Short-duration topical treatment of tinea pedis using terbinafine emulsion gel: results of a dose-ranging clinical trial.
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.
James
Ian G
IG
Spring House Surgery, Bolton, United Kingdom. iangordonjames@hotmail.com
Loria-Kanza
Yolanda
Y
Jones
Thomas C
TC
D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000935:Antifungal Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D009281:Naphthalenes / Q000008:administration & dosage / Q000627:therapeutic use*; D012720:Severity of Illness Index; D000077291:Terbinafine; D014008:Tinea Pedis / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome; D006113:United Kingdom
D000935:Antifungal Agents; D005782:Gels; D009281:Naphthalenes; D000077291:Terbinafine