Topical treatment of tinea corporis and tinea cruris with eberconazole (WAS 2160) cream 1% and 2%: a phase II dose-finding pilot study

Topische Behandlung der Tinea corporis und Tinea cruris mit Eberconazol-(WAS 2160)-1% und -2%- Creme: Eine Phase-II-Dosisfindungsstudie

Authors


Department of Microbiology, Hospital Universitario 12 de Octubre, Carretera de Andalucia Km. 5,400. E-28041 Madrid, Spain

Abstract

Summary. 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.

Zusammenfassung. In einer Phase-II-Dosisfindungsstudie wurden insgesamt 60 Patienten mit mykologisch gesicherter Tinea corporis und Tinea cruris in Gruppen zu je 15 mit Eberconazol-Creme 1% einmal am Tag (Gruppe A), 1% zweimal am Tag (Gruppe B), 2% einmal am Tag (Gruppe C) oder 2% zweimal am Tag (Gruppe D), behandelt. Die Behandlung wurde bis zwei Wochen nach der klinischen Heilung fortgesetzt, die maximale Behandlungsdauer war auf sechs Wochen begrenzt. Die vier Patientengruppen waren hinsichtlich der Verteilung der Zielläsionen, der klinischen Grunddaten und der Krankheitser-reger vergleichbar. Die statistische Untersuchung zeigte, daβ die mittlere Dauer bis zum Negativwer-den von Mikroskopie und Kultur, gemessen in Wochen, in den vier Gruppen ähnlich war. Es bestand kein signifikanter Unterschied zwischen den Gruppen hinsichtlich des Umfanges und der mittleren Dauer der Behandlung. Am Ende der Behandlung erwiesen sich 13 Patienten (87%) in Gruppe A, 14 Patienten (93%) in Gruppe B und 11 Patienten (73%) in den Gruppen C und D als wirksam behandelt (mykologische Sanierung und

Ancillary