NCT00216827已完成3 期
Calcipotriol Plus Betamethasone Dipropionate Gel Compared to Betamethasone Dipropionate in the Gel Vehicle, Calcipotriol in the Gel Vehicle, and the Gel Vehicle Alone in Scalp Psoriasis
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 1,485
- 试验地点
- 16
- 主要终点
- Overall disease severity according to investigator's assessment at week 8
研究概览
简要总结
The purpose of this study is to evaluate whether once daily treatment for up to 8 weeks of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel is safe and more effective than betamethasone 0.5 mg/g (as dipropionate) in the gel vehicle, calcipotriol 50 mcg/g in the gel vehicle or the gel vehicle used alone in patients with scalp psoriasis.
The primary outcome is the proportion of patients with absence of disease or very mild disease after 8 weeks of treatment.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Scalp psoriasis amenable to topical treatment
- •Psoriasis vulgaris on trunk and/or limbs
- •Extent of scalp psoriasis involving more than 10% of the total scalp area
- •Disease severity on the scalp graded as mild or worse by the investigator
- •Consenting out-patients of 18 years or above
排除标准
- •PUVA or Grenz ray therapy within 4 weeks prior to randomisation
- •UVB therapy within 2 weeks prior to randomisation
- •Systematic treatment with biological therapies, with a possible effect on scalp psoriasis within 6 months prior to randomisation
- •Systemic treatment with all other therapies than biologicals, with a possible effect on scalp psoriasis (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within 4 weeks prior to randomisation
- •Any topical treatment of the scalp (except for medicated shampoos and emollients) within 2 weeks prior to randomisation
- •Topical treatment of the face, trunk and/or limbs with very potent WHO group IV corticosteroids within 2 weeks prior to randomisation
- •Current diagnosis of erythrodermic, exfoliative or pustular psoriasis
结局指标
主要结局
Overall disease severity according to investigator's assessment at week 8
次要结局
- Overall disease severity according to investigator's assessment at week 2 and 4
- Overall disease severity according to patients at week 8
- Adverse events
- Total sign score at week 8
- Extent of scalp psoriasis at week 8
- Laboratory data
- Score for scaliness, redness and thickness at week 8
研究者
研究点 (16)
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