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  Issue 2 (2002)

GD News
Statement of the Society for Dermopharmacy
Duration of Therapy for Topical Treatment of Mycosis Pedis

According to the large-scale Achilles-Study [1] approximately one quarter of the population in Germany is affected by athlete's foot. This is why mycoses pedis belong to the quantitatively most significant infectious diseases. The pathogens causing the disease are in most cases dermatophytes of the genus trichophyton, in particular T. rubrum and T. mentagrophytes. Affected are mostly the interdigits. In general, the therapy is based on topical antimycotics. Compliance with the prescribed duration of application represents a significant factor inducing the therapy success.
Already since the middle of the forties [2, 3] the antimycotic activity of the so-called azoles has been known. These substances, belonging to the imidazole derivatives, possess a wide activity spectrum against dermatophytes, moulds, yeasts and gram-positive bacteria. The primary fungi static effect comes about by an inhibition of the biosynthesis of ergosterol, an essential element of the cell membrane of fungi. Under certain conditions, some azoles may have a fungicidal effect, yet in vivo only fungistatic concentrations are mostly achieved [4]. Besides the prototype Clotrimazole, in the meantime additional ten azole derivatives are available on the German market for local therapy, the majority of them in several presentation forms. In the first place presentation forms of creams, sprays, gels and powder are treatment possibilities for the treatment of mycosis pedis.

Statements by the GD are official position papers of the society, elaborated by its departments and other GD experts and approved for publication by the committee of the society.

Therapy Systems
of Azole Derivatives
In general, Clotrimazole has to be applied at mycosis pedis in the interdigits (tinea pedis interdigitalis) for a duration of four weeks. Corresponding information is contained in the package insert of all products concerned. In contrast, varying indications are made concerning the application frequency per day in relation to the respective base: thus the preparations available in various presentation forms by the first seller as well as most of the meanwhile very numerous generics have to be applied twice a day. However, on the market there are also a cream and a solution available, which are approved for an application once a day [5].

Drugs for external application on the basis of Bifonazole have to be applied only once a day with mycosis pedis. As further development of Clotrimazole Bifonazole penetrates skin well and is only gradually decomposed there [6]. Nevertheless, also with this substance a treatment duration of altogether three weeks is required. This therapy duration of several weeks, necessary with applications of azole derivatives, may entail an insufficient treatment by non-compliance of patients: since normally the subjective symptoms of the infection already disappear within the first week of treatment, every fourth patient ceases the therapy too early [7]. The consequences are comparably low cure rates as well as a large part of recurrence of the disease.

Short-term Therapy with Terbinafine

The drawbacks described for azole derivatives can be minimized by therapy cycles with short application duration and swift mycological healing. Thus, the allylamine derivative available in the form of a cream and a spray is approved for a short-term therapy of only seven days at an application once a day [8, 9]. The antimycotic effect of Terbinafine is due to an inhibition of the ergosterol biosynthesis as with azoles. Through inactivation of the enzyme squalene epoxidase an enrichment of toxically active squalene [10] comes at the same time about in the fungal cell besides inhibition of the ergosterol formation. This explains the fungicidal effect of the substance already at low concentration against dermatophytes, mould fungi and some yeasts. Terbinafine has been described as the most effective topical antimycotic as remedy for dermatophytes which are in the first place responsible for the development of mycosis pedis [11].

The effectiveness of the short-term therapy has been proven both for the Terbinafine-cream as well as for the spray by several controlled clinical studies [12-21]. The short-term therapy is bio-pharmaceutically substantiated by an enrichment of the active agent in the stratum corneum (controlled sustained release). Still seven days after the last application Terbinafine can be proven there in fungicidal concentrations [22]. In comparable clinical studies Terbinafine entailed higher cure rates as well as minimized recurrence and re-infections than with the azole derivatives Clotrimazole and Miconazole [16-20] despite the considerably shorter application duration. These results show that the epidermis attacked by the pathogen regains its integrity protecting from relapse and re-infections by the short-term therapy with Terbinafine.

Concluding it can be stated that numerous highly effective antimycotics are available for the therapy of mycosis pedis. However, compliance with the prescribed application duration is a prerequisite for a successful therapy. While azole derivatives always have to be applied in the course of several weeks to achieve their full clinical effectiveness, when using Terbinafine, an application duration of only seven days is sufficient if the interdigits are attacked. This swift duration of application considerably improves the compliance by the patient.

