Efficacy Evaluation of TCI153 Probiotics for Skin Beautification

NCT06166342 | Completed

• 1 other identifier: 23-091-B
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To assess TCI153 prebiotics product on skin condition improvement

Conditions

Skin Condition

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• The change of skin elasticity

  Change from Baseline skin elasticity at 8 weeks

• The change of skin erythema index

  Change from Baseline skin erythema index at 8 weeks

• The change of skin moisture

  Change from Baseline skin moisture at 8 weeks

• The change of transepidermal water loss (TEWL)

  Change from Baseline TEWL at 8 weeks

• The change of skin pores

  Change from Baseline AGEs at 8 weeks

Other Outcomes (5)

• The change of liver function biomarkers (AST, ALT) of blood

  Change from Baseline liver function biomarkers at 8 weeks

• The change of renal function biomarkers (creatinine, BUN) of blood

  Change from Baseline renal function biomarkers at 8 weeks

• The change of fasting blood glucose

  Change from Baseline blood glucose at 8 weeks

Study Arms (2)

Placebo sachet

PLACEBO COMPARATOR

consume 1 sachet per day

Dietary Supplement: Placebo sachet

TCI153 sachet

EXPERIMENTAL

consume 1 sachet per day

Dietary Supplement: TCI153 probiotic sachet

Interventions

Placebo sachet DIETARY_SUPPLEMENT

Consume 1 sachet daily

Placebo sachet

TCI153 probiotic sachet DIETARY_SUPPLEMENT

Consume 1 sachet daily

Also known as: Ligilactobacillus salivarius TCI153 sachet

TCI153 sachet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults aged above 18 years old

You may not qualify if:

• 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.

Sponsors & Collaborators

• TCI Co., Ltd.: lead

Study Sites (1)

Chia Nan University of Pharmacy & Science

Tainan, 71710, Taiwan

Location

MeSH Terms

Conditions

Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

• Chia-Hua Liang

  Chia Nan University of Pharmacy ＆ Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 12, 2023
• Study Start: September 15, 2023
• Primary Completion: June 30, 2024
• Study Completion: August 31, 2024
• Last Updated: October 26, 2024

Record last verified: 2024-10

Locations

TW (1)