Effects of Oral Collagen Drinks on Human Skin
2026年7月8日 更新者：TCI Co., Ltd.
The objective of this study is to evaluate the effect of oral collagen drink and MAXI collagen drink on human skin condition improvement.
研究概览
地位
完全的
详细说明
This study is a single-center, double-blinded, parallel human trial designed to evaluate the skin beauty effect of oral collagen drink and MAXI collagen drink.
Healthy adult participants aged 18-60 years will be enrolled. Participants will be informed to consume test samples daily for 4 consecutive weeks. Skin measurement and self-assessment questionnaires will be conducted at baseline (before intake), after 1 week, and 4 weeks of consumption.
研究类型
介入性
注册 (实际的)
105
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Beijing、中国
- Beijing Ewish Testing Technology Co.,ltd.
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
是的
描述
Inclusion Criteria:
- Healthy Chinese subjects aged 18 to 60 years, both male and female.
- Wrinkle Severity: Crow's feet graded 2-4; under-eye fine lines graded 2-5; nasolabial folds graded 1-3.
- Presence of facial skin laxity and sagging.
- Ability to undergo skin examinations and pre-treatment in the designated test areas.
- Ability to understand the trial process, participate voluntarily, and sign a written Informed Consent Form (ICF).
Exclusion Criteria:
- Pregnant or lactating women, or those planning to become pregnant in the near future.
- Highly sensitive constitution, history of allergic diseases, or history of allergies to cosmetics.
- Presence of skin diseases (e.g., psoriasis, eczema, atopic dermatitis, severe acne) or other chronic systemic diseases.
- Skin conditions in the test area such as birthmarks, hyperpigmentation, inflammation, scars, nevi (moles), or hypertrichosis (excessive hair).
- Use of anti-inflammatory drugs (e.g., oral or topical corticosteroids) within the past month.
- Use of cosmetics or other products with similar efficacy within the past 2 weeks.
- Participation in other human clinical trials for cosmetics within the past month.
- Any other conditions deemed unsuitable for participation based on clinical assessment.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Collagen Drink
oral intake 5 g collagen daily
|
consume 1 bottle of the test samples daily for 4 consecutive weeks, each bottle containing 5 g Collagen Powder
|
|
实验性的：MAXI Collagen Drink
oral intake 15 mL MAXI collagen daily (equivalent to 5 g of deep hydrolyzed collagen net weight)
|
consume 1 bottle of the test samples daily for 4 consecutive weeks, each bottle containing 15 mL MAXI Collagen Liquid (equivalent to 5 g of deep hydrolyzed collagen net weight)
|
|
实验性的：MAXI Collagen Drink_High dose
oral intake 30 mL MAXI collagen daily (equivalent to 10 g of deep hydrolyzed collagen net weight)
|
consume 1 bottle of the test samples daily for 4 consecutive weeks, each bottle containing 30 mL MAXI Collagen Liquid (equivalent to 10 g of deep hydrolyzed collagen net weight)
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The change of collagen fiber fluorescence intensity
大体时间：Change from Baseline collagen intensity at 4 weeks
|
SUPERVISION-780 In-Vivo Imaging System (Survface, China) was utilized to evaluate the density and quality of dermal collagen fibers.
|
Change from Baseline collagen intensity at 4 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The change of skin elasticity
大体时间：Change from Baseline skin elasticity at 4 weeks
|
Cutometer® MPA580 (CK, Germany) was utilized to measure the gross elasticity of the skin using suction method.
|
Change from Baseline skin elasticity at 4 weeks
|
|
The change of skin firmness
大体时间：Change from Baseline skin firmness at 4 weeks
|
Cutometer® MPA580 (CK, Germany) was utilized to measure skin firmness and the area under the suction curve.
|
Change from Baseline skin firmness at 4 weeks
|
|
The change of epidermal thickness
大体时间：Change from Baseline epidermal thickness at 4 weeks
|
SUPERVISION-780 In-Vivo Imaging System (Survface, China) was utilized to measure the depth of the epidermal layer using optical imaging.
|
Change from Baseline epidermal thickness at 4 weeks
|
|
The change of cheek skin roughness
大体时间：Change from Baseline skin roughness at 4 weeks
|
AEVA-HE (EOTECH, France) was utilized to measure the arithmetic average roughness (Ra value) of the cheek surface.
