NCT00243464已完成3 期
Calcipotriol Plus Betamethasone Dipropionate Gel Compared to DAIVONEX/DOVONEX Scalp Solution in Patients With 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
- 300
- 试验地点
- 10
- 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 plus betamethasone dipropionate gel is more effective than twice daily treatment of calcipotriol scalp solution in patients with scalp psoriasis. The primary outcome is patients with clear or minimal disease after 8 weeks treatment.
Further the occurrence of relapse and rebound after end of treatment in patients with clear or minimal disease will be investigated.
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
- Single
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 moderate 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
- •Systemic 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 non steroid 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
- Total sign score at week 8
- Overall disease severity according to the investigator's assessment at week 2 and 4
- Overall disease severity according to patients at week 8
- Score for redness, thickness and scaliness at week 8
- Relapse and rebound during the study
研究者
研究点 (10)
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