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临床试验/NCT05310994
NCT05310994已完成不适用

Efficacy Evaluation of Wasabi (Wasabia Japonica) Leaf 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3月28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 transepidermal water loss

研究概览

简要总结

To assess the efficacy of Wasabi Leaf 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
  • People with dull skin, pigmentation spots or acne-prone, acne scars
  • Acne severity assessment- Investigator's Global Assessment Scale (IGA) ≥ 2

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 transepidermal water loss

时间窗: Change from Baseline TEWL at 8 weeks

Tewameter® TM300 was utilized to measure transepidermal water loss (TEWL). Units: TEWL-values lower than 70 g/hm²

The change of skin sebum content

时间窗: Change from Baseline skin sebum content at 8 weeks

Sebumeter® SM815 was utilized to measure skin sebum content. Units: Sebumeter® units from 0-350

The change of skin erythema index

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

Mexameter® MX18 was utilized to measure skin erythema index. Units: arbitrary Mexameter® units (0-999)

The change of skin melanin index

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

Mexameter® MX18 was utilized to measure skin melanin index. Units: arbitrary Mexameter® units (0-999)

The change of a* (redness) values

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

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

The change of skin red area

时间窗: Change from Baseline skin red area at 8 weeks

VISIA Complexion Analysis System was utilized to measure skin red area. Units: arbitrary units

The change of total antioxidant capacity of blood

时间窗: Change from Baseline total antioxidant capacity at 8 weeks

Venous blood was sampled to measure total antioxidant capacity

The change of Interleukin-8 of blood

时间窗: Change from Baseline IL-8 at 8 weeks

Venous blood was sampled to measure IL-8

The change of Interleukin-6 of blood

时间窗: Change from Baseline IL-6 at 8 weeks

Venous blood was sampled to measure IL-6

The change of Insulin-Like Growth Factor-1 of blood

时间窗: Change from Baseline IGF-1 at 8 weeks

Venous blood was sampled to measure IGF-1

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 visible spots

时间窗: Change from Baseline visible spots at 8 weeks

VISIA Complexion Analysis System was utilized to measure skin spots. Units: arbitrary units

次要结局

  • The change of fasting blood glugose level(Change from Baseline fasting blood glugose level at 8 weeks)
  • The change of renal function biomarkers (creatinine, BUN) of blood(Change from Baseline renal function biomarkers at 8 weeks)
  • The change of Advanced glycation end products of blood(Change from Baseline AGEs at 8 weeks)
  • The change of UV spots(Change from Baseline UV spots at 8 weeks)
  • The change of blood lipid profile(Change from Baseline blood lipid profile at 8 weeks)
  • The change of skin hydration(Change from Baseline skin hydration at 8 weeks)
  • The change of brown spots(Change from Baseline brown spots at 8 weeks)
  • The change of liver function biomarkers (AST, ALT) of blood(Change from Baseline liver function biomarkers 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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