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Skin LaxityNCT05670977

Improved Skin Anti-aging Outcomes Associated With Collagen Fortified Consumption In 30 to 50-Year-old Women

A study testing Study product plus collagen supplement and Study product without collagen supplement in people with Skin Laxity and Skin Lines, run by Guangdong HuaPeptides Biotechnology Co., Ltd. at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to study the efficacy of collagen supplement on the moisture content and elasticity. 70 participants of 30-50 years old women will be enrolled from two study sites and randomly assigned to use two products (study product plus collagen supplement and placebo product without collagen… Read more about this study

Who is it for?
Ages 30 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Skin Laxity, Skin Lines
What is being tested?
Study product plus collagen supplement and Study product without collagen supplement
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
2 sitesChina
Study dates
16 Jan 2023to 31 Mar 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 30 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Chinese females, age between 30-50;
  • Be in general good health;
  • Understand the test procedure, read, and sign an appropriate Informed Consent Form indicating their willingness to participate;
  • Have mild to moderate darker skin tone 3 on Unilever visual scale of 1~9;
  • Have mild pigmentation level 2 on Unilever visual scale of 0~9;
  • Have visual grading score on crow's feet 3 on Unilever visual scale of 0~9;
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  • Have visual grading score on peri-oral 3 on Unilever visual scale of 0~9;
  • Have visual grading score on nasolabial folds 3 on Unilever visual scale of 0~9;
  • Tolerate to well-known anti-aging actives;
  • Agree to not use any other creams, lotions, moisturizers on the face, other than what is provided for the duration of the study;
  • Agree to refrain from wearing make-up (such as foundation, eye shadow, lipstick etc.) or any skin care products on the face on the study visits;
  • Agree to avoid washing the treatment site area for two hours following product application and agree to avoid washing appliances (i.e., sponge, wash cloth, loofah, etc.).

Who cannot join

  • Have used any skin lightening /anti-aging benefits products at least one month before this study
  • Subject having done facial injections and/or aesthetic surgery.
  • Be involved in any aspect of test administration, i.e., evaluating or overseeing activities related to product.
  • Have participated in any clinical study involving the test sites within the previous 6 months, or is subject participating in any clinical study concurrently.
  • Have a history of any type of bagcer, including but not limited to any type of skin bagcer (squamous or basal cell carcinoma at the treatment site) or history of malignant melanoma at any body site.
  • Have a history of skin disease or the presence of a skin condition on the test sites that the Investigator feels would interfere with the study.
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  • Be taking antihistamines (> 3x/week) or anti-inflammatory (> 8x/week) on a regular basis, or has the subject taken systemic or topical steroidal medications within 4 weeks of study enrolment.
  • Have any of the following conditions or factors that the investigator believes may affect the response of the skin or the interpretation of the test results, including, but not limited to, diabetes, pregnancy, lactation.
  • Have any cuts/abrasions on the test site at baseline.
  • Have had a suspicious skin lesion removed by a dermatologist at any time.
  • The subject is an employee of sponsor or the site conducting the study.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Ai'er Hospital

    Shanghai, Shanghai Municipality

  • SPRIM Central Lab

    Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: A Randomized, Double Blind, Controlled Study of Improved Skin Anti-aging Outcomes Associated With Collagen Fortified Consumption In 30 to 50-Year-old Women

The goal of this clinical trial is to study the efficacy of collagen supplement on the moisture content and elasticity.

70 participants of 30-50 years old women will be enrolled from two study sites and randomly assigned to use two products (study product plus collagen supplement and placebo product without collagen supplement) for 2 months.

Researchers will compare the two groups to validate the assumption that there is significant improvement on skin anti-aging effect for participants using study product plus collagen supplement.

Read the detailed description

This study is two arms, randomized, double-blind controlled trial. There will be two study sites and 35 eligible participants at each study site will be enrolled with the expectation of having 30 participants completed per study group. Particants will be randomly allocated to use one of the two study products defined in the trial protocol for two months. Up to three study visits will be made by the participant over a 2-month period. All relevant data will be captured and recorded into CTMS (Clinical Trial Management System). The data will be analyzed and reported after the completion of the study.

Being tested
Study product plus collagen supplement, Study product without collagen supplement
Keywords
Collagen, skin anti-aging, skin moisture, skin elasticity
Medical subject headings
Cutis Laxa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Study product plus collagen supplementDietary supplement

    The participants in this arm will use the assigned product for 2 months, 5g one time, once a day.

