HealthyNCT05680857
Efficacy and Safety of Products Containing Marine Collagen Peptide and Coenzyme Q10 for Skin Rejuvenation
A study testing Product containing marine collagen peptide and Coenzyme Q10. in people with Healthy, run by USMARI Research & Innovation Centre at 1 site in Malaysia.
Trial summary
This is a placebo-controlled study conducted to investigates the safety and efficacy of products containing marine collagen peptide and CoQ10 in enhancing skin rejuvenation of Malaysian women. Read more about this study
- Who is it for?
- Ages 35 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Product containing marine collagen peptide and Coenzyme Q10.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Dec 2022to 30 Oct 2023
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Malaysian citizen
- Women aged 35 - 45 years old
- Willing to participate
Who cannot join
- Women with skin diseases or any underlying diseases.
- Pregnant, breastfeeding women or planned pregnancy during the study period
- Allergy to collagen or other ingredients that may be found in the product.
- Women who had any cosmetic procedures such as botox, laser and light treatment, facial surgery, and any procedures that may improve skin hydration, elasticity, wrinkles, and brightening of skin four weeks before the study.
- Women who took any dietary supplements, functional foods, or medicines that could have the same or similar effects as the product evaluated in this study in the past three months.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
Petaling Jaya, Selangor, 47810
About this study
Official title: The Efficacy and Safety of Products Containing Marine Collagen Peptide and Coenzyme Q10 for Skin Rejuvenation in Malaysian Women
This is a placebo-controlled study conducted to investigates the safety and efficacy of products containing marine collagen peptide and CoQ10 in enhancing skin rejuvenation of Malaysian women. The study duration is 28 days and the skin assessment will be carried out at baseline, Day 14 and Day 28.The main questions it aims to answer are:
- The effect of product on skin hydration of women in Malaysia.
- The effect of product on skin elasticity of women in Malaysia.
- The effect of product on skin wrinkle of women in Malaysia.
- The skin brightening effect of product on Malaysian women.
- To observe any adverse effect occurrence with the consumption of the product.
- Conditions
- Healthy
- Being tested
- Placebo, Product containing marine collagen peptide and Coenzyme Q10.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Product doesn't have active ingredients i.e. marine collagen peptide and Coenzyme Q10.
Product containing marine collagen peptide and Coenzyme Q10.Other
Product containing marine collagen peptide and Coenzyme Q10.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The placebo group will receive a product in sachet form that doesn't have marine collagen peptide and Coenzyme Q10. Receives: Other: Placebo |
| Product containing marine collagen peptide and Coenzyme Q10. | Experimental | This group will receive the product containing marine collagen peptide from the fish origin and Coenzyme Q10 in sachet form. Receives: Other: Product containing marine collagen peptide and Coenzyme Q10. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in skin hydration from baseline and at Day 14 and Day 28 after consumption of a product.
Skin hydration will be assessed using JANUS III skin analyzer and comparison will be made with placebo group.
Measured: Baseline, Day 14 and Day 28
Changes in skin elasticity from baseline and at Day 14 and Day 28 after consumption of a product.
Skin elasticity will be assessed using JANUS III skin analyzer comparison will be made with placebo group.
Measured: Baseline, Day 14 and Day 28
Changes in skin wrinkles from baseline and at Day 14 and Day 28 after consumption of a product.
Skin wrinkles will be assessed using JANUS III skin analyzer comparison will be made with placebo group.
Measured: Baseline, Day 14 and Day 28
Changes in skin tone from baseline and at Day 14 and Day 28 after consumption of a product.
Skin hydration will be assessed using JANUS III skin analyzer comparison will be made with placebo group.
Measured: Baseline, Day 14 and Day 28
Adverse effect after consumption of product containing marine collagen peptide and coenzyme Q10.
