Skin ConditionNCT04878536
Efficacy Testing of Collagen Elixir
A study testing Collagen drink and Blank in people with Skin Condition, run by TCI Co., Ltd. at 1 site in Taiwan.
Trial summary
To assess Isagenix-Collagen Elixir on skin condition improvement Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Condition
- What is being tested?
- Collagen drink and Blank
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 May 2021to 25 Oct 2021
- 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 years and older
- 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, liver, kidney.
- 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.
- Constant drug use
- Participated cosmetic product human study in the past 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy Testing of Collagen Drink
To assess Isagenix-Collagen Elixir on skin condition improvement
- Conditions
- Skin Condition
- Being tested
- Collagen drink, Blank
- Medical subject headings
- Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen drinkDietary supplement
Also called Isagenix-Collagen Elixir
Testing product
BlankDietary supplement
Placebo drink
| Study group | Role | What they receive |
|---|---|---|
| Placebo drink | Placebo comparator | Not described Receives: Dietary Supplement: Blank |
| Collagen drink | Experimental | Not described Receives: Dietary Supplement: Collagen drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of skin wrinkles
VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units
Measured: Change from Baseline skin wrinkles at 4 weeks
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 collagen density
DermaLab® Series SkinLab Combo was utilized to measure skin pores. Units: arbitrary units
Measured: Change from Baseline skin collagen density at 4 weeks
The change of skin elasticity
Soft Plus was utilized to measure skin elasticity. Units: arbitrary units
Measured: Change from Baseline skin elasticity at 4 weeks
The change of MMP-1 of blood
Venous blood was sampled to measure MMP-1
Measured: Change from Baseline MMP-1 at 4 weeks
The change of TIMP-1 of blood
Venous blood was sampled to measure TIMP-1
Measured: Change from Baseline TIMP-1 at 4 weeks
Secondary outcomes (14)
The change of skin melanin index
Soft Plus was utilized to measure skin melanin index. Units: arbitrary units
Measured: Change from Baseline skin melanin index at 4 weeks
The change of skin L* value
Chroma Meter MM500 was utilized to measure skin L* value. Units: arbitrary units, 0-100
Measured: Change from Baseline L* value at 4 weeks
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 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 skin UV spots
VISIA Complexion Analysis System was utilized to measure skin UV spots. Units: arbitrary units
Measured: Change from Baseline skin UV spots at 4 weeks
The change of skin brown spots
VISIA Complexion Analysis System was utilized to measure skin brown spots. Units: arbitrary units
Measured: Change from Baseline skin brown spots at 4 weeks
The change of TNF-α of blood
Venous blood was sampled to measure TNF-α
Measured: Change from Baseline TNF-α at 4 weeks
The change of IL-10 of blood
Venous blood was sampled to measure IL-10
Measured: Change from Baseline IL-10 at 4 weeks
The change of SOD-RBC of blood
Venous blood was sampled to measure SOD-RBC
Measured: Change from Baseline SOD-RBC at 4 weeks
The change of f-thiols of blood
Venous blood was sampled to measure f-thiols
Measured: Change from Baseline f-thiols at 4 weeks
The change of t-GSH of blood
Venous blood was sampled to measure t-GSH
Measured: Change from Baseline t-GSH at 4 weeks
The change of GST-RBC of blood
Venous blood was sampled to measure GST-RBC
Measured: Change from Baseline GST-RBC at 4 weeks
The change of MDA of blood
Venous blood was sampled to measure MDA
Measured: Change from Baseline MDA at 4 weeks
The change of blood total antioxidant capacity (TAC)
Venous blood was sampled to measure concentrations of TAC
Measured: Change from Baseline TAC 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 posted7 May 2021
- Study start18 May 2021
- Primary completion30 Jul 2021
- Study completion25 Oct 2021
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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- TCI Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chia-Hua Liang, Principal investigator, Chia Nan University of Pharmacy ＆ Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04878536
- Sponsor's protocol ID
- 21-042-B
- Status last verified
- Mar 2022
- First submitted
- 6 May 2021
- Last updated
- 31 Mar 2022
- 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 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Testing of Collagen Drink
- ClinicalTrials.gov ID
- NCT04878536
- Acronym / sponsor ID
- 21-042-B
- Conditions
- Skin Condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- TCI Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 May 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 25 Oct 2021 (actual)
- First posted
- 7 May 2021 (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 Isagenix-Collagen Elixir on skin condition improvement
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo drink | Placebo comparator | Dietary Supplement: Blank |
| Collagen drink | Experimental | Dietary Supplement: Collagen drink |
Who may qualify
- Ages
- 20 years and older
- 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, liver, kidney.
- 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 |
|---|---|---|
| Collagen drinkAlso: Isagenix-Collagen ElixirTesting product | Dietary supplement | Collagen drink |
| BlankPlacebo drink | Dietary supplement | Placebo drink |
Primary outcome
The change of skin wrinkles
Time frame: Change from Baseline skin wrinkles at 4 weeks
VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units
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
The change of skin collagen density
Time frame: Change from Baseline skin collagen density at 4 weeks
DermaLab® Series SkinLab Combo was utilized to measure skin pores. Units: arbitrary units
The change of skin elasticity
Time frame: Change from Baseline skin elasticity at 4 weeks
Soft Plus was utilized to measure skin elasticity. Units: arbitrary units
The change of MMP-1 of blood
Time frame: Change from Baseline MMP-1 at 4 weeks
Venous blood was sampled to measure MMP-1
The change of TIMP-1 of blood
Time frame: Change from Baseline TIMP-1 at 4 weeks
Venous blood was sampled to measure TIMP-1
14 secondary outcomes
The change of skin melanin index
Time frame: Change from Baseline skin melanin index at 4 weeks
The change of skin L* value
Time frame: Change from Baseline L* value at 4 weeks
The change of skin moisture
Time frame: Change from Baseline skin moisture at 4 weeks
The change of skin spots
Time frame: Change from Baseline skin spots at 4 weeks
The change of skin UV spots
Time frame: Change from Baseline skin UV spots at 4 weeks
The change of skin brown spots
Time frame: Change from Baseline skin brown spots at 4 weeks
The change of TNF-α of blood
Time frame: Change from Baseline TNF-α at 4 weeks
The change of IL-10 of blood
Time frame: Change from Baseline IL-10 at 4 weeks
The change of SOD-RBC of blood
Time frame: Change from Baseline SOD-RBC at 4 weeks
The change of f-thiols of blood
Time frame: Change from Baseline f-thiols at 4 weeks
The change of t-GSH of blood
Time frame: Change from Baseline t-GSH at 4 weeks
The change of GST-RBC of blood
Time frame: Change from Baseline GST-RBC at 4 weeks
The change of MDA of blood
Time frame: Change from Baseline MDA at 4 weeks
The change of blood total antioxidant capacity (TAC)
Time frame: Change from Baseline TAC 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 31 Mar 2022.
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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.
Chia-Hua Liang principal investigator
Chia Nan University of Pharmacy ＆ Science
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 drink and Blank 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 31 Mar 2022. 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 wrinkles (time frame: Change from Baseline skin wrinkles at 4 weeks). The study lists 6 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 31 Mar 2022.