Cream Short-term Efficacy Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Time effect of skin smoothness (Visual)
研究概览
简要总结
This study aimed to evaluate the short-term efficacy of a facial cream (Formula# 899675 44A) on improving various skin quality and wrinkle parameters after a single application. A total of 44 healthy Chinese women aged 20 to 50 years, with all skin types including 50% sensitive skin, were enrolled. Participants applied the cream once to the full face and neck under supervision, and outcomes were assessed at baseline (T0), 10 hours (T10h), and 24 hours (T24h) post-application. Clinical evaluations and photo-based imaging were used to assess skin plumpness, smoothness, radiance, and multiple types of wrinkles. At the end of the study, 42 participants completed the protocol.
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
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •* 1.Chinese female with 20-50 years old (Must have 20-30 years old). 2.In general, good health at the time of the study. 3.All skin types, with 50% sensitive skin. 4.Regular users for cleanser, anti-aging cream and sunscreen product. 5.Self-declare with plumpness, smoothness and wrinkles problems. 6.Clinical grading by dermatologist in terms of: Underneath eye wrinkles: 2≤grade≤4; Forehead wrinkles: 1 \ 1; Skin smoothness: 3≤ grade≤ 6 (0-9 scale); Skin plumpness: 3≤ grade≤ 6 (0-9 scale); 7.Did not participate any clinical test or cosmetic product test on skin within 3 months.
- •8.Did not participate any chemical/beauty procedures for previous 6 months. 9.No disagreement of dermatologist because of other reasons that exclude the participation of the subject.
- •10.Were willing and able to participate as evidenced by signing of informed consent and photo release form.
- •11.Must be willing to comply with all study protocol requirements.
排除标准
- •1.Pregnant or breast-feeding woman or woman planning pregnancy during the study.
- •2.Subject deprived of rights by a court or administrative order. 3.Major subject to a guardianship order. 4.Subject residing in a health or social care establishment. 5.Patient in an emergency setting. 6.Subject with a skin disease in the test areas as well as skin allergy (particularly e.g., acne, rosacea, eczema).
- •7.Subject presenting a stable or progressive serious disease (per investigator's assessment).
- •8.Immuno-compromised subject. 9.Subject with history of allergy to cosmetic or personal care products or ingredients.
- •10.Subject presenting excessive exposure to sunlight or UV radiation (investigator's assessment).
- •11.Subjects regularly practicing aquatic or nautical sports. 12.Subjects regularly attending a sauna. 13.Subject with physical highly sensitive constitution. 14.Subject with cardiovascular or circulatory history. 15.Subject with a history of skin cancer or malignant melanoma. 16.Intake of antihistamines, antibiotics, corticosteroids, non-steroidal anti-inflammatories or immune-suppressants in the last 6 months before study.
研究组 & 干预措施
Test Cream Single Application Group
Participants applied the test cream (Formula# 899675 44A, 30 mL) once to the full face and neck under staff supervision. Application was followed by massaging designated wrinkle-prone areas including the forehead, crow's feet, underneath eyes, nasolabial folds, and neck folds. Clinical assessments and imaging analysis were performed at T0, T10h, and T24h post-application.
干预措施: Test Cream (Other)
结局指标
主要结局
Time effect of skin smoothness (Visual)
时间窗: Compare to baseline, Time point at 10 hours, Time point at 24 hours.
Time effect of cheek plumpness (Visual)
时间窗: Compare to baseline, Time point at 10 hours, Time point at 24 hours.
Time effect of skin radiance (Visual)
时间窗: Compare to baseline, Time point at 10 hours, Time point at 24 hours.
Time effect of skin elasticity (Tactile)
时间窗: Compare to baseline, 10h, 24h
次要结局
- Time effect of global fine lines (Visual)(Compare to baseline, Time point at 10 hours, Time point at 24 hours.)
- Time effect of forehead wrinkles (Photo analysis)(Compare to baseline, Time point at 10 hours, Time point at 24 hours.)
- Time effect of crow's feet wrinkles (Photo analysis)(Compare to baseline, Time point at 10 hours, Time point at 24 hours.)
- Time effect of skin firmness (Visual)(Compare to baseline, Time point at 10 hours, Time point at 24 hours.)
- Time effect of nasolabial folds (Photo analysis)(Compare to baseline, Time point at 10 hours, Time point at 24 hours.)
- Time effect of skin hydration (Corneometer)(Compare to baseline, Time point at 10 hours, Time point at 24 hours.)
- Time effect of skin TEWL (Tewameter)(Compare to baseline, Time point at 10 hours, Time point at 24 hours.)
- Time effect of skin glossiness (Glossymeter)(Compare to baseline, Time point at 10 hours, Time point at 24 hours.)
- Time effect of skin redness (Chromameter)(Compare to baseline, Time point at 10 hours, Time point at 24 hours.)