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CompletedNCT05670977Updated Apr 13, 2023

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

An interventional study of Study product plus collagen supplement and Study product without collagen supplement in Skin Laxity and Skin Lines, sponsored by Guangdong HuaPeptides Biotechnology Co., Ltd.. Completed at 2 sites in China. Open to female participants aged 30 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-13.

Sponsored by Guangdong HuaPeptides Biotechnology Co., Ltd. · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
30 Years to 50 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Skin Laxity
  • Skin Lines

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Keywords

  • Collagen
  • skin anti-aging
  • skin moisture
  • skin elasticity
03

In context

Cutis Laxa

147 studies on the registry are indexed under Cutis Laxa; 35 are open to participants now.

This study's enrollment of 70 is above the median of 30 across 129 interventional studies indexed under Cutis Laxa.

Browse Cutis Laxa studies →

Lead sponsor

This is the only study on the registry with Guangdong HuaPeptides Biotechnology Co., Ltd. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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;
  • 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.).

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
70 participants (actual)

Study arms

  • Active comparator
    Study product plus collagen supplement

    5g/bag, containing the following ingredients per 5g serving: * Collagen tripeptide 1500 mg * Elastin peptide 150 mg

    Dietary Supplement: Study product plus collagen supplement

  • Placebo comparator
    Study product without collagen supplement

    5g/bag, containing the following ingredients per 5g serving: * Peach juice 8 mg * Erythritol 10 mg

    Dietary Supplement: Study product without collagen supplement

Interventions

  • Dietary supplementStudy product plus collagen supplement

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

  • Dietary supplementStudy product without collagen supplement

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

06

What researchers measure

Primary outcomes

  1. Skin Elasticity

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

    Time frame: baseline day 0, day 60

  2. Skin Moisture

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

    Time frame: baseline day 0, day 60

Secondary outcomes

  1. Skin Barrier

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

    Time frame: 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

    Time frame: baseline day 0, day 30, day 60

  3. Facial Glow

    The changes of Facial Glow by expert visual assessment

    Time frame: 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

    Time frame: baseline day 0, day 30, day 60

07

Study locations

2 sites
  • Ai'er Hospital
    Shanghai, Shanghai, China
  • SPRIM Central Lab
    Shanghai, Shanghai, China
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05670977
Lead sponsor
Guangdong HuaPeptides Biotechnology Co., Ltd.
Responsible party
Sponsor
First posted
Jan 4, 2023
Start date
Jan 16, 2023
Primary completion
Mar 12, 2023
Completion
Mar 31, 2023
Last update
Apr 13, 2023

Study contacts

Yun Wang, MD
principal investigator · NO. 9 Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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