drugs Dermatol. 2013;12(8):911-918.
  25. Parish LC, Parish JL, Routh HB, et al. A randomized, double-blind, vehicle-controlled efficacy and safety study of naftifine 2% cream in the treatment of tinea pedis. J Drugs Dermatol. 2011;10(11):1282-1228.
  26. Elewski BE, Rich P, Pollak R, et al. Efinaconazole 10% solution in the treatment of toenail onychomycosis: Two phase III multicenter, randomized, double- blind studies. J Am Acad Dermatol. 2013;68(4):600-608.
  27. Elewski BE, Aly R, Baldwin SL, et al. Efficacy and safety of tavaborole topical solution, 5%, a novel boron-based antifungal agent, for the treatment of toenail onychomycosis: Results from 2 randomized phase-III studies. J Am Acad Dermatol. 2015;73:62-69.
  28. Gupta AK, Fleckman P, Baran R. Ciclopirox nail lacquer topical solution 8% in the treatment of toenail onychomycosis. J Am Acad Dermatol. 2000;43(suppl 4):s70-s80.
  29. Drake LA, Shear NH, Arlette JP, et al. Oral terbinafine in the treatment of toenail onychomycosis: North American multicenter trial. J Am Acad Dermatol. 1997;37(5 pt 1):740-745.
  30. Odom RB, Aly R, Scher RK, et al. A multicenter, placebo-controlled, double-blind study of intermittent therapy with itraconazole for the treatment of onychomycosis of the fingernail. J Am Acad Dermatol. 1997;36(2 pt 1):231-235.
  31. Elewski BE, Scher RK, Aly R, et al. Double-blind, randomized comparison of itraconazole capsules vs. placebo in the treatment of toenail onychomycosis. Cutis. 1997;59(4):217-220.
  32. Havu V, Brandt H, Heikkilä H, et al. A double-blind, randomized study comparing itraconazole pulse therapy with continuous dosing for the treatment of toe-nail onychomycosis. Br J Dermatol. 1997;136(2):230-234.
  33. Hay RJ, Baran R. Onychomycosis: a proposed revision of the clinical classification. J Am Acad Dermatol. 2011;65(6):1219-1227.
  34. Markinson BC, Caldwell BD. Efinaconazole topical solution, 10%: efficacy in patients with onychomycosis and coexisting tinea pedis. J Am Podiatr Med Assoc. 2015 Apr 13. [Epub ahead of print]
  35. Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials. 1996;17(1):1-12.
  36. Werschler WP, Bondar G, Armstrong D. Assessing treatment outcomes in toenail onychomycosis clinical trials. Am J Clin Dermatol. 2004;5(3):145-152.
  37. Jones TM, Jarratt MT, Mendez-Moguel I, et al. A randomized, multicenter, double-blind, vehicle-controlled study evaluating the efficacy and safety of luliconazole cream 1% once daily for 7 days in patients aged ≥ 12 years with tinea cruris. J Drugs Dermatol. 2014;13(1):32-38
  38. Parish LC, Parish JL, Routh HB, et al. A double-blind, randomized, vehicle-controlled study evaluating the efficacy and safety of naftifine 2% cream in tinea cruris. J Drugs Dermatol. 2011;10(10):1142-1147.
  39. De Cuyper C, Hindryckx PH. Long-term outcomes in the treatment of toenail onychomycosis. Br J Dermatol. 1999;141(suppl 56):s15-s20.
  40. Kondori N, Tehrani PA, Strömbeck L, Faergemann J. Comparison of dermatophyte PCR kit with conventional methods for detection of dermatophytes in skin specimens. Mycopathologia. 2013;176(3-4):237-241.
  41. Spiliopoulou A, Bartzavali C, Jelastopulu E, Anastassiou ED, Christofidou M. Evaluation of a commercial PCR test for the diagnosis of dermatophyte nail infections. J Med Microbiol. 2015;64(pt 1):25-31.
  42. Gupta AK, Ryder J, Summerbell RC. Comparison of efficacy criteria across onychomycosis trials: need for standardization. Int J Dermatol. 2003;42(4):312-315.
  43. Haneke E, Tajerbashi M, De Doncker P, Heremans A. Itraconazole in the treatment of onychomycosis: a double-blind comparison with miconazole. Dermatology. 1998;196(3):323-329.
  44. Honeyman JF, Talarico FS, Arruda LHF, et al. Itraconazole versus terbinafine (Lamisil®): which is better for the treatment of onychomycosis? J Eur Acad Dermatol Venereol. 1997;9:215-221.
  45. Wang DL, Wang AP, Li RY, Wang R. Therapeutic efficacy and safety of one-week intermittent therapy with itraconazole for onychomycosis in a Chinese patient population. Dermatology. 1999;199(1):47-49.
  46. Gupta AK, Lynde CW, Konnikov N. Single-blind, randomized, prospective study of sequential itraconazole and terbinafine pulse compared with terbinafine pulse for the treatment of toenail onychomycosis. J Am Acad Dermatol. 2001;44(3):485-491.
  47. Gupta AK, Cooper EA. Comparison of visual assessments versus planimetry assessments in a large-scale clinical trial of onychomycosis. J Dermatolog Treat. 2014;25(3):256-259.
  48. Faergemann J, Correia O, Nowicki R, Ro BI. Genetic predisposition--understanding underlying mechanisms of onychomycosis. J Eur Acad Dermatol Venerol. 2005;19(suppl 1): 17-19.