Back to resultsEfficacy Testing of Collagen Drink on Skin Beauty and Sleep Aid
Primary Purpose
Skin Condition, Sleep Disturbance
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Placebo drink
Collagen Juice Drink
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, liver, kidney.
- Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.
- Female who is pregnant or nursing
- Constant drug use
- Received facial laser therapy, chemical peeling or UV overexposure (>3 hours everyday) in the past 4 weeks.
- Students taught by the PI
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
Cutometer® MPA580 was utilized to measure skin elasticity. 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 sleep quality
Self-assessment questionnaire was utilized to survey sleep quality.
The change of AGEs of blood
Venous blood was sampled to measure AGEs
The change of TIMP-1 of blood
Venous blood was sampled to measure TIMP-1
The change of desmosine of blood
Venous blood was sampled to measure desmosine
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 pores
VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units
The change of skin a* value
Chroma Meter MM500 was utilized to measure skin a* value. Units: arbitrary units
The change of skin hydration
Corneometer® CM825 was utilized to measure skin hydration. Units: arbitrary Corneometer® units 0-120
The change of transepidermal water loss
Tewameter® TM300 was utilized to measure skin hydration. Units: g/hm²
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05182814
Brief Title
Efficacy Testing of Collagen Drink on Skin Beauty and Sleep Aid
Official Title
Efficacy Testing of Collagen Drink on Skin Beauty and Sleep Aid
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 10, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
April 30, 2022 (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 Drink on skin condition and sleep quality improvement
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Condition, Sleep Disturbance
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)
Placebo drink
Intervention Description
Blank
Intervention Type
Dietary Supplement
Intervention Name(s)
Collagen Juice Drink
Other Intervention Name(s)
LISAVEI® Collagen Juice Drink
Intervention Description
Testing product
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 8 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 8 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 8 weeks
Title
The change of skin elasticity
Description
Cutometer® MPA580 was utilized to measure skin elasticity. Units: arbitrary units
Time Frame
Change from Baseline skin elasticity at 8 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 8 weeks
Title
The change of sleep quality
Description
Self-assessment questionnaire was utilized to survey sleep quality.
Time Frame
Change from Baseline sleep quality at 8 weeks
Title
The change of AGEs of blood
Description
Venous blood was sampled to measure AGEs
Time Frame
Change from Baseline AGEs at 8 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 8 weeks
Title
The change of desmosine of blood
Description
Venous blood was sampled to measure desmosine
Time Frame
Change from Baseline desmosine at 8 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 8 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 8 weeks
Title
The change of skin a* value
Description
Chroma Meter MM500 was utilized to measure skin a* value. Units: arbitrary units
Time Frame
Change from Baseline skin a* value at 8 weeks
Title
The change of skin hydration
Description
Corneometer® CM825 was utilized to measure skin hydration. Units: arbitrary Corneometer® units 0-120
Time Frame
Change from Baseline skin hydration at 8 weeks
Title
The change of transepidermal water loss
Description
Tewameter® TM300 was utilized to measure skin hydration. Units: g/hm²
Time Frame
Change from Baseline transepidermal water loss at 8 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
Constant drug use
Received facial laser therapy, chemical peeling or UV overexposure (>3 hours everyday) in the past 4 weeks.
Students taught by the PI
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 Drink on Skin Beauty and Sleep Aid
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