Skin DiseasesNCT05143034
the Evaluation of the Efficacy of TCI66207 on the Skin.
A study testing TCI66207 Essence in people with Skin Diseases, run by TCI Co., Ltd. at 1 site in Taiwan.
Trial summary
The purpose of this study is to explore the evaluation of the efficacy of TCI66207 deep-sea live-face bacteria on the skin. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Diseases
- What is being tested?
- TCI66207 Essence
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2018to 31 Dec 2019
- 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 volunteers aged above 20 years old
- Subject has dull skin.
Who cannot join
- .Subject 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.
- Subjects who have large spots (area >3 square centimeter) or abnormal acne.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Research & Design Center, TCI CO., Ltd
Taipei, Neipu Township, 114
About this study
Official title: Evaluation of Skin Efficacy of TCI66207
The purpose of this study is to explore the evaluation of the efficacy of TCI66207 deep-sea live-face bacteria on the skin.
- Conditions
- Skin Diseases
- Being tested
- TCI66207 Essence, Placebo Essence
- Medical subject headings
- Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCI66207 EssenceDietary supplement
Use it twice a day after washing your face in the morning and evening for a total of 4 weeks.
Placebo EssenceDietary supplement
Use it twice a day after washing your face in the morning and evening for a total of 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| TCI66207 Essence | Experimental | Essence Receives: Dietary Supplement: TCI66207 Essence |
| Placebo Essence | Placebo comparator | Not described Receives: Dietary Supplement: Placebo Essence |
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: Subjects will be tested in the 4th week.
The change of skin elasticity
Cutometer® dual MPA 580 was utilized to measure skin elasticity (parameter R2). Units: μm penetration depth into the probe opening, expressed as curvesCorneometer® units 0-120
Measured: Subjects will be tested in the 4th week.
The change of skin wrinkles
VISIA Complexion Analysis System was utilized to measure wrinkles. Units: arbitrary units
Measured: Subjects will be tested in the 4th week.
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: Subjects will be tested in the 4th week.
The change of skin texture
VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units
Measured: Subjects will be tested in the 4th week.
The change of skin pores
VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units
Measured: Subjects will be tested in the 4th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start1 Nov 2018
- Primary completion30 Nov 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin DiseasesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- TCI Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chia-Hua Liang, Ph.D, Principal investigator, Chia Nan University of Pharmacy ＆ Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143034
- Sponsor's protocol ID
- TSMH No.18-148-A
- Status last verified
- Nov 2021
- First submitted
- 22 Nov 2021
- Last updated
- 7 Dec 2021
- 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 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Skin Efficacy of TCI66207
- ClinicalTrials.gov ID
- NCT05143034
- Acronym / sponsor ID
- TSMH No.18-148-A
- Conditions
- Skin Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- TCI Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 3 Dec 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.
The purpose of this study is to explore the evaluation of the efficacy of TCI66207 deep-sea live-face bacteria on the skin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCI66207 Essence | Experimental | Dietary Supplement: TCI66207 EssenceEssence |
| Placebo Essence | Placebo comparator | Dietary Supplement: Placebo Essence |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy volunteers aged above 20 years old
- Subject has dull skin.
Key exclusion criteria (5 listed)
- .Subject 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.
- Subjects who have large spots (area >3 square centimeter) or abnormal acne.
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 |
|---|---|---|
| TCI66207 EssenceUse it twice a day after washing your face in the morning and evening for a total of 4 weeks. | Dietary supplement | TCI66207 Essence |
| Placebo EssenceUse it twice a day after washing your face in the morning and evening for a total of 4 weeks. | Dietary supplement | Placebo Essence |
Primary outcome
The change of skin moisture
Time frame: Subjects will be tested in the 4th week.
Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120
The change of skin elasticity
Time frame: Subjects will be tested in the 4th week.
Cutometer® dual MPA 580 was utilized to measure skin elasticity (parameter R2). Units: μm penetration depth into the probe opening, expressed as curvesCorneometer® units 0-120
The change of skin wrinkles
Time frame: Subjects will be tested in the 4th week.
VISIA Complexion Analysis System was utilized to measure wrinkles. Units: arbitrary units
The change of skin collagen density
Time frame: Subjects will be tested in the 4th week.
DermaLab® USB - 20 MHz High Freq. Ultrasound probe was utilized to scan and analyze skin collagen density. Units: Intensity score
The change of skin texture
Time frame: Subjects will be tested in the 4th week.
VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units
The change of skin pores
Time frame: Subjects will be tested in the 4th week.
VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units
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 7 Dec 2021.
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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, Ph.D 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 TCI66207 Essence in people with Skin Diseases, 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 2 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 7 Dec 2021. 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: Subjects will be tested in the 4th week.). 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 7 Dec 2021.