Skin AgingNCT06847035
Efficacy Study of Oral Collagen Peptide on Skin Condition Improvement
A study testing Active Comparator in people with Skin Aging, run by Shanghai Meifute Biotechnology Co., Ltd at 1 site in China.
Trial summary
To assess if oral intake of collagen peptide can improve skin conditions such as skin thickness, density and firmness. Read more about this study
- Who is it for?
- Ages 35 to 55 years, women only
- Conditions the study is for
- Skin Aging
- What is being tested?
- Active Comparator
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 25 Jul 2024to 19 Nov 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy female adults aged between 35-55 years old
- With fine wrinkles and skin laxity
- Personal informed consents to participate in the study
- Agree to keep their daily skincare routine unchanged for the duration of the study
- Maintain good sun protection habits
- 5. Agree to refrain from wearing make-up on the face on the each study visit
Who cannot join
- Female who is pregnant or nursing or planning to become pregnant during the course of the study
- Individuals who are in the perimenopausal stage.
- BMI<18.5 or BMI >27.9
- Individuals suffering from chronic systemic diseases such as cardiovascular, cerebrovascular, liver, and kidney diseases.
- Individuals who have diabetes.
- Individuals suffering from skin conditions such as psoriasis, eczema, atopic dermatitis, and severe acne.
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- Individuals with depression or sleep disorders, those who smoke, and those who abuse alcohol.
- Individuals who are using hormonal drugs, medications for obesity, absorption inhibitors, antidepressants, or appetite suppressants.
- Individuals who have used hormones or anti-inflammatory drugs on their face and upper arms within the past two months.
- Individuals who received facial laser therapy, chemical peeling or UV overexposure in the past 3 months
- Individuals who can not avoid prolonged exposure to sunlight.
- Individuals who are currently participating in other clinical studies or trials.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Fumei Dermatology Clinic
Shanghai, Shanghai Municipality, 021
About this study
Official title: Efficacy Study of Oral Collagen Peptide on Skin Conditions
To assess if oral intake of collagen peptide can improve skin conditions such as skin thickness, density and firmness.
Read the detailed description
This is an one site, randomized, double-blind controlled clinical trial to assess the oral supplement of LISAVEI collagen peptide solid beverage on skin ageing improvement. Study product with collagen peptide and placebo product without collagen were randomly assigned to 90 eligible participants enrolled according to the inclusion and exclusion criteria. They took the assigned product once daily dissolved in 100 ml warm water for 12 weeks with 4-week regression phase(without intake of the test products), and visit the study site in Shanghai for four times(before starting the treatment, after 8 and 12 weeks, and 4 weeks after the last intake). Skin measurements including skin firmness, skin density, skin hydration and skin barrier were carried out at each visit with professional equipment and imaging system. Data were analyzed to validate if the administration of the test collagen peptide solid beverage will improve skin aging parameters such as firmness, thickness, density, hydration and skin barrier compared to placebo. The lasting effect was also observed by comparing between the two groups after 4-week regression time.
- Conditions
- Skin Aging
- Being tested
- Active Comparator, Placebo Comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active ComparatorDietary supplement
LISAVEI collagen peptide solid beverage ( contain 5 g collagen peptide)，once daily for 12 weeks
Placebo ComparatorDietary supplement
Also called placebo solid beverage
placebo solid beverage (Maltodextrin with edible flavor)，once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator | Active comparator | collagen peptide solid beverage Receives: Dietary Supplement: Active Comparator |
| Placebo Comaprator | Placebo comparator | placebo solid beverage Receives: Dietary Supplement: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin firmness
The changes of skin firmness parameter tested by Cutometer MPA580
Measured: before product treatment (T 0), after 8 weeks(T 1)and 12 weeks(T 2) of daily product intake, 4 weeks after the last intake(T 3, 4-week regression phase)
Skin thickness
The changes of skin thickness （μm） tested by Ultrascan UC 22
Measured: before product treatment (T 0), after 8 weeks(T 1)and 12 weeks(T 2) of daily product intake, 4 weeks after the last intake(T 3, 4-week regression phase)
Skin density
The changes of skin density tested by Ultrascan UC 22
Measured: before product treatment (T 0), after 8 weeks(T 1)and 12 weeks(T 2) of daily product intake, 4 weeks after the last intake(T 3, 4-week regression phase)
Secondary outcomes (3)
Skin hydration
The changes of skin hydration tested by Corneometer CM825
Measured: before product treatment (T 0), after 8 weeks(T 1)and 12 weeks(T 2) of daily product intake, 4 weeks after the last intake(T 3, 4-week regression phase)
Skin barrier
The changes of Trans Epidermal Water Loss (skin barrier parameter) tested by Tewameter TM300
Measured: before product treatment (T 0), after 8 weeks(T 1)and 12 weeks(T 2) of daily product intake, 4 weeks after the last intake(T 3, 4-week regression phase)
Facial image
Photo documents of left, right and frontal facial views
Measured: before product treatment (T 0), after 8 weeks(T 1)and 12 weeks(T 2) of daily product intake, 4 weeks after the last intake(T 3, 4-week regression phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start25 Jul 2024
- Primary completion19 Nov 2024
- Study completion19 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin AgingStudies 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Meifute Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847035
- Sponsor's protocol ID
- YKEC-2024-001
- Status last verified
- Jan 2025
- First submitted
- 21 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang Y, Zhu W, Luo W, Ma Y, Zhou Y. The Sustained Effects of Bioactive Collagen Peptides on Skin Health: A Randomized, Double-Blind, Placebo-Controlled Clinical Study. J Cosmet Dermatol. 2025 Dec;24(12):e70565. doi: 10.1111/jocd.70565.
