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

Abstract

In a double-blind phase III study the efficacy and tolerance of eberconazole 1% cream was compared with clotrimazole 1% cream, applied twice daily for four consecutive weeks in 157 patients, with mycologically proven cutaneous candidosis (24 patients, 25 infected sites) and in 133 patients with dermatophyte skin infections (141 treated sites). The analysis was carried out by number of infected and treated sites. The four groups of sites and the distribution of target lesions were similar. The distribution of the sum of clinical scores and infecting organisms were also similar. There were no differences between the groups in terms of the range and mean duration of infection. At the end of therapy and on follow-up in skin candidosis the proportion of patients with effective treatment was 73 and 50% for clotrimazole and eberconazole, respectively. Premature termination due to adverse effects was 26.7% for clotrimazole and 20% for eberconazole. At the end of treatment 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 effective in 72% of treated sites, whereas clotrimazole was effective in 61%, this difference was not statistically significant (P = 0.15). There were three 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 medication.