Satisfaction Survey - Cicaplast Mains
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- satisfaction rate
研究概览
简要总结
The participants presenting with hand problems and meeting the inclusion criteria are asked to apply the study product for one month. They are evaluated before and after treatment.
详细描述
The international, open, observational survey is conducted in 3 different countries.
Regarding the statistical analysis, the global satisfaction is described in 5 classes and in 2 classes "Satisfied + Very satisfied" vs. "Neither satisfied nor dissatisfied + Not so satisfied + Not at all satisfied". The 95% Confidence Interval (CI) of the percent of "Satisfied + Very satisfied" is also given.
On patients who already used cream at the inclusion, the following analyses are performed:
- Cross-tabulation between both visits,
- Test of the evolution between both visits using a special procedure for ordinal data with repeated measures,
- Description of a summary variable in 3 classes (Improved / No change / Worsened).
For the analysis of the hands problems, each sign is described at the inclusion and at the evaluation visit. The difference Evaluation-Inclusion is also given. The evolution of the sign is performed by a Wilcoxon test for matched samples.
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
- 是
入选标准
- •professionals that work on different activities related to hair in a beauty salon
- •professionals presenting with current hand problems such as dryness, redness, irritations, cracks and fissures
排除标准
- •professionals that do not meet the inclusion criteria
结局指标
主要结局
satisfaction rate
时间窗: from baseline to Day28
satisfaction questionnaire with a 5-point scale
次要结局
- evaluation of hands problems (dryness, redness, irritations, cracks, fissures)(from baseline to Day28)