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OpenTrials
Completed

NCT Number: NCT05310994

Efficacy Evaluation of Wasabi Leaf Extract on Skin

To assess the efficacy of Wasabi Leaf Extract on skin

Completed

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Key information

Conditions

Skin Condition Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China Medical University

Taichung, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Placebo drink

Dietary Supplement

consume 1 bottle per day

Wasabi Leaf Extract Drink

Dietary Supplement

consume 1 bottle per day

Other names: Wasabi (Wasabia japonica) leaf extract drink

Primary outcomes

  1. The change of skin melanin index

    Time frame: Change from Baseline skin melanin index at 8 weeks

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

  2. The change of skin erythema index

    Time frame: Change from Baseline skin erythema index at 8 weeks

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

  3. The change of skin sebum content

    Time frame: Change from Baseline skin sebum content at 8 weeks

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

  4. The change of transepidermal water loss

    Time frame: 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

  5. The change of L* (lightness) values

    Time frame: Change from Baseline L* value at 8 weeks

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

  6. The change of a* (redness) values

    Time frame: Change from Baseline a* value at 8 weeks

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

  7. The change of visible spots

    Time frame: Change from Baseline visible spots at 8 weeks

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

  8. The change of skin red area

    Time frame: Change from Baseline skin red area at 8 weeks

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

  9. The change of total antioxidant capacity of blood

    Time frame: Change from Baseline total antioxidant capacity at 8 weeks

    Venous blood was sampled to measure total antioxidant capacity

  10. The change of Interleukin-6 of blood

    Time frame: Change from Baseline IL-6 at 8 weeks

    Venous blood was sampled to measure IL-6

  11. The change of Interleukin-8 of blood

    Time frame: Change from Baseline IL-8 at 8 weeks

    Venous blood was sampled to measure IL-8

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

    Time frame: Change from Baseline IGF-1 at 8 weeks

    Venous blood was sampled to measure IGF-1

Secondary outcomes

  1. The change of skin hydration

    Time frame: Change from Baseline skin hydration at 8 weeks

    Corneometer® CM825 was utilized to measure skin hydration. Units: arbitrary

  2. The change of UV spots

    Time frame: Change from Baseline UV spots at 8 weeks

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

  3. The change of brown spots

    Time frame: Change from Baseline brown spots at 8 weeks

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

  4. The change of Advanced glycation end products of blood

    Time frame: Change from Baseline AGEs at 8 weeks

    Venous blood was sampled to measure AGEs

  5. The change of liver function biomarkers (AST, ALT) of blood

    Time frame: Change from Baseline liver function biomarkers at 8 weeks

    Venous blood was sampled to measure liver function biomarkers

  6. The change of renal function biomarkers (creatinine, BUN) of blood

    Time frame: Change from Baseline renal function biomarkers at 8 weeks

    Venous blood was sampled to measure renal function biomarkers

  7. The change of fasting blood glugose level

    Time frame: Change from Baseline fasting blood glugose level at 8 weeks

    Venous blood was sampled to measure fasting blood glugose level

  8. The change of blood lipid profile

    Time frame: Change from Baseline blood lipid profile at 8 weeks

    Venous blood was sampled to measure blood lipid profile (total cholesterol, HDL-C, LDL-C, triglyceride)

Sponsors and collaborators

Lead sponsor

TCI Co., Ltd.

Industry

Registry information

Official study title

Efficacy Evaluation of Wasabi (Wasabia Japonica) Leaf Extract on Skin

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 5, 2022
Registry last updated
Sep 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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