Skin Abnormalities Clinical Trial
Official title:
A Randomized, Triple-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy of Vinh Wellness Collagen on Skin Elasticity, Wrinkles, and Moisturizing Effect
NCT number | NCT04449159 |
Other study ID # | 16ASHV |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 25, 2016 |
Est. completion date | May 16, 2018 |
Verified date | July 2020 |
Source | Vinh Hoan Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The most visible signs of aging are on the skin. As skin gets older it shows a decrease in epidermal thickness, with a flattening of the dermal-epidermal junction. At the same time, loss of elasticity and wrinkle formation begin. The objective of this randomized, triple-blind, placebo-controlled study is to evaluate the efficacy of Vinh Wellness Collagen on skin elasticity, wrinkles, and hydration over 12 weeks.
Status | Completed |
Enrollment | 50 |
Est. completion date | May 16, 2018 |
Est. primary completion date | May 16, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 45 Years to 60 Years |
Eligibility |
Inclusion Criteria: 1. Females aged 45 to 60 years 2. BMI between 20.0-29.9 kg/m2 (±1 kg/m2) 3. Female participant was not of child bearing potential, defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation, or are post-menopausal (natural or surgically with > 1 year since last menstruation) OR Females of childbearing potential agreed to use a medically approved method of birth control and have a negative urine pregnancy test result. A minimum of 3-months stable dose was required for females on a hormonal birth control. Acceptable methods of birth control included: 1. Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System) 2. Double-barrier method 3. Intrauterine devices 4. Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s) 5. Vasectomy of partner (shown successful as per appropriate follow-up) 4. Healthy as determined by laboratory results, medical history, and physical exam 5. No known medical or psychological condition that in the investigator's opinion would interfere with study participation 6. Has given voluntary, written, informed consent to participate in the study 7. Displayed visible signs of natural and photoaging in the face, as assessed through skin condition questionnaire at screening 8. Agreed to avoid prolonged exposure to UV radiation for the duration of the study Exclusion Criteria: 1. Women who were pregnant, breastfeeding, or planning to become pregnant during the trial 2. Acute or chronic skin disease (i.e. atopic dermatitis, eczema, rosacea, psoriasis) or dermatological disorders (scars, sunburns, moles) near the test sites 3. Topical medications used near the test area within 6 weeks prior to baseline 4. Use of tretinoin, adapalene, tazarotene or other topical medications for the treatment of skin aging near the test site during the 12 weeks preceding baseline 5. Application of topical alpha hydroxyl acids near the test site within 28 days of baseline 6. Use of, or planning to use, systemic corticosteroids within 28 days of baseline or during the study 7. Use of natural health supplements for improving the skin (specifically high concentrations of vitamin A, to be assessed on an individual basis) 8. Planned or unavoidable exposure to intense ultraviolet (UV) radiation during the study (such as sun tanning salons, vacations in a sunny climate or outdoor worker) 9. Botulinum toxin A (Botox) injection treatment near the test sites within 2 years of baseline or plan to receive this treatment during the study 10. Filler injection (collagen, hyaluronic acid, etc.) near the test sites within 2 years of baseline or plan to receive this treatment during the study 11. Tattoos on or near the test area 12. Unstable medical conditions 13. Consumption of more than 2 alcoholic drinks /day 14. Alcohol or drug abuse within 6 months of baseline 15. Tobacco use within 1 year of baseline 16. Use of medical marijuana 17. Participation in clinical research trial within 30 days prior to randomization 18. Allergy or sensitivity to study ingredients or who do not consume fish products (i.e. vegetarians) 19. Participants who were on a low protein diet 20. Cognitively impaired and/or unable to give informed consent 21. Any other condition which in the 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 (e.g. cardiovascular, renal, lung, diabetes, psychiatric illness, bleeding disorders, etc.) |
Country | Name | City | State |
---|---|---|---|
Canada | KGK Science Inc | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Vinh Hoan Corporation | KGK Science Inc. |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cheek skin elasticity | Cheek skin elasticity will be measured using the Cutometer® (MPA 580), which applies the suction method of negative pressure. The skin is drawn into the aperture of the probe using negative pressure, and after a defined time, is released again. The resistance of the skin to the negative pressure (firmness) and its ability to return into its original position (elasticity) are displayed as curves (penetration depth in mm/time) in real time during the analysis.The difference in cheek skin elasticity, measured as Gross skin elasticity (R2), between Vinh Wellness Collagen and placebo supplemented participants after 12 weeks. Cheek skin elasticity will be on a scale of 0-100; 0= no improvement, 100 = great improvement. | 12 weeks from baseline | |
