Efficacy Evaluation of Wasabi Leaf Extract on Skin

Sponsor
TCI Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05310994
Collaborator
(none)
50
1
2
4.1
12.2

Study Details

Study Description

Brief Summary

To assess the efficacy of Wasabi Leaf Extract on skin

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Placebo drink
  • Dietary Supplement: Wasabi Leaf Extract Drink
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official Title:
Efficacy Evaluation of Wasabi (Wasabia Japonica) Leaf Extract on Skin
Actual Study Start Date :
Mar 28, 2022
Anticipated Primary Completion Date :
May 31, 2022
Anticipated Study Completion Date :
Jul 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo drink

Dietary Supplement: Placebo drink
consume 1 bottle per day

Experimental: Wasabi Leaf Extract Drink

Dietary Supplement: Wasabi Leaf Extract Drink
consume 1 bottle per day
Other Names:
  • Wasabi (Wasabia japonica) leaf extract drink
  • Outcome Measures

    Primary Outcome Measures

    1. The change of skin melanin index [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 [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 [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 [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 [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 [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 [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 [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 [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 [Change from Baseline IL-6 at 8 weeks]

      Venous blood was sampled to measure IL-6

    11. The change of Interleukin-8 of blood [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 [Change from Baseline IGF-1 at 8 weeks]

      Venous blood was sampled to measure IGF-1

    Secondary Outcome Measures

    1. The change of skin hydration [Change from Baseline skin hydration at 8 weeks]

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

    2. The change of UV spots [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 [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 [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 [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 [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 [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 [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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 China Medical University Taichung Taiwan

    Sponsors and Collaborators

    • TCI Co., Ltd.

    Investigators

    • Principal Investigator: Hsiu-Mei Chiang, Prof., China Medical University, China
    • Study Director: Po-Yuan Wu, Dr., China Medical University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    TCI Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT05310994
    Other Study ID Numbers:
    • CMUH111-REC3-028
    First Posted:
    Apr 5, 2022
    Last Update Posted:
    Apr 5, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 5, 2022