NCT00576550已完成4 期
A Randomised Trial of a Moisturising Cream in Preventing Recurrence of Hand Eczema
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 3
- 主要终点
- Time to relapse of hand eczema
研究概览
简要总结
The purpose of this study is to investigate whether a moisturizing cream can prevent hand eczema.Patients with previous hand eczema will be studied. In the second part of the study, it will be explored if a treatment regimen of a topical corticosteroid once daily is not inferior to treatment twice daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically proven history of hand eczema
- •At inclusion controlled state of hand eczema (≤3 on Hand Eczema Extent Score, HEES)
- •Daily use of moisturising treatment
- •Either gender
- •Age 18 or above
- •Written Informed Consent
排除标准
- •Possible allergy to ingredients in the study medications
- •At study start active psoriatic lesions or active atopic eczema lesions on the hands. Active bacterial, fungal or viral infection of the hands
- •Patients who are pregnant or breast-feeding, or who plan to become pregnant during the course of the study
- •Use of any concomitant medication that may interfere with the study related activities or assessment of efficacy
- •Any patient related factor suggesting potential poor compliance with study procedures (e.g. psychiatric disorders, history of alcohol or substance abuse)
- •Any serious medical condition which, in the opinion of the investigator, may interfere with the evaluation of the results
- •Inclusion in a study of an investigational drug within 60 days prior to start of treatment
研究组 & 干预措施
1:1
Experimental
Part 1 of the study (maintenance part)
干预措施: Urea (Drug)
2:1
Experimental
Part 2 of the study (eczema part)
干预措施: betamethasone valerate (Drug)
2:2
Active Comparator
Part 2 of the study (eczema part)
干预措施: betamethasone valerate (Drug)
结局指标
主要结局
Time to relapse of hand eczema
时间窗: Up to 6 months
次要结局
- The number of patients showing clearance of hand eczema after betamethasone treatment once versus twice daily(2 weeks)
研究者
研究点 (3)
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