[Comparative double-blind study on ciclopiroxolamine cream and placebo cream in dermatophytoses (author's transl)]

In a controlled double-blind study involving 60 patients with dermatophytosis, cream containing 1% 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone, 2-aminoethanol salt (ciclopiroxolamine, Cic, Hoe 296, Batrafen cream) was compared with vehicle as to effectiveness and tolerability. Each treatment was applied to 30 patients, the compounds being assigned at random to be used for 21 days per patient. Assessed on clinical, cultural and microscopical findings. Cic cream proved to be significantly more effective than vehicle. Under the application of Cic cream, all (100%) of the cultures and native preparations became free of fungi (negative), whereas with vehicle only 27% and 23% negative cultures and native preparations, respectively, were obtained. The skin symptoms showed significantly more improvement with Cic cream than with vehicle. All 60 patients completed the study. No side effects occurred.