Malay Donald Scot, Kim Hye Rin, Perfetti Nicholas John, Marshall Yolanda R, Bregman Peter J, Vavra Allysa M
Staff Surgeon and Director of Podiatric Research, Penn Presbyterian Medical Center, Penn Podiatry University City, Philadelphia, PA, USA.
Staff Surgeon, Penn Presbyterian Medical Center, Penn Podiatry University City, Philadelphia, PA, USA.
Infect Dis Ther. 2025 May 25. doi: 10.1007/s40121-025-01165-8.
Pedal onychomycosis is common, and its treatment entails debridement combined with topical and/or oral antifungal medication.
In this study, 69 participants were randomly allocated to either active (31 [44.93%]) or placebo (38 [55.07%]) topical solution. The primary outcome was mycological cure, and secondary outcomes included visible nail plate involvement and toenail-related quality of life.
After a minimum duration of follow-up of 7 months and a maximum of 9 months, participants in the active solution group experienced statistically significantly greater mycological cure (1 [2.63%] placebo versus 17 [54.84%] active, p < 0.0001) and clinical cure (2 [5.56%] placebo versus 21 [70%] active, p < 0.0001), including 47.62% of which showed complete clearance of visible nail plate involvement with no residual gross nail plate dystrophy and improved toenail-related quality of life, including less symptom bothersomeness (p < 0.0344), less overall toenail problems (p < 0.0315), and greater satisfaction with treatment (p < 0.0195) as early as the 3-month follow-up visit. In addition, the active solution group experienced less frequent symptoms (p = 0.0046 at 9 months) and symptom bothersomeness (p = 0.0002 at 7 months, < 0.0001 at 9 months), less difficulty caring for toenails and better toenail appearance (p = 0.0250 at 7 months, p= 0.007 at 9 months), improved physical activity and less toenail pain (p = 0.0208 at 7 months, p = 0.003 at 9 months), less overall toenail problems (p = 0.0002 at 7 months, p = 0.0006 at 9 months), and greater treatment satisfaction (p = 0.0003 at 7 months, p = 0.0015 at 9 months).
Participants with pedal onychomycosis that were randomized to the active topical solution showed statistically significantly greater mycological and clinical cures, as well as improved quality of life, in comparison with those allocated to the placebo topical solution.
ISRCTN Protocol no. 77852934.
足部甲癣很常见，其治疗需要清创并联合局部和/或口服抗真菌药物。
在本研究中，69名参与者被随机分配至活性（31名[44.93%]）或安慰剂（38名[55.07%]）局部溶液组。主要结局为真菌学治愈，次要结局包括可见甲板受累情况和与趾甲相关的生活质量。
在最短随访7个月、最长随访9个月后，活性溶液组参与者的真菌学治愈率（安慰剂组1名[2.63%] vs活性组17名[54.84%]，p<0.0001）和临床治愈率（安慰剂组2名[5.56%] vs活性组21名[70%]，p<0.0001）在统计学上显著更高，其中47.62%的患者可见甲板受累完全清除，无残留明显甲板营养不良，且与趾甲相关的生活质量得到改善，包括早在3个月随访时症状困扰减轻（p<0.0344）、总体趾甲问题减少（p<0.0315）以及对治疗的满意度更高（p<0.0195）。此外，活性溶液组症状出现频率更低（9个月时p=0.0046）和症状困扰减轻（7个月时p=0.0002，9个月时p<0.0001），护理趾甲的难度更小且趾甲外观更好（7个月时p=0.0250，9个月时p=0.007），身体活动改善且趾甲疼痛减轻（7个月时p=0.0208，9个月时p=0.003），总体趾甲问题减少（7个月时p=0.0002，9个月时p=0.0006），治疗满意度更高（7个月时p=0.0003，9个月时p=0.0015）。
与分配至安慰剂局部溶液组的参与者相比，随机分配至活性局部溶液组的足部甲癣患者在真菌学和临床治愈率以及生活质量改善方面在统计学上显著更优。
ISRCTN方案编号77852934。
