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Efficacy Testing of Collagen Elixir

Primary Purpose

Skin Condition

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Collagen drink
Blank
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 - undefined (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, 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 in the past 4 weeks.
  • Constant drug use
  • Participated cosmetic product human study in the past 3 months.

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 drink

Arm Description

Outcomes

Primary Outcome Measures

The change of skin wrinkles
VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units
The change of skin texture
VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units
The change of skin collagen density
DermaLab® Series SkinLab Combo was utilized to measure skin pores. Units: arbitrary units
The change of skin elasticity
Soft Plus was utilized to measure skin elasticity. Units: arbitrary units
The change of MMP-1 of blood
Venous blood was sampled to measure MMP-1
The change of TIMP-1 of blood
Venous blood was sampled to measure TIMP-1

Secondary Outcome Measures

The change of skin melanin index
Soft Plus was utilized to measure skin melanin index. Units: arbitrary units
The change of skin L* value
Chroma Meter MM500 was utilized to measure skin L* value. Units: arbitrary units, 0-100
The change of skin moisture
Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120
The change of skin spots
VISIA Complexion Analysis System was utilized to measure skin spots. Units: arbitrary units
The change of skin UV spots
VISIA Complexion Analysis System was utilized to measure skin UV spots. Units: arbitrary units
The change of skin brown spots
VISIA Complexion Analysis System was utilized to measure skin brown spots. Units: arbitrary units
The change of TNF-α of blood
Venous blood was sampled to measure TNF-α
The change of IL-10 of blood
Venous blood was sampled to measure IL-10
The change of SOD-RBC of blood
Venous blood was sampled to measure SOD-RBC
The change of f-thiols of blood
Venous blood was sampled to measure f-thiols
The change of t-GSH of blood
Venous blood was sampled to measure t-GSH
The change of GST-RBC of blood
Venous blood was sampled to measure GST-RBC
The change of MDA of blood
Venous blood was sampled to measure MDA
The change of blood total antioxidant capacity (TAC)
Venous blood was sampled to measure concentrations of TAC

Full Information

First Posted
May 6, 2021
Last Updated
March 28, 2022
Sponsor
TCI Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04878536
Brief Title
Efficacy Testing of Collagen Elixir
Official Title
Efficacy Testing of Collagen Drink
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 18, 2021 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
October 25, 2021 (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 Isagenix-Collagen Elixir on skin 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
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo drink
Arm Type
Placebo Comparator
Arm Title
Collagen drink
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Collagen drink
Other Intervention Name(s)
Isagenix-Collagen Elixir
Intervention Description
Testing product
Intervention Type
Dietary Supplement
Intervention Name(s)
Blank
Intervention Description
Placebo drink
Primary Outcome Measure Information:
Title
The change of skin wrinkles
Description
VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units
Time Frame
Change from Baseline skin wrinkles at 4 weeks
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 collagen density
Description
DermaLab® Series SkinLab Combo was utilized to measure skin pores. Units: arbitrary units
Time Frame
Change from Baseline skin collagen density at 4 weeks
Title
The change of skin elasticity
Description
Soft Plus was utilized to measure skin elasticity. Units: arbitrary units
Time Frame
Change from Baseline skin elasticity at 4 weeks
Title
The change of MMP-1 of blood
Description
Venous blood was sampled to measure MMP-1
Time Frame
Change from Baseline MMP-1 at 4 weeks
Title
The change of TIMP-1 of blood
Description
Venous blood was sampled to measure TIMP-1
Time Frame
Change from Baseline TIMP-1 at 4 weeks
Secondary Outcome Measure Information:
Title
The change of skin melanin index
Description
Soft Plus was utilized to measure skin melanin index. Units: arbitrary units
Time Frame
Change from Baseline skin melanin index at 4 weeks
Title
The change of skin L* value
Description
Chroma Meter MM500 was utilized to measure skin L* value. Units: arbitrary units, 0-100
Time Frame
Change from Baseline L* value at 4 weeks
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 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 skin UV spots
Description
VISIA Complexion Analysis System was utilized to measure skin UV spots. Units: arbitrary units
Time Frame
Change from Baseline skin UV spots at 4 weeks
Title
The change of skin brown spots
Description
VISIA Complexion Analysis System was utilized to measure skin brown spots. Units: arbitrary units
Time Frame
Change from Baseline skin brown spots at 4 weeks
Title
The change of TNF-α of blood
Description
Venous blood was sampled to measure TNF-α
Time Frame
Change from Baseline TNF-α at 4 weeks
Title
The change of IL-10 of blood
Description
Venous blood was sampled to measure IL-10
Time Frame
Change from Baseline IL-10 at 4 weeks
Title
The change of SOD-RBC of blood
Description
Venous blood was sampled to measure SOD-RBC
Time Frame
Change from Baseline SOD-RBC at 4 weeks
Title
The change of f-thiols of blood
Description
Venous blood was sampled to measure f-thiols
Time Frame
Change from Baseline f-thiols at 4 weeks
Title
The change of t-GSH of blood
Description
Venous blood was sampled to measure t-GSH
Time Frame
Change from Baseline t-GSH at 4 weeks
Title
The change of GST-RBC of blood
Description
Venous blood was sampled to measure GST-RBC
Time Frame
Change from Baseline GST-RBC at 4 weeks
Title
The change of MDA of blood
Description
Venous blood was sampled to measure MDA
Time Frame
Change from Baseline MDA at 4 weeks
Title
The change of blood total antioxidant capacity (TAC)
Description
Venous blood was sampled to measure concentrations of TAC
Time Frame
Change from Baseline TAC at 4 weeks
Other Pre-specified Outcome Measures:
Title
The change of total cholesterol of blood
Description
Venous blood was sampled to measure total cholesterol
Time Frame
Change from Baseline total cholesterol at 4 weeks
Title
The change of triglyceride of blood
Description
Venous blood was sampled to measure triglyceride
Time Frame
Change from Baseline triglyceride at 4 weeks
Title
The change of SGOT of blood
Description
Venous blood was sampled to measure SGOT
Time Frame
Change from Baseline SGOT at 4 weeks
Title
The change of SGPT of blood
Description
Venous blood was sampled to measure SGPT
Time Frame
Change from Baseline SGPT at 4 weeks
Title
The change of BUN of blood
Description
Venous blood was sampled to measure BUN
Time Frame
Change from Baseline BUN at 4 weeks
Title
The change of creatinine of blood
Description
Venous blood was sampled to measure creatinine
Time Frame
Change from Baseline creatinine at 4 weeks
Title
The change of uric acid of blood
Description
Venous blood was sampled to measure uric acid
Time Frame
Change from Baseline uric acid at 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 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, 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 in the past 4 weeks. Constant drug use Participated cosmetic product human study in the past 3 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chia-Hua Liang
Organizational Affiliation
Chia Nan University of Pharmacy ＆ Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chia Nan University of Pharmacy & Science
City
Tainan City
ZIP/Postal Code
71710
Country
Taiwan

12. IPD Sharing Statement

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Efficacy Testing of Collagen Elixir

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