[1] Abeck D, Haneke E, Nolting S et al.: Onychomykose. Aktuelle Daten zu Epidemiologie, Erregerspektrum, Risikofaktoren sowie Beeinflussung der Lebensqualität. Dt. Ärztebl. 97 (2000) A 1964-1966
[2] Degitz K, Bracher F: Lokale Pilzinfektionen. Schriftenreihe der Bayrischen Landesapothekerkammer, Heft 62, 2001
[3] Seebacher C, : Dermatomykosen – Grundlagen und Therapie, in Schäfer-Korting M (Hrsg.): Optimierte Arzneimitteltherapie. Springer-Verlag (2001)
[4] Mutschler E, Geisslinger G, Kroemer HK, Schäfer-Korting M: Arzneimittelwirkungen, Lehrbuch der Pharmakologie und Toxikologie, 8. Auflage. Wissenschaftliche Verlagsgesellschaft, Stuttgart (2001)
[5] Fachinformation Mycofug®
[6] Fachinformation Canesten® Extra
[7] Meinhof W, Girardi RM, Stracke A: Patient noncompliance in dermatomycosis. Results of a survey among dermatologists and general practitioners and patients. Dermatologica 169, Suppl. 1 (1984) 57-66
[8] Fachinformation Lamisil®
[9] Korting HC, Kilburg A, Rychlik R: 1%ige Terbinafin-Creme zur Kurzzeittherapie bei Tinea pedis. Dtsch. Apoth. Ztg. 141 (2001) 3428-3432
[10] Ryder, NS: The mechanism of action of terbinafine. Clin. Exp. Dermatol. 14 (1989) 98-100
[11] Ryder, NS: Antifungal activity and mechanism of action of terbinafine. Rev. Contemp. Pharmacother. 8 (1997) 275-287
[12] Evans EGV, Seaman RAJ, James IGV: Short-duration therapy with terbinafine 1% cream in dermatophyte skin infections. Br. J. Dermatol. 130 (1994) 83-87
[13] Berman B, Ellis C, Leyden J et al: Efficacy of a 1-week, twice daily regimen of terbinafine 1% cream in the treatment of interdigital tinea pedis. J. Am. Acad. Dermatol. 26 (1992) 956-960
[14] Korting HC, Tietz HJ, Bräutigam M et al: One week terbinafine 1% cream (Lamisil®) once daily is effective in the treatment of interdigital tinea pedis: a vehicle controlled study. Med. Mycol. 39 (2001) 335-340
[15] Evans EGV.: Tinea pedis: Clinical experience and efficacy of short term treatment. Dermatology 194, Suppl. 1 (1997) 3-6 [16] Evans EGV, Dodman B, Williamson DM et al: Comparison of terbinafine and clotrimazole in treating tinea pedis. Br. Med. J. 307 (1993) 645-647
[17] Bergstresser PR, Elewski B, Hanifin J et al: Topical terbinafine and clotrimazole in interdigital tinea pedis: a multicenter comparison of cure and relapse rates with 1- and 4-week treatment regimens. J. Am. Acad. Dermatol. 28 (1993) 648-651
[18] Elewski B, Bergstresser PR, Hanifin J et al: Longterm outcome of patients with interdigital tinea pedis treated with terbinafine or clotrimazole. J. Am. Acad. Dermatol. 32 (1995) 290-292
[19] Schopf R, Hettler O, Bräutigam M 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 randomised, double-blind, multi-centre, 8-week clinical trial. Mycoses 42 (1999) 415-420
[20] Leenutaphong V, Tangwiwat, S, Muanprasat C et al: Double-blind study of the efficacy of 1 week topical terbinafine cream compared to 4 weeks miconazol cream in patients with tinea pedis. J. Med. Assoc. Thai. 82 (1999) 1006-1009
[21] Lebwohl M, Elewski B, Eisen D et al.: Efficacy and safety of terbinafine 1% solution in the treatment of interdigital tinea pedis and tinea corporis or tinea cruris. Cutis 67 (2001) 261-266
[22] Hill S, Thomas R, Smith SG, Finlay AJ: An investigation of the pharmacokinetics of topical terbinafine (Lamisil®) 1% cream. Br. J. Dermatol. 127 (1992) 396-400


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