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the Evaluation of the Efficacy of TCI66207 on the Skin.

Primary Purpose

Skin Diseases

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
TCI66207 Essence
Placebo Essence
Sponsored by
TCI Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Diseases

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Research & Design Center, TCI CO., Ltd

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TCI66207 Essence

Placebo Essence

Arm Description

Essence

Outcomes

Primary Outcome Measures

The change of skin moisture
Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120
The change of skin elasticity
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
The change of skin wrinkles
VISIA Complexion Analysis System was utilized to measure wrinkles. Units: arbitrary units
The change of skin collagen density
DermaLab® USB - 20 MHz High Freq. Ultrasound probe was utilized to scan and analyze skin collagen density. Units: Intensity score
The change of skin texture
VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units
The change of skin pores
VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units

Secondary Outcome Measures

Full Information

First Posted
November 22, 2021
Last Updated
December 6, 2021
Sponsor
TCI Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05143034
Brief Title
the Evaluation of the Efficacy of TCI66207 on the Skin.
Official Title
Evaluation of Skin Efficacy of TCI66207
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TCI Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TCI66207 Essence
Arm Type
Experimental
Arm Description
Essence
Arm Title
Placebo Essence
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
TCI66207 Essence
Intervention Description
Use it twice a day after washing your face in the morning and evening for a total of 4 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Essence
Intervention Description
Use it twice a day after washing your face in the morning and evening for a total of 4 weeks.
Primary Outcome Measure Information:
Title
The change of skin moisture
Description
Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120
Time Frame
Subjects will be tested in the 4th week.
Title
The change of skin elasticity
Description
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
Time Frame
Subjects will be tested in the 4th week.
Title
The change of skin wrinkles
Description
VISIA Complexion Analysis System was utilized to measure wrinkles. Units: arbitrary units
Time Frame
Subjects will be tested in the 4th week.
Title
The change of skin collagen density
Description
DermaLab® USB - 20 MHz High Freq. Ultrasound probe was utilized to scan and analyze skin collagen density. Units: Intensity score
Time Frame
Subjects will be tested in the 4th week.
Title
The change of skin texture
Description
VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units
Time Frame
Subjects will be tested in the 4th week.
Title
The change of skin pores
Description
VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units
Time Frame
Subjects will be tested in the 4th week.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy volunteers aged above 20 years old Subject has dull skin. Exclusion Criteria: .Subject with diseases of the skin, heart, liver, kidney, endocrine and other organs and patients with mental illness (according to medical history). 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 in the past 4 weeks. Subjects who have large spots (area >3 square centimeter) or abnormal acne.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chia-Hua Liang, Ph.D
Organizational Affiliation
Chia Nan University of Pharmacy ＆ Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research & Design Center, TCI CO., Ltd
City
Taipei
State/Province
Neipu Township
ZIP/Postal Code
114
Country
Taiwan

12. IPD Sharing Statement

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