Oosterhaven Jart Ate Franke, Schuttelaar Marie Louise Anna
Department of Dermatology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
BMJ Open. 2018 Jul 11;8(7):e020192. doi: 10.1136/bmjopen-2017-020192.
Systemic treatment with alitretinoin is registered for all clinical types of severe chronic hand eczema. However, it is especially effective in the hyperkeratotic subtype and less effective in non-hyperkeratotic forms. Cyclosporine A (cyclosporine) is prescribed for hand eczema in daily practice as well. It has shown to be particularly effective in patients with vesicular hand eczema. The primary objective of this study is to compare efficacy of alitretinoin and cyclosporine in the treatment of severe recurrent vesicular hand eczema.
This is an investigator-initiated randomised prospective open-label trial with blinded outcome assessment. Severity assessments and laboratory measurements will be conducted corresponding to daily practice. The study population will consist of 72 adult patients (age 18-75 years) with severe recurrent vesicular hand eczema. Patients are treated with either (group I) alitretinoin 30 mg once daily or (group II) cyclosporine with a starting dose of 5 mg/kg/day and a decrease in dosage after 8 weeks to 3-3.5 mg/kg/day. The treatment period is 24 weeks for both drugs. Primary endpoint for efficacy is response to treatment, defined as an improvement of ≥2 steps on a Physician Global Assessment, using a validated Photoguide, after 24 weeks of treatment. Secondary endpoints are improvement of Hand Eczema Severity Index, Quality of Life in Hand Eczema Questionnaire and a Patient Global Assessment. Adverse events and time to response will be registered. Furthermore, cost-utility, quality-adjusted life years and cost-effectiveness will be assessed with the EQ-5D-5L questionnaire while monitoring costs.
This protocol was reviewed and approved by the Medical Ethical Review Board of the University Medical Centre Groningen (reference METc 2015/375). The study will be conducted according to the principles of the Declaration of Helsinki, in accordance with the Dutch Medical Research Involving Human Subjects Act.
NCT03026946; Pre-results.
阿利维A酸的全身治疗已获批用于所有临床类型的重度慢性手部湿疹。然而，它在角化过度亚型中特别有效，而在非角化过度型中效果较差。环孢素A（环孢素）在日常实践中也用于治疗手部湿疹。它已显示在水疱型手部湿疹患者中特别有效。本研究的主要目的是比较阿利维A酸和环孢素在治疗重度复发性水疱型手部湿疹中的疗效。
这是一项由研究者发起的随机前瞻性开放标签试验，采用盲法结局评估。将按照日常实践进行严重程度评估和实验室测量。研究人群将包括72名患有重度复发性水疱型手部湿疹的成年患者（年龄18 - 75岁）。患者将接受以下治疗之一：（I组）阿利维A酸30毫克，每日一次；或（II组）环孢素，起始剂量为5毫克/千克/天，8周后剂量减至3 - 3.5毫克/千克/天。两种药物的治疗期均为24周。疗效的主要终点是对治疗的反应，定义为在使用经过验证的Photoguide进行24周治疗后，医生整体评估改善≥2级。次要终点是手部湿疹严重程度指数的改善、手部湿疹生活质量问卷和患者整体评估。将记录不良事件和反应时间。此外，将使用EQ - 5D - 5L问卷在监测成本的同时评估成本效用、质量调整生命年和成本效益。
本方案已由格罗宁根大学医学中心医学伦理审查委员会审查并批准（参考编号METc 2015/375）。本研究将根据《赫尔辛基宣言》的原则进行，符合荷兰涉及人类受试者的医学研究法案。
NCT03026946；预结果。
