Comparison of efficacy, safety and cost-effectiveness of clotrimazole 1% cream and sertaconazole 2% cream in patients suffering from of mild to moderate tinea corporis, attending tertiary care hospital out-patient department: a randomized, open-labeled, comparative, parallel group trial
Keywords:
Tinea corporis, Clotrimazole, Sertaconazole, Cost effectivenessAbstract
Background: Tinea corporis is a common dermatophytic infection of the body involving keratin layer of skin. This lesion presents as an annular plaque with an advancing border along with central clearing. Clotrimazole is topical, conventional imidazole antifungal drug and has given good efficacy in tinea corporis. Sertaconazole is new topical imidazole antifungal claimed to be superior to old topical imidazoles in tinea corporis. The aim of this study was to compare efficacy, safety and cost effectiveness of topical antifungals, clotrimazole 1% cream and sertaconazole 2% cream in patients suffering from mild to moderate tinea corporis attending out-patient department of tertiary care hospital in Vidarbha region of Maharashtra.
Methods: This was a prospective, comparative, randomized trial with 2 parallel treatment arms of 4 weeks duration. Patients were diagnosed on the basis of clinical evaluation and microscopic findings of KOH mount. Hundred patients were randomly assigned into two groups of clotrimazole 1% cream, and sertaconazole 2% cream with 50 patients in each group. Evaluation was carried out at baseline, 1st week, 2nd week and 4th week for efficacy parameters viz. itching, erythema and scaling, physician’s global assessment (PGA), safety and cost effectiveness.
Results: Topical sertaconazole 2% cream was highly efficacious and superior to clotrimazole 1% cream in improvement of clinical parameters, PGA and mycological cure at the end of the treatment phase. At end of the follow-up phase both the trial drugs were effective with no recurrence or relapse of tinea corporis. However, clotrimazole 1% cream was safe and cheaper.
Conclusions: Topical clotrimazole 1% cream and sertaconazole 2% were effective and well tolerated in patients of tinea corporis. Effectiveness of sertaconazole was early and superior with tolerable side-effects. However, clotrimazole was cost-effective.
References
Mohanty JC, Mohanty SK, Sahoo RC, Sahoo AS, Praharaj CH. Incidence of dermatophytosis in Orissa. Indian J Med Microbiol. 1998;16:78-80.
Singh S, Beena PM. Profile of dermatophyte infections in Baroda. Indian J Dermatol Venereol Leprol. 2003;69(4):281-3.
Alston SJ, Cohen BA, Braun M. Persistent and recurrent tinea corporis in children treated with combination antifungal/corticosteroid agents. Pediatrics. 2003;111(1):201-3.
Greenberg HL, Shwayder TA, Bieszk N, Fivenson DP. Clotrimazole/betamethasone diproprionate: a review of costs and complications in the treatment of common cutaneous fungal infections. Pediatr Dermatol. 2002;19(1):78-81.
Stary A, Soeltz-Szoets J, Ziegler C, Kinghorn GR, Roy RB. Comparison of the efficacy and safety of oral fluconazole and topical clotrimazole in patients with candida balanitis. Genitourin Med. 1996;72(2):98-102.
Sobel JD, Brooker D, Stein GE, Thomason JL, Wermeling DP, Bradley B, et al. Single oral dose fluconazole compared with conventional clotrimazole topical therapy of Candida vaginitis. Fluconazole Vaginitis Study Group. Am J Obstet Gynecol. 1995;172:1263-8.
Carrilo-Muñoz AJ, Tur C, Torres J. In-vitro antifungal activity of sertaconazole, bifonazole, ketoconazole, and miconazole against yeasts of the Candida genus. J Antimicrob Chemother. 1996;37(4):815-9.
Borelli C, Klövekorn G, Ernst TM, Bödeker RH, Korting HC, Neumeister C. Comparative study of 2% sertaconazole solution and cream formulations in patients with tinea corporis, tinea pedis interdigitalis, or a corresponding candidosis. Am J Clin Dermatol. 2007;8(6):371-8.
Wolverton SE. Comprehensive Dermatologic Drug Therapy. Volume 24. Philadelphia: WB Saunders Company; 2001: 501-3.
