A DOUBLE-BLIND, RANDOMIZED COMPARATIVE TRIAL - FLUTRIMAZOLE 1-PERCENTSOLUTION VERSUS BIFONAZOLE 1-PERCENT SOLUTION ONCE-DAILY IN DERMATOMYCOSES

In a double-blind, randomized study the efficacy and tolerance of flut rimazole 1% solution were compared with bifonazole 1% solution, applie d once daily for 4 weeks, in 40 patients with culturally proven dermat ophytosis or cutaneous candidosis. Forty patients with mycologically p roven pityriasis versicolor were treated with once-daily application f or 1 week. The four groups of patients and distribution of target lesi ons were similar, although in the flutrimazole group more patients had cutaneous candidosis (n = 8 versus n = 1). The distribution of the su m of clinical scores was also similar in both groups. At the end of th erapy the proportion of patients with negative microscopy and culture was 85% in the flutrimazole group and 65% in the bifonazole group. The re was a significant difference (P = 0.022) in terms of efficacy, sinc e 80% of patients in the flutrimazole group versus 40% in the bifonazo le group were judged to have received effective treatment. At the asse ssment 6 weeks after the end of therapy the percentages of flutrimazol e- and bifonazole-treated patients with negative mycology were 75% and 65% respectively. There were two relapses (one in each group), which represents a 5% rate. Fifteen flutrimazole-treated patients (75%) comp ared with 12-bifonazole-treated patients (60%) had overall effective t herapy. Two patients treated with bifonazole (10%) and one treated wit h flutrimazole (5%) had a premature termination due to adverse events attributable to the medication. On assessment 3 weeks after the end of treatment, the patients with pityriasis versicolor were all clinicall y and mycologically healed with negative fluorescence, including the p atients who withdrew from the full course of treatment (one in each gr oup). Nine weeks after the end of therapy all the patients remained cu red, with no relapses. The overall incidence of adverse events (mild l ocal reactions such as irritation, burning and itching) was one and se ven cases for bifonazole and flutrimazole respectively. One patient in each group had to abandon treatment owing to severe intolerance.