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Efficacy Testing of Collagen and Zhuyin Drinks

Primary Purpose

Skin Condition

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

About this trial

This is an interventional other trial for Skin Condition

Eligibility Criteria

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

Inclusion Criteria:

  • Healthy adults aged above 20 years old

Exclusion Criteria:

  • Subject who is not willing to participate in this study.
  • Patients 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.
  • Vegetarian
  • Subjects who have large spots (area >3 square centimeter) or abnormal acne.

Sites / Locations

  • Chia Nan University of Pharmacy ＆ Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo drink

Collagen and Zhuyin Drinks

Arm Description

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 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 TEWL
Tewameter® TM 300 was utilized to measure TEWL. Units: g/h/m2
The change of skin brightness
Glossymeter GL 200 was utilized to measure skin brightness. Units: arbitrary units
The change of interleukin-6
Venous blood was sampled to measure concentrations of interleukin-6.
The change of interleukin-8
Venous blood was sampled to measure concentrations of interleukin-8.
The change of Tumor necrosis factor
Venous blood was sampled to measure concentrations of Tumor necrosis factor.
The change of Matrix metalloproteinase-1
Venous blood was sampled to measure concentrations of Matrix metalloproteinase-1 .
The change of metallopeptidase inhibitor 1
Venous blood was sampled to measure concentrations of metallopeptidase inhibitor 1.

Secondary Outcome Measures

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 pores. Units: arbitrary units
The change of skin spots
VISIA Complexion Analysis System was utilized to measure skin spots. Units: arbitrary units
The change of red areas
VISIA Complexion Analysis System was utilized to measure red areas. Units: arbitrary units

Full Information

First Posted
February 10, 2020
Last Updated
December 10, 2020
Sponsor
TCI Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04266405
Brief Title
Efficacy Testing of Collagen and Zhuyin Drinks
Official Title
Efficacy Testing of Collagen and Zhuyin Drinks
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
March 9, 2020 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
December 1, 2020 (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
To assess collagen and zhuyin drink on skin & body condition improvement

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Single
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo drink
Arm Type
Placebo Comparator
Arm Title
Collagen and Zhuyin Drinks
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo drink
Intervention Description
consume 1 bottle (50 mL) per day for 28 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Collagen Cubilose Drink
Intervention Description
consume 1 bottle (50 mL) per day for 28 days
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
Change from Baseline skin moisture at 4 weeks
Title
The change of skin wrinkles
Description
VISIA Complexion Analysis System was utilized to measure wrinkles. Units: arbitrary units
Time Frame
Change from Baseline skin wrinkles at 4 weeks
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
Change from Baseline skin collagen density at 4 weeks
Title
The change of TEWL
Description
Tewameter® TM 300 was utilized to measure TEWL. Units: g/h/m2
Time Frame
Change from Baseline TEWL at 4 weeks
Title
The change of skin brightness
Description
Glossymeter GL 200 was utilized to measure skin brightness. Units: arbitrary units
Time Frame
Change from Baseline skin brightness at 4 weeks
Title
The change of interleukin-6
Description
Venous blood was sampled to measure concentrations of interleukin-6.
Time Frame
Change from Baseline skin brightness at 4 weeks
Title
The change of interleukin-8
Description
Venous blood was sampled to measure concentrations of interleukin-8.
Time Frame
Change from Baseline skin brightness at 4 weeks
Title
The change of Tumor necrosis factor
Description
Venous blood was sampled to measure concentrations of Tumor necrosis factor.
Time Frame
Change from Baseline skin brightness at 4 weeks
Title
The change of Matrix metalloproteinase-1
Description
Venous blood was sampled to measure concentrations of Matrix metalloproteinase-1 .
Time Frame
Change from Baseline skin brightness at 4 weeks
Title
The change of metallopeptidase inhibitor 1
Description
Venous blood was sampled to measure concentrations of metallopeptidase inhibitor 1.
Time Frame
Change from Baseline skin brightness at 4 weeks
Secondary Outcome Measure Information:
Title
The change of skin texture
Description
VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units
Time Frame
Change from Baseline skin texture at 4 weeks
Title
The change of skin pores
Description
VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units
Time Frame
Change from Baseline skin pores at 4 weeks
Title
The change of skin spots
Description
VISIA Complexion Analysis System was utilized to measure skin spots. Units: arbitrary units
Time Frame
Change from Baseline skin spots at 4 weeks
Title
The change of red areas
Description
VISIA Complexion Analysis System was utilized to measure red areas. Units: arbitrary units
Time Frame
Change from Baseline red areas at 4 weeks

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 adults aged above 20 years old Exclusion Criteria: Subject who is not willing to participate in this study. Patients 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. Vegetarian Subjects who have large spots (area >3 square centimeter) or abnormal acne.
Facility Information:
Facility Name
Chia Nan University of Pharmacy ＆ Science
City
Tainan
ZIP/Postal Code
71710
Country
Taiwan

12. IPD Sharing Statement

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Efficacy Testing of Collagen and Zhuyin Drinks

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