Bhatt Drishti, Singh Dr Adarshlata
Dermatology, Venereology and Leprosy, Datta Meghe Institute of Higher Education and Research, Wardha, 442001, India.
F1000Res. 2024 Apr 23;13:317. doi: 10.12688/f1000research.147725.1. eCollection 2024.
Hand eczema is a prevalent dermatological condition that significantly impacts the quality of life of affected individuals. Topical corticosteroids, such as Clobetasol Propionate, are commonly employed for management, but concerns regarding long-term use and potential side effects necessitate exploration of alternative treatments. This study protocol outlines a randomized controlled trial comparing the efficacy of topical Tofacitinib 2% ointment with Clobetasol Propionate 0.05% ointment in managing hand eczema.
The study will be a single-blinded, parallel-group, randomized controlled trial conducted at the Dermatology outpatient department of Acharya Vinoba Bhave Rural Hospital Sawangi Meghe, Wardha, from March 2023 to September 2025. Eligible participants diagnosed with hand eczema will be randomized into two groups: Group 1 will receive Clobetasol Propionate 0.05% ointment, and Group 2 will receive Tofacitinib 2% ointment. The primary outcome measure is the change from baseline in the Hand Eczema Severity Index (HECSI) score, assessed at two weeks and four weeks. Statistical analysis will utilize appropriate parametric and non-parametric tests, with a p-value <0.05 considered significant.
The study is anticipated to provide insights into the comparative efficacy and safety of Tofacitinib and Clobetasol Propionate in managing hand eczema. A favorable outcome for Tofacitinib could suggest its potential as an alternative or adjunctive therapy, offering a more targeted approach with fewer side effects. The findings may contribute to optimized treatment strategies for hand eczema, improving patient outcomes and guiding future research in dermatological therapeutics.
手部湿疹是一种常见的皮肤病,严重影响患者的生活质量。外用糖皮质激素,如丙酸氯倍他索,常用于治疗,但对长期使用及潜在副作用的担忧促使人们探索替代疗法。本研究方案概述了一项随机对照试验,比较2%托法替布软膏与0.05%丙酸氯倍他索软膏治疗手部湿疹的疗效。
该研究将于2023年3月至2025年9月在沃德哈萨万吉梅格阿查里亚·维诺巴·巴韦农村医院皮肤科门诊进行,为单盲、平行组随机对照试验。诊断为手部湿疹的合格参与者将被随机分为两组:第1组接受0.05%丙酸氯倍他索软膏,第2组接受2%托法替布软膏。主要结局指标是在两周和四周时评估的手部湿疹严重程度指数(HECSI)评分相对于基线的变化。统计分析将采用适当的参数检验和非参数检验,p值<0.05被认为具有统计学意义。
该研究有望深入了解托法替布和丙酸氯倍他索治疗手部湿疹的相对疗效和安全性。托法替布取得良好结果可能表明其作为替代或辅助治疗的潜力,提供一种更具针对性且副作用更少的方法。研究结果可能有助于优化手部湿疹的治疗策略,改善患者预后,并为皮肤病治疗的未来研究提供指导。