Therapeutic efficacy and safety of the new antimycotic sertaconazole in the treatment of Pityriasis versicolor.

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 21 patients suffering from Pityriasis versicolor (confirmed by KOH microscopic examination and exploration with Wood's light). The patients were divided into two treatment groups: one with 11 patients receiving sertaconazole 1% cream and the other with 10 patients receiving sertaconazole 2% cream. The cream was applied twice a day during 4 weeks. The data were assessed clinically and microscopically (optical and fluorescence). All the patients were cured (100% cure), showing excellent efficacy. A check-up performed after the end of the treatment showed no relapses of infection. The drug safety was optimum, since no local or general undesirable effects were recorded, nor were there any changes in the analytical parameters studied in the 21 patients. Because of its high antifungal activity and excellent safety, sertaconazole represents an important advance in the topical therapy of this disease.