- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07516756
Effect of Collagen Peptides on Skin Health: A Clinical Trial (BCP-Skin)
Impact of Oral Supplementation of Specific Bioactive Collagen Peptides on Human Skin Physiology: A Randomized, Double-Blind, Placebo-Controlled Trial
The goal of this clinical trial is to evaluate whether daily oral supplementation with 2.5 g of specific bioactive collagen peptides (SCP) can improve skin physiology in healthy adult women aged 35-55 years. The main questions it aims to answer are:
Does SCP supplementation increase skin hydration and barrier function? Does SCP improve skin elasticity, firmness, and collagen content? Does SCP reduce the appearance of periorbital wrinkles and improve overall skin appearance? Researchers will compare SCP supplementation to a placebo (a look-alike substance containing no collagen peptides) to see if SCP supports skin structure and appearance over eight weeks.
Participants will:
Consume one sachet of SCP or placebo daily for eight weeks Attend three study visits at baseline, week 4, and week 8 for facial imaging, instrumental skin measurements, and expert assessments Have objective measures taken, including skin hydration, transepidermal water loss, elasticity, firmness, dermal collagen content, and 3D wrinkle morphology Complete subjective skin assessments rated by trained evaluators using a visual analogue scale Report any adverse events or intolerance reactions at each visit This study is designed to provide an integrated evaluation of multiple skin parameters, including barrier function, biomechanical properties, dermal matrix composition, and wrinkle characteristics, in a single trial. By combining objective and subjective measures, the study aims to generate robust and clinically interpretable evidence for the effects of oral collagen peptide supplementation on skin health.
Study Overview
Status
Intervention / Treatment
Detailed Description
This clinical trial investigates whether daily oral supplementation with specific bioactive collagen peptides (SCP) can support healthy skin in adult women. Skin aging is a natural process influenced by genetics, hormones, and lifestyle, leading to wrinkles, reduced elasticity, and changes in skin structure. Collagen is a key protein that helps maintain skin strength and elasticity, and its levels decline with age.
The study will evaluate the effects of an 8-week course of SCP supplementation compared to a placebo in healthy women aged 35-55 years. Researchers aim to determine whether oral collagen peptides can improve skin hydration, elasticity, firmness, and overall appearance. This trial combines multiple objective and subjective measures to provide a comprehensive assessment of skin health, offering insights into non-invasive nutritional strategies to maintain skin structure and appearance over time.
The findings from this study are expected to enhance understanding of how collagen peptides affect skin physiology and contribute to evidence-based recommendations for supporting healthy skin.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Haidan
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Beijing, Haidan, China, 100142
- Beijing EWISH Testing Technology Co., Ltd
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Fitzpatrick skin type III-IV
- Presence of crow's feet wrinkles graded 2-4
- Presence of under-eye fine lines graded 2-5
- Generally in good health
- Able to comply with study procedures and visit schedule
Exclusion Criteria:
- Use of systemic or topical anti-inflammatory medication, including corticosteroids, within the 4 weeks prior to baseline
- Known hypersensitivity or allergy to any ingredient of the investigational products
- Pregnancy, breastfeeding, or intention to become pregnant during the study period
- History of relevant dermatological conditions: psoriasis, eczema, atopic dermatitis, or severe acne
- Presence of birthmarks, hyperpigmentation, active inflammation, or other visible skin abnormalities in the test areas
- Recent aesthetic procedures Use of anti-aging or topical treatments
- Intake of nutritional supplements
- Participation in other clinical studies within the past 2 months
- Significant lifestyle or dietary changes during the study period
- Excessive UV exposure
- Systemic diseases, including heart, immune, vascular, liver, gallbladder, or kidney disorders
- Known allergies to foods, cosmetics, skincare products, or topical medications
- Any other condition that, in the investigator's opinion, would make the participant ineligible
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Specific Collagen Peptides
Participants in this arm receive 2.5 g of specific bioactive collagen peptides (VERISOL®) once daily for 8 weeks.
The powder is dissolved in warm water and consumed orally.
The supplement contains defined collagen peptides derived from bovine type I collagen, which have been shown to support skin hydration, elasticity, firmness, dermal collagen content, and wrinkle reduction.
Participants continue their usual lifestyle habits while taking the supplement.
|
Participants in this arm receive 2.5 g of specific bioactive collagen peptides (VERISOL®) once daily for 8 weeks.
The powder is dissolved in warm water and consumed orally.
The supplement contains defined collagen peptides derived from bovine type I collagen, which have been shown to support skin hydration, elasticity, firmness, dermal collagen content, and wrinkle reduction.
Participants continue their usual lifestyle habits while taking the supplement.
|
|
Placebo Comparator: Maltodextrin
Participants in this arm receive a matching placebo sachet once daily for 8 weeks.
