NCT01052467已完成不适用
Topical Treatment of Scalp Psoriasis With the Fixed Combination of Calcipotriol and Betamethason (Xamiol® Gel)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 724
- 试验地点
- 1
- 主要终点
- Physician's Global Assessment of scalp psoriasis
研究概览
简要总结
This non-interventional, prospective, non-controlled study of Xamiol® Gel, a fixed combination of calcipotriol and betamethason dipropionate, shall investigate in daily routine the efficacy, tolerability and changes in quality-of-life parameters in patients with scalp psoriasis
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with scalp psoriasis if a treatment with Xamiol® gel is planned anyway
排除标准
- •Contraindications of Xamiol® Gel listed in the German package insert
- •Pretreatment with Xamiol® within the last 4 weeks
- •Systemic treatment of psoriasis
- •UV light therapy
结局指标
主要结局
Physician's Global Assessment of scalp psoriasis
时间窗: After approximately 4 weeks
次要结局
- Patient's Quality of Life(After approximately 4 weeks)
研究者
研究点 (1)
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ong-term treatment of Scalp Psoriasis with Calciptriol plus Betamethasone dipropionate gel.A phase III safety study of a new gel containing calcipotriol 50mcg/g plus betamethasone 0.5 mg/g (as dipropionate) used once daily, as needed, in scalp psoriasis.Psoriasis of the scalpExtent: Minimum 10% of the total scalp areaDisease severity: Graded as moderate, severe, or very severe according to the investigator's global assessment of disease severityClinical signs of psoriasis vulgaris on trunk and/or limbs, or earlier diagnosed with psoriasis vulgaris on trunk and/or limbsMedDRA version: 7.0Level: LLTClassification code 10037115EUCTR2004-002861-19-GBEO Pharmaceutical Products Ltd. A/S (LEO Pharma A/S)800
进行中（未招募）
1 期
ong-term treatment of Scalp Psoriasis with Calciptriol plus Betamethasone dipropionate gel.A phase III safety study of a new gel containing calcipotriol 50mcg/g plus betamethasone 0.5 mg/g (as dipropionate) used once daily, as needed, in scalp psoriasis.EUCTR2004-002861-19-DKEO Pharma A/S800