Efficacy Evaluation of TCI153 Probiotics for Skin Beautification

Skin Condition Clinical Trial

Official title:

Efficacy Evaluation of TCI153 Probiotics for Skin Beautification

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06166342
• Other study ID #: 23-091-B
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: May 2024

Study information

• Verified date: January 2024
• Source: TCI Co., Ltd.
• Contact: Chia-Hua Liang
• Phone: +886-06-2661911
• Email: tinna_ling[@]mail.cnu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess TCI153 prebiotics product on skin condition improvement

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Skin Condition
• Skin Diseases

Intervention

Dietary Supplement:
• Placebo sachet
Consume 1 sachet daily
• TCI153 probiotic sachet
Consume 1 sachet daily

Locations

Country	Name	City	State
Taiwan	Chia Nan University of Pharmacy & Science	Tainan City

Sponsors (1)

Lead Sponsor	Collaborator
TCI Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The change of liver function biomarkers (AST, ALT) of blood	Fasting venous blood was sampled to measure liver function biomarkers	Change from Baseline liver function biomarkers at 8 weeks
Other	The change of renal function biomarkers (creatinine, BUN) of blood	Fasting venous blood was sampled to measure renal function biomarkers	Change from Baseline renal function biomarkers at 8 weeks
Other	The change of fasting blood glucose	Fasting venous blood was sampled to measure blood glucose	Change from Baseline blood glucose at 8 weeks
Other	The change of sialic acid	Fasting venous blood was sampled to measure sialic acid	Change from Baseline sialic acid at 8 weeks
Other	The change of Epidermal Growth Factor (EGF)	Fasting venous blood was sampled to measure EGF	Change from Baseline EGF at 8 weeks
Primary	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
Primary	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
Primary	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
Primary	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	The change of skin elasticity	Cutometer® MPA580 was utilized to measure skin elasticity. Units: arbitrary units	Change from Baseline skin elasticity at 8 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	The change of gut microbiome composition	Gut microbiome sequencing	Change from Baseline AGEs at 8 weeks