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临床试验/NCT05765461
NCT05765461已完成不适用

Effect of Lipikar Baume AP+M on Quality of Life and Pain Related to Atopic Dermatitis and Other Skin Diseases With Dryness or Severe Xerosis on Adults

Cosmetique Active International1 个研究点 分布在 1 个国家目标入组 4,631 人开始时间: 2019年12月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4,631
试验地点
1
主要终点
change in the intensity of skin disease

研究概览

简要总结

This study aims at evaluating the effect of a topical product on the improvement of quality of life and pain of patients suffering from atopic dermatitis or other skin diseases with dryness or severe xerosis. Patients aged 16 years and over are asked to apply the product once or twice a day for 2 months. They may be prescribed a corticosteroid upon decision of the dermatologist.

详细描述

The general approach of the statistical methodology is the following:

  • The qualitative variables are described with number and percent of each level.
  • The quantitative variables are described with mean and standard deviation.
  • All statistical hypotheses are performed at the 5% significance level using 2-sided tests.
  • Given the large sample size, no normality assessment will be done.
  • Mean reduction rate for quantitative variables is calculated as (mean v0 - mean v1)/mean v0)*100.
  • Due to the high number of zeros at inclusion in the self-assessment quantitative criteria, analyses will concern only patient with an intensity above 0 at inclusion or at final visit.
  • Response rate for qualitative variables is calculated as the percent of patients with at least on level decrease between the two visits.
  • Response rate for satisfaction is the percent of patients declaring being Satisfied or Very satisfied.
  • Response rate for tolerance is the percent of patients declaring the tolerance High or Excellent.

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
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • atopic dermatitis or other skin disease with dryness or severe xerosis

排除标准

  • patients not suffering from atopic dermatitis or other skin disease with dryness or severe xerosis

结局指标

主要结局

change in the intensity of skin disease

时间窗: from baseline to Day56

The dermatologist evaluates the intensity of the skin condition on a 5-point scale (from absent to very severe)

次要结局

  • change in the intensity of skin dryness(from baseline to Day56)
  • evolution of the inflammatory lesions surface(from baseline to Day56)
  • change in the intensity of pruritus(from baseline to Day56)
  • change in the quality of sleep(from baseline to Day56)
  • change in the daily discomfort(from baseline to Day56)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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