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.
OBJECTIVE
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.
Dermatology Department, Peking University First Hospital, 8# Xishiku Street, Xicheng District, Beijing, 100034, China, lry0660@gmail.com.
Ruo Yu
RY
Li
A P
AP
Wang
J H
JH
Xu
L Y
LY
Xi
M H
MH
Fu
M
M
Zhu
M L
ML
Xu
X Q
XQ
Li
W
W
Lai
W D
WD
Liu
X Y
XY
Lu
Z Q
ZQ
Gong
D000279:Administration, Cutaneous; D000328:Adult; D000935:Antifungal Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D044466:Asian People / Q000208:ethnology*; D004311:Double-Blind Method; D004890:Erythema / Q000139:chemically induced / Q000175:diagnosis; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes / Q000008:administration & dosage* / Q000009:adverse effects*; D000077291:Terbinafine; D014008:Tinea Pedis / Q000175:diagnosis / Q000188:drug therapy* / Q000208:ethnology*; D016896:Treatment Outcome; D055815:Young Adult
D000935:Antifungal Agents; D009281:Naphthalenes; D000077291:Terbinafine