Skin ConditionNCT04266405
Efficacy Testing of Collagen and Zhuyin Drinks
A study testing Collagen Cubilose Drink in people with Skin Condition, run by TCI Co., Ltd. at 1 site in Taiwan.
Trial summary
To assess collagen and zhuyin drink on skin \& body condition improvement Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Condition
- What is being tested?
- Collagen Cubilose Drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Mar 2020to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults aged above 20 years old
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
To assess collagen and zhuyin drink on skin \& body condition improvement
- Conditions
- Skin Condition
- Being tested
- Placebo drink, Collagen Cubilose Drink
- Medical subject headings
- Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo drinkDietary supplement
consume 1 bottle (50 mL) per day for 28 days
Collagen Cubilose DrinkDietary supplement
consume 1 bottle (50 mL) per day for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo drink | Placebo comparator | Not described Receives: Dietary Supplement: Placebo drink |
| Collagen and Zhuyin Drinks | Experimental | Not described Receives: Dietary Supplement: Collagen Cubilose Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of skin moisture
Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120
Measured: Change from Baseline skin moisture at 4 weeks
The change of skin wrinkles
VISIA Complexion Analysis System was utilized to measure wrinkles. Units: arbitrary units
Measured: Change from Baseline skin wrinkles at 4 weeks
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
Measured: Change from Baseline skin collagen density at 4 weeks
The change of TEWL
Tewameter® TM 300 was utilized to measure TEWL. Units: g/h/m2
Measured: Change from Baseline TEWL at 4 weeks
The change of skin brightness
Glossymeter GL 200 was utilized to measure skin brightness. Units: arbitrary units
Measured: Change from Baseline skin brightness at 4 weeks
The change of interleukin-6
Venous blood was sampled to measure concentrations of interleukin-6.
Measured: Change from Baseline skin brightness at 4 weeks
The change of interleukin-8
Venous blood was sampled to measure concentrations of interleukin-8.
Measured: Change from Baseline skin brightness at 4 weeks
The change of Tumor necrosis factor
Venous blood was sampled to measure concentrations of Tumor necrosis factor.
Measured: Change from Baseline skin brightness at 4 weeks
The change of Matrix metalloproteinase-1
Venous blood was sampled to measure concentrations of Matrix metalloproteinase-1 .
Measured: Change from Baseline skin brightness at 4 weeks
The change of metallopeptidase inhibitor 1
Venous blood was sampled to measure concentrations of metallopeptidase inhibitor 1.
Measured: Change from Baseline skin brightness at 4 weeks
Secondary outcomes (4)
The change of skin texture
VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units
Measured: Change from Baseline skin texture at 4 weeks
The change of skin pores
VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units
Measured: Change from Baseline skin pores at 4 weeks
The change of skin spots
VISIA Complexion Analysis System was utilized to measure skin spots. Units: arbitrary units
Measured: Change from Baseline skin spots at 4 weeks
The change of red areas
VISIA Complexion Analysis System was utilized to measure red areas. Units: arbitrary units
Measured: Change from Baseline red areas at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start9 Mar 2020
- Primary completion31 Jul 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- TCI Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266405
- Sponsor's protocol ID
- 20-003-B
- Status last verified
- Dec 2020
- First submitted
- 10 Feb 2020
- Last updated
- 11 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Testing of Collagen and Zhuyin Drinks
- ClinicalTrials.gov ID
- NCT04266405
- Acronym / sponsor ID
- 20-003-B
- Conditions
- Skin Condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- TCI Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 12 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess collagen and zhuyin drink on skin \& body condition improvement
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo drink | Placebo comparator | Dietary Supplement: Placebo drink |
| Collagen and Zhuyin Drinks | Experimental | Dietary Supplement: Collagen Cubilose Drink |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults aged above 20 years old
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo drinkconsume 1 bottle (50 mL) per day for 28 days | Dietary supplement | Placebo drink |
| Collagen Cubilose Drinkconsume 1 bottle (50 mL) per day for 28 days | Dietary supplement | Collagen and Zhuyin Drinks |
Primary outcome
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
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
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
The change of TEWL
Time frame: Change from Baseline TEWL at 4 weeks
Tewameter® TM 300 was utilized to measure TEWL. Units: g/h/m2
The change of skin brightness
Time frame: Change from Baseline skin brightness at 4 weeks
Glossymeter GL 200 was utilized to measure skin brightness. Units: arbitrary units
The change of interleukin-6
Time frame: Change from Baseline skin brightness at 4 weeks
Venous blood was sampled to measure concentrations of interleukin-6.
The change of interleukin-8
Time frame: Change from Baseline skin brightness at 4 weeks
Venous blood was sampled to measure concentrations of interleukin-8.
The change of Tumor necrosis factor
Time frame: Change from Baseline skin brightness at 4 weeks
Venous blood was sampled to measure concentrations of Tumor necrosis factor.
The change of Matrix metalloproteinase-1
Time frame: Change from Baseline skin brightness at 4 weeks
Venous blood was sampled to measure concentrations of Matrix metalloproteinase-1 .
The change of metallopeptidase inhibitor 1
Time frame: Change from Baseline skin brightness at 4 weeks
Venous blood was sampled to measure concentrations of metallopeptidase inhibitor 1.
4 secondary outcomes
The change of skin texture
Time frame: Change from Baseline skin texture at 4 weeks
The change of skin pores
Time frame: Change from Baseline skin pores at 4 weeks
The change of skin spots
Time frame: Change from Baseline skin spots at 4 weeks
The change of red areas
Time frame: Change from Baseline red areas at 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collagen Cubilose Drink in people with Skin Condition, run by TCI Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of skin moisture (time frame: Change from Baseline skin moisture at 4 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2020.