Skin ConditionNCT06306105
Assessment of Anti-aging Efficacy of Marine Collagen Peptides
A study testing Marine Collagen Peptides in people with Skin Condition and Hair Fragility, run by TCI Co., Ltd. at 1 site in Taiwan.
Trial summary
To assess the anti-aging efficacy of Marine Collagen Peptides on skin, hair and finger nails for human Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Condition, Hair Fragility, Nails, Ingrown
- What is being tested?
- Marine Collagen Peptides
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Mar 2024to 31 Aug 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults aged above 18 years old
Who cannot join
- Subjects who are not volunteers
- Subjects who have been diagnosed with dermatitis, cirrhosis, and chronic kidney failure
- Subjects who have known cosmetic, drug or food allergies.
- Patients are taking medicine for chronic diseases
- Subjects receiving treatments for scalp, hair transplant, and other scalp medical care in past 12 weeks.
- Subjects getting a manicure and perm in past 12 weeks.
Show all 11Show fewer
- Female who is pregnant or nursing or planning to become pregnant during the course of the study.
- Subjects receiving facial laser therapy, chemical peeling or UV overexposure (\> 3 hr/week) in the past 12 weeks.
- Students who are currently taking courses taught by the principal investigator of this trial.
- Subjects are not willing to reveal the results of pictures after taking the product
- Vegetarian.
Trial locations and contacts
1 site in 1 country.
About this study
To assess the anti-aging efficacy of Marine Collagen Peptides on skin, hair and finger nails for human
- Conditions
- Skin Condition, Hair Fragility, Nails, Ingrown
- Being tested
- Marine Collagen Peptides, placebo drink
- Keywords
- fish collagen
- Medical subject headings
- Skin Diseases, Nails, Ingrown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marine Collagen PeptidesDietary supplement
Also called Coral club Promarine Collagen Tripeptides
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 |
| Marine Collagen Peptides drinks | Experimental | Not described Receives: Dietary Supplement: Marine Collagen Peptides |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of skin hydation
Corneometer® CM825 (CK, Germany) was utilized to measure skin surface hydation. Units: arbitrary Corneometer® units 0-120.
Measured: Change from Baseline skin skin hydation at 12 weeks
The change of skin wrinkles
VISIA Complexion Analysis was utilized to measure skin wrinkles. Units: the amount of detectable wrinkles
Measured: Change from Baseline skin wrinkles at 12 weeks
The change of skin elasticity
Cutometer® MPA580 was utilized to measure skin elasticity. Units: visco-elasticity in %.
Measured: Change from Baseline skin elasticity at 12 weeks
The change of skin collagen density
DermaLab® Series SkinLab Combo was utilized to measure skin collagen density. Units: arbitrary units
Measured: Change from Baseline skin collagen density at 12 weeks
The change of hair diameters
Mitutoyo C/N293-100 was utilized to measure hair diameters. Units: millimeter
Measured: Change from Baseline hair diameters at 12 weeks
The change of hair loss amount
Collect and measure the weight of loss hair. Units: gram
Measured: Change from Baseline hair loss amount at 12 weeks
The change of hair roots diameters
Mitutoyo C/N293-100 was utilized to measure hair roots diameters. Units: millimeter
Measured: Change from Baseline hair roots diameters at 12 weeks
The change of hair density
Soft Plus was utilized to picture and observe hair density.
Measured: Change from Baseline hair density at 12 weeks
The change of hair follicle strength
Pull up the hair of the frontal bone, temporal bone and occipital bone (approximately 60 hairs/area) to assess the number of hair loss in each area. Units: the number of loss hair
Measured: Change from Baseline hair follicle strength at 12 weeks
The change of thumbs nail color
Chroma Meter MM500 was utilized to measure thumbs nail color. Units: L* index
Measured: Change from Baseline thumbs nail color at 12 weeks
The change of nails appearence
Picture taken was utilized to record and observe nails appearence.
Measured: Change from Baseline nails appearence at 12 weeks
The change of nails growth
Marking the position of middle fingers lunula was utilized to record and observe nails growth. Units: milimeter
Measured: Change from Baseline marking position at 12 weeks
The degree of nails fragility
Iron ruler was utilized to evaluate nails fragility. Picture taken was utilized to record and observe the change of nails fragility.
