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Drug Profile

Once-daily luliconazole cream 1% for the treatment of interdigital tinea pedis

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References

  • Papers of special note have been highlighted as:
  • • Of interest
  • •• Of considerable interest
  • Weinstein A, Berman B. Topical treatment of common superficial tinea infections. Am Fam Physician. 2002;65:2095–2102.
  • Bell-Syer SE, Hart R, Crawford F, et al. Oral treatments for fungal infections of the skin of the foot. Cochrane Database Syst Rev. 2002;10:CD003584.
  • Havlickova B, Czaika VA, Friedrich M. Epidemiological trends in skin mycoses worldwide. Mycoses. 2008;51:2–15.
  • Vena GA, Chieco P, Posa F, et al. Epidemiology of dermatophytoses: retrospective analysis from 2005 to 2010 and comparison with previous data from 1975. New Microbiol. 2012;35:207–213.
  • Hainer BL. Dermatophyte infections. Am Fam Physician. 2003;67:101–108.
  • Hirschmann JV, Raugi GJ. Pustular tinea pedis. J Am Acad Dermatol. 2000;42:132–133.
  • Crawford F. Athlete’s foot and fungally infected toe nails. Clin Evid. 2002;7:1458–1466.
  • Masri-Fridling GD. Dermatophytosis of the feet. Dermatol Clin. 1996;14:33–40.
  • Zuber TJ, Baddam K. Superficial fungal infection of the skin. Where and how it appears help determine therapy. Postgrad Med. 2001;109:117–132.
  • 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;50:748–752.
  • Legge BS, Grady JF, Lacey AM. The incidence of tinea pedis in diabetic versus nondiabetic patients with interdigital macerations: a prospective study. J Am Podiatr Med Assoc. 2008;98:353–356.
  • Bell-Syer SE, Hart R, Crawford F, et al A systematic review of oral treatments for fungal infections of the skin of the feet. J Dermatolog Treat. 2001;12:69–74.
  • 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 Dermatol. 1996;34:282–286.
  • Takiuchi I, Morishita N, Hamaguchi T, et al. Treatment outcome and relapse with short-term oral terbinafine (250 mg/day) in tinea pedis. Jpn J Med Mycol. 2005;46:285–289.
  • Gupta AK, Einarson TR, Summerbell RC, et al. An overview of topical antifungal therapy in dermatomycoses. A North American perspective. Drugs. 1998;55:645–674.
  • Storm A, Benfeldt E, Andersen SE, et al. A prospective study of patient adherence to topical treatments: 95% of patients underdose. J Am Acad Dermatol. 2008;59(6):975–980.
  • Feldman SR, Horn EJ, Balkrishnan R, et al. Psoriasis: improving adherence to topical therapy. J Am Acad Dermatol. 2008;59(6):1009–1101.
  • Uchida K, Nishiyama Y, Yamaguchi H. In vitro antifungal activity of luliconazole (NND-502), a novel imidazole antifungal agent. J Infect Chemother. 2004;10:216–219.

• Key preclinical study.

  • Koga H, Tsuji Y, Inoue K, et al. In vitro antifungal activity of luliconazole against clinical isolates from patients with dermatomycoses. J Infect Chemother. 2006;12:163–165.

• Key preclinical study.

• Key preclinical study.

  • Niwano Y, Kuzuhara N, Kodama H, et al. In vitro and in vivo antidermatophyte activities of NND-502, a novel optically active imidazole antimycotic agent. Antimicrob Agents Chemother. 1998;42:967–970.
  • Fujita S, Matsuyama T. Experimental tinea pedis induced by non-abrasive inoculation of Trichophyton mentagrophytes arthrospores on the plantar part of a guinea pig foot. J Med Vet Mycol. 1987;25:203–213.
  • Uchida K, Tanaka T, Yamaguchi H. Achievement of complete mycological cure by topical anti-fungal agent NND-502 in guinea pig model of tinea pedis. Microbiol Immunol. 2003;47:143–146.
  • Arika T, Yokoo M, Yamaguchi H. Topical treatment with butenafine significantly lowers relapse rate in an interdigital tinea pedis model in guinea pigs. Antimicrob. Agents Chemother. 1992;36:2523–2525.
  • Ghannoum MA, Long L, Kim HG, et al. Efficacy of terbinafine compared to lanoconazole and luliconazole in the topical treatment of dermatophytosis in a guinea pig model. Med Mycol. 2010;48:491–497.
  • Watanabe S, Takahashi H, Nishikawa T, et al. Dose-finding comparative study of 2 weeks of luliconazole cream treatment for tinea pedis – comparison between three groups (1%, 0.5%, 0.1%) by a multi-center randomized double-blind study. Mycoses. 2007;50(1):35–40.
  • Jarratt M, Jones T, Kemper S, et al. Luliconazole for the treatment of interdigital tinea pedis: a double-blind, vehicle-controlled study. Cutis. 2013;91(4):203–210.

•• Clinical Study comparing 2- and 4-weeks’ treatment.

  • Draelos ZD, Vlahovic TC, Gold MH, et al. A randomized, double-blind, vehicle-controlled trial of luliconazole cream 1% in the treatment of interdigital tinea pedis. J Clin Aesthet Dermatol. 2014;7(10):20–27.

•• Pivotal phase III clinical study.

  • 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.

•• Pivotal phase III clinical study.

  • Watanabe S, Takahashi H, Nishikawa T, et al. A comparative clinical study between 2 weeks of luliconaozle 1% cream treatment and 4 weeks of bifonazole 1% cream treatment for tinea pedis. Mycoses. 2006;49(3):236–241.

• Only comparative clinical study currently published.

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