NCT07208227已完成不适用
In-use Tolerance and Efficacy Study Under Dermatological and Ophthalmological Controls - Face Cream, RV4983A - LA3365
Pierre Fabre Dermo Cosmetique1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2021年10月27日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Global tolerance assessment
研究概览
简要总结
Tolerance and efficacy study of an anti aging cream on 44 subjects aged between 45 and 65 years, with sensitive skin and deep wrinkles. This study is conducted as a national, monocentric, non-randomized open trial.
Planning of the visits:
- Visit 1: Inclusion (Day 1)
- Visit 2: Intermediate visit (Day 29), a window of +48 hours is allowed
- Visit 3: End of study (Day 57), a window of +72 hours is allowed The maximum duration of participation for a subject is 60 days.
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
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Global tolerance assessment
时间窗: At the end of the study, after Last Patient Out, (after Day 57)
Global tolerance is assessed on the "tolerance population" which includes all the subjects who applied at least once investigational product. Global assessment of the dermatological and ophthalmological tolerance is done by the investigator. This assessment allows for attribution of one of the 5 levels : excellent, very good, good, moderate, bad.
次要结局
- Ra parameter to evaluate smoothing/anti-wrinkle effect(Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57).)
- Rt parameter to evaluate smoothing/anti-wrinkle effect(Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57).)
- Rz parameter to evaluate smoothing/anti-wrinkle effect(Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57).)
- Clinical scoring of the visibility of crow's feet wrinkles(Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57).)
- Clinical scoring of the Smoothness of the skin(Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57).)
- Clinical scoring of the Firmness of the skin(Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57).)
- Clinical scoring of the Skin plumpness(Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57).)
- Clinical scoring of Radiance/ Luminosity based on photographs(Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57).)
- Clinical scoring of homogeneity of skin texture based on photographs(Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57).)
- Clinical scoring of Skin brightness based on photographs(Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57).)
- Clinical scoring of homogeneity of skin tone based on photographs(Visit 1 (Day 1, before investigational product application), Visit 2 (Day 29) and Visit 3 (Day 57).)
研究者
研究点 (1)
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