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学科主题: 临床医学
题名:
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
作者: Li, Ruo Yu1; Wang, A. P.1; Xu, J. H.2; Xi, L. Y.3; Fu, M. H.4; Zhu, M.2; Xu, M. L.5; Li, X. Q.3; Lai, W.6; Liu, W. D.4; Lu, X. Y.5; Gong, Z. Q.6
刊名: CLINICAL DRUG INVESTIGATION
发表日期: 2014-03-01
DOI: 10.1007/s40261-014-0171-8
卷: 34, 期:3, 页:223-230
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Pharmacology & Pharmacy
研究领域[WOS]: Pharmacology & Pharmacy
关键词[WOS]: DERMATOPHYTES
英文摘要:

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.

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.

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 a parts per thousand currency sign 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 a parts per thousand currency sign 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 a parts per thousand currency sign 0.001). Both 1 % terbinafine FFS and placebo were safe and well tolerated based on adverse events and investigator and patient assessments.

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.

语种: 英语
项目资助者: Beijing Novartis Pharma Ltd. ; Novartis
WOS记录号: WOS:000331655400008
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/49993
Appears in Collections:北京大学第一临床医学院_皮肤性病科_期刊论文

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作者单位: 1.Peking Univ, Hosp 1, Dept Dermatol, Beijing 100034, Peoples R China
2.Fudan Univ, Huashan Hosp, Shanghai 200433, Peoples R China
3.Sun Yat Sen Mem Hosp, Dept Dermatol, Guangzhou, Guangdong, Peoples R China
4.Chinese Acad Med Sci, Inst Dermatol, Nanjing, Jiangsu, Peoples R China
5.Peking Univ, Hosp 3, Dept Dermatol, Beijing 100034, Peoples R China
6.Sun Yat Sen Univ, Dept Dermatol, Affiliated Hosp 3, Guangzhou 510275, Guangdong, Peoples R China

Recommended Citation:
Li, Ruo Yu,Wang, A. P.,Xu, J. H.,et al. 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[J]. CLINICAL DRUG INVESTIGATION,2014,34(3):223-230.
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