Multi-centre double-blind trial on the efficacy and safety of sertaconazole 2% cream in comparison with miconazole 2% cream on patients suffering from cutaneous mycoses.

The efficacy and tolerance of 7-chloro-3-[1-(2,4-dichlorophenyl)-2- (1H-imidazol-1-yl)ethoxy-methyl]benzo[b]thiophene (sertaconazole, FI-7045, CAS 99592-32-2) 2% dermatological cream in two daily applications compared with miconazole 2% cream in two daily applications were studied on 631 patients suffering from superficial cutaneous mycosis (sertaconazole n = 317, miconazole n = 314), in a double-blind, controlled multicentre trial with parallel groups. The therapeutic efficacy was evaluated by clinical assessment of the improvement of the lesion and symptoms, a microscopic test on the presence of hyphae or mycelia in the affected area and a culture test on the presence of active infection. Tolerance and safety were evaluated by a general blood analysis and interrogation of the patient on adverse effects. The rate of clinical cures for both treatments at the end of the follow-up was 95.6% for sertaconazole and 88.1% for miconazole, with the difference being statistically significant. In the comparative analysis of the actuarial curve, it was observed that the patients treated with sertaconazole were cured earlier and in a higher proportion than those treated with miconazole, with the difference being significant. The negative result of the microscope examination and culture test confirmed the superiority of sertaconazole over miconazole, already after 14 days of treatment. At the end of the follow-up, 98.6% of the patients in the sertaconazole group obtained a negative culture test result, as opposed to 91.7% in the miconazole group, with the difference being highly significant.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes