Efficacy Evaluation of Wasabi Leaf Extract on Skin

Study Overview
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Brief Summary
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To assess the efficacy of Wasabi Leaf Extract on skin

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

Conditions
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Skin Condition

Intervention / Treatment
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* Dietary Supplement: Placebo drink
* Dietary Supplement: Wasabi Leaf Extract Drink


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo drink<br> | Dietary Supplement: Placebo drink<br>* consume 1 bottle per day<br>|
| Experimental: Wasabi Leaf Extract Drink<br> | Dietary Supplement: Wasabi Leaf Extract Drink<br>* consume 1 bottle per day<br>* Other names: Wasabi (Wasabia japonica) leaf extract drink;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of skin melanin index | Mexameter® MX18 was utilized to measure skin melanin index. Units: arbitrary Mexameter® units (0-999) | Change from Baseline skin melanin index at 8 weeks | 
| The change of skin erythema index | Mexameter® MX18 was utilized to measure skin erythema index. Units: arbitrary Mexameter® units (0-999) | Change from Baseline skin erythema index at 8 weeks | 
| The change of skin sebum content | Sebumeter® SM815 was utilized to measure skin sebum content. Units: Sebumeter® units from 0-350 | Change from Baseline skin sebum content at 8 weeks | 
| The change of transepidermal water loss | Tewameter® TM300 was utilized to measure transepidermal water loss (TEWL). Units: TEWL-values lower than 70 g/hm² | Change from Baseline TEWL at 8 weeks | 
| The change of L* (lightness) values | Spectrophotometer SCM-108 was utilized to measure skin L* value. Units: arbitrary units | Change from Baseline L* value at 8 weeks | 
| The change of a* (redness) values | Spectrophotometer SCM-108 was utilized to measure skin a* value. Units: arbitrary units | Change from Baseline a* value at 8 weeks | 
| The change of visible spots | VISIA Complexion Analysis System was utilized to measure skin spots. Units: arbitrary units | Change from Baseline visible spots at 8 weeks | 
| The change of skin red area | VISIA Complexion Analysis System was utilized to measure skin red area. Units: arbitrary units | Change from Baseline skin red area at 8 weeks | 
| The change of total antioxidant capacity of blood | Venous blood was sampled to measure total antioxidant capacity | Change from Baseline total antioxidant capacity at 8 weeks | 
| The change of Interleukin-6 of blood | Venous blood was sampled to measure IL-6 | Change from Baseline IL-6 at 8 weeks | 
| The change of Interleukin-8 of blood | Venous blood was sampled to measure IL-8 | Change from Baseline IL-8 at 8 weeks | 
| The change of Insulin-Like Growth Factor-1 of blood | Venous blood was sampled to measure IGF-1 | Change from Baseline IGF-1 at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of skin hydration | Corneometer® CM825 was utilized to measure skin hydration. Units: arbitrary | Change from Baseline skin hydration at 8 weeks | 
| The change of UV spots | VISIA Complexion Analysis System was utilized to measure UV spots. Units: arbitrary units | Change from Baseline UV spots at 8 weeks | 
| The change of brown spots | VISIA Complexion Analysis System was utilized to measure brown spots. Units: arbitrary units | Change from Baseline brown spots at 8 weeks | 
| The change of Advanced glycation end products of blood | Venous blood was sampled to measure AGEs | Change from Baseline AGEs at 8 weeks | 
| The change of liver function biomarkers (AST, ALT) of blood | Venous blood was sampled to measure liver function biomarkers | Change from Baseline liver function biomarkers at 8 weeks | 
| The change of renal function biomarkers (creatinine, BUN) of blood | Venous blood was sampled to measure renal function biomarkers | Change from Baseline renal function biomarkers at 8 weeks | 
| The change of fasting blood glugose level | Venous blood was sampled to measure fasting blood glugose level | Change from Baseline fasting blood glugose level at 8 weeks | 
| The change of blood lipid profile | Venous blood was sampled to measure blood lipid profile (total cholesterol, HDL-C, LDL-C, triglyceride) | Change from Baseline blood lipid profile at 8 weeks |