12-Week Serum Efficacy Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Dermatologist-Assessed Wrinkle Attributes
研究概览
简要总结
This study aims to evaluate the anti-aging and skin tone improvement effects of two facial serums over a 12-week period. It was conducted at a single research center with a 2-week washout period followed by full-face application of the test products for 12 weeks.
A total of at least 120 healthy Chinese female participants aged 18 to 45 were enrolled and divided into two treatment groups:Each group included both early aging (18-29 years) and mature aging (30-45 years) subgroups, with at least 30 participants in each subgroup.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Chinese female aged 18-45 years (evenly split among Early aging [18-29 years] and Mature aging [30-45 years]).
- •All skin types (dry, normal, oily, or mixed).
- •Currently experiencing lack of radiance, roughness, dullness, and fine lines or wrinkles on facial skin as self-claimed.
- •Early aging group (18-29 years): Must present with corresponding severity for the attributes evaluated by Dermatologist, including:
- •Skin smoothness, radiance, dullness: grade between 2 and 6 (scale 0-9);
- •Size of acne marks (PIH): size ≥ 2;
- •Small folds on nasolabial zone: grade between 1 and 3 (Skin Aging Atlas, 0-6 scale, Page 56-57).
- •Mature aging group (30-45 years): Must present with corresponding severity for the attributes evaluated by Dermatologist, including:
- •Skin smoothness, radiance, dullness: grade between 4 and 6 (scale 0-9);
- •Small folds on nasolabial zone: grade between 1 and 4 (Skin Aging Atlas, 0-6 scale, Page 56-57);
- •Forehead wrinkles: grade ≥ 2 (Skin Aging Atlas, 0-8 scale, Page 32-33);
- •Crow's feet wrinkles: grade ≥ 2 (Skin Aging Atlas, 0-6 scale, Page 40-41).
- •Regular user of serum and sunscreen products.
- •Did not participate in any clinical test or cosmetic product test on skin within the last 3 months.
- •No exclusion by dermatologist due to other medical or dermatological reasons.
- •In general good health at the time of the study.
- •Willing and able to participate as evidenced by signing of informed consent and photo release form.
- •Must be willing to comply with all study protocol requirements (including using only the skincare products provided during the study and not taking topical or oral treatments such as retinol, hormones, or antioxidant health supplements).
排除标准
- 未提供
结局指标
主要结局
Change in Dermatologist-Assessed Wrinkle Attributes
时间窗: from Baseline to Week 12
Crow's feet wrinkles, forehead wrinkles, global wrinkles, small folds on nasolabial zone and global fine lines will be evaluated by dermatologist.
Self-assessment Questionnaire
时间窗: 12 weeks
Participants will complete a 5-point self-assessment questionnaire at Timm, T4w, T8w, and T12w, evaluating their perception of skin softness, smoothness, plumpness, elasticity, hydration, oil control, and visible aging signs. Ratings from 4 to 5 will be used to calculate "Top 2 box" percentage.
Change in Dermatologist-Assessed Skin Texture and Quality Attributes
时间窗: from Baseline to Week 12
Skin smoothness (visual), skin elasticity, skin softness, skin firmness, skin plumpness, cheek pores will be evaluated by dermatologist.
Change in Dermatologist-Assessed Skin Tone Attributes
时间窗: from Baseline to Week 12
Skin radiance, skin translucency, skin pigmentation, skin fairness, skin tone evenness and skin dullness will be evaluated by dermatologist.
次要结局
- Change in Skin Hydration Measured by Corneometer(12 weeks)
- Change in Skin Elasticity Measured by Cutometer(12 weeks)
- Change in Transepidermal Water Loss (TEWL) Measured by Vapometer(12 weeks)
- Change in Facial Image-Based Skin Parameters Using VISIA-CR(12 weeks)
- Change in Cheek Skin Surface Condition Using VisioScan VC20(12 weeks)