NCT00404196已完成2 期
LEO19123 Cream in the Treatment of Hand Eczema
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Proof of concept
研究概览
简要总结
To compare the efficacy and safety of two different dose combinations of LEO19123 cream (calcipotriol and LEO80122) with LEO19123 cream vehicle for 3 weeks in the treatment of patients with hand eczema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of hand eczema with or without atopic etiology/background
- •Investigator.s Global Assessment of disease severity graded as at least mild at Visit 1
- •Patients should be Caucasian males aged from 18 years
- •Attending a hospital outpatient clinic or the private practise of a dermatologist.
- •Following verbal and written information about the trial, the patient must provide signed and dated informed consent before any trial related activity is carried out, including activities relating to wash-out periods.
排除标准
- •Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine) or corticosteroids within 4 weeks prior to randomisation. (Inhaled or intranasal steroids for asthma or rhinitis may be used).
- •PUVA or UVB therapy on the hands within 4 weeks prior to randomisation.
- •Topical treatment with immunomodulators (pimecrolimus, tacrolimus) or corticosteroids from WHO groups III or IV on the hands within 2 weeks prior to randomisation.
- •Other topical therapy on the hands (except for the use of emollient) within 1 week prior to randomisation.
- •Use of other treatment (drug, non-drug) on the hands during the trial except for the use of investigational product and emollient.
- •Concurrent skin diseases on the hands.
- •Current diagnosis of exfoliative dermatitis.
- •Significant clinical infection (impetiginised hand eczema) on the hands, which requires antibiotic treatment.
- •Known or suspected hypersensitivity to component(s) of the investigational product.
- •Positive patch test as defined in protocol
- •Known or suspected severe renal insufficiency or severe hepatic disorders.
- •Patients with history/signs/symptoms suggestive of an abnormality of calcium homeostasis associated with clinically significant hypercalcaemia.
- •Patients with history of cancer except for basal cell carcinoma.
- •Current participation in any other interventional clinical trial.
- •Patients who have received treatment with any nonmarketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within 4 weeks prior to randomisation.
- •Previously randomised in this study.
- •Patients known or, in the opinion of the investigator, is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency, or psychotic state).
结局指标
主要结局
Proof of concept
次要结局
- Safety
研究者
研究点 (2)
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