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临床试验/NCT05311020
NCT05311020已完成不适用

Efficacy Evaluation of Pitaya Ovule Extract on Skin

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: 2022年10月19日最近更新:
适应症

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 the efficacy of Pitaya Ovule Extract on skin

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

入选标准

  • 20 to 65-year-old males or females

排除标准

  • Received medical cosmetic treatment (including cosmetic skin care, laser, fruit acid peeling, injection or plastic surgery, etc.) currently or within one month before the trial
  • Outdoor workers (exposed to the sun more than 5 hours a day)
  • People who are breastfeeding, pregnant or planning to become pregnant during the test (self-report)
  • People with heart, liver, kidney, endocrine and other major organic diseases (self-reported)
  • People who have undergone major surgery (according to medical history)
  • People who take drugs for a long time
  • People with mental illness
  • Students who are currently taking courses taught by the principal investigator of this trial

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 MPA580 was utilized to measure skin elasticity. Units: arbitrary units

The change of skin pores

时间窗: Change from Baseline skin pores at 8 weeks

IRV skin analyzer was utilized to measure skin pores. Units: arbitrary units

The change of Advanced glycation end products of blood

时间窗: Change from Baseline AGEs at 8 weeks

Venous blood was sampled to measure AGEs

The change of skin texture

时间窗: Change from Baseline skin texture at 8 weeks

IRV skin analyzer was utilized to measure skin texture. Units: arbitrary units

The change of skin tone

时间窗: Change from Baseline skin tone at 8 weeks

IRV skin analyzer was utilized to measure skin tone. Units: arbitrary units

The change of Matrix metalloproteinases (MMP-2, MMP-9) of blood

时间窗: Change from Baseline MMPs at 8 weeks

Venous blood was sampled to measure MMPs

The change of L* (lightness) values

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

Spectrophotometer SCM-108 was utilized to measure skin L\* value. Units: arbitrary units

The change of skin collagen density

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

DermaLab® Combo Ultrasound module was utilized to measure skin collagen density. Units: arbitrary units

The change of skin wrinkles

时间窗: Change from Baseline skin wrinkles at 8 weeks

IRV skin analyzer was utilized to measure skin wrinkles. Units: arbitrary units

The change of RAGE (receptor for advanced glycation end products) of blood

时间窗: Change from Baseline RAGE at 8 weeks

Venous blood was sampled to measure RAGE

次要结局

  • The change of liver function biomarkers (AST, ALT) of blood(Change from Baseline liver function biomarkers at 8 weeks)
  • The change of blood lipid profile(Change from Baseline blood lipid profile at 8 weeks)
  • The change of fasting blood glucose level(Change from Baseline fasting blood glucose level at 8 weeks)
  • The change of renal function biomarkers (creatinine, BUN) of blood(Change from Baseline renal function biomarkers at 8 weeks)
  • Change from Baseline insulin level at 8 weeks(Change from Baseline insulin level at 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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