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临床试验/NCT02310646
NCT02310646已完成3 期

A Clinical Trial Gathering Insight of Patient Reported Factors That Influence Preference Following Once Daily Topical Treatment With LEO 90100 Aerosol Foam and Daivobet® Gel in Subjects With Psoriasis Vulgaris

LEO Pharma1 个研究点 分布在 1 个国家目标入组 219 人开始时间: 2015年1月最近更新:
适应症
干预措施
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
219
试验地点
1
主要终点
Overall Treatment Preference by Subject's Preference Assessment (SPA) at Week 2 and Association With Baseline Characteristics

研究概览

简要总结

To gather insight on how product attributes affect usability by investigating the factors that are thought to influence patient preference to topical anti-psoriatic treatments.

详细描述

An international, multi-centre, prospective, open-label, randomised, 2-arm, cross-over study with 14-days once daily treatment in subjects with psoriasis vulgaris. To gather insight on how product attributes affect usability by investigating the factors that are thought to influence patient preference to topical anti-psoriatic treatments.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

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

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Treatment group 1

Active Comparator

Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel

干预措施: Daivobet® gel (Drug)

Treatment group 1

Active Comparator

Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel

干预措施: LEO 90100 Aerosol Foam (Drug)

Treatment group 2

Active Comparator

Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam

干预措施: LEO 90100 Aerosol Foam (Drug)

Treatment group 2

Active Comparator

Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam

干预措施: Daivobet® gel (Drug)

结局指标

主要结局

Overall Treatment Preference by Subject's Preference Assessment (SPA) at Week 2 and Association With Baseline Characteristics

时间窗: 2 weeks

The SPA questionnaire was completed at Week 2 and consisted of 2 parts: (i) the subject indicated if they preferred LEO 90100 foam or Daivobet® gel based on their experience using these products for 1 week each during the 2-weeks treatment period; (ii) the subject indicated how much each of the 22 items under the application, formulation, and container domains contributed to their overall decision of which product they preferred. This part of the SPA tool used a 4-point scale ranging from 'very important factor' to 'not at all important factor'. The statistical significance of each of the following 7 baseline characteristics (gender, age, disease severity, distribution, plaque size, skin thickness, onset) was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors. Results of multiple regression analyses are provided in the Clinical Study Report which can be found on the LEO Pharma website.

次要结局

未报告次要终点

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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