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American Journal of Clinical Dermatology

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01-12-2007 | Original Research Article

Comparative Study of 2% Sertaconazole Solution and Cream Formulations in Patients with Tinea Corporis, Tinea Pedis Interdigitalis, or a Corresponding Candidosis

Authors: Dr Claudia Borelli, Gunther Klövekorn, Thomas-Matthias Ernst, Rolf-Hasso Bödeker, Hans Christian Korting, Claudia Neumeister

Published in: American Journal of Clinical Dermatology | Issue 6/2007

Abstract

Background: Based on the results of numerous preclinical and clinical studies, sertaconazole can be considered a safe and effective drug for the treatment of fungal skin infections.

Objective: The objective of the study was to compare the efficacy of a solution containing 2% sertaconazole with the well established 2% sertaconazole cream formulation in patients with tinea corporis, tinea pedis interdigitalis, or a corresponding candidosis.

Methods: This was a prospective, open-label, randomized, controlled, parallel-group, multicenter, noninferiority therapy study. Patients received either sertaconazole solution or cream twice daily for 28 days. The full analysis set comprised 160 patients in the solution group and 153 patients in the cream group. The primary efficacy parameter was a combination of culture test result and total clinical score. Efficacy was defined by eradication of the pathogen and reduction of the total clinical score between pretreatment and the final visit.

Results: Efficacy was documented in 90.6% of patients using the solution and 88.9% of those using the cream (full analysis set). No adverse events occurred.

Conclusion: Solution and cream formulations of 2% sertaconazole applied for 28 days were associated with comparable efficacy and safety in the treatment of fungal skin infections.

The use of trade names is for product identification purposes only and does not imply endorsement.

Carrillo-Munoz AJ, Torres-Rodriguez JM. In-vitro antifungal activity of sertaconazole, econazole, and bifonazole against Candida spp. J Antimicrob Chemother 1995; 36: 713–6PubMedCrossRef

Carillo-Munoz AJ, Tur-Tur C. Comparative study of antifungal activity of serta- conazole, terbinafine, and bifonazole against clinical isolates of Candida spp., Cryptococcus neoformans and dermatophytes. Chemotherapy 1997; 43: 387–92PubMedCrossRef

Carrillo-Munoz AJ, Tur-Tur C, Bornay-Llinares FJ, et al. Comparative study of the in vitro antifungal activity of bifonazole, naftifine and sertaconazole against yeasts. J Chemother 1999; 11: 187–90PubMed

Drouhet E, Dupont B. In vitro antifungal activity of sertaconazole. Arzneimittelfor-schung 1992; 42: 705–10

Martin-Mazuelos E, Aller AI, Morilla D, et al. Antifungal activity of sertaconazole in vitro against clinical isolates of Candida spp. Chemotherapy 1996; 42: 112–7PubMedCrossRef

Palacin C, Sacristan A, Ortiz JA. In vitro activity of sertaconazole. Arzneimittelfor-schung 1992; 42: 699–705

Palacin C, Sacristan A, Ortiz JA. In vitro comparative study of the fungistatic and fungicidal activity of sertaconazole and other antifungals against Candida albicans. Arzneimittelforschung 1992; 42: 711–4PubMed

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: 147–52PubMedCrossRef

Carrillo-Muñoz AJ, Tur C, Estivill D, et al. In vitro antifungal activity of sertacon- nozazole and bifonazole against dermatophytes. J Mycol Med 1995; 5: 235–8

10.

Carrillo-Muñoz AJ, Tur C, Torres J. In vitro antifungal activity of sertaconazole, noz bifonazole, ketoconazole and miconazole against yeasts of the Candida genus.J Antimicrob Chemother 1996; 37: 815–9CrossRef

11.

Carrillo-Muñoz AJ, Bri´ S, Quind´ G, et al. Sertaconazole: in vitro antifungal noz oos activity against vaginal and other superficial yeast isolates. J Chemother 2001; 13: 555–62PubMed

12.

Carrillo-Muñoz AJ, Fern´andez-Torres B, C´ardenes DC, et al. In vitro activity of sertaconazole against dermatophyte isolates with reduced fluconazole susceptibility. Chemotherapy 2003; 49: 248–51PubMedCrossRef

13.

Carrillo-Muñoz AJ, Fern´andez-Torres B, Guarro J. In vitro antifungal activity of sertaconazole against 309 dermatophyte clinical isolates. J Chemother 2003; 15: 555–7PubMed

14.

