Efficacy and safety of 1 % terbinafine film-forming solution in Chinese patients with tinea pedis: a randomized, double-blind, placebo-controlled, multicenter, parallel-group study

Abstract

Background and objectives: Superficial fungal skin infections are treated using topical antifungals. The aim of this study was to demonstrate the efficacy of a single application of 1 % terbinafine film-forming solution (FFS) versus placebo for the treatment of tinea pedis in the Chinese population.

Methods: Six centers in China randomized 290 patients in a 1:1 ratio to receive either 1 % terbinafine FFS or FFS vehicle (placebo) once on the affected foot/feet. Efficacy assessments included microscopy and mycologic culture, and assessing clinical signs and symptoms at baseline, and at weeks 1 and 6 after the topical treatment. All adverse events were recorded.

Results: At week 6, 1 % terbinafine FFS was superior to placebo for effective treatment rate (63 vs. 8 %); clinical cure (30 vs. 6 %); mycological cure (86 vs. 12 %); negative microscopy (90 vs. 24 %); and negative mycological culture (90 vs. 27 %): all p ≤ 0.001 and clinically relevant. At week 6, 1 % terbinafine FFS was clinically superior to placebo for the absence of: erythema (69 vs. 29 %); desquamation (33 vs. 8 %); and pruritus (70 vs. 30 %): all p ≤ 0.001 and clinically relevant. At week 6, differences in the average total signs and symptoms scores were significantly lower for 1 % terbinafine FFS versus placebo (p ≤ 0.001). Both 1 % terbinafine FFS and placebo were safe and well tolerated based on adverse events and investigator and patient assessments.

Conclusions: This double-blind, randomized, multicenter study demonstrated one single topical application of 1 % terbinafine FFS was safe and effective in the treatment of tinea pedis in the Chinese population.

Fig. 1

Summary of treatment results at week 6, of 1 % terbinafine film-forming solution (FFS) versus placebo, assessed by effective treatment, mycologic cure, and clinical cure (full analysis set)

Fig. 2

Signs and symptoms scores of erythema at baseline and at weeks 1 and 6, of 1 % terbinafine film-forming solution (FFS) versus placebo (full analysis set). p < 0.001 week 6 versus baseline

Fig. 3

Signs and symptoms scores of desquamation at baseline and at weeks 1 and 6, of 1 % terbinafine film-forming solution (FFS) versus placebo (full analysis set). p < 0.001 week 6 versus baseline

Fig. 4

Signs and symptoms scores of pruritus at baseline and at weeks 1 and 6, of 1 % terbinafine film-forming solution (FFS) versus placebo (full analysis set). p < 0.001 week 6 versus baseline