Therapy
Randomized Study of an Anti-dermatophytic Agent M-732 in Patients with Tinea Pedis
—Non-inferiority Study of Liquid to Cream—
2007 Volume 69 Issue 3 Pages 300-308
Details
2007 Volume 69 Issue 3 Pages 300-308
M-732 (liranaftate) is a novel thiocarbamate with high antifungal activity towards dermatophytes. Its 2% cream, (Zefnart® cream 2%) is marketed by Torii Pharmaceutical Co., Ltd. in Japan for the treatment of tinea. This multi-center, open-label and randomized study was conducted to demonstrate the non-inferiority of M-732 liquid (test agent) to M-732 cream (control agent) with regard to efficacy. Outcome criteria were that the 95% confidence interval (CI) of the difference between the two preparations would not be below the margin of -10% in both the dermatophyte disappearance rate (negative conversion rate) and skin symptom improvement rate (skin improvement rate). The negative conversion rates for the liquid and cream were 74.8% (101/135) and 70.1% (96/137), respectively; the lower end of the 95% CI of the difference was -5.9%. The skin improvement rates for the liquid and cream were 97.0% (131/135) and 94.9% (130/137), respectively; the lower end of the 95% CI of the difference was -2.5%. Such adverse events as local irritation that might be related to preparations were observed in 2.1% (3/146) of subjects treated with liquid and in 2.8% (4/144) of subjects treated with cream (p=0.722). Abnormal laboratory findings were found in one subject treated with liquid (elevated AST) and one subject treated with cream (elevated urine glucose). Based on the above results, we concluded that M-732 liquid is not inferior to M-732 cream in efficacy and that the liquid is as safe as the cream.