The placebo contains plant-derived maltodextrin and is identical in appearance, taste, and texture to the collagen peptide supplement.
It is dissolved in warm water and consumed orally.
Participants continue their usual lifestyle habits while taking the placebo.
|
Participants in this arm receive a matching placebo sachet once daily for 8 weeks.
The placebo contains plant-derived maltodextrin and is identical in appearance, taste, and texture to the collagen peptide supplement.
It is dissolved in warm water and consumed orally.
Participants continue their usual lifestyle habits while taking the placebo.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
stratum corneum hydration (SCH)
Time Frame: From enrollment to the end of treatment at 8 weeks
|
Stratum corneum hydration (SCH) measures the water content in the outermost layer of the skin, reflecting the skin's ability to retain moisture and maintain a healthy barrier. In this study, SCH is the primary efficacy endpoint, used to compare the effect of daily oral supplementation with specific bioactive collagen peptides (SCP) versus placebo over an 8-week period. SCH is assessed using a Corneometer CM825 at the cheek. Each site is measured six times, and the mean value is used for analysis. Higher SCH values indicate better skin hydration, whereas lower values suggest dryness or impaired barrier function. Changes in SCH over time are compared between the treatment and placebo groups to evaluate the impact of collagen peptide supplementation on skin hydration. |
From enrollment to the end of treatment at 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Transepidermal Water Loss (TEWL)
Time Frame: From enrollment to the end of treatment at 8 weeks
|
TEWL measures the rate of water loss through the skin, indicating the integrity of the skin barrier.
In this study, TEWL is assessed using the Tewameter TM 300 at the cheek in triplicate, with mean values used for analysis.
Higher TEWL values suggest impaired barrier function, while lower values indicate better barrier integrity.
Changes over the 8-week supplementation period are compared between the collagen peptide and placebo groups.
|
From enrollment to the end of treatment at 8 weeks
|
|
Skin Elasticity (R2 and R5) and Firmness (F4)
Time Frame: From enrollment to the end of treatment at 8 weeks
|
Skin elasticity and firmness are evaluated using the Cutometer MPA580, which applies controlled suction to assess the biomechanical properties of the cheek. R2 (gross elasticity): overall skin elasticity R5 (net elasticity): elastic recovery relative to total deformation F4 (firmness): resistance to deformation Measurements are performed in triplicate and averaged. These parameters provide insight into the skin's structural resilience and are compared between treatment and placebo groups over 8 weeks. |
From enrollment to the end of treatment at 8 weeks
|
|
Dermal collagen content
Time Frame: From enrollment to the end of treatment at 8 weeks
|
Dermal collagen content is measured non-invasively using the SIAMETRICS SIAscope V at a 2 mm depth of the cheek.
This device quantifies dermal chromophores, including collagen, to assess the integrity and composition of the dermal extracellular matrix.
Changes over the 8-week intervention are compared between the SCP and placebo groups.
|
From enrollment to the end of treatment at 8 weeks
|
|
Wrinkle Morphology
Time Frame: From enrollment to the end of treatment at 8 weeks
|
Wrinkle characteristics around the eyes (area, volume, depth) are measured using the Derma TOP 3D imaging system.
|
From enrollment to the end of treatment at 8 weeks
|
|
Skin Appearance (3D Imaging + VAS)
Time Frame: From enrollment to the end of treatment at 8 weeks
|
Full-face 2D images are captured with VISIA-CR for additional objective assessments, including spots, skin tone, hydration, and elasticity. Subjective evaluations are performed using a Visual Analogue Scale (VAS) by three trained evaluators, assessing: Smoothness Glossiness Fineness Elasticity Crow's feet and under-eye fine lines VAS scores range from 0 to 10. Higher values indicate better outcomes for attributes such as smoothness, elasticity, and glossiness, while lower values reflect improvement in periorbital wrinkles. Changes over the 8-week supplementation period are compared between treatment and placebo groups. |
From enrollment to the end of treatment at 8 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Steffen Oesser, Dr, Collagen Research Institute, Schauenburgerstr. 116, D-24118 Kiel
Publications and helpful links
General Publications
- Vollmer DL, West VA, Lephart ED. Enhancing Skin Health: By Oral Administration of Natural Compounds and Minerals with Implications to the Dermal Microbiome. Int J Mol Sci. 2018;19:3059. https://doi.org/10.3390/ijms19103059.
- Dähnhardt D, Dähnhardt-Pfeiffer S, Segger D, Poeggeler B, Lemmnitz G. Restoration of the Ultrastructural Integrity of the Dermal Collagen Network by 12-Week Ingestion of Special Collagen Peptides. Dermatol Ther (Heidelb). 2024;14:2509-21. https://doi.org/10.1007/s13555-024-01251-8.
