the Evaluation of the Efficacy of TCI66207 on the Skin.

December 6, 2021 updated by: TCI Co., Ltd.

Evaluation of Skin Efficacy of TCI66207

The purpose of this study is to explore the evaluation of the efficacy of TCI66207 deep-sea live-face bacteria on the skin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • 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 Locations

  • Taiwan
    • Neipu Township
      • Taipei, Neipu Township, Taiwan, 114
        • Research & Design Center, TCI CO., Ltd

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

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy volunteers aged above 20 years old
  2. Subject has dull skin.

Exclusion Criteria:

  1. .Subject with diseases of the skin, heart, liver, kidney, endocrine and other organs and patients with mental illness (according to medical history).
  2. Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.
  3. Female who is pregnant or nursing or planning to become pregnant during the course of the study.
  4. Received facial laser therapy, chemical peeling or UV overexposure in the past 4 weeks.
  5. Subjects who have large spots (area >3 square centimeter) or abnormal acne.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TCI66207 Essence
Essence
Dietary supplement: TCI66207 Essence
Use it twice a day after washing your face in the morning and evening for a total of 4 weeks.
Placebo Comparator: Placebo Essence
Dietary supplement: Placebo Essence
Use it twice a day after washing your face in the morning and evening for a total of 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of skin moisture
Time Frame: Subjects will be tested in the 4th week.
Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120
Subjects will be tested in the 4th week.
The change of skin elasticity
Time Frame: Subjects will be tested in the 4th week.
Cutometer® dual MPA 580 was utilized to measure skin elasticity (parameter R2). Units: μm penetration depth into the probe opening, expressed as curvesCorneometer® units 0-120
Subjects will be tested in the 4th week.
The change of skin wrinkles
Time Frame: Subjects will be tested in the 4th week.
VISIA Complexion Analysis System was utilized to measure wrinkles. Units: arbitrary units
Subjects will be tested in the 4th week.
The change of skin collagen density
Time Frame: Subjects will be tested in the 4th week.
DermaLab® USB - 20 MHz High Freq. Ultrasound probe was utilized to scan and analyze skin collagen density. Units: Intensity score
Subjects will be tested in the 4th week.
The change of skin texture
Time Frame: Subjects will be tested in the 4th week.
VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units
Subjects will be tested in the 4th week.
The change of skin pores
Time Frame: Subjects will be tested in the 4th week.
VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units
Subjects will be tested in the 4th week.

Collaborators and Investigators

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

Sponsor

TCI Co., Ltd.

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)

November 1, 2018

Primary Completion (Actual)

November 30, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

November 22, 2021

First Submitted That Met QC Criteria

November 22, 2021

First Posted (Actual)

December 3, 2021

Study Record Updates

Last Update Posted (Actual)

December 7, 2021

Last Update Submitted That Met QC Criteria

December 6, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSMH No.18-148-A

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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