Serum Instant Anti-Redness Efficacy Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Clinical scoring for skin redness
研究概览
简要总结
This study is a mono-centric, om-site use, random half-face application, blank control study. 64 female adult subjects will be enrolled and divided into 2 groups in the study, recruited according to inclusion and non-inclusion criteria listed above. At least 30 subjects for each group should complete the test in this 1 visit study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Chinese women aged from 20-40 years old.
- •Self-declared mild sensitive skin.
- •Regular users of cleanser, Serum, moisturizer and sunscreen product.
- •Self-declare with skin concerns of redness and easy to flushing.
- •Willing to be exposed to infrared light on the facial skin to induce facial redness (can tolerate heat sensation on the face).
- •Clinical grading of skin redness(visual) ≥ 4 after infrared light[2] induction (5-10 mins) by dermatologist.
- •No disagreement of dermatologist because of other reasons that exclude the participation of the subject.
- •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 (pay attention to: only use the provided product during the study, not take topical or oral treatment like retinol, hormone, anti-oxidant health-care products which may impact the efficacy of study).
排除标准
- •Allergic to infrared light
- •Pregnant or breast-feeding woman or woman planning pregnancy during the study.
- •Subject deprived of rights by a court or administrative order.
- •Major subject to a guardianship order.
- •Subject residing in a health or social care establishment.
- •Patient in an emergency setting.
- •Subject with a skin disease in the test areas (particularly e.g, acne, rosacea, eczema).
- •Subjects with history of atopy, allergic reactions, irritation or intense discomfort feelings to topical-use products, medication, cosmetic or personal care products or ingredients.
- •Subject presenting a stable or progressive serious disease (per investigator's assessment).
- •Immuno-compromised subject.
- •Subject presenting excessive exposure to sunlight or UV radiation (investigator's assessment).
- •Subjects regularly practicing aquatic or nautical sports.
- •Subjects regularly attending a sauna.
- •Subject with cardiovascular or circulatory history.
- •Subject with a history of skin cancer or malignant melanoma.
- •Intake of antihistamines, antibiotics, corticosteroids, non-steroidal anti-inflammatories or immune-suppressants in the last 6 months before study
结局指标
主要结局
Clinical scoring for skin redness
时间窗: Baseline, Time point post-induction 5 min.
Participants: N= 30
Consumer Questionnaire
时间窗: Time point post-intervention 10 sec, Time point post-intervention 1 min, Time point post-intervention 5 min，Time point post-intervention 1 hour, Time point post-intervention 2 hours.
Participants: N= 60
Instrumental Assessment (Erythema index)
时间窗: Baseline, Time point post-induction 5 min , Time point post-intervention 5 min，Time point post-intervention 1 hour, Time point post-intervention 2 hours.
Participants: N= 30, by Mexameter
Image Capture and Analysis（Redness area ratio）
时间窗: Baseline, Time point post-induction 5 min , Time point post-intervention 5 min，Time point post-intervention 1 hour, Time point post-intervention 2 hours.
Participants: N= 30，by VISIA 7
次要结局
未报告次要终点