- Lin P, Alexander RA, Liang C-H, Liu C, Lin Y-H, Lin Y-H, et al. Collagen formula with Djulis for improvement of skin hydration, brightness, texture, crow's feet, and collagen content: A double-blind, randomized, placebo-controlled trial. J Cosmet Dermatol. 2021;20:188-94. https://doi.org/10.1111/jocd.13500.
- Inacio PAQ, Chaluppe FA, Aguiar GF, Coelho C de F, Vieira RP. Effects of Hydrolyzed Collagen as a Dietary Supplement on Fibroblast Activation: A Systematic Review. Nutrients. 2024;16:1543. https://doi.org/10.3390/nu16111543.
- Dierckx S, Patrizi M, Merino M, González S, Mullor JL, Nergiz-Unal R. Collagen peptides affect collagen synthesis and the expression of collagen, elastin, and versican genes in cultured human dermal fibroblasts. Front Med. 2024;11. https://doi.org/10.3389/fmed.2024.1397517.
- Fu Y, Young JF, Rasmussen MK, Dalsgaard TK, Lametsch R, Aluko RE, et al. Angiotensin I-converting enzyme-inhibitory peptides from bovine collagen: insights into inhibitory mechanism and transepithelial transport. Food Res Int. 2016;89 Pt 1:373-81. https://doi.org/10.1016/j.foodres.2016.08.037.
- Feng M, Betti M. Transepithelial transport efficiency of bovine collagen hydrolysates in a human Caco-2 cell line model. Food Chem. 2017;224:242-50. https://doi.org/10.1016/j.foodchem.2016.12.044.
- Osawa Y, Mizushige T, Jinno S, Sugihara F, Inoue N, Tanaka H, et al. Absorption and metabolism of orally administered collagen hydrolysates evaluated by the vascularly perfused rat intestine and liver in situ. Biomed Res. 2018;39:1-11. https://doi.org/10.2220/biomedres.39.1.
- Liu Z, Li Y, Song H, He J, Li G, Zheng Y, et al. Collagen peptides promote photoaging skin cell repair by activating the TGF-β/Smad pathway and depressing collagen degradation. Food Funct. 2019;10:6121-34. https://doi.org/10.1039/C9FO00610A.
- Wang L, Zhang Y, Zhu Z, Zheng F, Gao R. Food-derived collagen peptides: safety, metabolism, and anti-skin-aging effects. Current Opinion in Food Science. 2023;51:101012. https://doi.org/10.1016/j.cofs.2023.101012.
- He X, Gao X, Guo Y, Xie W. Research Progress on Bioactive Factors against Skin Aging. International Journal of Molecular Sciences. 2024;25:3797. https://doi.org/10.3390/ijms25073797.
- Yang Q, Li H, Zhang H, Ma L, Zhang X, Wu J. Effectiveness of dietary supplements for skin photoaging in healthy adults: a systematic review and meta-analysis of randomized controlled trials. Front Med (Lausanne). 2025;12:1582946. https://doi.org/10.3389/fmed.2025.1582946.
- Michelotti A, Cestone E, De Ponti I, Pisati M, Sparta E, Tursi F. Oral intake of a new full-spectrum hyaluronan improves skin profilometry and ageing: a randomized, double-blind, placebo-controlled clinical trial. Eur J Dermatol. 2021;31:798-805. https://doi.org/10.1684/ejd.2021.4176.
- Morgado-Carrasco D, Gil-Lianes J, Jourdain E, Piquero-Casals J. Oral Supplementation and Systemic Drugs for Skin Aging: A Narrative Review. Actas Dermosifiliogr. 2023;114:114-24. https://doi.org/10.1016/j.ad.2022.09.014.
- Czajka A, Kania EM, Genovese L, Corbo A, Merone G, Luci C, et al. Daily oral supplementation with collagen peptides combined with vitamins and other bioactive compounds improves skin elasticity and has a beneficial effect on joint and general wellbeing. Nutr Res. 2018;57:97-108. https://doi.org/10.1016/j.nutres.2018.06.001.
- Proksch E, Zdzieblik D, Oesser S. The Oral Intake of Specific Bovine-Derived Bioactive Collagen Peptides Has a Stimulatory Effect on Dermal Matrix Synthesis and Improves Various Clinical Skin Parameters. Cosmetics. 2025;12:79. https://doi.org/10.3390/cosmetics12020079.
- 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;27:113-9. https://doi.org/10.1159/000355523.
- Zague V, Pinheiro ALTA, Pinto JR, Facchini G, Eberlin S. Oral Collagen Oligopeptides as a Modulator of Skin Health: A Comprehensive Evaluation of Clinical and Molecular Effects. Journal of Medicinal Food. 2025;28:869-76. https://doi.org/10.1089/jmf.2024.0252.
