ANTI-DYNAMIC LINE Test for Cream: A Mono-centric 8-week Clinical Evaluation on Facial and Neck Dynamic Wrinkles in Chinese Female Subjects Aged 18-35
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Time effect of facial and neck wrinkles (Dermatologist-assessed)
研究概览
简要总结
The goal of this clinical trial is to find out whether a new cream (Formula# 899675 44A) can help reduce dynamic facial and neck wrinkles in young Chinese women. The main questions it aims to answer are:
- Does the cream lower the appearance of forehead wrinkles, crow's feet, under-eye wrinkles, and nasolabial folds when participants smile or raise their eyebrows?
- Does the cream help reduce horizontal neck folds when participants lower their heads?
About 45 healthy women between the ages of 18 and 35 will take part in this 10-week study. They will:
- Stop using other anti-aging products for 2 weeks (wash-out period)
- Apply the study cream on their face and neck twice a day for 8 weeks
- Visit the clinic 4 times for facial and neck photo collection and clinical assessments
- Learn to make standard facial expressions for photo comparisons
Researchers will compare wrinkle changes using dermatologist scores and photo grading at different time points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •1. Chinese female aged 18-35 years old.
- •2. All skin types will be contained, including 50% sensitive skin.
- •3. Regular users of cleanser, anti-aging cream and sunscreen product.
- •4. Self-claim having concerns of wrinkles problems.
- •5. Presenting with obvious dynamic wrinkles while making smiling/raising eyebrow expression ( expression reach max condition) evaluated by Dermatologist：
- •* Raise eyebrow: Forehead wrinkles (Loreal Atlas, 1\1)
- •6. Did not participate in any clinical test or cosmetic product test on skin within 3 months.
- •7. Did not participate any chemical procedures for previous 2 months; and willing to not participate any procedures during the whole study.
- •8. No disagreement of dermatologist because of other reasons that exclude the participation of the Subject.
- •9. In general, good health at the time of the study.
- •10. Willing and able to participate as evidenced by signing of informed consent and photorelease form.
- •11. Must be willing to comply with all study protocol requirements (pay attention to not take topical or oral treatment like retinol, hormone, antioxidant health-care products which may affect the efficacy of test products).
排除标准
- •Intending to get pregnant, pregnant, lactating or within 6 months of delivery.
- •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).
- •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).
- •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
Time effect of facial and neck wrinkles (Dermatologist-assessed)
时间窗: Baseline (T0) to Week 8 (T8wk)
Clinical scoring of dynamic wrinkles in five facial and neck areas: forehead wrinkles (raising eyebrow), crow's feet wrinkles, underneath eye wrinkles, nasolabial folds (smiling), and horizontal neck folds (lowering head), as assessed by dermatologist at T0, T4wk, and T8wk using the Skin Aging Atlas. Assessment is based on facial expression photos and in-person evaluation. Wilcoxon Signed Rank Test will be used to analyze changes from baseline.
Time effect of facial and neck wrinkles (Dermatologist-assessed)
时间窗: Baseline (T0) to Week 8 (T8wk)
Clinical scoring of dynamic wrinkles in five facial and neck areas: forehead wrinkles (raising eyebrow), crow's feet wrinkles, underneath eye wrinkles, nasolabial folds (smiling), and horizontal neck folds (lowering head), as assessed by dermatologist at T0, T4wk, and T8wk using the Skin Aging Atlas. Assessment is based on facial expression photos and in-person evaluation. Wilcoxon Signed Rank Test will be used to analyze changes from baseline.
次要结局
- Time effect of facial wrinkles (Expression image-based)(Baseline (T0) to Week 8 (T8wk))
- Time effect of adverse events and intolerance reactions(Baseline (T0) to Week 8 (T8wk))
- Time effect of product compliance (Twice-daily usage)(Baseline (T0) to Week 8 (T8wk))
- Time effect of facial wrinkles (Expression image-based)(Baseline (T0) to Week 8 (T8wk))
- Time effect of adverse events and intolerance reactions(Baseline (T0) to Week 8 (T8wk))
- Time effect of product compliance (Twice-daily usage)(Baseline (T0) to Week 8 (T8wk))