New Topical Therapeutic Options in the Management of Superficial Fungal Infections

October 2015 | Volume 14 | Issue 10 | Supplement Individual Articles | 35 | Copyright © October 2015


Joshua A. Zeichner MD

Department of Dermatology, Mount Sinai Hospital, New York, NY

of the respective subjects receiving the vehicle. Efinaconazole was also safe and well-tolerated.
The final antifungal reviewed in this article is tavaborole, a boron-based pharmaceutical approved by the FDA in 2014 for the treatment of toenail onychomycosis caused by Trichophyton rubrum and T mentagrophytes. Two phase 3, multicenter, randomized, double-blind, vehicle-controlled trials evaluated the safety and efficacy of tavaborole 5% topical solution in adults with distal subungual onychomycosis, which affected 20% to 60% of a great toenail. The first phase 3 trial included 594 subjects, and the second phase 3 trial included 604 subjects. The trials’ primary end point was a complete cure of the affected toenail that was defined by a negative mycology and a fully cleared toenail at week 52. In the first trial, 6.5% of subjects achieved a complete clearance compared with 1% for placebo (P<.001), and in the second trial 9.1% of subjects achieved a complete clearance compared with 1.5% for placebo (P<.001). Tavaborole was safe and well tolerated, and the most common treatment-related application site AEs in the 2 trials were exfoliation (2.7%), erythema (1.6%), and dermatitis (1.3%).
Dermatophyte infections of the skin and nails are a common problem in the United States that warrant therapy. Newer antifungal agents such as luliconazole, efinaconazole, naftifine, and tavaborole augment the armamentarium of drugs available for treating these infections effectively. Early intervention can also lead to excellent clinical outcomes, with improvement in appearance and patient discomfort, reduction in the risk of spread or superinfection, and improvement in overall QOL.

DISCLOSURES

Joshua A. Zeichner MD is an advisory board member, consultant, investigator, and speaker for Valeant Pharmaceuticals; and an advisory board member for Anacor, Exeltis, and PharmaDerm.

REFERENCES

  1. Hainer BL. Dermatophyte infections. Am Fam Physician. 2003;67(1):101-108.
  2. Ameen M. Epidemiology of superficial fungal infections. Clin Dermatol. 2010;28(2):197-201.
  3. Sigurgeirsson B, Baran R. The prevalence of onychomycosis in the global population: a literature study. J Eur Acad Dermatol Venereol. 2014;28(11):1480-1491.
  4. 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(7):704-712.
  5. Havlickova B, Czaika VA, Friedrich M. Epidemiological trends in skin mycoses worldwide. Mycoses. 2008;51(suppl 4):s2-s15.
  6. Foster KW, Ghannoum MA, Elewski BE. Epidemiologic surveillance of cutaneous fungal infection in the United States from 1999 to 2002. J Am Acad Dermatol. 2004;50(5):748-752.
  7. 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.
  8. Hainer BL. Dermatophyte infections. Am Fam Physician. 2003;67(1):101-108.
  9. Bristow I. Non-ulcerative skin pathologies of the diabetic foot. Diabetes Metab Res Rev. 2008;24(suppl 1):s84-s89.
  10. Rich P, Elewski B, Scher RK, Pariser D. Diagnosis, clinical implications, and complications of onychomycosis. Semin Cutan Med Surg. 2013;32(2 suppl 1):s5-s8.
  11. Rich, P. Efinaconazole topical solution, 10%: the benefits of treating onychomycosis early. J Drugs Dermatol. 2015;14(1):58-62.
  12. Milobratovic D, Jankovic S, Vukicevic J, Marinkovic J, Jankovic J, Railic Z. Quality of life in patients with toenail onychomycosis. Mycoses. 2013;56(5):543-551.
  13. Szepietowski JC, Reich A, Pacan P, et al. Evaluation of quality of life in patients with toenail onychomycosis by Polish version of an international onychomycosis-specific questionnaire. J Eur Acad Dermatol Venereol. 2007;21(4):491-496.
  14. Drake LA, Dinehart SM, Farmer ER, et al. Guidelines of care for superficial mycotic infections of the skin: tinea corporis, tinea cruris, tinea faciei, tinea manuum, and tinea pedis. Guidelines/Outcomes Committee. American Academy of Dermatology. J Am Acad Derm. 1996;34(2 pt 1):282-286.
  15. Kircik L. Topical Treatment Adherence for Psoriasis. Skin Therapy Letter. http://www.skintherapyletter.com/fp/2008/4.2/2.html Accessed July 30 2015.
  16. Zhang, Y, Camp WL, Elewski BE. Advances in topical and systemic antifungals. Clin Dermatol. 2007;25(2):165-183.
  17. LUZU (luliconazole) Cream, 1% . Prescribing Information. Nov 2013.
  18. Koga H, Nanjoh Y, Makimura K, Tsuboi R. In vitro antifungal activities of luliconazole, a new topical imidazole. Med Mycol. 2009;47(6):640-647.
  19. Koga H, Nanjoh Y, Inoue K, et al. Luliconazole, a novel topical imidazole: results of the preclinical studies. Isham. 2006:0090.
  20. 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.
  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):838-834.
  22. Stein Gold LF, Parish LC, Vlahovic T, Plaum S, 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 Aug;12(8):911-8.
  23. JUBLIA (efinaconazole) topical solution, 10%. Prescribing Information. June 2014.
  24. Tatsumi Y, Yokoo M, Arika T, Yamaguchi H. In vitro antifungal activity of KP-103, a novel triazole derivative, and its therapeutic efficacy against experimental plantar tinea pedis and cutaneous candidiasis in guinea pigs. Antimicrob Agents Chemother. 2001;45(5):1493-1499.
  25. Tatsumi Y, Yokoo M, Senda H, Kakehi K. Therapeutic efficacy of topically applied KP-103 against experimental tinea unguium in guinea pigs in comparison with amorolfine and terbinafine. Antimicrob Agents Chemother. 2002;46(12):3797-3801.
  26. Kircik LH. Enhancing transungual delivery and spreading of efinaconazole under the nail plate through a unique formulation approach. J Drugs Dermatol. 2014;13(12):1457-1461.
  27. Sakamoto M, Sugimoto N, Kawabata H, et al. Transungual delivery of efinaconazole: its deposition in the nail of onychomycosis patients and in vitro fungicidal activity in human nails. J Drugs Dermatol. 2014;13(11):1388-1392.
  28. Elewski BE, Pollak RA, Pillai R, Olin JT. Access of efinaconazole topical solution, 10%, to the infection site by spreading through the subungual space. J Drugs Dermatol. 2014;13(11):1394-1398.
  29. Zeichner JA, Stein Gold L, Korotzer A. Penetration of ((14)C)-Efinaconazole topical solution, 10%, does not appear to be influenced by nail polish. J Clin Aesthet Dermatol. 2014 Sep;7(9):34-36.
  30. 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.
  31. Lipner SR, Scher RK. Management of onychomycosis and co-existing tinea pedis. J Drugs Dermatol. 2015;14(5):492-494
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