Back to resultsEfficacy Evaluation of Wasabi Leaf Extract on Skin
Primary Purpose
Skin Condition
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Placebo drink
Wasabi Leaf Extract Drink
Sponsored by
About this trial
This is an interventional other trial for Skin Condition
Eligibility Criteria
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
Sites / Locations
- China Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo drink
Wasabi Leaf Extract Drink
Arm Description
Outcomes
Primary Outcome Measures
The change of skin melanin index
Mexameter® MX18 was utilized to measure skin melanin index. Units: arbitrary Mexameter® units (0-999)
The change of skin erythema index
Mexameter® MX18 was utilized to measure skin erythema index. Units: arbitrary Mexameter® units (0-999)
The change of skin sebum content
Sebumeter® SM815 was utilized to measure skin sebum content. Units: Sebumeter® units from 0-350
The change of transepidermal water loss
Tewameter® TM300 was utilized to measure transepidermal water loss (TEWL). Units: TEWL-values lower than 70 g/hm²
The change of L* (lightness) values
Spectrophotometer SCM-108 was utilized to measure skin L* value. Units: arbitrary units
The change of a* (redness) values
Spectrophotometer SCM-108 was utilized to measure skin a* value. Units: arbitrary units
The change of visible spots
VISIA Complexion Analysis System was utilized to measure skin spots. Units: arbitrary units
The change of skin red area
VISIA Complexion Analysis System was utilized to measure skin red area. Units: arbitrary units
The change of total antioxidant capacity of blood
Venous blood was sampled to measure total antioxidant capacity
The change of Interleukin-6 of blood
Venous blood was sampled to measure IL-6
The change of Interleukin-8 of blood
Venous blood was sampled to measure IL-8
The change of Insulin-Like Growth Factor-1 of blood
Venous blood was sampled to measure IGF-1
Secondary Outcome Measures
The change of skin hydration
Corneometer® CM825 was utilized to measure skin hydration. Units: arbitrary
The change of UV spots
VISIA Complexion Analysis System was utilized to measure UV spots. Units: arbitrary units
The change of brown spots
VISIA Complexion Analysis System was utilized to measure brown spots. Units: arbitrary units
The change of Advanced glycation end products of blood
Venous blood was sampled to measure AGEs
The change of liver function biomarkers (AST, ALT) of blood
Venous blood was sampled to measure liver function biomarkers
The change of renal function biomarkers (creatinine, BUN) of blood
Venous blood was sampled to measure renal function biomarkers
The change of fasting blood glugose level
Venous blood was sampled to measure fasting blood glugose level
The change of blood lipid profile
Venous blood was sampled to measure blood lipid profile (total cholesterol, HDL-C, LDL-C, triglyceride)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05310994
Brief Title
Efficacy Evaluation of Wasabi Leaf Extract on Skin
Official Title
Efficacy Evaluation of Wasabi (Wasabia Japonica) Leaf Extract on Skin
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
June 15, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TCI Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To assess the efficacy of Wasabi Leaf Extract on skin
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Condition
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo drink
Arm Type
Placebo Comparator
Arm Title
Wasabi Leaf Extract Drink
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo drink
Intervention Description
consume 1 bottle per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Wasabi Leaf Extract Drink
Other Intervention Name(s)
Wasabi (Wasabia japonica) leaf extract drink
Intervention Description
consume 1 bottle per day
Primary Outcome Measure Information:
Title
The change of skin melanin index
Description
Mexameter® MX18 was utilized to measure skin melanin index. Units: arbitrary Mexameter® units (0-999)
Time Frame
Change from Baseline skin melanin index at 8 weeks
Title
The change of skin erythema index
Description
Mexameter® MX18 was utilized to measure skin erythema index. Units: arbitrary Mexameter® units (0-999)
Time Frame
Change from Baseline skin erythema index at 8 weeks
Title
The change of skin sebum content
Description
Sebumeter® SM815 was utilized to measure skin sebum content. Units: Sebumeter® units from 0-350
Time Frame
Change from Baseline skin sebum content at 8 weeks
Title
The change of transepidermal water loss
Description
Tewameter® TM300 was utilized to measure transepidermal water loss (TEWL). Units: TEWL-values lower than 70 g/hm²
Time Frame
Change from Baseline TEWL at 8 weeks
Title
The change of L* (lightness) values
Description
Spectrophotometer SCM-108 was utilized to measure skin L* value. Units: arbitrary units
Time Frame
Change from Baseline L* value at 8 weeks
Title
The change of a* (redness) values
Description
Spectrophotometer SCM-108 was utilized to measure skin a* value. Units: arbitrary units
Time Frame
Change from Baseline a* value at 8 weeks
Title
The change of visible spots
Description
VISIA Complexion Analysis System was utilized to measure skin spots. Units: arbitrary units
Time Frame
Change from Baseline visible spots at 8 weeks
Title
The change of skin red area
Description
VISIA Complexion Analysis System was utilized to measure skin red area. Units: arbitrary units
Time Frame
Change from Baseline skin red area at 8 weeks
Title
The change of total antioxidant capacity of blood
Description
Venous blood was sampled to measure total antioxidant capacity
Time Frame
Change from Baseline total antioxidant capacity at 8 weeks
Title
The change of Interleukin-6 of blood
Description
Venous blood was sampled to measure IL-6
Time Frame
Change from Baseline IL-6 at 8 weeks
Title
The change of Interleukin-8 of blood
Description
Venous blood was sampled to measure IL-8
Time Frame
Change from Baseline IL-8 at 8 weeks
Title
The change of Insulin-Like Growth Factor-1 of blood
Description
Venous blood was sampled to measure IGF-1
Time Frame
Change from Baseline IGF-1 at 8 weeks
Secondary Outcome Measure Information:
Title
The change of skin hydration
Description
Corneometer® CM825 was utilized to measure skin hydration. Units: arbitrary
Time Frame
Change from Baseline skin hydration at 8 weeks
Title
The change of UV spots
Description
VISIA Complexion Analysis System was utilized to measure UV spots. Units: arbitrary units
Time Frame
Change from Baseline UV spots at 8 weeks
Title
The change of brown spots
Description
VISIA Complexion Analysis System was utilized to measure brown spots. Units: arbitrary units
Time Frame
Change from Baseline brown spots at 8 weeks
Title
The change of Advanced glycation end products of blood
Description
Venous blood was sampled to measure AGEs
Time Frame
Change from Baseline AGEs at 8 weeks
Title
The change of liver function biomarkers (AST, ALT) of blood
Description
Venous blood was sampled to measure liver function biomarkers
Time Frame
Change from Baseline liver function biomarkers at 8 weeks
Title
The change of renal function biomarkers (creatinine, BUN) of blood
Description
Venous blood was sampled to measure renal function biomarkers
Time Frame
Change from Baseline renal function biomarkers at 8 weeks
Title
The change of fasting blood glugose level
Description
Venous blood was sampled to measure fasting blood glugose level
Time Frame
Change from Baseline fasting blood glugose level at 8 weeks
Title
The change of blood lipid profile
Description
Venous blood was sampled to measure blood lipid profile (total cholesterol, HDL-C, LDL-C, triglyceride)
Time Frame
Change from Baseline blood lipid profile at 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsiu-Mei Chiang, Prof.
Organizational Affiliation
China Medical University, China
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Po-Yuan Wu, Dr.
Organizational Affiliation
China Medical University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
China Medical University
City
Taichung
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Efficacy Evaluation of Wasabi Leaf Extract on Skin
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