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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.

Li RY, Wang AP, Xu JH, Xi LY, Fu MH, Zhu M, Xu ML, Li XQ, Lai W, Liu WD, Lu XY, Gong ZQ - Clin Drug Investig (2014)

Bottom Line: 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 ≤ 0.001 and clinically relevant.Both 1 % terbinafine FFS and placebo were safe and well tolerated based on adverse events and investigator and patient assessments.

View Article: PubMed Central - PubMed

Affiliation: Dermatology Department, Peking University First Hospital, 8# Xishiku Street, Xicheng District, Beijing, 100034, China, lry0660@gmail.com.

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.

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Related in: MedlinePlus

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
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Fig4: 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

Mentions: Figure 4 illustrates the signs and symptoms scores of pruritus characteristics at baseline, and at weeks 1 and 6. At baseline, the percentage of patients with mild, moderate, and severe ratings of pruritus was similar between both treatment groups, with the majority of patients experiencing severe or moderate pruritus (in 85 % and 84 % of patients in the 1 % terbinafine FFS and placebo groups, respectively). However, over time, 1 % terbinafine FFS was significantly more effective than placebo. At week 1, about 60 % of the patients still experienced pruritus; however, the percentage of patients reporting moderate to severe pruritus was almost twice that in the placebo group compared with the 1 % terbinafine FFS group (19 vs. 34 %). At Week 6, 70 % of patients reported absence of pruritus in the 1 % terbinafine FFS group, compared with only 30 % in the placebo group. Mild and moderate pruritus was observed in 25 % and 3 % of patients in the 1 % terbinafine group FFS, respectively, compared with 38 % and 21 % in the placebo group, respectively. Interestingly, at week 6, no patients reported severe pruritus in the 1 % terbinafine FFS group, compared with 13 patients (11 %) in the placebo group. The difference in pruritus severity was statistically significant (p < 0.001).Fig. 4


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.

Li RY, Wang AP, Xu JH, Xi LY, Fu MH, Zhu M, Xu ML, Li XQ, Lai W, Liu WD, Lu XY, Gong ZQ - Clin Drug Investig (2014)

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
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3926983&req=5

Fig4: 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
Mentions: Figure 4 illustrates the signs and symptoms scores of pruritus characteristics at baseline, and at weeks 1 and 6. At baseline, the percentage of patients with mild, moderate, and severe ratings of pruritus was similar between both treatment groups, with the majority of patients experiencing severe or moderate pruritus (in 85 % and 84 % of patients in the 1 % terbinafine FFS and placebo groups, respectively). However, over time, 1 % terbinafine FFS was significantly more effective than placebo. At week 1, about 60 % of the patients still experienced pruritus; however, the percentage of patients reporting moderate to severe pruritus was almost twice that in the placebo group compared with the 1 % terbinafine FFS group (19 vs. 34 %). At Week 6, 70 % of patients reported absence of pruritus in the 1 % terbinafine FFS group, compared with only 30 % in the placebo group. Mild and moderate pruritus was observed in 25 % and 3 % of patients in the 1 % terbinafine group FFS, respectively, compared with 38 % and 21 % in the placebo group, respectively. Interestingly, at week 6, no patients reported severe pruritus in the 1 % terbinafine FFS group, compared with 13 patients (11 %) in the placebo group. The difference in pruritus severity was statistically significant (p < 0.001).Fig. 4

Bottom Line: 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 ≤ 0.001 and clinically relevant.Both 1 % terbinafine FFS and placebo were safe and well tolerated based on adverse events and investigator and patient assessments.

View Article: PubMed Central - PubMed

Affiliation: Dermatology Department, Peking University First Hospital, 8# Xishiku Street, Xicheng District, Beijing, 100034, China, lry0660@gmail.com.

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.

Show MeSH
Related in: MedlinePlus