Phase II study of the therapeutic efficacy and safety of the new antimycotic sertaconazole in the treatment of superficial mycoses caused by Candida albicans.

Abstract

The activity 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) was studied in a randomized parallel double-blind clinical trial on 20 patients suffering from superficial mycosis caused by Candida albicans (confirmed microscopically and microbiologically). The patients were divided into two groups; one received sertaconazole 1% cream (10 patients) and the other received sertaconazole 2% cream (10 patients), over a period of 28 days. Clinical, microscopic and microbiological parameters were evaluated. Analytical parameters such as the appearance of possible undesirable effects (both local and general) were also monitored. The cure was total for 19 out of the 20 patients, demonstrating high efficacy. There were no relapses of infection in any of the cured patients. No local or general effects were recorded during the trial. The analytical parameters remained within normal limits. The clinical and microbiological cure, absence of relapses and the non-existence of local and general undesirable effects indicate that sertaconazole may represent an important advance in the therapy of superficial mycosis caused by Candida albicans.