ASSESSMENT OF CLINICAL, INSTRUMENTAL AND NOTICED EFICACY BY SUBJECTS OF A COSMETIC PRODUCT 12.0417.01.090 UNDER NORMAL CONDITIONS OF USE Study With Dermatological Follow-up Including Instrumental Measurements
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- skin oiliness
研究概览
简要总结
A clinical study with 56 healthy subjects (both sexes) aged between 13 to 25 years old. Subjects enrolled had a minimum of 5 inflammatory lesions (papules, nodules and pustules) and 10 non-inflammatory lesions (open and closed comedones), determined by dermatologist. The clinical evaluation considered in oiliness, shininess and global aspect of the skin too. Instrumental assessment of oiliness and shininess was performed, respectively, by Sebumeter and Sebutape.
IThe tested cleanser was used twice daily (morning and evening) during 28 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
- 13 Years 至 26 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects aged 13-25 years
- •mild to moderate acne on the face
- •signed informed consent
排除标准
- •subjects below 13 years and above 26 years
- •severe acne on the face
结局指标
主要结局
skin oiliness
时间窗: Day 28
instrumental measurement Sebumeter
Closed comedones
时间窗: Day 28
count
Global lesion count
时间窗: Day 28
using GEA scale
skin sebutape
时间窗: Day 28
instrumental measurement Sebumeter
subject satisfaction
时间窗: Day 28
questionnaire
papules
时间窗: Day 28
count
次要结局
未报告次要终点