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OpenTrials
Completed

NCT Number: NCT06166342

Efficacy Evaluation of TCI153 Probiotics for Skin Beautification

To assess TCI153 prebiotics product on skin condition improvement

Completed

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Key information

Conditions

Skin Condition Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chia Nan University of Pharmacy & Science

Tainan, 71710, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo sachet

Dietary Supplement

Consume 1 sachet daily

TCI153 probiotic sachet

Dietary Supplement

Consume 1 sachet daily

Other names: Ligilactobacillus salivarius TCI153 sachet

Primary outcomes

  1. The change of skin wrinkles

    Time frame: Change from Baseline skin wrinkles at 8 weeks

    VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units

  2. The change of skin texture

    Time frame: Change from Baseline skin texture at 8 weeks

    VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units

  3. The change of skin melanin index

    Time frame: Change from Baseline skin melanin index at 8 weeks

    Mexameter® MX18 was utilized to measure skin melanin index. Units: arbitrary units

  4. The change of skin L* value

    Time frame: Change from Baseline L* value at 8 weeks

    Chroma Meter MM500 was utilized to measure skin L* value. Units: arbitrary units, 0-100

Secondary outcomes

  1. The change of skin elasticity

    Time frame: Change from Baseline skin elasticity at 8 weeks

    Cutometer® MPA580 was utilized to measure skin elasticity. Units: arbitrary units

  2. The change of skin erythema index

    Time frame: Change from Baseline skin erythema index at 8 weeks

    Mexameter® MX18 was utilized to measure skin erythema index. Units: arbitrary units

  3. The change of skin moisture

    Time frame: Change from Baseline skin moisture at 8 weeks

    Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120

  4. The change of transepidermal water loss (TEWL)

    Time frame: Change from Baseline TEWL at 8 weeks

    Tewameter® TM 210 was utilized to measure TEWL. Units: g/hm²

  5. The change of skin pores

    Time frame: Change from Baseline AGEs at 8 weeks

    VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units

  6. The change of gut microbiome composition

    Time frame: Change from Baseline AGEs at 8 weeks

    Gut microbiome sequencing

Other outcomes

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

    Time frame: Change from Baseline liver function biomarkers at 8 weeks

    Fasting venous blood was sampled to measure liver function biomarkers

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

    Time frame: Change from Baseline renal function biomarkers at 8 weeks

    Fasting venous blood was sampled to measure renal function biomarkers

  3. The change of fasting blood glucose

    Time frame: Change from Baseline blood glucose at 8 weeks

    Fasting venous blood was sampled to measure blood glucose

  4. The change of sialic acid

    Time frame: Change from Baseline sialic acid at 8 weeks

    Fasting venous blood was sampled to measure sialic acid

  5. The change of Epidermal Growth Factor (EGF)

    Time frame: Change from Baseline EGF at 8 weeks

    Fasting venous blood was sampled to measure EGF

Sponsors and collaborators

Lead sponsor

TCI Co., Ltd.

Industry

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 12, 2023
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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