BACKGROUND: In the treatment of tinea pedis, current terbinafine formulations are applied once or twice daily for 7 days. A terbinafine emulsion gel formulation has been developed to provide a 5-day treatment course for tinea pedis. OBJECTIVE: To determine the lowest effective concentration of terbinafine (1% or 3%) emulsion gel applied once daily for 5 days for the treatment of tinea pedis. METHODS: This double-blind, placebo-controlled study evaluated the efficacy of 1% and 3% terbinafine gel for 5 days in 84 outpatients with tinea pedis. The primary efficacy endpoint was the percentage of patients with effective treatment (negative microscopy and culture with only mild erythema/desquamation/pruritus [total score<or=2]) at study endpoint (last post-baseline observation up to and including week 6). RESULTS:Efficacy rates with terbinafine 1% and 3% emulsion gel were significantly higher than with placebo (86% and 68% vs 11%, respectively; p<0.001). Similarly, mycological cure rates were significantly greater with terbinafine 1% and 3% gel (97% and 89%, respectively) than with placebo (22%; p<0.001). CONCLUSIONS:Terbinafine 1% emulsion gel used once daily for 5 days was the lowest effective concentration, and was significantly superior to placebo. Both concentrations were effective and safe, providing convenient, short-duration treatment of tinea pedis.
RCT Entities:
BACKGROUND: In the treatment of tinea pedis, current terbinafine formulations are applied once or twice daily for 7 days. A terbinafine emulsion gel formulation has been developed to provide a 5-day treatment course for tinea pedis. OBJECTIVE: To determine the lowest effective concentration of terbinafine (1% or 3%) emulsion gel applied once daily for 5 days for the treatment of tinea pedis. METHODS: This double-blind, placebo-controlled study evaluated the efficacy of 1% and 3% terbinafine gel for 5 days in 84 outpatients with tinea pedis. The primary efficacy endpoint was the percentage of patients with effective treatment (negative microscopy and culture with only mild erythema/desquamation/pruritus [total score<or=2]) at study endpoint (last post-baseline observation up to and including week 6). RESULTS: Efficacy rates with terbinafine 1% and 3% emulsion gel were significantly higher than with placebo (86% and 68% vs 11%, respectively; p<0.001). Similarly, mycological cure rates were significantly greater with terbinafine 1% and 3% gel (97% and 89%, respectively) than with placebo (22%; p<0.001). CONCLUSIONS:Terbinafine 1% emulsion gel used once daily for 5 days was the lowest effective concentration, and was significantly superior to placebo. Both concentrations were effective and safe, providing convenient, short-duration treatment of tinea pedis.
Authors: Katrien Van Bocxlaer; Kerri-Nicola McArthur; Andy Harris; Mo Alavijeh; Stéphanie Braillard; Charles E Mowbray; Simon L Croft Journal: Pharmaceutics Date: 2021-04-08 Impact factor: 6.321