TOPICAL TREATMENT OF TINEA-CORPORIS AND TINEA-CRURIS WITH EBERCONAZOLE (WAS-2160) CREAM 1-PERCENT AND 2-PERCENT - A PHASE-II DOSE-FINDING PILOT-STUDY

In a phase II pilot dose-finding study 60 patients with mycologically proven tinea corporis and tinea cruris were treated with eberconazole cream 1% once daily (group A, 15 patients), 1% twice daily (group B, 15 patients), 2% once daily (group C, 15 patients) or 2% twice daily (group D, 15 patients). Treatment was continued for 2 weeks after clinical cure; the maximum duration of treatment was limited to 6 weeks. The characteristics of the four groups of patients, distribution of the target lesions, clinical sum of baseline scores and infecting organisms were similar. Statistical examination showed that the mean time of appearance in weeks of negative microscopy and culture was similar in the four groups. There was no significant difference between the groups in terms of the range and mean duration of treatment. By the end of the study, treatment was effective in 13 patients (87%) in group A, 14 (93%) in group B and 11 (73%) in both groups C and D (mycological cure and clinical cure or residual minimal signs and symptoms). One patient: in group A did not respond to treatment and two patients in group C had to withdraw because of side-effects. No undesirable effects or significant changes were seen in the blood tests. At the assessment 6 weeks post therapy, eberconazole was judged to have been effective in 93% of patients in group A, 100% of patients in groups B and D and 61% of patients in group C. Although not statistically significant, a trend towards more favourable results was seen in group B when considering the mean time of appearance of clinical cure and negative KOH and culture.