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Giornale Italiano di Dermatologia e Venereologia 1999 June;134(3):263-9


language: Italian

Multicenter open randomised comparative study on efficacy and safety of topical fluconazole 0.5% vs econazole lipogel 1% in the treatment of localised dermatomycoses

Califano L. 1, Cannavò S. P. 1, Ghittoni S. 2, Martini P. 2, Guarneri B. 1, Peonia G. 2

1 Università degli Studi - Messina, Policlinico Universitario, Istituto di Dermatologia; 2 Ospedale «Campo di Marte» - Lucca, Divisione di Dermatologia


Background. Objective: to evaluate the safety and efficacy of fluconazole gel 0.5% versus econazole lipogel 1% in patients with localised dermatomycoses (Tinea corporis, cruris or pedis).
Methods. Prospective, open randomised comparative study. Topical treatment was to be administered once daily for up to 1-3 weeks (Tinea corporis or cruris) or 6 weeks (Tinea pedis). Subjects were assessed at entry, then weekly until the end of treatment and 2 and 4 weeks after the end of treatment (follow-up). Setting: 2 dermatology clinics in Italy. Measures: Clinical and mycological efficacy; evolution of symptoms; incidence of adverse events.
Results. Sixty patients were evaluated for efficacy (31 fluconazole, 29 econazole). The distribution of each type of dermatomycosis was similar in both groups. At the end of treatment, complete cure was obtained in 29 patients (94%) in the fluconazole group and 24 (83%) in the econazole group. At the last follow-up visit, recurrences were observed in 2 (6%) and 4 (14%), respectively. Mycological eradication was obtained in 94% in the fluconazole group and 83% in the econazole group at the end of treatment. At the last follow-up visit, 2 mycological failures were observed in the fluconazole group and 5 in the econazole group. In addition, signs and symptoms were significantly reduced in both groups when compared with baseline from the second week of treatment (p<0.05). Mean duration of treatment was 26±6 days for the fluconazole group and 27±4 for the econazole group. Both treatments were well tolerated locally and systemically in all 61 patients enrolled.
Conclusions. Fluconazole gel 0.5% showed similar efficacy in the topical treatment of localised dermatomycoses when compared with econazole lipogel 1%. Both treatments were equally tolerated in all patients. Treatment duration was generally 4 weeks.

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