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Change from Baseline skin roughness at 4 weeks
|
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The change of the Dermal-Epidermal Junction (DEJ) structures
大体时间：Change from Baseline DEJ status at 4 weeks
|
SUPERVISION-780 In-Vivo Imaging System (Survface, China) was utilized to assess the structural integrity and epithelial-connective tissue interface (ECTI) of the DEJ.
|
Change from Baseline DEJ status at 4 weeks
|
|
The change of nasolabial folds volume
大体时间：Change from Baseline wrinkle parameters at 4 weeks
|
AEVA-HE (EOTECH, France) was utilized to quantify the 3D morphological changes of the nasolabial folds volume.
|
Change from Baseline wrinkle parameters at 4 weeks
|
|
The change of nasolabial folds depth
大体时间：Change from Baseline wrinkle parameters at 4 weeks
|
AEVA-HE (EOTECH, France) was utilized to quantify the 3D morphological changes of the nasolabial folds depth.
|
Change from Baseline wrinkle parameters at 4 weeks
|
|
The change of crow's feet volume
大体时间：Change from Baseline crow's feet parameters at 4 weeks
|
AEVA-HE (EOTECH, France) was utilized to measure the severity of crow's feet volume.
|
Change from Baseline crow's feet parameters at 4 weeks
|
|
The change of crow's feet depth
大体时间：Change from Baseline crow's feet parameters at 4 weeks
|
AEVA-HE (EOTECH, France) was utilized to measure the severity of crow's feet depth.
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Change from Baseline crow's feet parameters at 4 weeks
|
|
The change of the volume of fine lines under the eyes
大体时间：Change from Baseline fine lines at 4 weeks
|
AEVA-HE (EOTECH, France) was utilized to assess the volume of fine lines under the eyes.
|
Change from Baseline fine lines at 4 weeks
|
|
The change of the mean depth of fine lines under the eyes
大体时间：Change from Baseline fine lines at 4 weeks
|
AEVA-HE (EOTECH, France) was utilized to assess the mean depth of fine lines under the eyes.
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Change from Baseline fine lines at 4 weeks
|
|
The change of cheek (malar) volume
大体时间：Change from Baseline cheek volume at 4 weeks
|
AEVA-HE (EOTECH, France) was utilized to measure the 3D volume of the cheek area for lifting effects.
|
Change from Baseline cheek volume at 4 weeks
|
|
The change of jawline length
大体时间：Change from Baseline jawline parameters at 4 weeks
|
AEVA-HE (EOTECH, France) was utilized to measure the linear length and contour of the jawline.
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Change from Baseline jawline parameters at 4 weeks
|
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The change of skin pores counts
大体时间：Change from Baseline pore parameters at 4 weeks
|
AEVA-HE (EOTECH, France) was utilized to perform 3D imaging and quantification of skin pores counts.
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Change from Baseline pore parameters at 4 weeks
|
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The change of skin pores volume
大体时间：Change from Baseline pore parameters at 4 weeks
|
AEVA-HE (EOTECH, France) was utilized to perform 3D imaging and quantification of skin pores volume.
|
Change from Baseline pore parameters at 4 weeks
|
|
The change of skin hydration
大体时间：Change from Baseline skin hydration at 4 weeks
|
Corneometer® CM825 (CK, Germany) was utilized to measure skin surface hydration.
Units: arbitrary Corneometer® units 0-120.
|
Change from Baseline skin hydration at 4 weeks
|
|
The change of transepidermal water loss (TEWL)
大体时间：Change from Baseline TEWL at 4 weeks
|
Tewameter® TM300 (CK, Germany) was utilized to measure the evaporation rate of water from the skin.
Units: g/h/m^2.
|
Change from Baseline TEWL at 4 weeks
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The change of skin brightness (L*)
大体时间：Change from Baseline skin brightness (L*) at 4 weeks
|
Skin-Colorimeter CL400 (CK, Germany) was utilized to measure skin brightness (L*).
|
Change from Baseline skin brightness (L*) at 4 weeks
|
|
The change of skin individual typology angle (ITA)
大体时间：Change from Baseline skin ITA at 4 weeks
|
Skin-Colorimeter CL400 (CK, Germany) was utilized to measure skin individual typology angle (ITA).
|
Change from Baseline skin ITA at 4 weeks
|
|
The change of skin color parameters
大体时间：Change from Baseline skin redness (a*) at 4 weeks
|
Skin-Colorimeter CL400 (CK, Germany) was utilized to measure skin redness (a*).
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Change from Baseline skin redness (a*) at 4 weeks
|
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The change of skin color parameters
大体时间：Change from Baseline skin yellow tone (b*) at 4 weeks
|
Skin-Colorimeter CL400 (CK, Germany) was utilized to measure skin yellow tone (b*).
|
Change from Baseline skin yellow tone (b*) at 4 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：YAO PAN、Beijing Ewish Testing Technology Co.,ltd.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年5月12日
初级完成 (实际的)
2026年6月15日
研究完成 (实际的)
2026年6月30日
研究注册日期
首次提交
2026年5月8日
首先提交符合 QC 标准的
2026年5月18日
首次发布 (实际的)
2026年5月26日
研究记录更新
最后更新发布 (实际的)
2026年7月10日
上次提交的符合 QC 标准的更新
2026年7月8日
最后验证
2026年7月1日
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