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临床试验/NCT04237818
NCT04237818已完成不适用

The Evaluation of Chenopodium Formosanum and Fagopyrum Esculentum Extract on Anti-aging Effect

TCI Co., Ltd.1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
TCI Co., Ltd.
入组人数
50
试验地点
1
主要终点
The change of skin elasticity

研究概览

简要总结

To assess Chenopodium Formosanum and Fagopyrum Esculentum Extract on skin anti-aging

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
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy adults aged between 20-65 years old
  • •Subjects must read and sign the informed consent form after the study has been fully explained.
  • •Subjects are willing to cooperate and comply with all of the regulation during the trial.
  • •Subject should inform to investigator immediately if adverse effect is happened.
  • •Subjects are willing to avoid UV overexposure during the trial (include indoor tanning treatment).

排除标准

  • •Subjects who have known cosmetic, drug or food allergies.
  • •Subjects who have severe desquamation, tattoo, sunburn, peeling skin or other skin condition might impact measurement.
  • •Subjects with any physical condition judged by the researcher not to be eligible for this study.
  • •Subjects with uncontrollable physical condition such as high blood pressure, thyroid disease, diabetes, etc.
  • •Female who is pregnant or nursing or planning to become pregnant during the course of the study.
  • •Those who are currently participating in other clinical trials or who have just concluded a clinical trial two weeks ago.
  • •Women who have started contraceptive or change current hormone contraceptive methods within 3 months.

研究组 & 干预措施

Placebo drink

Placebo Comparator

干预措施: Placebo drink (Dietary Supplement)

Chenopodium Formosanum and Fagopyrum Esculentum Extract drink

Experimental

干预措施: Chenopodium Formosanum and Fagopyrum Esculentum Extract drink (Dietary Supplement)

结局指标

主要结局

The change of skin elasticity

时间窗: Change from Baseline skin elasticity at 8 weeks

Cutometer® dual MPA 580 is utilized to measure skin elasticity (parameter R2). Units: μm penetration depth into the probe opening, expressed as curves

The change of skin wrinkles

时间窗: Change from Baseline skin wrinkles at 8 weeks

3D Full-Face Skin Analyzer IRV is utilized to measure wrinkles. Units: arbitrary units

The change of skin moisture

时间窗: Change from Baseline skin moisture at 8 weeks

Corneometer® CM825 is utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120

The change of skin collagen density

时间窗: Change from Baseline skin collagen density at 8 weeks

DermaLab® combo - 20 MHz High Freq. Ultrasound probe is utilized to scan and analyze skin collagen density. Units: Intensity score

The change of skin melanin index

时间窗: Change from Baseline skin melanin index at 8 weeks

Mexameter® MX 18 is utilized to measure skin melanin index. Units: arbitrary Mexameter® units (0-999)

The change of skin brightness

时间窗: Change from Baseline skin brightness at 8 weeks

3D Full-Face Skin Analyzer IRV is utilized to measure skin brightness. Units: arbitrary units

The change of skin L*a*b* value

时间窗: Change from Baseline skin L*a*b* value at 8 weeks

Color Spectrophotometer SCM-104/108 is utilized to measure skin L\*a\*b\* value. Units: arbitrary units

The change of skin tone

时间窗: Change from Baseline skin tone at 8 weeks

3D Full-Face Skin Analyzer IRV was utilized to measure skin tone. Units: arbitrary units

次要结局

  • The change of skin pores(Change from Baseline skin pores at 8 weeks)
  • The change of transepidermal water loss (TEWL)(Change from Baseline TEWL at 8 weeks)
  • The change of skin texture(Change from Baseline skin texture at 8 weeks)
  • The change of skin spots(Change from Baseline skin spots at 8 weeks)
  • The change of skin erythema level(Change from Baseline skin erythema level at 8 weeks)
  • Self-assessment questionnaire(8 weeks)

研究者

发起方
TCI Co., Ltd.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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