A randomized controlled study to compare efficacy and safety of azathioprine and methotrexate in patients of hand eczema.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To compare the clinical and functional outcome in each group, as assessed by HECSI and DLQI.
研究概览
简要总结
Hand eczema is an inflammatory skin disorder, clinically characterized by erythema, infiltration, hyperkeratosis, oedema, and vesicles. Secondary signs may be scaling, hyperkeratotic areas, fissures, erosions, and bacterial infections, chiefly with Staphylococcus aureus. In addition to the hands, the wrists and the forearms are often involved. Hand eczema is common, with a 1-year prevalence of approximately 10% in the adult population.Hand eczema is typically a dynamic condition extending over years, and its morphology may vary over time, both clinically and histologically. Erythema, oedema and vesicles are characteristic of acute eczema, whereas infiltration, hyperkeratosis and fissures are seen in chronic eczema. Hand eczema generally begins as acute eczema and then passes into a phase with chronic changes, sometimes with periods of acute eruptions. Important symptoms in patients of hand eczema are itching and pain in fissures if present.
Patients with hand eczema experience significantly diminished health related quality of life (QOL) resulting in physical and mental disability even though it involves a relatively small percentage of the body surface area. This is often comparable with other chronic diseases (e.g. diabetes, depression, heart disease). Hand eczema is often notoriously difficult to treat and unresponsive to traditional topical agents. The treatment of hand eczema must be tailored to the individual patient. Hand eczema of recent onset should be treated quickly and effectively to prevent chronicity. At the same time, an effort should be made to determine the aetiology of the eczema, and instruction on skin care and prevention should be given. When treatment is being chosen, the severity of the eczema, whether it is acute or chronic, and its morphology should be taken into account. There is no consensus about the treatment of hand eczema and current therapeutic options include avoidance of allergens and irritants, emollients, topical and systemic corticosteroids and other immunosuppressive drugs. There is limited randomized controlled trial (RCT) data regarding the use of systemic immunosuppressive agents for hand eczema. Methotrexate is an off-label treatment option for chronic hand eczema, although the effectiveness is only discussed in small case series. An RCT comparing azathioprine 50 mg daily and a very potent topical corticosteroid with the very potent topical corticosteroid alone suggests possible additive benefit from lowâ€dose azathioprine.There are no studies that have compared Azathioprine with Methotrexate in the management of hand eczema hence in this study, we intend to compare the efficacy and safety of Azathioprine versus Methotrexate in patients of hand eczema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients diagnosed as moderate to severe hand eczema (HECSI score >12).
- •Age >18 years.
排除标准
- •1.Patients with hepatic/ renal disease/pulmonary fibrosis.
- •2.Severe anaemia, leucopenia or thrombocytopenia.
- •3.Active infectious disease or immune system deficiency including AIDS.
- •4.Pregnant or lactating women.
- •5.Significant abnormalities in liver function (serum bilirubin, AST, ALT, and ALP> 1.5 times the upper limit of normal), viral hepatitis or cirrhosis.
- •6.H/o excessive alcohol consumption.
- •7.H/o intolerance/hypersensitivity to azathioprine and/or methotrexate.
结局指标
主要结局
To compare the clinical and functional outcome in each group, as assessed by HECSI and DLQI.
时间窗: week 2, 4, 8 and 12
To compare the safety and tolerability of each drug by regular evaluation of clinical and biochemical parameters.
时间窗: week 2, 4, 8 and 12
次要结局
- 〈Evaluate the clinicodemographic factors predicting response in each group.(To study the MOAHLFA index for demographic characteristics of patients.)