Carrillo-Muñoz AJ, Guglietta J, et al. In vitro antifungal activity of sertaconazole noz compared with nine other drugs against 250 clinical isolates of dermatophytes and Scopulariopsis brevicaulis. Chemotherapy 2004; 50: 308–13PubMedCrossRef

15.

Alomar C, Bassas S, Casas M, 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: 767–73PubMed

16.

Palacin C, Sacristan A, Ortiz JA. In vivo activity of sertaconazole in experimental candidiasis in the mouse. Drugs Exp Clin Res 1990; 16: 469–73PubMed

17.

Palacin C, Sacristan A, Ortiz JA. In vivo activity of sertaconazole in experimental dermatophytosis in guinea pigs. Arzneimittelforschung 1992; 42: 714–8PubMed

18.

Pedragosa R, Gonzalez B, Martin M, et al. Therapeutic efficacy and safety of the new antimycotic sertaconazole in the treatment of cutaneous dermatophytosis. Arzneimittelforschung 1992; 42: 760–3PubMed

19.

Umbert P, Nasarre J, Bello A, et al. Phase II study of the therapeutic efficacy and safety of the new antimycotic sertaconazole in the treatment of superficial mycoses caused by Candida albicans. Arzneimittelforschung 1992; 42: 757–60PubMed

20.

Carrillo-Munoz AJ, Giusiano G, Ezkurra PA, et al. Sertaconazole: updated review of a topical antifungal agent. Expert Rev Anti Infect Ther 2005; 3: 333–42PubMedCrossRef

21.

Agut J, Palacin C, Sacristan A, et al. Inhibition of ergosterol synthesis by sertaconazole in Candida albicans. Arzneimittelforschung 1992; 42: 718–20PubMed

22.

Agut J, Palacin C, Salgado J, et al. Direct membrane-damaging effect of sertaconazole on Candida albicans as a mechanism of its fungicidal activity. Arzneimit- telforschung 1992; 42: 721–4

23.

Guarro J, Figueras MJ, Cano J. Alterations produced by sertaconazole in the morphology and ultrastructure of Candida albicans. Mycoses 1989; 32: 283–95PubMedCrossRef

24.

Agut J, Moren M, Rego M, et al. Pharmacokinetic evaluation of labelled sertacon-azole after dermal application. Arzneimittelforschung 1992; 42: 748–51PubMed

25.

ICH harmonised tripartite guideline. Statistical principles for clinical trials: E9. 1998 Feb 5 [online]. Available from URL: http://www.ich.org/ [Accessed 2008 Nov 7]

26.

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 (2 Pt 1): 282–6CrossRef

27.

Schäfer H, Zesch A, Stüttgen G. Skin permeability. Berlin: Springer, 1982

28.

Surber C, Smith EW. The mystical effects of dermatological vehicles. Dermatology 2005; 210: 157–68PubMedCrossRef

29.

Korting HC, Rychlik R, Pfeil B. Treatment of interdigital tinea pedis [in German]. Dtsch Med Wochenschr 2003; 128: 1819–24PubMedCrossRef

30.

Jones B, Jarvis P, Lewis JA, et al. Trials to assess equivalence: the importance of rigorous methods. BMJ 1996; 313: 36–9PubMedCrossRef

31.

Susilo R, Korting HC, Strauss UP, et al. Dermatomycoses of the glabrous skin: a double-blind, randomised, comparative trial of sertaconazole 2% cream once daily versus vehicle. Clin Drug Invest 2003; 23: 387–94CrossRef

32.

Gentle JC, Jones GR, Roberts DT. Efficacy of miconazole in the topical treatment of tinea pedis in sportsmen. Br J Dermatol 1975; 93: 79–84CrossRef

33.

Kieser M, Friede T. Planning and analysis of three-arm non-inferiority trials with binary endpoints. Stat Med 2007; 26: 253–73PubMedCrossRef

Title: Comparative Study of 2% Sertaconazole Solution and Cream Formulations in Patients with Tinea Corporis, Tinea Pedis Interdigitalis, or a Corresponding Candidosis
Authors: Dr Claudia Borelli
Gunther Klövekorn
Thomas-Matthias Ernst
Rolf-Hasso Bödeker
Hans Christian Korting
Claudia Neumeister
Publication date: 01-12-2007
Publisher: Springer International Publishing
Published in: American Journal of Clinical Dermatology / Issue 6/2007
Print ISSN: 1175-0561
Electronic ISSN: 1179-1888
DOI: https://doi.org/10.2165/00128071-200708060-00007

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Comparative Study of 2% Sertaconazole Solution and Cream Formulations in Patients with Tinea Corporis, Tinea Pedis Interdigitalis, or a Corresponding Candidosis

Abstract

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

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