Facial Wrinkles Clinical Trial
Official title:
Oral Supplementation With Low Molecular Weight Collagen Peptides Improves Facial Wrinkles and Skin Hydration: Results From a Six-Week Randomized, Double-Blind, Placebo-Controlled Study
NCT number | NCT06321770 |
Other study ID # | 075-2022 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 15, 2023 |
Est. completion date | May 24, 2023 |
Verified date | March 2024 |
Source | Gala Servicios Clinicos S.L. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The present study aims to investigate the efficacy of daily supplementation with COLLinstant® LMW over a 6-week period in improving visible signs of aging. This in-cludes assessing its impact on skin wrinkle reduction, as well as its potential to en-hance skin elasticity and moisturization. COLLinstant® LMW was administered orally in a single-center, randomized, double-blind, placebo-controlled clinical trial. A sec-ondary objective involves comparing skin improvement, product satisfaction, and monitoring adverse events among middle-aged female volunteers.
Status | Completed |
Enrollment | 80 |
Est. completion date | May 24, 2023 |
Est. primary completion date | April 16, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 30 Years to 60 Years |
Eligibility | Inclusion Criteria: - Women (aged 30-65 years) with phototypes I-IV, who were mentally and physically healthy, had a BMI 20.0-29.9 kg/m2 and displayed visible signs of natural and photoaging on their face (crow´s feet) rated from moderate to severe Exclusion Criteria: - Pregnancy, lactation, acute or chronic skin disease or dermatological disorder; use of natural health supplements for improving the skin within 1 month before the start of the study; low protein diet; planned or unavoidable exposure to UV radiation; tattoos on or near the test area; use of systemic corticosteroids or applied topical alpha hydroxyl acids near the test site within 4 weeks of enrolment; use of topical medications near the test area within 6 weeks of enrolment; Botulinum toxin A (Botox) treatment or filler injection (collagen, hyaluronic acid, etc) near the test sites within 2 years of enrolment; subjects cognitively impaired and/or unable to give informed consent; or had any other condition which in the medical investigator's opinion may adversely affect the individual's ability to complete the study or its measures or which may pose significant risk to the individual. |
Country | Name | City | State |
---|---|---|---|
Spain | GALA Laboratories | Don Benito | Badajoz |
Lead Sponsor | Collaborator |
---|---|
Gala Servicios Clinicos S.L. |
Spain,
Asserin J, Lati E, Shioya T, Prawitt J. The effect of oral collagen peptide supplementation on skin moisture and the dermal collagen network: evidence from an ex vivo model and randomized, placebo-controlled clinical trials. J Cosmet Dermatol. 2015 Dec;14(4):291-301. doi: 10.1111/jocd.12174. Epub 2015 Sep 12. — View Citation
Bolke L, Schlippe G, Gerss J, Voss W. A Collagen Supplement Improves Skin Hydration, Elasticity, Roughness, and Density: Results of a Randomized, Placebo-Controlled, Blind Study. Nutrients. 2019 Oct 17;11(10):2494. doi: 10.3390/nu11102494. — View Citation
Choi FD, Sung CT, Juhasz ML, Mesinkovsk NA. Oral Collagen Supplementation: A Systematic Review of Dermatological Applications. J Drugs Dermatol. 2019 Jan 1;18(1):9-16. — View Citation
de Miranda RB, Weimer P, Rossi RC. Effects of hydrolyzed collagen supplementation on skin aging: a systematic review and meta-analysis. Int J Dermatol. 2021 Dec;60(12):1449-1461. doi: 10.1111/ijd.15518. Epub 2021 Mar 20. — View Citation
Lupu MA, Gradisteanu Pircalabioru G, Chifiriuc MC, Albulescu R, Tanase C. Beneficial effects of food supplements based on hydrolyzed collagen for skin care (Review). Exp Ther Med. 2020 Jul;20(1):12-17. doi: 10.3892/etm.2019.8342. Epub 2019 Dec 17. — View Citation
