COMPARATIVE EFFICACY AND TOLERABILITY OF ECONAZOLE LIPOSOMAL GEL 1-PERCENT, BRANDED ECONAZOLE CONVENTIONAL CREAM 1-PERCENT AND GENERIC CLOTRIMAZOLE CREAM 1-PERCENT IN TINEA-PEDIS

This controlled, double-blind trial investigated the use of liposomes as a drug carrier system. Treatment either encompassed once-daily appl ication for 14 days of econazole liposome gel 1%, branded econazole cr eam 1% or a generic clotrimazole cream 1%. For confirmatory data analy sis mycological cure defined as negative findings upon microscopy and culture on day 7 served as a prime target parameter. A total of 535 pa tients were recruited. Intent-to-treat analysis revealed no significan t differences. Analysis based on evaluable patients in particular tend ed to indicate a higher cure rate based on microscopy and culture look ed at simultaneously on day 28 in the econazole liposome gel treatment group. Values obtained were 80.2, 73.1 and 69.0%, respectively, for e conazole liposome gel, branded econazole cream and generic clotrimazol e cream (P = 0.080, Cochran-Mantel-Haenszel test). Moreover, tolerabil ity was considered slightly better in the econazole liposome gel group , compared with the econazole cream and clotrimazole cream treatment g roups, being classified as very good in 69.7, 62.6 and 64.9% of patien ts, 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.