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Italian multicentre trial comparing itraconazole with griseofulvin in the treatment of dermatomycoses. Preliminary results
Author(s) -
Finzi A.,
Cilli P.
Publication year - 1992
Publication title -
journal of the european academy of dermatology and venereology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.655
H-Index - 107
eISSN - 1468-3083
pISSN - 0926-9959
DOI - 10.1111/j.1468-3083.1992.tb00678.x
Subject(s) - itraconazole , griseofulvin , medicine , tolerability , tinea capitis , erythema , dermatology , adverse effect , randomized controlled trial , clinical trial , antifungal
The results of previous international studies have suggested that itraconazole is significantly superior to griseofulvin in the treatment of tinea corporis/cruris. The aim of our study was to compare the efficacy and tolerability of the two agents in a larger number of patients with dermatomycoses. This study is ongoing in 46 Italian Centers of Dermatology. From this total of 46 Centers, the patients of 16 Centers have been included for the “ad interim” analysis. One hundred and thirty‐four patients were randomized to treatment with either itraconazole 100 mg once daily for 15 days (73 patients) or griseofulvin 375–1000 mg daily for a mean of 17 days (61 patients). The patients were assessed clinically and mycologically before entering the trial, at the end of therapy and again 30 days after the end of treatment. Both groups showed a statistically significant improvement in desquamation, erythema and subjective complaints, with a trend in favour of itraconazole, despite the significantly shorter duration of treatment. Thirty days after the end of therapy, microscopic results were negative in 91.5% of the itraconazole group and 71.7% of the griseofulvin group. Cultures were negative in 80% and 65%, respectively. A significantly higher proportion of patients in the itraconazole group than in the griseofulvin group experienced both clinical and mycological recovery. One patient in the itraconazole group and three in the griseofulvin group reported adverse experiences. The preliminary results of this study show that itraconazole is well tolerated and more effective than griseofulvin. Furthermore, itraconazole demonstrated a more rapid action than griseofulvin.