Efficacy of Topical Antifungal Nail Solution Versus Topical Placebo Solution for the Treatment of Pedal Onychomycosis: A Randomized Controlled Trial.

IF 4.7 3区 医学 Q1 INFECTIOUS DISEASES
Donald Scot Malay, Hye Rin Kim, Nicholas John Perfetti, Yolanda R Marshall, Peter J Bregman, Allysa M Vavra
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引用次数: 0

Abstract

Introduction: Pedal onychomycosis is common, and its treatment entails debridement combined with topical and/or oral antifungal medication.

Methods: 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.

Results: 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).

Conclusions: 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.

Trial registration: ISRCTN Protocol no. 77852934.

局部抗真菌指甲溶液与局部安慰剂溶液治疗足趾甲真菌病的疗效:一项随机对照试验。
脚掌真菌病是常见的,其治疗需要清创结合局部和/或口服抗真菌药物。方法:在本研究中,69名参与者随机分配到有效(31人[44.93%])或安慰剂(38人[55.07%])局部溶液组。主要结果是真菌学治愈,次要结果包括可见的甲板受累和趾甲相关的生活质量。结果:在最短7个月和最长9个月的随访后,活性溶液组的参与者获得了具有统计学意义的更高的真菌学治愈率(安慰剂组为1[2.63%],活性溶液组为17 [54.84%],p)。与分配给安慰剂局部溶液的患者相比,随机分配给活性局部溶液的脚癣患者在统计学上显示出更大的真菌学和临床治愈率,以及生活质量的改善。试验注册:ISRCTN协议号。77852934.
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Infectious Diseases and Therapy
Infectious Diseases and Therapy Medicine-Microbiology (medical)
CiteScore
8.60
自引率
1.90%
发文量
136
审稿时长
6 weeks
期刊介绍: Infectious Diseases and Therapy is an international, open access, peer-reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of infectious disease therapies and interventions, including vaccines and devices. Studies relating to diagnostic products and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to, bacterial and fungal infections, viral infections (including HIV/AIDS and hepatitis), parasitological diseases, tuberculosis and other mycobacterial diseases, vaccinations and other interventions, and drug-resistance, chronic infections, epidemiology and tropical, emergent, pediatric, dermal and sexually-transmitted diseases.
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