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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study product plus collagen supplement | Active Comparator | 5g/bag, containing the following ingredients per 5g serving:
|
|
| Study product without collagen supplement | Placebo Comparator | 5g/bag, containing the following ingredients per 5g serving:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study product plus collagen supplement | Dietary Supplement | The participants in this arm will use the assigned product for 2 months, 5g one time, once a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Skin Elasticity | The changes of skin elasticity from baseline to day 60 by CK Cutometer MPA580 | baseline day 0, day 60 |
| Skin Moisture | The changes of skin moisture from baseline to day 60 by Corneometer CM 825 | baseline day 0, day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Skin Barrier | The changes of skin barrier in terms of TEWL (Trans Epidermal Water Loss) by Aquaflux F200 | baseline day 0, day 30, day 60 |
| Lines/Wrinkles | The changes of the lines/wrinkles on the face by Miravex Antera 3D imaging system |
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Inclusion Criteria:
Exclusion Criteria:
Participants must be women of 30-50 years old
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| Name | Affiliation | Role |
|---|---|---|
| Yun Wang, MD | NO. 9 Hospital affiliated to Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ai'er Hospital | Shanghai | Shanghai Municipality | China | |||
| SPRIM Central Lab |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23949208 | Background | 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. | |
| 24401291 | Background |
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| Study product without collagen supplement | Dietary Supplement | The participants in this arm will use the assigned product for 2 months, 5g one time, once a day. |
|
| baseline day 0, day 30, day 60 |
| Facial Glow | The changes of Facial Glow by expert visual assessment | baseline day 0, day 30, day 60 |
| Skin Diagnosis | The skin diagnosis (4 modes and 2 side views) with VISIA CR Facial Imaging System | baseline day 0, day 30, day 60 |
| Shanghai |
| Shanghai Municipality |
| China |
| 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. |
| 34958693 | Background | 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. |
| 34313461 | Background | 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. |
| 35785442 | Background | 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. |
| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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