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临床试验/NCT02636101
NCT02636101已完成不适用

Xamiol® Gel in BODY Psoriasis : lonG-term Management of Psoriasis vUlgARis With Xamiol® Gel in Daily Clinical Practice of Russian Dermatologists. A Long-term Observational, Prospective Study

LEO Pharma1 个研究点 分布在 1 个国家目标入组 603 人开始时间: 2016年1月最近更新:
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
603
试验地点
1
主要终点
Adherence to treatment

研究概览

简要总结

This study aims to describe the patient population treated and the real-life patients' experiences with Xamiol®gel in the long term, up to 52 weeks management of body psoriasis vulgaris in Russia. The result will increase the knowledge on Xamiol®gel enabling dermatologists and patients to optimize its use in the long term management of 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

入选标准

  • Psoriasis vulgaris on body
  • Patients planned to receive topical treatment on the body with calcipotriol/betamethasone gel
  • Written informed consent

排除标准

  • No or very mild symptoms of psoriasis vulgaris on the body at study start
  • Any on-going treatments at study start with topical steroids, salicylic acid or its combination
  • Other topical treatment for body psoriasis
  • Pregnancy or planned pregnancy within treatment period
  • Contraindications according to prescribing information.

结局指标

主要结局

Adherence to treatment

时间窗: Around 8 weeks after treatment initiation

Number of days during the last 7 days with no treatment

Patient reported treatment satisfaction

时间窗: Around 8 weeks after treatment initiation

Patient preference compared with previous therapy

次要结局

  • Frequency of treatment after completion of initial treatment(12 months)
  • Physician Global Assessment of Psoriasis(Around 8 weeks after treatment initiation)
  • Overall rate of treatment success(Around 8 weeks)
  • To evaluate the effect of treatment with Xamiol®gel on patients quality of life(Around 8 weeks)
  • Patient's willingness to pay(12 months)

研究者

发起方
LEO Pharma
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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