Skin ConditionNCT06194487
Efficacy Evaluation of Collagen Drink Products
A study testing MAXI Collagen drink and Normal fish collagen drink in people with Skin Condition, run by TCI Co., Ltd. at 1 site in Taiwan.
Trial summary
To assess MAXI Collagen drink on skin condition improvement Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Condition
- What is being tested?
- MAXI Collagen drink and Normal fish collagen drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2023to 26 Jan 2024
- 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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults aged 35-65 years old
Who cannot join
- Subject with skin surface damage larger than $50 coin area.
- Subject who had skin allergies caused by diet or undrwent cosmetic or medical treatment within 6 months.
- Subject who is a vegetarian and allergic to seafood, alcohol or listed ingredients in the product.
- Students who are currently taking courses taught by the principal investigator of this trial.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Applied Cosmetology, Hungkuang University
Taichung, 433304
About this study
To assess MAXI Collagen drink on skin condition improvement
- Conditions
- Skin Condition
- Being tested
- Placebo drink, MAXI Collagen drink, Normal fish collagen 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 (50mL) per day
MAXI Collagen drinkDietary supplement
consume 1 bottle (50mL) per day
Normal fish collagen drinkDietary supplement
consume 1 bottle (50mL) per day
| Study group | Role | What they receive |
|---|---|---|
| Placebo drink | Placebo comparator | consume 1 bottle (50mL) per day Receives: Dietary Supplement: Placebo drink |
| MAXI Collagen drink | Experimental | consume 1 bottle (50mL) per day Receives: Dietary Supplement: MAXI Collagen drink |
| Normal fish collagen drink | Active comparator | consume 1 bottle (50mL) per day Receives: Dietary Supplement: Normal fish collagen drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of skin collagen density
DermaLab® Series SkinLab Combo was utilized to measure skin collagen density. Units: arbitrary units
Measured: Day 0, Day 7, Day 28
The change of skin elasticity
Cutometer® Dual MPA 580 was utilized to measure skin elasticity. Units: arbitrary units
Measured: Day 0, Day 7, Day 28
The change of skin moisture
Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120
Measured: Day 0, Day 7, Day 28
The change of skin texture
VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units
Measured: Day 0, Day 7, Day 28
Secondary outcomes (5)
The change of transepidermal water loss (TEWL)
Tewameter® TM 300 was utilized to measure TEWL. Units: g/hm²
Measured: Day 0, Day 7, Day 28
The change of skin wrinkles
VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units
Measured: Day 0, Day 7, Day 28
The change of skin pores
VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units
Measured: Day 0, Day 7, Day 28
The change of skin colour
PANTONE® CAPSURE™ RM200-PT01 was utilized to measure skin colour. Units: arbitrary units
Measured: Day 0, Day 7, Day 28
The change of self-assessment skin condition
A self-assessment questionnaire was collected to evaluate skin condition
Measured: Day 0, Day 7, Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start1 Oct 2023
- Primary completion29 Dec 2023
- Study completion26 Jan 2024
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- TCI Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tzu Fang Hsu, Principal investigator, Department of Applied Cosmetology, Hungkuang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194487
- Sponsor's protocol ID
- 23-073-A
- Status last verified
- May 2024
- First submitted
- 22 Dec 2023
- Last updated
- 6 May 2024
- 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 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Evaluation of Collagen Drink Products
- ClinicalTrials.gov ID
- NCT06194487
- Acronym / sponsor ID
- 23-073-A
- Conditions
- Skin Condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- TCI Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 26 Jan 2024 (actual)
- First posted
- 8 Jan 2024 (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 MAXI Collagen drink on skin condition improvement
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo drink | Placebo comparator | Dietary Supplement: Placebo drinkconsume 1 bottle (50mL) per day |
| MAXI Collagen drink | Experimental | Dietary Supplement: MAXI Collagen drinkconsume 1 bottle (50mL) per day |
| Normal fish collagen drink | Active comparator | Dietary Supplement: Normal fish collagen drinkconsume 1 bottle (50mL) per day |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults aged 35-65 years old
Key exclusion criteria (4 listed)
- Subject with skin surface damage larger than $50 coin area.
- Subject who had skin allergies caused by diet or undrwent cosmetic or medical treatment within 6 months.
- Subject who is a vegetarian and allergic to seafood, alcohol or listed ingredients in the product.
- Students who are currently taking courses taught by the principal investigator of this trial.
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 (50mL) per day | Dietary supplement | Placebo drink |
| MAXI Collagen drinkconsume 1 bottle (50mL) per day | Dietary supplement | MAXI Collagen drink |
| Normal fish collagen drinkconsume 1 bottle (50mL) per day | Dietary supplement | Normal fish collagen drink |
Primary outcome
The change of skin collagen density
Time frame: Day 0, Day 7, Day 28
DermaLab® Series SkinLab Combo was utilized to measure skin collagen density. Units: arbitrary units
The change of skin elasticity
Time frame: Day 0, Day 7, Day 28
Cutometer® Dual MPA 580 was utilized to measure skin elasticity. Units: arbitrary units
The change of skin moisture
Time frame: Day 0, Day 7, Day 28
Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120
The change of skin texture
Time frame: Day 0, Day 7, Day 28
VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units
5 secondary outcomes
The change of transepidermal water loss (TEWL)
Time frame: Day 0, Day 7, Day 28
The change of skin wrinkles
Time frame: Day 0, Day 7, Day 28
The change of skin pores
Time frame: Day 0, Day 7, Day 28
The change of skin colour
Time frame: Day 0, Day 7, Day 28
The change of self-assessment skin condition
Time frame: Day 0, Day 7, Day 28
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 6 May 2024.
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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.
Tzu Fang Hsu principal investigator
Department of Applied Cosmetology, Hungkuang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAXI Collagen drink and Normal fish collagen 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 4 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 6 May 2024. 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 collagen density (time frame: Day 0, Day 7, Day 28). The study lists 4 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 6 May 2024.