The Efficacy and Safety of CollaSel Pro® Hydrolyzed Collagen Peptide Supplementation without Addons in Improving Skin Health in Adult Females: A Double Blind, Randomized, Placebo-Controlled Clinical Study Using Biophysical and Skin Imaging Techniques
Abstract
:1. Introduction
2. Materials and Methods
2.1. Manufacturing and Quality Evaluation of Collagen
2.2. Study Design
2.3. Data Collection
2.4. Test Product and Placebo
2.5. Measurement of Skin Elasticity, Skin Hydration, and Skin Roughness
2.6. 3D Facial Scanning and Image Processing
2.7. Surface Analysis for Facial Soft Tissue Sagging
2.8. Statistical Analysis
3. Results
3.1. Baseline Characteristics (n = 112)
3.2. Skin Elasticity in Test Product and Placebo Groups
3.3. Skin Hydration in Test Product and Placebo Groups
3.4. Skin Roughness in Test Product and Placebo Groups
3.5. 3D Surface Analysis for Facial Configuration in Test Product and Placebo Groups
3.6. Safety Data
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Test Product (Hydrolyzed Collagen Peptide) Group (n = 57) | Placebo Group (n = 55) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Baseline Visit | Treatment Period Visits | EOS Visit | Baseline Visit | Treatment Period Visits | EOS Visit | ||||||
Skin Measurements | Day 0 | Week 1 | Week 4 | Week 8 | Week 12 | Day 0 | Week 1 | Week 4 | Week 8 | Week 12 | |
Skin elasticity (mPa) | n | 57 | 57 | 57 | 57 | 56 | 55 | 54 | 55 | 55 | 55 |
mean(SD) | 39.9 (4.7) | 39.9 (5.2) | 40.7 (6.0) | 43.0 (7.4) | 41.8 (4.3) | 39.9 (6.3) | 39.1 (6.0) | 39.7 (5.0) | 40.3 (3.3) | 40.2 (3.3) | |
p-value | vs. baseline | 0.883 | 0.222 | 0.009 | 0.001 | 0.251 | 0.753 | 0.571 | 0.693 | ||
vs. week 1 | 0.237 | 0.006 | 0.01 | 0.218 | 0.078 | 0.066 | |||||
vs. week 4 | 0.049 | 0.14 | 0.298 | 0.392 | |||||||
vs. week 8 | 0.175 | 0.754 | |||||||||
p-value vs. placebo | 0.971 | 0.494 | 0.328 | 0.017 | 0.027 | ||||||
Skin hydration (g/m3) | n | 57 | 57 | 57 | 57 | 56 | 55 | 54 | 55 | 55 | 55 |
mean(SD) | 52.2 (16.1) | 57.4 (17.8) | 59.0 (18.2) | 65.8 (18.9) | 64.6 (14.4) | 54.8 (14.2) | 55.0 (12.5) | 53.5 (14.1) | 53.1 (14.9) | 60.1 (15.8) | |
p-value | vs. baseline | 0.003 | 0.002 | <0.001 | <0.001 | 0.846 | 0.47 | 0.467 | 0.017 | ||
vs. week 1 | 0.47 | <0.001 | <0.001 | 0.329 | 0.285 | 0.03 | |||||
vs. week 4 | 0.001 | 0.004 | 0.835 | 0.005 | |||||||
vs. week 8 | 0.336 | 0.002 | |||||||||
p-value vs. placebo | 0.367 | 0.412 | 0.076 | <0.001 | 0.115 | ||||||
Skin roughness (μg/cm2) | n | 53 | 56 | 56 | 56 | 56 | 53 | 51 | 55 | 55 | 55 |
mean(SD) | 24.8 (18.2) | 34.1 (21.8) | 39.6 (15.8) | 40.2 (20.4) | 53.1 (24.1) | 22.0 (13.8) | 28.1 (16.3) | 26.1 (16.3) | 24.9 (20.9) | 35.4 (25.6) | |
p-value | vs. baseline | 0.002 | <0.001 | <0.001 | <0.001 | <0.001 | 0.044 | 0.235 | <0.001 | ||
vs. week 1 | 0.08 | 0.033 | <0.001 | 0.024 | 0.115 | 0.076 | |||||
vs. week 4 | 0.447 | <0.001 | 0.687 | 0.002 | |||||||
vs. week 8 | 0.001 | <0.001 | |||||||||
p-value vs. placebo | 0.371 | 0.111 | <0.001 | <0.001 | <0.001 |
Test Product Group | Placebo Group | ||||||
---|---|---|---|---|---|---|---|
