- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04225091
Efficacy Evaluation of Triple up® Collagen Drink on Skin Condition
November 27, 2020 updated by: TCI Co., Ltd.
To assess Triple up® Collagen Drink on skin condition improvement
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
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
-
-
-
Tainan, Taiwan, 71710
- Chia Nan University of Pharmacy & Science
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo drink
|
consume 1 bottle (50 mL) per day for 28 days
Other Names:
|
Experimental: Triple up® Collagen Drink
|
consume 1 bottle (50 mL) per day for 28 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The change of skin moisture
Time Frame: Change from Baseline skin moisture at 4 weeks
|
Corneometer® CM825 was utilized to measure skin moisture.
Units: arbitrary Corneometer® units 0-120
|
Change from Baseline skin moisture at 4 weeks
|
The change of skin elasticity
Time Frame: Change from Baseline skin elasticity at 4 weeks
|
Cutometer® dual MPA 580 was utilized to measure skin elasticity (parameter R2).
Units: μm penetration depth into the probe opening, expressed as curves
|
Change from Baseline skin elasticity at 4 weeks
|
The change of skin wrinkles
Time Frame: Change from Baseline skin wrinkles at 4 weeks
|
VISIA Complexion Analysis System was utilized to measure wrinkles.
Units: arbitrary units
|
Change from Baseline skin wrinkles at 4 weeks
|
The change of skin collagen density
Time Frame: Change from Baseline skin collagen density at 4 weeks
|
DermaLab® USB - 20 MHz High Freq.
Ultrasound probe was utilized to scan and analyze skin collagen density.
Units: Intensity score
|
Change from Baseline skin collagen density at 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The change of skin texture
Time Frame: Change from Baseline skin texture at 4 weeks
|
VISIA Complexion Analysis System was utilized to measure skin texture.
Units: arbitrary units
|
Change from Baseline skin texture at 4 weeks
|
The change of skin pores
Time Frame: Change from Baseline skin pores at 4 weeks
|
VISIA Complexion Analysis System was utilized to measure skin pores.
Units: arbitrary units
|
Change from Baseline skin pores at 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chia-Hua Liang, Chia Nan University of Pharmacy & Science
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)
January 30, 2020
Primary Completion (Actual)
April 21, 2020
Study Completion (Actual)
May 7, 2020
Study Registration Dates
First Submitted
January 6, 2020
First Submitted That Met QC Criteria
January 8, 2020
First Posted (Actual)
January 13, 2020
Study Record Updates
Last Update Posted (Actual)
November 30, 2020
Last Update Submitted That Met QC Criteria
November 27, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-098-B
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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