Efficacy Evaluation of TCI153 Probiotics for Skin Beautification

Not Applicable

Completed

• Conditions: Skin Condition
• Interventions: Dietary Supplement: Placebo sachet; Dietary Supplement: TCI153 probiotic sachet

• Registration Number: NCT06166342
• Lead Sponsor: TCI Co., Ltd.

Brief Summary

To assess TCI153 prebiotics product on skin condition improvement

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-15
• Study First Submitted: 2023-11-29
• Study First Submitted QC: 2023-12-04
• Study First Posted: 2023-12-12
• Primary Completion: 2024-06-30
• Study Completion: 2024-08-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo sachet	Placebo sachet	consume 1 sachet per day
TCI153 sachet	TCI153 probiotic sachet	consume 1 sachet per day

Primary Outcome Measures

Name	Time	Method
The change of skin L* value	Change from Baseline L* value at 8 weeks	Chroma Meter MM500 was utilized to measure skin L\* value. Units: arbitrary units, 0-100
The change of skin wrinkles	Change from Baseline skin wrinkles at 8 weeks	VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units
The change of skin texture	Change from Baseline skin texture at 8 weeks	VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units
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 units

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chia Nan University of Pharmacy & Science; 🇨🇳 Tainan City, Taiwan