Baseline Visit | Treatment Visit | EOS Visit | Baseline Visit | Treatment Visit | EOS Visit | ||
3D Surface Analysis | Day 0 | Week 8 | Week 12 | Day 0 | Week 8 | Week 12 | |
RMS (mm) | n | 28 | 28 | 28 | 25 | 23 | 25 |
mean(SD) | 1.10 (0.21) | 1.02 (0.21) | 1.09 (0.20) | 1.08 (0.25) | 1.03 (0.15) | 1.11 (0.24) | |
p-value | vs. baseline | 0.012 | 0.546 | 0.659 | 0.493 | ||
vs. week 8 | 0.017 | 0.605 | |||||
p-value vs. placebo | 0.493 | 0.532 | 0.894 | ||||
RMS (mm) * | n | 23 | 23 | 23 | 20 | 18 | 20 |
mean(SD) | 1.12 (0.22) | 1.03 (0.22) | 1.06 (0.21) | 1.1 (0.27) | 1.03 (0.15) | 1.06 (0.24) | |
p-value | vs. baseline | 0.009 | 0.027 | 0.94 | 0.48 | ||
vs. week 8 | 0.23 | 0.47 |
Patients with adverse events (N) | 19 |
Number of SAEs (n) | 0 |
Number of AEs (n) | 43 |
Type of AEs, n(%) | |
Nausea | 9 (20.9) |
Constipation | 4 (9.3) |
Mild itching | 2 (4.7) |
Menstrual bleeding increase | 2 (4.7) |
Oedema | 2 (4.7) |
Dry mouth | 2 (4.7) |
Bloating | 2 (4.7) |
Skin tension increased | 2 (4.7) |
Weight increase | 2 (4.7) |
Vomiting | 2 (4.7) |
Halitosis | 1 (2.3) |
Dry skin | 1 (2.3) |
Fatigue | 1 (2.3) |
Heat | 1 (2.3) |
Diarrhea | 1 (2.3) |
Abdominal pain | 1 (2.3) |
Thirst | 1 (2.3) |
Mild tingling | 1 (2.3) |
Headache | 1 (2.3) |
Rash | 1 (2.3) |
Drowsiness | 1 (2.3) |
Acne | 1 (2.3) |
Cracked nail | 1 (2.3) |
State of repletion | 1 (2.3) |
Total | 43 (100.0) |
Relation to study drug, n(%) | |
Certain | - |
Probable/Likely | - |
Possible | 32 (74.4) |
Unlikely | 11 (25.6) |
Severity | |
Mild | 41 (95.3) |
Moderate | 2 (4.7) |
Severe | 0 (0.0) |
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Demir-Dora, D.; Ozsoy, U.; Yildirim, Y.; Yilmaz, O.; Aytac, P.; Yilmaz, B.; Dogan Kurtoglu, E.; Akman, A.; Tezman, S.; Inaloz, H.S.; et al. The Efficacy and Safety of CollaSel Pro® Hydrolyzed Collagen Peptide Supplementation without Addons in Improving Skin Health in Adult Females: A Double Blind, Randomized, Placebo-Controlled Clinical Study Using Biophysical and Skin Imaging Techniques. J. Clin. Med. 2024, 13, 5370. https://doi.org/10.3390/jcm13185370
Demir-Dora D, Ozsoy U, Yildirim Y, Yilmaz O, Aytac P, Yilmaz B, Dogan Kurtoglu E, Akman A, Tezman S, Inaloz HS, et al. The Efficacy and Safety of CollaSel Pro® Hydrolyzed Collagen Peptide Supplementation without Addons in Improving Skin Health in Adult Females: A Double Blind, Randomized, Placebo-Controlled Clinical Study Using Biophysical and Skin Imaging Techniques. Journal of Clinical Medicine. 2024; 13(18):5370. https://doi.org/10.3390/jcm13185370
Chicago/Turabian StyleDemir-Dora, Devrim, Umut Ozsoy, Yilmaz Yildirim, Oguz Yilmaz, Peri Aytac, Beste Yilmaz, Emel Dogan Kurtoglu, Ayse Akman, Selim Tezman, Huseyin Serhat Inaloz, and et al. 2024. "The Efficacy and Safety of CollaSel Pro® Hydrolyzed Collagen Peptide Supplementation without Addons in Improving Skin Health in Adult Females: A Double Blind, Randomized, Placebo-Controlled Clinical Study Using Biophysical and Skin Imaging Techniques" Journal of Clinical Medicine 13, no. 18: 5370. https://doi.org/10.3390/jcm13185370