A 12-week, Randomized, Double-Blind, Placebo-Controlled Human Clinical Study to Evaluate the Efficacy and Safety of Small-Molecular-Weight Deer Antler Collagen (NP-2007) for Improving Skin Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change from Baseline in Skin Hydration at 12 weeks
研究概览
简要总结
The objective of this study is to evaluate the efficacy and safety of Small-molecular-weight deer antler collagen (NP-2007) on skin health, including skin hydration, transepidermal water loss (TEWL), elasticity, and eye wrinkles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy females between 35 and 65 years of age
- •Subjects with dry skin (Skin capacitance ≤ 49 units measured by Corneometer® CM 825)
- •Subjects with eye wrinkles (grade 3 or higher based on visual assessment scale)
- •Subjects who voluntarily signed the informed consent form after receiving a full explanation of the study
- •Subjects who are available for follow-up visits at scheduled times throughout the study period
排除标准
- •1) Subjects with skin diseases (atopic dermatitis, psoriasis, etc.) in the test area
- •2) Subjects who have used skin-related medications (steroids, etc.) within 1 month
- •3) Subjects with a history of hypersensitivity to the test ingredients or severe food allergies
- •4) Pregnant or lactating women, or those planning to become pregnant
- •5) Subjects who have participated in other clinical trials within the past 3 months
- •6) Any other conditions that the investigator deems unsuitable for participation
结局指标
主要结局
Change from Baseline in Skin Hydration at 12 weeks
时间窗: Baseline, 6 weeks, 12 weeks
Measured using Corneometer® CM 825. The unit of measure is arbitrary units (AU) ranging from 0 to 120. Higher scores indicate improved skin moisture.
Change from Baseline in Transepidermal Water Loss (TEWL) at 12 Weeks
时间窗: Baseline, 6 weeks, 12 weeks
Measured using Tewameter® TM 300. The unit of measure is g/m²/h. Lower values indicate improved skin barrier function.
Change from Baseline in Skin Scaling at 12 Weeks
时间窗: Baseline, 6 weeks, 12 weeks
Evaluated using D-Squame® and image analysis. Higher values indicate more scaling (worse), lower values indicate improvement.
Change from Baseline in Skin Roughness at 12 Weeks
时间窗: Baseline, 6 weeks, 12 weeks
Measured using Visiometer® SV 700. Assesses the texture of the skin surface. Lower values indicate smoother skin.
Change from Baseline in Eye Wrinkles (Ra) at 12 Weeks
时间窗: Baseline, 6 weeks, 12 weeks
Quantitative analysis of eye wrinkles (crow's feet) using Visiometer® SV 700. Ra represents the average roughness in millimeters (mm). Lower values indicate improved wrinkle depth.
Change from Baseline in Skin Elasticity (R2) at 12 Weeks
时间窗: Baseline, 6 weeks, 12 weeks
Measured using Cutometer® MPA 580. R2 represents gross elasticity (0 to 1 scale). Higher values indicate better skin elasticity.
次要结局
- Investigator's Visual Assessment Grade for Eye Wrinkles(Clinical grading of eye wrinkle severity by a dermatologist. The grade is based on a visual scale from 0 to 9 (0 = None, 9 = Very Severe). Lower grades indicate clinical improvement in wrinkle severity.)
- Participant Subjective Questionnaire Assessment for Skin Improvement(Participants assess skin improvement and satisfaction through a self-report questionnaire using a 5-point Likert scale (1 = Very Dissatisfied, 5 = Very Satisfied). Higher scores indicate greater satisfaction with the product's efficacy.)