Therapeutic efficacy and safety of the new antimycotic sertaconazole in the treatment of cutaneous dermatophytosis.

ABSTRACT

7-Chloro-3-[1-(2,4-dichlorophenyl)-2-(1H-imidazol-1-yl)ethoxy-methyl] benzo[b]thiophene (sertaconazole, FI-7045, CAS 99592-32-2) is a new antimycotic which, in experimental infection studies, proved to possess potent antifungal activity. In a randomized, parallel, double-blind trial, the activity of sertaconazole cream was studied in 20 patients suffering from superficial mycoses caused by dermatophytes, confirmed by microscopic examination (KOH) and culture test. The patients, who were included in accordance with microbiological, microscopic and clinical criteria, were divided into two groups of 10 and were treated with sertaconazole 1% or sertaconazole 2% (cream) twice a day for 28 days. Both treatments achieved a total cure of the disease, with a cure being reached in a shorter time in the group of patients treated with sertaconazole 2%. No undesirable effects or statistically significant changes in the blood tests conducted at the end of the trial were observed. The results of the trial show that sertaconazole 2% cream is more effective. In view of the advantages offered by topical therapy over systemic therapy and of the good results obtained in patients with dermatophytosis, sertaconazole may represent an important advance in the therapy of superficial dermatophytoses.