NCT07271628
已完成
不适用
Evaluation of the Moisturizing Effect of Study Product AV0018B and the Persistence of This Effect After Repeated Applications, Compared to an Untreated Control Area.
Pierre Fabre Dermo Cosmetique1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年10月4日最近更新:
概览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pierre Fabre Dermo Cosmetique
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cutaneous Capacitance
概览
简要总结
This study is a monocentric, intra-individual, controlateral design study, on the internal and posterointernal side of the forearms, to evaluate the moisturizing effect of study product AV0018B and of the persistence of this effect after repeated applications for 7 days, compared to a control area with no application of study product.
The study takes place over a 8-day period and involves 2 visits :
- Inclusion visit: Day 1 (1timepoint (Time 1) before any study product application)
- End-of-study visit: Day 8 (2 timepoints : Time 2 : 12±2h after last application , and Time 3 : 8±4h after Time 2)
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
- 20 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 20 to 55 years, inclusive
- •Phototype I to V, inclusive
- •Low hairiness and absence of prominent veins on the internal and posterointernal side of the forearms.
- •No shaving/hair removal of forearms
- •Dehydrated forearms, with HI ≤ 35 (posterointernal side of the forearms)
- •Not taking part in another clinical research study.
- •Having signed the consent form.
- •Having health insurance.
排除标准
- •Population:
- •Pregnant, breastfeeding women.
- •Subjects declaring to have hot flushes.
- •With sunburn on forearms.
- •Frequently washing their forearms for professional reasons or out of habit.
- •Application of keratolytic and/or self-tanning products to the upper limbs in the 4 weeks prior to inclusion.
- •Application of skin care (Hydrating, nourishing) or exfoliating products to the upper limbs in the 2 weeks prior to inclusion.
- •Application of water or hygiene products to the upper limbs since the last wash on the evening before inclusion.
- •Participating in another study on the forearms (not including kinetics studies) in the 2 weeks prior to inclusion.
- •Participating in a kinetics study on the forearms in the 48 hours prior to inclusion.
结局指标
主要结局
Cutaneous Capacitance
时间窗: - Visit 1 : Day 1 - Time 1 - Visit 2 : Day 8 - Time 2 (12±2hours after last application) and Time 3 (8±4hours after Time 2)
Cutaneous capacitance is measured by Corneometry at posterointernal sides of forearms.
次要结局
- Illustrative Photographs(- Visit 1 : Day 1 - Time 1 - Visit 2 : Day 8 - Time 2 (12±2hours after last application) and Time 3 (8±4hours after Time 2))
研究者
研究点 (1)
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