A double-blind randomized comparative trial: eberconazole 1% cream, versusclotrimazole 1% cream twice daily in Candida and dermatophyte skin infections

In a double-blind phase III study the efficacy and tolerance of eberconazol e 1% cream was compared with clotrimazole 1% cream, applied twice daily for four consecutive weeks in 157 patients, with mycologically proven cutaneou s candidosis (24 patients, 25 infected sites) and in 133 patients with derm atophyte skin infections (141 treated sites). The analysis was carried out by number of infected and treated sites. The four groups of sites and the d istribution of target lesions were similar. The distribution of the sum of clinical scores and infecting organisms were also similar. There were no di fferences between the groups in terms of the range and mean duration of inf ection. At the end of therapy and on follow-up in skin candidosis the propo rtion of patients with effective treatment was 73 and 500'0 for clotrimazol e and eberconazole, respectively. Premature termination due to adverse effe cts was 26.7% for clotrimazole and 20% for eberconazole. At the end of trea tment of dermatophyte infections the proportion of patients with effective treatment was 46% for clotrimazole and 61% for eberconazole. At the overall assessment (6 weeks after the end of treatment) eberconazole was judged ef fective in 72% of treated sites, whereas clotrimazole was effective in 61%, this difference was not statistically significant (P = 0.15), There were t hree relapses (4%) in the clotrimazole-treated group and one relapse (1%)! in the eberconazole group. One patient treated with eberconazole cream (1%) had a premature termination due to adverse events attributable to the medi cation.