Efficacy and Safety of Neticonazole Hydrochloride 1% Cream in the Treatment of Tinea Pedis: A Multicenter, Randomized, Double-Blind Active-Controlled Noninferiority Trial
Author(s)
Meihua Fu, MD.
Institute of Dermatology, Chinese Academy of Medical Science, Nanjing, China.
Institute of Dermatology, Chinese Academy of Medical Science, Nanjing, China.
OBJECTIVES: Neticonazole is a broad-spectrum, long-acting imidazole antifungal with limited clinical data in Chinese populations with tinea pedis. This study aimed to evaluate the efficacy and safety of neticonazole in treating Chinese patients with tinea pedis.
METHODS: This multicenter, randomized, double-blind, active-controlled, non-inferiority trial enrolled adults with clinically and mycologically confirmed tinea pedis across 13 centers in China. Participants were randomly assigned to receive 1% neticonazole or 1% bifonazole cream once daily for 4 weeks. The primary endpoint was clinical efficacy at the end of treatment, defined as the proportion of patients achieving either cure (100% reduction in total symptom score [TSS]) or marked response (≥60% reduction in TSS). The non-inferiority margin was set at 10%.
RESULTS: A total of 422 patients were randomized (neticonazole group, n=211; bifonazole group, n=211), and all patients were included in the full analysis set. At week 4, the clinical response rate was 80.09% (95% confidence interval [CI] 74.71-85.48) in the neticonazole group and 72.04% (95% CI 65.98-78.09) in the bifonazole group (difference 8.05%, 95% CI -0.06 to 16.16), meeting the predefined non-inferiority margin. Two weeks post-treatment, the fungal clearance rate was significantly higher in the neticonazole group than in the bifonazole group (84.29% vs 70.98%; P=0.0018). MIC₅₀ and MIC₉₀ values at baseline were lower for neticonazole (0.030 μg/mL and 0.060 μg/mL) than for bifonazole (0.060 μg/mL and 0.125 μg/mL), suggesting stronger antifungal activity. Both treatments were well tolerated, with treatment-related adverse events reported in 8.53% and 9.00% of patients in the neticonazole and bifonazole groups, respectively; the most common events were local application site reactions.
CONCLUSIONS: Neticonazole cream demonstrated non-inferior clinical efficacy and superior post-treatment fungal clearance compared with bifonazole, with a favorable safety profile in Chinese patients with tinea pedis.
METHODS: This multicenter, randomized, double-blind, active-controlled, non-inferiority trial enrolled adults with clinically and mycologically confirmed tinea pedis across 13 centers in China. Participants were randomly assigned to receive 1% neticonazole or 1% bifonazole cream once daily for 4 weeks. The primary endpoint was clinical efficacy at the end of treatment, defined as the proportion of patients achieving either cure (100% reduction in total symptom score [TSS]) or marked response (≥60% reduction in TSS). The non-inferiority margin was set at 10%.
RESULTS: A total of 422 patients were randomized (neticonazole group, n=211; bifonazole group, n=211), and all patients were included in the full analysis set. At week 4, the clinical response rate was 80.09% (95% confidence interval [CI] 74.71-85.48) in the neticonazole group and 72.04% (95% CI 65.98-78.09) in the bifonazole group (difference 8.05%, 95% CI -0.06 to 16.16), meeting the predefined non-inferiority margin. Two weeks post-treatment, the fungal clearance rate was significantly higher in the neticonazole group than in the bifonazole group (84.29% vs 70.98%; P=0.0018). MIC₅₀ and MIC₉₀ values at baseline were lower for neticonazole (0.030 μg/mL and 0.060 μg/mL) than for bifonazole (0.060 μg/mL and 0.125 μg/mL), suggesting stronger antifungal activity. Both treatments were well tolerated, with treatment-related adverse events reported in 8.53% and 9.00% of patients in the neticonazole and bifonazole groups, respectively; the most common events were local application site reactions.
CONCLUSIONS: Neticonazole cream demonstrated non-inferior clinical efficacy and superior post-treatment fungal clearance compared with bifonazole, with a favorable safety profile in Chinese patients with tinea pedis.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
CO94
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas