Efficacy Evaluation of TCI153 Probiotics for Skin Beautification

Study Overview
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Brief Summary
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To assess TCI153 prebiotics product on skin condition improvement

Official Title
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Efficacy Evaluation of TCI153 Probiotics for Skin Beautification

Conditions
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Skin Condition

Intervention / Treatment
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* Dietary Supplement: Placebo sachet
* Dietary Supplement: TCI153 sachet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults aged above 18 years old Exclusion Criteria: Subject who is not willing to participate in this study. Patients with diseases of the skin, liver, kidney. Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder. Female who is pregnant or nursing or planning to become pregnant during the course of the study. Received facial laser therapy, chemical peeling or UV overexposure (> 3 hr/week) in the past 4 weeks. Constant drug use Students who are currently taking courses taught by the principal investigator of this trial. Subject who is not willing to have their photos published in public.

Ages Eligible for Study
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Minimum Age: 18 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 sachet<br>consume 1 sachet per day | Dietary Supplement: Placebo sachet<br>* Consume 1 sachet daily<br>|
| Experimental: TCI153 sachet<br>consume 1 sachet per day | Dietary Supplement: TCI153 sachet<br>* Consume 1 sachet daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of skin wrinkles | VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units | Change from Baseline skin wrinkles at 8 weeks | 
| The change of skin texture | VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units | Change from Baseline skin texture at 8 weeks | 
| The change of skin melanin index | Mexameter® MX18 was utilized to measure skin melanin index. Units: arbitrary units | Change from Baseline skin melanin index at 8 weeks | 
| The change of skin L* value | Chroma Meter MM500 was utilized to measure skin L* value. Units: arbitrary units, 0-100 | Change from Baseline L* value at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of skin elasticity | Cutometer® MPA580 was utilized to measure skin elasticity. Units: arbitrary units | Change from Baseline skin elasticity at 8 weeks | 
| The change of skin erythema index | Mexameter® MX18 was utilized to measure skin erythema index. Units: arbitrary units | Change from Baseline skin erythema index at 8 weeks | 
| The change of skin moisture | Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120 | Change from Baseline skin moisture at 8 weeks | 
| The change of transepidermal water loss (TEWL) | Tewameter® TM 210 was utilized to measure TEWL. Units: g/hm² | Change from Baseline TEWL at 8 weeks | 
| The change of skin pores | VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units | Change from Baseline AGEs at 8 weeks | 
| The change of gut microbiome composition | Gut microbiome sequencing | Change from Baseline AGEs at 8 weeks |