Efficacy Evaluation of TCI153 Probiotics for Skin Beautification

October 23, 2024 updated by: TCI Co., Ltd.
To assess TCI153 prebiotics product on skin condition improvement

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Taiwan
      • Tainan City, Taiwan, 71710
        • Chia Nan University of Pharmacy & Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo sachet
consume 1 sachet per day
Dietary supplement: Placebo sachet
Consume 1 sachet daily
Experimental: TCI153 sachet
consume 1 sachet per day
Dietary supplement: TCI153 probiotic sachet
Consume 1 sachet daily
Other Names:
  • Ligilactobacillus salivarius TCI153 sachet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Change from Baseline skin wrinkles at 8 weeks
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
Change from Baseline skin texture at 8 weeks
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
Change from Baseline skin melanin index at 8 weeks
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
Change from Baseline L* value at 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Change from Baseline skin elasticity at 8 weeks
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
Change from Baseline skin erythema index at 8 weeks
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
Change from Baseline skin moisture at 8 weeks
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
Change from Baseline TEWL at 8 weeks
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
Change from Baseline AGEs at 8 weeks
The change of gut microbiome composition
Time Frame: Change from Baseline AGEs at 8 weeks
Gut microbiome sequencing
Change from Baseline AGEs at 8 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Change from Baseline liver function biomarkers at 8 weeks
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
Change from Baseline renal function biomarkers at 8 weeks
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
Change from Baseline blood glucose at 8 weeks
The change of sialic acid
Time Frame: Change from Baseline sialic acid at 8 weeks
Fasting venous blood was sampled to measure sialic acid
Change from Baseline sialic acid at 8 weeks
The change of Epidermal Growth Factor (EGF)
Time Frame: Change from Baseline EGF at 8 weeks
Fasting venous blood was sampled to measure EGF
Change from Baseline EGF at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TCI Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chia-Hua Liang, Chia Nan University of Pharmacy & Science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 12, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23-091-B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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