Long CC, Finlay AY. The finger-tip unit – a new practical measure. Clin Exp Dermatol. 1991;16(6):444-7.
Cohen DJ, Reynolds MR. Interpreting the results of cost-effectiveness studies. J Am Coll Cardiol. 2008;52(25):2119-26.
Kanwar AJ, Mamta, Chander J. Superficial fungal infections. In: Valia RG, Valia AR, editors. IADVL Textbook and Atlas of Dermatology. 2nd Edition. Mumbai: Bhalani Publishing House; 2001: 215-58.
Bindu V, Pavithran K. Clinico-mycological study of dermatophytosis in Calicut. Indian J Dermatol Venereol Leprol. 2002;68(5):259-61.
Peerapur BV, Inamdar AC, Pushpa PV, Srikant B. Clinico mycological study of dermatophytosis in Bijapur. Indian J Dermatol Venerol Leprol. 2004;22:273-74.
Vidhya Lakshmi CP, Bengalorkar GM, Kumar VS. Clinical efficacy of topical terbinafine versus topical luliconazole in treatment of tinea corporis/Tinea cruris patients. Br J Pharm Res. 2013;3(4):1001-14.
Banerjee M, Ghosh AK, Basak S, Das KD, Gangopadhyay DN. Comparative evaluation of effectivity and safety of topical amorolfine and clotrimazole in the treatment of tinea corporis. Indian J Dermatol. 2011;56(6):657-62.
Suschka S, Fladung B, Merk HF. Clinical comparison of the efficacy and tolerability of once daily Canesten with twice daily Nizoral (clotrimazole 1% cream vs. ketoconazole 2% cream) during a 28-day topical treatment of interdigital tinea pedis. Mycoses. 2002;45(3-4):91-6.
Jerajani H, Janaki C, Kumar S, Phiske M. Comparative assessment of the efficacy and safety of sertaconazole (2%) cream versus terbinafine cream (1%) versus luliconazole (1%) cream in patients with dermatophytoses: a pilot study. Indian J Dermatol. 2013;58(1):34-8.
Pfaller MA, Sutton DA. Review of in vitro activity of sertaconazole nitrate in the treatment of superficial fungal infections. Diagn Microbiol Infect Dis. 2006;56(2):147-52.
Carrillo-Muñoz AJ, Quindós G, Del Valle O, Santos P, Giusiano G, Guardia C, et al. In vitro antifungal activity of sertaconazole nitrate against recent isolates of onychomycosis causative agents. J Chemother. 2008;20(4):521-3.
Sur R, Babad JM, Garay M, Liebel FT, Southall MD. Anti-inflammatory activity of sertaconazole nitrate is mediated via activation of a p38-COX-2-PGE2 pathway. J Invest Dermatol. 2008;128(2):336-44.
Sharma A, Saple DG, Surjushe A, Rao GR, Kura M, Ghosh S, et al. Efficacy and tolerability of sertaconazole nitrate 2% cream vs. miconazole in patients with cutaneous dermatophytosis. Mycoses. 2011;54(3):217-22.
Alomar C, Bassas S, Casas M, Crespo V, Ferrándiz C, Fonseca E, et al. Multi-centre double-blind trial on the efficacy and safety of sertaconazole 2% cream in comparison with miconazole 2% cream on patients suffering from cutaneous mycoses. Arzneimittelforschung. 1992;42(5A):767-73.
Schopf R, Hettler O, Bräutigam M, Weidinger G, Kaben U, Mayser P, et al. Efficacy and tolerability of terbinafine 1% topical solution used for 1 week compared with 4 weeks clotrimazole 1% topical solution in the treatment of interdigital tinea pedis: a randomized, double-blind, multi-centre, 8-week clinical trial. Mycoses. 1999;42(5-6):415-20.
Savin R, Jorizzo J. The safety and efficacy of sertaconazole nitrate cream 2% for tinea pedis. Cutis. 2006;78(4):268-74.
del Palacio A, Ortiz FJ, Pérez A, Pazos C, Garau M, Font E. A double-blind randomized comparative trial: eberconazole 1% cream versus clotrimazole 1% cream twice daily in Candida and dermatophyte skin infections. Mycoses. 2001;44(5):173-80.
