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

• Published in: Clinical drug investigation 2014-03, Vol.34 (3), p.223-230
• Main Authors: Li, Ruo Yu, Wang, A. P., Xu, J. H., Xi, L. Y., Fu, M. H., Zhu, M., Xu, M. L., Li, X. Q., Lai, W., Liu, W. D., Lu, X. Y., Gong, Z. Q.
• Format: Article
• Language: English
• Subjects: Administration, Cutaneous; Adult; Antifungal Agents - administration & dosage; Antifungal Agents - adverse effects; Asian Continental Ancestry Group - ethnology; Double-Blind Method; Erythema - chemically induced; Erythema - diagnosis; Female; Follow-Up Studies; Humans; Internal Medicine; Male; Medicine; Medicine & Public Health; Middle Aged; Naphthalenes - administration & dosage; Naphthalenes - adverse effects; Original; Original Research Article; Pharmacology/Toxicology; Pharmacotherapy; Tinea Pedis - diagnosis; Tinea Pedis - drug therapy; Tinea Pedis - ethnology; Treatment Outcome; Young Adult
• ISSN: 1173-2563; 1179-1918
• DOI: 10.1007/s40261-014-0171-8

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.