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Giornale Italiano di Dermatologia e Venereologia 2000 April;135(2):229-35

Copyright © 2000 EDIZIONI MINERVA MEDICA

language: English

Comparative double blind, double dummy study on the efficacy and safety of fluconazole 100 mg/day versus terbinafine 250 mg/day in the treatment of dermatomycoses

Baldari U., Righini M. G., Ascari Raccagni A., Ghittoni L. *, Biggio P. **, Pau M. **, Aste N. **

From the Unità Operativa di Dermatologia Azienda USL, Forlì * Dipartimento di Dermatologia Ospedale Campo di Marte, Lucca ** Dipartimento di Dermatologia Università degli Studi, Cagliari


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Background. A double blind, double dummy, multicentre study was performed comparing fluconazole 100 mg/day with terbinafine 250 mg/day in the treatment of superficial mycoses, including tinea cruris, tinea pedis e tinea corporis and cutaneous candidiasis.
Methods. Treatment duration was comprised between 2 and 6 weeks according to the type and severity of infections. Mycological and clinical responses were evaluated at the end of therapy and 4 and 8 weeks after the end of treatment. A total of 42 patients were enrolled, of which 39 were evaluated for efficacy (21 treated with fluconazole and 18 with terbinafine).
Results. At the end of treatment, all patients in both groups were assessed as clinical success. At the second follow-up visit, clinical success was achieved in 16/16 (100%) patients treated with fluconazole and 12/15 (80%) patients treated with terbinafine. Mycological success at the end of therapy was achieved in 14/20 (70%) patients treated with fluconazole and 12/18 (66.7%) patients treated with terbinafine. Corresponding numbers at the 2nd follow-up were 87.5% and 73.3%, respectively. It should be noted that mycological persistences or relapses were associated with successful clinical outcomes in the fluconazole group, whereas this was not the case in the terbinafine group and in particular in 3 patients (20%) with mycological failure at the 2nd follow-up presenting also clinical relapses.
Conclusions. In conclusion, there is good evidence of the excellent safety and efficacy of fluconazole 100 mg/day, that can be chosen as the first line treatment in dermatomycoses.

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