Back to resultsEfficacy Evaluation of Triple up® Collagen Drink on Skin Condition
Primary Purpose
Skin Condition
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Testing product
Blank
Sponsored by
About this trial
This is an interventional other trial for Skin Condition
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.
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
Triple up® Collagen Drink
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 elasticity
Cutometer® dual MPA 580 was utilized to measure skin elasticity (parameter R2). Units: μm penetration depth into the probe opening, expressed as curves
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04225091
Brief Title
Efficacy Evaluation of Triple up® Collagen Drink on Skin Condition
Official Title
Efficacy Evaluation of Triple up® Collagen Drink on Skin Condition
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 30, 2020 (Actual)
Primary Completion Date
April 21, 2020 (Actual)
Study Completion Date
May 7, 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 Triple up® Collagen Drink 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
Participant
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo drink
Arm Type
Placebo Comparator
Arm Title
Triple up® Collagen Drink
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Testing product
Other Intervention Name(s)
Triple up® Collagen Drink
Intervention Description
consume 1 bottle (50 mL) per day for 28 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Blank
Other Intervention Name(s)
Placebo 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 elasticity
Description
Cutometer® dual MPA 580 was utilized to measure skin elasticity (parameter R2). Units: μm penetration depth into the probe opening, expressed as curves
Time Frame
Change from Baseline skin elasticity 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
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
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, 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.
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
ZIP/Postal Code
71710
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Efficacy Evaluation of Triple up® Collagen Drink on Skin Condition
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