The Evaluation of Chenopodium Formosanum and Fagopyrum Esculentum Extract on Anti-aging Effect

Study Overview
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Brief Summary
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To assess Chenopodium Formosanum and Fagopyrum Esculentum Extract on skin anti-aging

Official Title
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The Evaluation of Chenopodium Formosanum and Fagopyrum Esculentum Extract on Anti-aging Effect

Conditions
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Skin Condition

Intervention / Treatment
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* Dietary Supplement: Placebo drink
* Dietary Supplement: Chenopodium Formosanum and Fagopyrum Esculentum Extract drink


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults aged between 20-65 years old Subjects must read and sign the informed consent form after the study has been fully explained. Subjects are willing to cooperate and comply with all of the regulation during the trial. Subject should inform to investigator immediately if adverse effect is happened. Subjects are willing to avoid UV overexposure during the trial (include indoor tanning treatment). Exclusion Criteria: Subjects who have known cosmetic, drug or food allergies. Subjects who have severe desquamation, tattoo, sunburn, peeling skin or other skin condition might impact measurement. Subjects with any physical condition judged by the researcher not to be eligible for this study. Subjects with uncontrollable physical condition such as high blood pressure, thyroid disease, diabetes, etc. Female who is pregnant or nursing or planning to become pregnant during the course of the study. Those who are currently participating in other clinical trials or who have just concluded a clinical trial two weeks ago. Women who have started contraceptive or change current hormone contraceptive methods within 3 months.

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 2 bottle (30 mL) per day for 56 days<br>|
| Experimental: Chenopodium Formosanum and Fagopyrum Esculentum Extract drink<br> | Dietary Supplement: Chenopodium Formosanum and Fagopyrum Esculentum Extract drink<br>* consume 2 bottle (30 mL) per day for 56 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of skin moisture | Corneometer® CM825 is utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120 | Change from Baseline skin moisture at 8 weeks | 
| The change of skin elasticity | Cutometer® dual MPA 580 is utilized to measure skin elasticity (parameter R2). Units: μm penetration depth into the probe opening, expressed as curves | Change from Baseline skin elasticity at 8 weeks | 
| The change of skin wrinkles | 3D Full-Face Skin Analyzer IRV is utilized to measure wrinkles. Units: arbitrary units | Change from Baseline skin wrinkles at 8 weeks | 
| The change of skin collagen density | DermaLab® combo - 20 MHz High Freq. Ultrasound probe is utilized to scan and analyze skin collagen density. Units: Intensity score | Change from Baseline skin collagen density at 8 weeks | 
| The change of skin tone | 3D Full-Face Skin Analyzer IRV was utilized to measure skin tone. Units: arbitrary units | Change from Baseline skin tone at 8 weeks | 
| The change of skin brightness | 3D Full-Face Skin Analyzer IRV is utilized to measure skin brightness. Units: arbitrary units | Change from Baseline skin brightness at 8 weeks | 
| The change of skin melanin index | Mexameter® MX 18 is 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 L*a*b* value | Color Spectrophotometer SCM-104/108 is utilized to measure skin L*a*b* value. Units: arbitrary units | Change from Baseline skin L*a*b* value at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of transepidermal water loss (TEWL) | Tewameter® TM 300 is utilized to measure transepidermal water loss. Units: g/hm² | Change from Baseline TEWL at 8 weeks | 
| The change of skin texture | 3D Full-Face Skin Analyzer IRV is utilized to measure skin texture. Units: arbitrary units | Change from Baseline skin texture at 8 weeks | 
| The change of skin pores | 3D Full-Face Skin Analyzer IRV is utilized to measure skin pores. Units: arbitrary units | Change from Baseline skin pores at 8 weeks | 
| The change of skin spots | 3D Full-Face Skin Analyzer IRV is utilized to measure skin spots. Units: arbitrary units | Change from Baseline skin spots at 8 weeks | 
| The change of skin erythema level | Mexameter® MX 18 is utilized to measure skin erythema level. Units: arbitrary Mexameter® units (0-999) | Change from Baseline skin erythema level at 8 weeks | 
| Self-assessment questionnaire | Questionnaire is utilized to assess skin condition of the subjects. Units: score | 8 weeks |