PubMed 41311286
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study of Oral Collagen Peptide on Skin Conditions
- ClinicalTrials.gov ID
- NCT06847035
- Acronym / sponsor ID
- YKEC-2024-001
- Conditions
- Skin Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Shanghai Meifute Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 19 Nov 2024 (actual)
- Study completion
- 19 Nov 2024 (actual)
- First posted
- 26 Feb 2025 (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 if oral intake of collagen peptide can improve skin conditions such as skin thickness, density and firmness.
Detailed description
This is an one site, randomized, double-blind controlled clinical trial to assess the oral supplement of LISAVEI collagen peptide solid beverage on skin ageing improvement. Study product with collagen peptide and placebo product without collagen were randomly assigned to 90 eligible participants enrolled according to the inclusion and exclusion criteria. They took the assigned product once daily dissolved in 100 ml warm water for 12 weeks with 4-week regression phase(without intake of the test products), and visit the study site in Shanghai for four times(before starting the treatment, after 8 and 12 weeks, and 4 weeks after the last intake). Skin measurements including skin firmness, skin density, skin hydration and skin barrier were carried out at each visit with professional equipment and imaging system. Data were analyzed to validate if the administration of the test collagen peptide solid beverage will improve skin aging parameters such as firmness, thickness, density, hydration and skin barrier compared to placebo. The lasting effect was also observed by comparing between the two groups after 4-week regression time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator | Active comparator | Dietary Supplement: Active Comparatorcollagen peptide solid beverage |
| Placebo Comaprator | Placebo comparator | Dietary Supplement: Placebo Comparatorplacebo solid beverage |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy female adults aged between 35-55 years old
- With fine wrinkles and skin laxity
- Personal informed consents to participate in the study
- Agree to keep their daily skincare routine unchanged for the duration of the study
- Maintain good sun protection habits
Key exclusion criteria (12 listed)
- Female who is pregnant or nursing or planning to become pregnant during the course of the study
- Individuals who are in the perimenopausal stage.
- BMI<18.5 or BMI >27.9
- Individuals suffering from chronic systemic diseases such as cardiovascular, cerebrovascular, liver, and kidney diseases.
- Individuals who have diabetes.
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 |
|---|---|---|
| Active ComparatorLISAVEI collagen peptide solid beverage ( contain 5 g collagen peptide)，once daily for 12 weeks | Dietary supplement | Active Comparator |
| Placebo ComparatorAlso: placebo solid beverageplacebo solid beverage (Maltodextrin with edible flavor)，once daily for 12 weeks | Dietary supplement | Placebo Comaprator |
Primary outcome
Skin firmness
Time frame: before product treatment (T 0), after 8 weeks(T 1)and 12 weeks(T 2) of daily product intake, 4 weeks after the last intake(T 3, 4-week regression phase)
The changes of skin firmness parameter tested by Cutometer MPA580
Skin thickness
Time frame: before product treatment (T 0), after 8 weeks(T 1)and 12 weeks(T 2) of daily product intake, 4 weeks after the last intake(T 3, 4-week regression phase)
The changes of skin thickness （μm） tested by Ultrascan UC 22
Skin density
Time frame: before product treatment (T 0), after 8 weeks(T 1)and 12 weeks(T 2) of daily product intake, 4 weeks after the last intake(T 3, 4-week regression phase)
The changes of skin density tested by Ultrascan UC 22
3 secondary outcomes
Skin hydration
Time frame: before product treatment (T 0), after 8 weeks(T 1)and 12 weeks(T 2) of daily product intake, 4 weeks after the last intake(T 3, 4-week regression phase)
Skin barrier
Time frame: before product treatment (T 0), after 8 weeks(T 1)and 12 weeks(T 2) of daily product intake, 4 weeks after the last intake(T 3, 4-week regression phase)
Facial image
Time frame: before product treatment (T 0), after 8 weeks(T 1)and 12 weeks(T 2) of daily product intake, 4 weeks after the last intake(T 3, 4-week regression phase)
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 28 Feb 2025.
- Derived from this study: PubMed 41311286Wang Y, Zhu W, Luo W, Ma Y, Zhou Y. The Sustained Effects of Bioactive Collagen Peptides on Skin Health: A Randomized, Double-Blind, Placebo-Controlled Clinical Study. J Cosmet Dermatol. 2025 Dec;24(12):e70565. doi: 10.1111/jocd.70565.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Comparator in people with Skin Aging, run by Shanghai Meifute Biotechnology Co., Ltd at 1 site in China.
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 6 inclusion and 12 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 28 Feb 2025. 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 China. 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?
Skin firmness (time frame: before product treatment (T 0), after 8 weeks(T 1)and 12 weeks(T 2) of daily product intake, 4 weeks after the last intake(T 3, 4-week regression phase)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06847035, which also lists 1 linked publication.
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 28 Feb 2025.