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. — View Citation
Pu SY, Huang YL, Pu CM, Kang YN, Hoang KD, Chen KH, Chen C. Effects of Oral Collagen for Skin Anti-Aging: A Systematic Review and Meta-Analysis. Nutrients. 2023 Apr 26;15(9):2080. doi: 10.3390/nu15092080. — View Citation
Ryu HS, Joo YH, Kim SO, Park KC, Youn SW. Influence of age and regional differences on skin elasticity as measured by the Cutometer. Skin Res Technol. 2008 Aug;14(3):354-8. doi: 10.1111/j.1600-0846.2008.00302.x. — View Citation
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Skin wrinkling volume (px^3) | Measurement of skin wrinkling volume (px^3) was evaluated at the crow's feet region and changes were analyzed and digitally photographed in all patients by VisioFace® 1000D (equipped with a high-resolution reflex camera) | 6 weeks | |
Primary | Skin wrinkling area (px^2) | Measurement of skin wrinkling area (px^2) was evaluated at the crow's feet region and changes were analyzed and digitally photographed in all patients by VisioFace® 1000D (equipped with a high-resolution reflex camera) | 6 weeks | |
Primary | Skin wrinkling depth (px) | Measurement of skin wrinkling depth (px) was evaluated at the crow's feet region and changes were analyzed and digitally photographed in all patients by VisioFace® 1000D (equipped with a high-resolution reflex camera) | 6 weeks | |
Primary | R0= Skin firmness (mm) | R0 was used as a measure of skin firmness (mm), assessed at the crow's feet region. A Cutometer® dual MPA 580 (Courage & Khazaka) was used to assess skin biomechanical properties | 6 weeks | |
Primary | R2= gross elasticity (%) of the skin | R2 was used as measure of skin gross elasticity (%), assessed at the crow's feet region. A Cutometer® dual MPA 580 (Courage & Khazaka) was used to assess skin biomechanical properties | 6 weeks | |
Primary | R5= Skin net elasticity (%) | R5 was used as measure of skin net elasticity (%), assessed at the crow's feet region. A Cutometer® dual MPA 580 (Courage & Khazaka) was used to assess skin biomechanical properties | 6 weeks | |
Primary | R7= Skin elastic recovery (%) | R7 was used as a measure of skin elastic recovery (%), assessed at the crow's feet region. A Cutometer® dual MPA 580 (Courage & Khazaka) was used to assess skin biomechanical properties | 6 weeks | |
Primary | R9= Skin fatigue (mm) | R9 was used as a measure of skin fatigue (mm), assessed at the crow's feet region, so a Cutometer® dual MPA 580 (Courage & Khazaka) was used to assess skin biomechanical properties | 6 weeks | |
Primary | Skin hydration (AU) | Measurement of skin hydration (AU) of the stratum corneum was performed at each study visit by the electrical capacitance method using a Corneometer® CM 825 (Courage & Khazaka, Cologne, Germany). | 6 weeks | |
Secondary | Subjective perception of product efficacy | After 6 weeks of treatment, the volunteers filled out questionnaires, to subjectively assess their perception of efficacy. A 3-point Likert scale with the following items: Dissatisfied, slightly satisfied and very satisfied, was used. | At (T6), six weeks after the trial began | |
Secondary | Subjective perception of the organoleptic characteristics of the product | After 6 weeks of treatment, the volunteers filled out questionnaires, to subjectively assess their subjective perception of the organoleptic properties. A 3-point Likert scale with the following items: Dissatisfied, slightly satisfied and very satisfied, was used. | At (T6), six weeks after the trial began | |
Secondary | Opinion on the degree of satisfaction with the product | After 6 weeks of treatment, the volunteers filled out questionnaires, to subjectively evaluate their level of satisfaction with the product. A 3-point Likert scale with the following items: Dissatisfied, slightly satisfied and very satisfied, was used. | At (T6), six weeks after the trial began |
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