Cosmetic Efficacy Testing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in Facial Skin Elasticity (R0, R1 and F4)
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy of a facial and neck cream containing Vitamin K2 in improving skin hydration, elasticity, firmness, and reducing wrinkles in 36 female participants aged 35-60 years with concerns of facial dryness, dullness, laxity, and neck lines. The main questions it aims to answer are:
Does the test cream significantly improve skin hydration (Corneometer), reduce transepidermal water loss (Vapometer), and enhance skin elasticity and firmness (Cutometer) compared to a control cream?
Does the test cream significantly reduce wrinkle severity (assessed by Rz and Ra parameters via AEVA-HE rapid optical imaging) in areas including the neck, cheeks, marionette lines, and crow's feet compared to a control cream?
Researchers will compare the test cream (applied to one randomized half-face and neck) to the control cream (applied to the contralateral half-face and neck) to see if the test cream demonstrates superior efficacy in improving the measured skin parameters.
Participants will:
Apply the test cream to one assigned side of the face and neck, and the control cream to the other side, twice daily for 8 weeks.
Attend evaluation visits at baseline, 2, 4, and 8 weeks for instrumental measurements (skin hydration, TEWL, elasticity, rapid optical imaging, facial imaging) and to complete subjective questionnaires.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Is a Chinese female aged between 35 and 60 years (inclusive).
- •Presents with facial skin concerns including dryness, dullness, and laxity.
- •Has crow's feet (outer canthus wrinkles) with a visual assessment grade of 2 to 4 (on a 0-6 scale).
- •Self-reports concerns about neck wrinkles.
- •Is in good general health at the time of screening.
- •Is willing and able to provide written informed consent.
- •Is willing and able to comply with all study procedures and product usage requirements for the duration of the study.
排除标准
- •Is planning pregnancy, is pregnant, lactating, or within 6 months postpartum.
- •Has a history of severe systemic diseases, immunodeficiency, or autoimmune diseases.
- •Has a history of allergic diseases or has experienced cosmetic allergies within the past 1-2 years.
- •Has had dermatological diseases on the test areas (face and neck) or is undergoing related medical treatment within the past 3 months.
- •Has an active cold, influenza, or other acute illness at the study start that may affect participation.
- •Is currently participating, or has participated within the past month, in another clinical study involving the test areas.
- •Is deemed unsuitable for participation by a dermatologist's assessment.
研究组 & 干预措施
Face-and-Neck Cream
Participants apply the Face-and-Neck Cream (containing 0.05% Vitamin K2) to one randomly assigned half of the face and neck. Used twice daily (morning and evening) for 8 weeks.
干预措施: Face-and-Neck Cream (with 0.05% Vitamin K2) (Other)
Placebo Face-and-Neck Cream
Participants apply the Placebo Face-and-Neck Cream (base formulation without Vitamin K2) to the contralateral half of the face and neck. Used twice daily (morning and evening) for 8 weeks.
干预措施: Placebo Face-and-Neck Cream (Other)
结局指标
主要结局
Change in Facial Skin Elasticity (R0, R1 and F4)
时间窗: At Baseline, Week 2, Week 4, and Week 8
Assessed using a Cutometer MPA580.Measurements are taken on the cheek area. R0 (Uf) represents the maximum skin deformation under suction. A lower R0 value indicates greater resistance to tensile deformation, reflecting superior skin firmness. R1 (Uf - Ua) quantifies the immediate elastic recovery after suction release. A lower R1 value signifies faster restoration to baseline morphology, demonstrating enhanced skin elasticity. F4, the viscoelastic fatigue parameter, quantifies energy dissipation during cyclic skin deformation. A lower F4 value indicates enhanced viscoelastic integrity of the skin.
Change in Roughness Parameters (Ra and Rz ) of Face and Neck Wrinkles
时间窗: At Baseline, Week 2, Week 4, and Week 8
Assessed by AEVA-HE rapid optical imaging system. Ra represents the arithmetic average of absolute deviations of skin surface profile points from the mean line across the entire assessment length. It quantifies the overall smoothness of the skin surface. Lower Ra values indicate smoother skin with less pronounced wrinkle formation. Rz is calculated by dividing the skin surface profile into five equal sampling lengths. The parameter represents the arithmetic mean of the distances between the highest peaks and deepest valleys within each segment, quantifying the extreme variations in skin surface topography. As a key indicator of macro-textural irregularities, lower Rz values correspond to reduced skin unevenness.
Change in Facial Sagging (Mandibular Plane Angle)
时间窗: At Baseline, Week 2, Week 4, Week 8
Quantified by analyzing standard white-light photographs taken with a VISIA imaging system. The mandibular plane angle is measured in degrees (°) using image analysis software (Image-Pro Plus). An increase in the angle indicates a sharper, more defined, and firmer jawline contour.
次要结局
- Change in Skin Hydration(At Baseline, Week 2, Week 4, Week 8)
- Change in Facial Transepidermal Water Loss (TEWL)(At Baseline, Week 2, Week 4, Week 8)