  • Study product without collagen supplementDietary supplement

    The participants in this arm will use the assigned product for 2 months, 5g one time, once a day.

Study groups in NCT05670977
Study groupRoleWhat they receive
Study product plus collagen supplementActive comparator5g/bag, containing the following ingredients per 5g serving: * Collagen tripeptide 1500 mg * Elastin peptide 150 mg
Receives: Dietary Supplement: Study product plus collagen supplement
Study product without collagen supplementPlacebo comparator5g/bag, containing the following ingredients per 5g serving: * Peach juice 8 mg * Erythritol 10 mg
Receives: Dietary Supplement: Study product without collagen supplement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Skin Elasticity

    The changes of skin elasticity from baseline to day 60 by CK Cutometer MPA580

    Measured: baseline day 0, day 60

  2. Skin Moisture

    The changes of skin moisture from baseline to day 60 by Corneometer CM 825

    Measured: baseline day 0, day 60

Secondary outcomes (4)

  1. Skin Barrier

    The changes of skin barrier in terms of TEWL (Trans Epidermal Water Loss) by Aquaflux F200

    Measured: baseline day 0, day 30, day 60

  2. Lines/Wrinkles

    The changes of the lines/wrinkles on the face by Miravex Antera 3D imaging system

    Measured: baseline day 0, day 30, day 60

  3. Facial Glow

    The changes of Facial Glow by expert visual assessment

    Measured: baseline day 0, day 30, day 60

  4. Skin Diagnosis

    The skin diagnosis (4 modes and 2 side views) with VISIA CR Facial Imaging System

    Measured: baseline day 0, day 30, day 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2023
  2. Study start16 Jan 2023
  3. Primary completion12 Mar 2023
  4. Study completion31 Mar 2023

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05670977
Sponsor's protocol ID
22-SM-12-HT-001
Status last verified
Apr 2023
First submitted
2 Jan 2023
Last updated
13 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Proksch E, Segger D, Degwert J, Schunck M, Zague V, Oesser S. Oral supplementation of specific collagen peptides has beneficial effects on human skin physiology: a double-blind, placebo-controlled study. Skin Pharmacol Physiol. 2014;27(1):47-55. doi: 10.1159/000351376. Epub 2013 Aug 14.

    PubMed 23949208

  • Proksch E, Schunck M, Zague V, Segger D, Degwert J, Oesser S. Oral intake of specific bioactive collagen peptides reduces skin wrinkles and increases dermal matrix synthesis. Skin Pharmacol Physiol. 2014;27(3):113-9. doi: 10.1159/000355523. Epub 2013 Dec 24.

    PubMed 24401291

  • Shariff R, Du Y, Dutta M, Kumar S 5th, Thimmaiah S, Doraiswamy C, Kumari A, Kale V, Nair N, Zhang S, Joshi M, Santhanam U, Qiang Q, Damodaran A. Superior even skin tone and anti-ageing benefit of a combination of 4-hexylresorcinol and niacinamide. Int J Cosmet Sci. 2022 Feb;44(1):103-117. doi: 10.1111/ics.12759. Epub 2022 Feb 1.

    PubMed 34958693

  • Wang L, Xu YN, Chu CC, Jing Z, Chen Y, Zhang J, Pu M, Mi T, Du Y, Liang Z, Doraiswamy C, Zeng T, Wu J, Chen L. Facial Skin Microbiota-Mediated Host Response to Pollution Stress Revealed by Microbiome Networks of Individual. mSystems. 2021 Aug 31;6(4):e0031921. doi: 10.1128/mSystems.00319-21. Epub 2021 Jul 27.

    PubMed 34313461

  • Du Y, Doraiswamy C, Mao J, Zhang Q, Liang Y, Du Z, Vasantharaghavan R, Joshi MK. Facial skin characteristics and concerns in Indonesia: A cross-sectional observational study. Skin Res Technol. 2022 Sep;28(5):719-728. doi: 10.1111/srt.13189. Epub 2022 Jul 4.

    PubMed 35785442

Questions about this trial

What is this clinical trial studying?

A study testing Study product plus collagen supplement and Study product without collagen supplement in people with Skin Laxity and Skin Lines, run by Guangdong HuaPeptides Biotechnology Co., Ltd. at 2 sites 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 12 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 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 Elasticity (time frame: baseline day 0, day 60). The study lists 2 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 NCT05670977, which also lists 5 linked publications.

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 13 Apr 2023.

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