Comparative efficacy and tolerability of econazole liposomal gel 1%, branded econazole conventional cream 1% and generic clotrimazole cream 1% in tinea pedis

被引：16

作者：

Korting, HC ^{[1
]}

Klovekorn, W ^{[1
]}

Klovekorn, G ^{[1
]}

Orfanos, C ^{[1
]}

Heilgemeir, E ^{[1
]}

Hornstein, M ^{[1
]}

Keilig, W ^{[1
]}

Kreisel, S ^{[1
]}

Kuster, S ^{[1
]}

Ludwig, G ^{[1
]}

Maier, F ^{[1
]}

Manske, L ^{[1
]}

Matt, P ^{[1
]}

Mende, B ^{[1
]}

PonceDePoschl, E ^{[1
]}

Schalla, M ^{[1
]}

Tannenberg, H ^{[1
]}

KochSchulte, U ^{[1
]}

Meisel, C ^{[1
]}

Selzle, D ^{[1
]}

机构：

[1] HAUTARZTPRAXIS,GILCHING,GERMANY

来源：

CLINICAL DRUG INVESTIGATION | 1997年 / 14卷 / 04期

关键词：

D O I：

10.2165/00044011-199714040-00006

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

This controlled, double-blind trial investigated the use of liposomes as a drug carrier system. Treatment either encompassed once-daily application for 14 days of econazole liposome gel 1%, branded econazole cream 1% or a generic clotrimazole cream 1%. For confirmatory data analysis mycological cure defined as negative findings upon microscopy and culture on day 7 served as a prime target parameter. A total of 535 patients were recruited. Intent-to-treat analysis revealed no significant differences. Analysis based on evaluable patients in particular tended to indicate a higher cure rate based on microscopy and culture looked at simultaneously on day 28 in the econazole liposome gel treatment group. Values obtained were 80.2, 73.1 and 69.0%, respectively, for econazole liposome gel, branded econazole cream and generic clotrimazole cream (P = 0.080, Cochran-Mantel-Haenszel test). Moreover, tolerability was considered slightly better in the econazole liposome gel group, compared with the econazole cream and clotrimazole cream treatment groups, being classified as very good in 69.7, 62.6 and 64.9% of patients, respectively. Thus, further trials addressing the benefit-to-risk ratio appear warranted in which analysis should be based on evaluable patients rather than intent-to-treat.

引用

页码：286 / 293

页数：8

共 15 条

[1] SINGLE BILAYER LIPOSOMES PREPARED WITHOUT SONICATION [J].