Based on adverse effect occurrence on participants that occur during study period (28 days)
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start1 Dec 2022
- Primary completion11 Jul 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- USMARI Research & Innovation Centre
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680857
- Sponsor's protocol ID
- UMRAMREC005-22
- Status last verified
- Nov 2023
- First submitted
- 27 Dec 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Products Containing Marine Collagen Peptide and Coenzyme Q10 for Skin Rejuvenation in Malaysian Women
- ClinicalTrials.gov ID
- NCT05680857
- Acronym / sponsor ID
- UMRAMREC005-22
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- USMARI Research & Innovation CentreIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 11 Jul 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 11 Jan 2023 (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.
This is a placebo-controlled study conducted to investigates the safety and efficacy of products containing marine collagen peptide and CoQ10 in enhancing skin rejuvenation of Malaysian women. The study duration is 28 days and the skin assessment will be carried out at baseline, Day 14 and Day 28.The main questions it aims to answer are:
- The effect of product on skin hydration of women in Malaysia.
- The effect of product on skin elasticity of women in Malaysia.
- The effect of product on skin wrinkle of women in Malaysia.
- The skin brightening effect of product on Malaysian women.
- To observe any adverse effect occurrence with the consumption of the product.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboThe placebo group will receive a product in sachet form that doesn't have marine collagen peptide and Coenzyme Q10. |
| Product containing marine collagen peptide and Coenzyme Q10. | Experimental | Other: Product containing marine collagen peptide and Coenzyme Q10.This group will receive the product containing marine collagen peptide from the fish origin and Coenzyme Q10 in sachet form. |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Malaysian citizen
- Women aged 35 - 45 years old
- Willing to participate
Key exclusion criteria (5 listed)
- Women with skin diseases or any underlying diseases.
- Pregnant, breastfeeding women or planned pregnancy during the study period
- Allergy to collagen or other ingredients that may be found in the product.
- Women who had any cosmetic procedures such as botox, laser and light treatment, facial surgery, and any procedures that may improve skin hydration, elasticity, wrinkles, and brightening of skin four weeks before the study.
- Women who took any dietary supplements, functional foods, or medicines that could have the same or similar effects as the product evaluated in this study in the past three months.
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 |
|---|---|---|
| PlaceboProduct doesn't have active ingredients i.e. marine collagen peptide and Coenzyme Q10. | Other | Placebo |
| Product containing marine collagen peptide and Coenzyme Q10.Product containing marine collagen peptide and Coenzyme Q10. | Other | Product containing marine collagen peptide and Coenzyme Q10. |
Primary outcome
Changes in skin hydration from baseline and at Day 14 and Day 28 after consumption of a product.
Time frame: Baseline, Day 14 and Day 28
Skin hydration will be assessed using JANUS III skin analyzer and comparison will be made with placebo group.
Changes in skin elasticity from baseline and at Day 14 and Day 28 after consumption of a product.
Time frame: Baseline, Day 14 and Day 28
Skin elasticity will be assessed using JANUS III skin analyzer comparison will be made with placebo group.
Changes in skin wrinkles from baseline and at Day 14 and Day 28 after consumption of a product.
Time frame: Baseline, Day 14 and Day 28
Skin wrinkles will be assessed using JANUS III skin analyzer comparison will be made with placebo group.
Changes in skin tone from baseline and at Day 14 and Day 28 after consumption of a product.
Time frame: Baseline, Day 14 and Day 28
Skin hydration will be assessed using JANUS III skin analyzer comparison will be made with placebo group.
Adverse effect after consumption of product containing marine collagen peptide and coenzyme Q10.
Time frame: 28 Days
Based on adverse effect occurrence on participants that occur during study period (28 days)
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 29 Nov 2023.
- Individual participant dataSharing planned: No
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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 Product containing marine collagen peptide and Coenzyme Q10. in people with Healthy, run by USMARI Research & Innovation Centre at 1 site in Malaysia.
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 3 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 29 Nov 2023. 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 Malaysia. 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?
Changes in skin hydration from baseline and at Day 14 and Day 28 after consumption of a product. (time frame: Baseline, Day 14 and Day 28). The study lists 5 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 29 Nov 2023.