Anti-Redness Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Skin Erythema Index via Mexameter® MX 18
研究概览
简要总结
This clinical study is a single-center, randomized, split-face, on-site controlled trial conducted at Shanghai China-Norm Quality Technical Service Co., Ltd. The primary objective is to evaluate the efficacy of Eucerin Ultrasensitive Repair Intensive Source Serum in providing instant and long-lasting (24-hour) soothing and repairing effects under induced redness conditions. The design involves recruiting 30 healthy Chinese female subjects aged 18-60 years, who meet stringent inclusion/exclusion criteria, including absence of skin conditions and no recent participation in similar studies. Redness is induced using 50% Glycolic Acid on the entire face and tape stripping on both forearms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Chinese female whose age range from 18 to 60 years old;
- •Be in general good health and good mental state;
- •Have no any broken,scars,birthmarks and other imperfections on the test area;
- •Redness/erythema≥grade 2 after modelling inducing and the score of redness must be increased after inducing;
- •Not currently be participating in any other study involving the test area(Face and Forearm);
- •Not have participated in any other study involving the test area in the past one month;
- •Be willing to read,understand and able to sign the Informed Consent Form and Photo Release From;
- •Be willing to comply with all study protocol requirements.
排除标准
- •Intending to get pregnant, be pregnant, be lactating, be within 6 months of delivery or be unwilling to take necessary precautions to avoid a pregnancy;
- •Having used antihistamine drugs in the past 1 week or immunosuppressants in the past 1 month;
- •Taken anti-allergic drug/injections in the past 1 month;
- •Presently have allergies, allergic dermatitis or skin disease;
- •Have sensitivity or even allergy to topical products, ingredients or fragranced products;
- •Have history of allergies;
- •Have history of suffering from skin diseases (such as psoriasis, eczema, skin cancer, etc.);
- •Have used any anti-inflammatory treatment on the test area within 2 months prior to this study starting date;
- •Has a chronic medical condition that may interfere with testing (e.g., asthma, insulin-dependent diabetes, lupus, rheumatoid arthritis or other immune/auto-immune diseases);
- •Have used any scrubs or peeling product (regardless of method) or self-tanning products or oil control products in the past 3 days;
- •Have received cosmetic medical procedures on the face (such as injectable anti-wrinkle products, cosmetic surgery, tattoo removal, home light facial procedures or home use medical devices, etc.) in the past 1 month;
- •Have excessive sun exposure or ultraviolet light exposure in the past 1 month;
- •Have applied ortho-hydroxybenzoic acid, hydroquinone in the past 3 months; or used prescriptions (such as antibiotic, retinoids, alpha hydroxyl acid and steroid), oral contraceptives；
- •Avoid providing emergency contact;
- •Subjects that are not compliant with the selection criteria or not proper for participation as determined by Principal Investigator;
- •An employee of the cosmetic companies or Shanghai China-Norm Quality technical service Co., Ltd.
结局指标
主要结局
Skin Erythema Index via Mexameter® MX 18
时间窗: From Baseline to 24-hour after product repeat application
Colorimetry (avalue) via Chromameter CM26dG *
时间窗: from Baseline to 24-hour after product repeat application
Skin Scaliness (Desquamation) via Squamescan® 850A
时间窗: from Baseline to 24-hour after product repeat application
Forearm Skin Redness (avalue) via Cross-Polarized Light Imaging *
时间窗: From Baseline to 24-hour after product repeat application
The a\*value is a parameter in the CIELAB color space (also known as Lab) that quantifies a color's position along the red-green axis .
Facial Skin Redness and Colorimetry (a* value) via VISIA-CRP Imaging
时间窗: from Baseline to 24-hour after product repeat application
Skin Surface Evenness (SEsc) via UV Video Capture and SELS Analysis
时间窗: from Baseline to 24-hour after product repeat application
次要结局
未报告次要终点