- Chen C-C, Chang S-S, Chang C-H, Hu C-C, Nakao Y, Yong SM, et al. Randomized, double-blind, four-arm pilot study on the effects of chicken essence and type II collagen hydrolysate on joint, bone, and muscle functions. Nutrition Journal. 2023;22:17. https://doi.org/10.1186/s12937-023-00837-w.
- Lee E, Ahn DK, Kim JH, Lee S, Kim HJ, Lee HK, et al. Skin Anti-Aging and Moisturizing Effects of Low-Molecular-Weight Collagen Peptide Supplementation in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. 2025;35:1-11. https://doi.org/10.4014/jmb.2507.07008.
- 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;27:47-55. https://doi.org/10.1159/000351376.
- Miyanaga M, Uchiyama T, Motoyama A, Ochiai N, Ueda O, Ogo M. Oral Supplementation of Collagen Peptides Improves Skin Hydration by Increasing the Natural Moisturizing Factor Content in the Stratum Corneum: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Skin Pharmacol Physiol. 2021;34:115-27. https://doi.org/10.1159/000513988.
- Inoue N, Sugihara F, Wang X. Ingestion of bioactive collagen hydrolysates enhance facial skin moisture and elasticity and reduce facial ageing signs in a randomised double-blind placebo-controlled clinical study. Journal of the Science of Food and Agriculture. 2016;96:4077-81. https://doi.org/10.1002/jsfa.7606.
- Lee M, Kim E, Ahn H, Son S, Lee H. Oral intake of collagen peptide NS improves hydration, elasticity, desquamation, and wrinkling in human skin: a randomized, double-blinded, placebo-controlled study. Food Funct. 2023;14:3196-207. https://doi.org/10.1039/d2fo02958h.
- Kim D-U, Chung H-C, Choi J, Sakai Y, Lee B-Y. Oral Intake of Low-Molecular-Weight Collagen Peptide Improves Hydration, Elasticity, and Wrinkling in Human Skin: A Randomized, Double-Blind, Placebo-Controlled Study. Nutrients. 2018;10:826. https://doi.org/10.3390/nu10070826.
- Oesser S, Schunk M, Proksch E. Positive effect of fish-derived Bioactive Collagen Peptides on skin health. International Journal on Nutraceuticals, Functional Foods and Novel Foods. 2020;1:127-33. https://doi.org/10.17470/NF-020-0018.
- Boelsma E, Hendriks HF, Roza L. Nutritional skin care: health effects of micronutrients and fatty acids123. The American Journal of Clinical Nutrition. 2001;73:853-64. https://doi.org/10.1093/ajcn/73.5.853.
- Cole MA, Quan T, Voorhees JJ, Fisher GJ. Extracellular matrix regulation of fibroblast function: redefining our perspective on skin aging. J Cell Commun Signal. 2018;12:35-43. https://doi.org/10.1007/s12079-018-0459-1.
- Konstantinou E, Longange E, Kaya G. Mechanisms of Senescence and Anti-Senescence Strategies in the Skin. Biology (Basel). 2024;13:647. https://doi.org/10.3390/biology13090647.
- Burke KE. Environmental aging of the skin: new insights. par. 2020;7:N/A-N/A. https://doi.org/10.20517/2347-9264.2020.154
- Csekes E, Račková L. Skin Aging, Cellular Senescence and Natural Polyphenols. Int J Mol Sci. 2021;22:12641. https://doi.org/10.3390/ijms222312641
- Shin J-W, Kwon S-H, Choi J-Y, Na J-I, Huh C-H, Choi H-R, et al. Molecular Mechanisms of Dermal Aging and Antiaging Approaches. International Journal of Molecular Sciences. 2019;20:2126. https://doi.org/10.3390/ijms20092126.
- Wang AS, Dreesen O. Biomarkers of Cellular Senescence and Skin Aging. Front Genet. 2018;9:247. https://doi.org/10.3389/fgene.2018.00247.
- Lephart ED, Naftolin F. Factors Influencing Skin Aging and the Important Role of Estrogens and Selective Estrogen Receptor Modulators (SERMs). Clin Cosmet Investig Dermatol. 2022;15:1695-709. https://doi.org/10.2147/CCID.S333663.
- Zheng Z, Zong Y, Ma Y, Tian Y, Pang Y, Zhang C, et al. Glucagon-like peptide-1 receptor: mechanisms and advances in therapy. Sig Transduct Target Ther. 2024;9:1-29. https://doi.org/10.1038/s41392-024-01931-z
- Bocheva G, Slominski RM, Slominski AT. Neuroendocrine Aspects of Skin Aging. Int J Mol Sci. 2019;20:2798. https://doi.org/10.3390/ijms20112798
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SECCR2024-97-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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