DermatologyNCT06322589
Evaluation of Human Efficacy of SOD Like Super Drink
A study testing SOD like Super Drink in people with Dermatology, run by TCI Co., Ltd. at 1 site in Taiwan.
Trial summary
To assess the efficacy of SOD like Super Drink on anti-oxidant capacity, immuno regulation and skin for human Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatology
- What is being tested?
- SOD like Super Drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2024to 30 Jun 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy adults aged between 30-65 years old
Who cannot join
- Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder
- Patients with diseases of the skin, liver, kidney.
- 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 (> 3 hr/week) in the past 4 weeks.
- 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
China Medical University of department of cosmeceutics
Taichung, 406040
About this study
To assess the efficacy of SOD like Super Drink on anti-oxidant capacity, immuno regulation and skin for human
- Conditions
- Dermatology
- Being tested
- SOD like Super Drink, placebo drink
- Keywords
- Skin analysis, Skin care products
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOD like Super DrinkDietary supplement
Also called AVON SOD like Super Drink
consume 1 bottle per day
placebo drinkDietary supplement
consume 1 bottle per day
| Study group | Role | What they receive |
|---|---|---|
| placebo drink | Placebo comparator | Not described Receives: Dietary Supplement: placebo drink |
| SOD like Super Drink | Experimental | Not described Receives: Dietary Supplement: SOD like Super Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
the volume of skin wrinkles
IRV full-face skin analyzer was utilized to measure skin wrinkles. Units: arbitrary units
Measured: Volume change from Baseline skin wrinkles at 8 weeks
the roughness of skin texture
IRV full-face skin analyzer was utilized to measure skin texture. Units: arbitrary units
Measured: Rating skin roughness from Baseline skin texture at 8 weeks
the change of skin elasticity
Cutometer® was utilized to measure skin elasticity. Units: arbitrary units
Measured: Change from Baseline skin elasticity at 8 weeks
the change of Total Anti-oxidative Capacity (TAC) of blood
venous blood was sampled to measure TAC
Measured: Change from Baseline TAC at 8 weeks
the change of Superoxide Dismutase (SOD) of blood
venous blood was sampled to measure SOD
Measured: Change from Baseline SOD at 8 weeks
the change of Glutathione S-transferase (GST) of blood
venous blood was sampled to measure GST
Measured: Change from Baseline GST at 8 weeks
the change of Glutathione (GSH) of blood
venous blood was sampled to measure GSH
Measured: Change from Baseline GSH at 8 weeks
the change of Malondialdehyde (MDA) of blood
venous blood was sampled to measure MDA
Measured: Change from Baseline MDA at 8 weeks
the change of immune-related cytokines of blood
venous blood was sampled to measure immune-related cytokines
Measured: Change from Baseline immune-related cytokines at 8 weeks
Secondary outcomes (4)
the change of skin surface hydration
Corneometer® CM 825 was utilized to measure skin surface hydration. Units: arbitrary units
Measured: Change from Baseline skin surface hydration at 8 week
the change of skin Transepidermal Water Loss (TEWL)
Tewameter® TM 300 was utilized to measure TEWL. Units: arbitrary units
Measured: Change from Baseline TEWL at 8 week
the change of Skin Melanin Index
Mexameter® MX 18was utilized to measure Melanin Index. Units: arbitrary units
Measured: Change from Baseline skin Melanin Index at 8 week
the change of Skin Erythema Index
Mexameter® MX 18was utilized to measure skin Erythema Index. Units: arbitrary units
Measured: Change from Baseline skin Erythema Index at 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start1 Mar 2024
- Primary completion15 May 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatologyStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- TCI Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hsiu-Mei Chiang, Principal investigator, China Medical University of department of cosmeceutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322589
- Sponsor's protocol ID
- CMUH112-REC3-175
- Status last verified
- Dec 2024
- First submitted
- 29 Feb 2024
- Last updated
- 6 Dec 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 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Human Efficacy of SOD Like Super Drink
- ClinicalTrials.gov ID
- NCT06322589
- Acronym / sponsor ID
- CMUH112-REC3-175
- Conditions
- Dermatology
- Keywords
- Skin analysis, Skin care products
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- TCI Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 21 Mar 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 the efficacy of SOD like Super Drink on anti-oxidant capacity, immuno regulation and skin for human
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: placebo drink |
| SOD like Super Drink | Experimental | Dietary Supplement: SOD like Super Drink |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy adults aged between 30-65 years old
Key exclusion criteria (5 listed)
- Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder
- Patients with diseases of the skin, liver, kidney.
- 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 (> 3 hr/week) in the past 4 weeks.
- 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 |
|---|---|---|
| SOD like Super DrinkAlso: AVON SOD like Super Drinkconsume 1 bottle per day | Dietary supplement | SOD like Super Drink |
| placebo drinkconsume 1 bottle per day | Dietary supplement | placebo drink |
Primary outcome
the volume of skin wrinkles
Time frame: Volume change from Baseline skin wrinkles at 8 weeks
IRV full-face skin analyzer was utilized to measure skin wrinkles. Units: arbitrary units
the roughness of skin texture
Time frame: Rating skin roughness from Baseline skin texture at 8 weeks
IRV full-face skin analyzer was utilized to measure skin texture. Units: arbitrary units
the change of skin elasticity
Time frame: Change from Baseline skin elasticity at 8 weeks
Cutometer® was utilized to measure skin elasticity. Units: arbitrary units
the change of Total Anti-oxidative Capacity (TAC) of blood
Time frame: Change from Baseline TAC at 8 weeks
venous blood was sampled to measure TAC
the change of Superoxide Dismutase (SOD) of blood
Time frame: Change from Baseline SOD at 8 weeks
venous blood was sampled to measure SOD
the change of Glutathione S-transferase (GST) of blood
Time frame: Change from Baseline GST at 8 weeks
venous blood was sampled to measure GST
the change of Glutathione (GSH) of blood
Time frame: Change from Baseline GSH at 8 weeks
venous blood was sampled to measure GSH
the change of Malondialdehyde (MDA) of blood
Time frame: Change from Baseline MDA at 8 weeks
venous blood was sampled to measure MDA
the change of immune-related cytokines of blood
Time frame: Change from Baseline immune-related cytokines at 8 weeks
venous blood was sampled to measure immune-related cytokines
4 secondary outcomes
the change of skin surface hydration
Time frame: Change from Baseline skin surface hydration at 8 week
the change of skin Transepidermal Water Loss (TEWL)
Time frame: Change from Baseline TEWL at 8 week
the change of Skin Melanin Index
Time frame: Change from Baseline skin Melanin Index at 8 week
the change of Skin Erythema Index
Time frame: Change from Baseline skin Erythema Index at 8 week
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 Dec 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.
Hsiu-Mei Chiang principal investigator
China Medical University of department of cosmeceutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOD like Super Drink in people with Dermatology, 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 5 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 Dec 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 volume of skin wrinkles (time frame: Volume change from Baseline skin wrinkles at 8 weeks). The study lists 9 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 Dec 2024.