Measured: Change from Baseline nails fragility at 12 weeks
Secondary outcomes (1)
The change of self-assessment skin, hair, and nails condition
A self-assessment questionnaire was collected and evaluate skin, hair, and nails condition
Measured: Change from Baseline skin, hair, and nails condition at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start4 Mar 2024
- Primary completion30 Jun 2024
- Study completion31 Aug 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
- Prevention
- 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, Ph.D., Principal investigator, Chia Nan University of Pharmacy ＆ Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306105
- Sponsor's protocol ID
- 23-118-B
- Status last verified
- Sep 2024
- First submitted
- 5 Mar 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Anti-aging Efficacy of Marine Collagen Peptides
- ClinicalTrials.gov ID
- NCT06306105
- Acronym / sponsor ID
- 23-118-B
- Conditions
- Skin Condition, Hair Fragility, Nails, Ingrown
- Keywords
- fish collagen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- TCI Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 12 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 anti-aging efficacy of Marine Collagen Peptides on skin, hair and finger nails for human
Study design
- Primary purpose
- Prevention
- 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 |
| Marine Collagen Peptides drinks | Experimental | Dietary Supplement: Marine Collagen Peptides |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults aged above 18 years old
Key exclusion criteria (11 listed)
- Subjects who are not volunteers
- Subjects who have been diagnosed with dermatitis, cirrhosis, and chronic kidney failure
- Subjects who have known cosmetic, drug or food allergies.
- Patients are taking medicine for chronic diseases
- Subjects receiving treatments for scalp, hair transplant, and other scalp medical care in past 12 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 |
|---|---|---|
| Marine Collagen PeptidesAlso: Coral club Promarine Collagen Tripeptidesconsume 1 bottle per day | Dietary supplement | Marine Collagen Peptides drinks |
| placebo drinkconsume 1 bottle per day | Dietary supplement | placebo drink |
Primary outcome
The change of skin hydation
Time frame: Change from Baseline skin skin hydation at 12 weeks
Corneometer® CM825 (CK, Germany) was utilized to measure skin surface hydation. Units: arbitrary Corneometer® units 0-120.
The change of skin wrinkles
Time frame: Change from Baseline skin wrinkles at 12 weeks
VISIA Complexion Analysis was utilized to measure skin wrinkles. Units: the amount of detectable wrinkles
The change of skin elasticity
Time frame: Change from Baseline skin elasticity at 12 weeks
Cutometer® MPA580 was utilized to measure skin elasticity. Units: visco-elasticity in %.
The change of skin collagen density
Time frame: Change from Baseline skin collagen density at 12 weeks
DermaLab® Series SkinLab Combo was utilized to measure skin collagen density. Units: arbitrary units
The change of hair diameters
Time frame: Change from Baseline hair diameters at 12 weeks
Mitutoyo C/N293-100 was utilized to measure hair diameters. Units: millimeter
The change of hair loss amount
Time frame: Change from Baseline hair loss amount at 12 weeks
Collect and measure the weight of loss hair. Units: gram
The change of hair roots diameters
Time frame: Change from Baseline hair roots diameters at 12 weeks
Mitutoyo C/N293-100 was utilized to measure hair roots diameters. Units: millimeter
The change of hair density
Time frame: Change from Baseline hair density at 12 weeks
Soft Plus was utilized to picture and observe hair density.
The change of hair follicle strength
Time frame: Change from Baseline hair follicle strength at 12 weeks
Pull up the hair of the frontal bone, temporal bone and occipital bone (approximately 60 hairs/area) to assess the number of hair loss in each area. Units: the number of loss hair
The change of thumbs nail color
Time frame: Change from Baseline thumbs nail color at 12 weeks
Chroma Meter MM500 was utilized to measure thumbs nail color. Units: L* index
The change of nails appearence
Time frame: Change from Baseline nails appearence at 12 weeks
Picture taken was utilized to record and observe nails appearence.
The change of nails growth
Time frame: Change from Baseline marking position at 12 weeks
Marking the position of middle fingers lunula was utilized to record and observe nails growth. Units: milimeter
The degree of nails fragility
Time frame: Change from Baseline nails fragility at 12 weeks
Iron ruler was utilized to evaluate nails fragility. Picture taken was utilized to record and observe the change of nails fragility.
1 secondary outcome
The change of self-assessment skin, hair, and nails condition
Time frame: Change from Baseline skin, hair, and nails condition at 12 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 19 Sep 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.
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 Marine Collagen Peptides in people with Skin Condition and Hair Fragility, 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 11 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 19 Sep 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 hydation (time frame: Change from Baseline skin skin hydation at 12 weeks). The study lists 13 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 19 Sep 2024.