A Randomized Controlled Clinical Study of Terbinafine Powder Versus Miconazole for the Treatment of Tinea mamun/Pedis and Tinea Corporis/Cruris

OBJECTIVE: Terbinafine is a synthetic allyamine antifungi agent which has been shown to be fungicidal against dermatophytes. In order to evaluate the safety and efficacy of the new formulation 1 % terbinafine powder in the treatment of dermatomycoses. METHODS: A randomized controlled clinical observation was conducted. 2% miconazole powder was chosen as the control. 210 patients with dermatomycoses were randomly divided into terbanifine group or miconazole group, of which 104 patients were assigned to terbinafine group, 106 patients to miconazole group. They were administed topically with terbinafine or miconazole powder twice per day for 2 weeks with tinea corporis and tinea cruris, for 3 weeks with tinea mannus and tinea pedis. Both clinical and mycological efficacy were evaluated by clinical manifestations and the results of direct microscopy and/or culture. RESULTS: The curative rates of terbinafine and miconazole group were 50.0% and 35.8%(P0.05), the effective rates were 88.5% and 88.7% (P0.05), the mycological clearance rates were 88.5% and 78.3%(P0.05), respectively. The adverse drug reaction rates were 4.8% and 4.7%(P0.05). CONCLUSION : it was the safety and efficacy of the 1 %terbinafine powder in the treatment of dermatomycoses.