A 4-Week Lifting and Firming Efficacy Study Comparing a Retinol-Based Day Cream and a Lotion and Toner Bundle
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Clinical Assessment by Dermatologist
研究概览
简要总结
This is a single-center, parallel-arm, 4-week interventional study designed to evaluate the lifting and firming efficacy of two facial care regimens in middle-aged Chinese women. Participants were randomly assigned to use either a retinol-based day cream or a lotion-and-toner bundle. The study included dermatologist assessment, standardized facial photography, and self-assessment questionnaires. A total of 132 healthy women aged 45-55 with facial skin sagging were enrolled. The primary objective was to compare improvement in lifting grades after 4 weeks of product use. The trial was conducted at China-Norm Quality Technical Service Co., Ltd., in Shanghai, China.
详细描述
This 4-week study evaluated the efficacy of two skincare regimens on facial lifting and firmness in middle-aged Chinese women. Participants were randomly assigned to one of two arms: (1) retinol-based day cream or (2) a bundle of toner and lotion. The study included a 3-week wash-out period, followed by a 4-week treatment phase with full-face application. Assessments were conducted at T0 (baseline), Timm (immediate post-use), and T4w (end of 4-week use), using dermatologist grading (0-9 scale), DEEP imaging system, and self-reported questionnaires. Participants were required to avoid other skincare products during the study. A total of 132 subjects were enrolled; at least 80 completed clinical evaluation. The primary outcome was improvement in lifting grade from T0 to T4w; secondary outcomes included imaging analysis and subjective satisfaction. The study followed GCP principles and received ethical approval from the Ethics Committee at China-Norm. No serious adverse events were reported.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- All
- 接受健康志愿者
- 是
入选标准
- •Chinese female with 45-55 years old.
- •All skin types (dry, normal, oily or mixed).
- •Regular users for toner, lotion and cream.
- •Self-claim with lack of firmness and has sagging concern.
- •Presenting with corresponding severity for the attribute evaluated by Dermatologist included:
- •Lifting (global face): 3≤grade≤6 (0-9 scale)
- •The BMI range should ≤24.9, and the BMI (BMI =Weight (kg)/ Height²(m²)) should remain stable within the range throughout the entire testing period.
- •Did not participate any clinical test or cosmetic product test on skin within 3 months.
- •Did not participate any chemical procedures for previous 6 months and during the whole study.
- •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 & photo release form.
- •Must be willing to comply with all study protocol requirements (pay attention: only use the skin care products provided during the study, not take topical or oral treatment like retinol, hormone, antioxidant health-care products which may affect the test product).
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.
- •Subjects regularly practicing aquatic or nautical sports.
- •Subjects 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
Clinical Assessment by Dermatologist
时间窗: Baseline and Week 4
Lifting grade (0-9 scale) will be evaluated by dermatologist at T-3w, T0 (baseline), Timm and T4w.Six areas will be evaluated separately: eyebrow, upper eyelid, nasolabial zone, apple cheek, corner of mouth and jaw.
次要结局
- Change in Facial Wrinkle Depth Measured by Standardized Digital Photography and Image Analysis Software(Baseline and Week 4)
- Questionnaire(Baseline and Week 4)