Test Serum 4-Week Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Skin Hydration Level via Corneometer CM825
研究概览
简要总结
This 4-week, mono-centric clinical study employed a randomized three-arm design to evaluate the efficacy of a test serum. The study compared three interventions: the test serum used alone, the test serum used in combination with hyaluronic acid (HA) injection, and HA injection alone. It aimed to assess their effects on skin quality and wrinkles in 90 healthy Chinese female subjects aged 25-40. Evaluations were conducted at multiple timepoints through clinical assessments, instrumental measurements, and image analysis.
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
- Single (Investigator)
入排标准
- 年龄范围
- 25 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Chinese female with 25-40 years old.
- •All skin types by subjects' self-perceived.
- •Willing to perform HA injection.
- •Did not perform any of the beauty procedure projects in the past 6 months.
- •Lack of hydration, radiance, brightness, smoothness, firmness and elasticity by self-claimed.
- •Presenting with corresponding severity for the attribute evaluated by Dermatologist included:
- •Radiance, smoothness, elasticity, cheek plumpness and firmness: 3≤grade≤
- •Global fine lines: 3≤grade.
- •Underneath eye wrinkles: 2≤grade≤
- •Forehead wrinkles: 1<grade≤
- •Glabella wrinkles: 1<grade.
- •All accept not to use any cosmetics, skincare products, beauty equipment, all topical medications and cleansing products on face at visit days.
- •Did not participate any clinical test or cosmetic product test on skin within 1 months.
- •No disagreement of dermatologist because of other reasons that exclude the participation of the volunteer.
- •In general, good health at the time of the study.
- •Willing and able to participate as evidenced by signing of informed consent & photo release form.
- •Must be willing to comply with all study protocol requirements.
排除标准
- •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 as well as skin allergy (particularly e.g., acne, rosacea, eczema).
- •Subject presenting a stable or progressive serious disease (per investigator's assessment).
- •Immuno-compromised subject.
- •Subject with history of allergy to cosmetic or personal care products or ingredients.
- •Subject presenting excessive exposure to sunlight or UV radiation (investigator's assessment).
- •Subject with history of sunlight sensitivity or allergies.
- •Subject regularly practicing aquatic or nautical sports.
- •Subject regularly attending a sauna.
- •Subject with physical highly sensitive constitution.
- •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
Skin Hydration Level via Corneometer CM825
时间窗: Measurements are taken at Baseline (T0) , 10 minutes post-application (for Group 1 only), 1 hour post-application (T1h) , Day 1 (T1D) , Day 3 (T3D) , Day 7 (T7D) , Day 14 (T14D) , Day 21 (T21D) , and Day 28 (T28D) .
Skin Barrier Function via Vapometer® (TEWL Measurement)
时间窗: Measurements are taken at Baseline (T0) , 10 minutes post-application (for Group 1 only), 1 hour post-application (T1h) , Day 1 (T1D) , Day 3 (T3D) , Day 7 (T7D) , Day 14 (T14D) , Day 21 (T21D) , and Day 28 (T28D) .
Skin Hydration Level via Corneometer CM825
时间窗: Measurements are taken at Baseline (T0) , 10 minutes post-application (for Group 1 only), 1 hour post-application (T1h) , Day 1 (T1D) , Day 3 (T3D) , Day 7 (T7D) , Day 14 (T14D) , Day 21 (T21D) , and Day 28 (T28D) .
Skin Barrier Function via Vapometer® (TEWL Measurement)
时间窗: Measurements are taken at Baseline (T0) , 10 minutes post-application (for Group 1 only), 1 hour post-application (T1h) , Day 1 (T1D) , Day 3 (T3D) , Day 7 (T7D) , Day 14 (T14D) , Day 21 (T21D) , and Day 28 (T28D) .
Skin Elasticity via Cutometer® Dual MPA 580
时间窗: Measurements are taken at Baseline (T0) , 10 minutes post-application (for Group 1 only), 1 hour post-application (T1h) , Day 1 (T1D) , Day 3 (T3D) , Day 7 (T7D) , Day 14 (T14D) , Day 21 (T21D) , and Day 28 (T28D) .
Facial Skin Redness and Wrinkle Mapping via VISIA-7 Imaging
时间窗: Images are captured at Baseline (T0) , 10 minutes post-application (for Group 1 only), 1 hour post-application (T1h) , Day 1 (T1D) , Day 3 (T3D) , Day 7 (T7D) , Day 14 (T14D) , Day 21 (T21D) , and Da
3D Topographical Analysis of Wrinkles and Pores via Antera 3D
时间窗: Measurements are taken at Baseline (T0) , 10 minutes post-application (for Group 1 only), 1 hour post-application (T1h) , Day 1 (T1D) , Day 3 (T3D) , Day 7 (T7D) , Day 14 (T14D) , Day 21 (T21D) , and Day 28 (T28D) .
Subjective Skin Tolerance and Sensation via Self-Assessment Questionnaire
时间窗: Questionnaires are administered at Baseline (T0) , 10 minutes post-application (for Group 1 only), 1 hour post-application (T1h) , Day 1 (T1D) , Day 3 (T3D) , Day 7 (T7D) , Day 14 (T14D) , Day 21 (T21D) ,
次要结局
未报告次要终点