Prospective, Observational, Non-interventional, Multicenter Study on the Efficacy and Tolerability of Calcipotriol/Betamethasone Aerosol Foam (Enstilar®) in Patients With Plaque Psoriasis Under Daily Practice Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 410
- 试验地点
- 1
- 主要终点
- Investigator Global Assessment
研究概览
简要总结
This study aims to assess how the Enstilar® aerosol foam performs in daily real-life practice with regards to effectiveness and convenience of application to psoriasis plaques on body and extremities. In addition the profiles of patients prescribed Enstilar® will be described, and preceeding, concomitant and follow-up management will be mapped. The study will be conducted in about 100 dermatology clinics all over Germany,
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
- •≥ 18 years of age
- •Psoriasis vulgaris
- •Lesions on trunk and/or extremities of at least mild severity
- •Treatment with Enstilar® planned
- •Signed informed consent to participate
排除标准
- •Enrolled in any interventional clinical trial
- •Ongoing or recent treatment with any systemic psoriasis
- •Ongoing or recent treatment with UV-therapy
- •Ongoing or previous treatment with Enstilar®
- •Psoriasis of scalp only
- •Other forms of psoriasis, e.g. erythrodermic or pustular psoriasis
- •More than 30% of surface area affected by psoriasis
- •Any contraindications or known allergies to Enstilar® or its ingredients
- •Incapacitated patients under institutionalized care
研究组 & 干预措施
Enstilar®
Patients with psoriasis vulgaris plaques on body and/or extremities will apply Enstilar® (calcipotriol /betamethasone dipropionate (50 micrograms/g + 0.5 mg/g) cutaneous foam) once daily for up to 4 weeks, according to the approved labelling of Enstilar® in Germany.
干预措施: Enstilar® (Drug)
结局指标
主要结局
Investigator Global Assessment
时间窗: Week 4
5-point Likert scale
Percentage of total body surface area affected
时间窗: 4 weeks
Percentage
Absence of related adverse events (ADR)
时间窗: 4 weeks
Proportion of patients with no ADRs
次要结局
- Patient reported satisfaction with tolerability(4 weeks)
- Patient reported satisfaction with convenience(4 weeks)
- Patient reported itching(4 weeks)
- Patient reported sleep loss(4 weeks)
- Patient reported erythema(4 weeks)
- Patient reported scaling(4 weeks)
- Patient reported dry skin(4 weeks)
- Patient reported overall treatment satisfaction(4 weeks)
- PASI 50(4 weeks)
- Patient Global Assessment(4 weeks)
- PASI 75(4 weeks)
- Patient reported satisfaction with effectiveness(4 weeks)
- Dermatology Life Quality Index(4 weeks)