Secondary | Underarm skin elasticity | Underarm elasticity will be measured using the Cutometer® (MPA 580), which applies the suction method of negative pressure. The skin is drawn into the aperture of the probe using negative pressure, and after a defined time, is released again. The resistance of the skin to the negative pressure (firmness) and its ability to return into its original position (elasticity) are displayed as curves (penetration depth in mm/time) in real time during the analysis. The difference in underarm skin elasticity between Vinh Wellness Collagen and placebo supplemented participants after 12 weeks. Underarm skin elasticity will be on a scale of 0-100; 0= no improvement, 100 = great improvement. | 12 weeks from baseline | |
Secondary | Cheek Skin hydration | Cheek skin hydration is evaluated by the Corneometer® (CM 825) using the capacitance method, which is based on the different dielectric constant of water and other substances. Using the corneometer probe, an electric scatter field penetrates ting during the measurement and the dielectricity is determined. The results are stored on the device software as arbitrary units. The difference in cheek skin hydration between Vinh Wellness Collagen and placebo supplemented participants after 12 weeks. Cheek skin hydration will be on a scale of 0-100; 0= no improvement, 100 = great improvement. | 12 weeks from baseline | |
Secondary | Nasolabial wrinkles | Nasolabial skin wrinkles will be measured by the Modified Fitzpatrick Wrinkle Scale using images acquired by VISIA imaging which utilizes multi-spectral imaging and analysis capture visual information for wrinkles. The difference in nasolabial wrinkles between placebo and Vinh Wellness Collagen participants after 12 weeks of supplementation. The Modified Fitzpatrick Wrinkle Scale (MFWS) is a validated questionnaire that can evaluate skin wrinkle severity. It is on a scale of 0-3; 0 = no wrinkle, 3 = deep wrinkle. | 12 weeks from baseliine | |
Secondary | Skin quality using visual analogue scale (VAS) scores | Skin quality takes account of different measures including skin elasticity, skin hydration, radiance of skin, skin firmness, skin wrinkles and overall feel of skin. Each of these parameters are measured on a scale of 0 - 100; 0 = no improvement. 100 - great improvement. The difference in skin quality VAS scores between placebo and Vinh Wellness Collagen supplemented participants after 12 weeks of supplementation ona scale of 0 - 100; 0 = no improvement, 100 - great improvement. | 12 weeks from baseliine | |
Secondary | Net Skin elasticity | The difference in cheek skin elasticity measured as Net Skin elasticity (R5), between Vinh Wellness Collagen and placebo supplemented participants after 12 weeks. Net skin elasticity is the elastic (immediate stretch) component of the skin without the viscous deformation. Data is represented as the difference between baseline and week 6, baseline and week 12 and between week 6 and week 12. A negative value indicates loss of skin elasticity while a positive number denotes an improved elasticity | Baseline, week 6 and week 12. | |
Secondary | Biological elasticity | This is a measure of skin recovery after deformation. The difference in cheek skin elasticity, measured as biological elasticity (R7), between Vinh Wellness Collagen and placebo supplemented participants after 12 weeks. Data is represented as the difference between baseline and week 6, baseline and week 12 and between week 6 and week 12. A negative value indicates loss of skin elasticity while a positive number denotes an improved elasticity | Baseline, week 6 and week 12. | |
Secondary | Viscoelastic recovery (overall elasticity) | This is a measure of overall skin elasticity. It is calculated using viscous recovery area of the skin relative to the maximum recovery area. Increases in elasticity are considered an improvement. | 12 weeks from baseliine | |
Secondary | Systolic and diastolic blood pressure | Average blood pressure (systolic and diastolic) values for the Vihn Wellness Collagen group will be compared with those of the placebo group using statistical analysis to determine significant difference between the two groups. In addition, within group comparison will be made to determine time-dependent change between baseline versus week 6, baseline versus week 12 as well as week 6 versus week 12. | Baseline, week 6 and week 12. | |
Secondary | Heart rate | Average heart rate values for the Vihn Wellness Collagen group will be compared with those of the placebo group using statistical analysis to determine significant difference between the two groups. In addition, within group comparison will be made to determine time-dependent change between baseline versus week 6, baseline versus week 12 as well as week 6 versus week 12. | Baseline, week 6 and week 12. | |
Secondary | Body weight | Average body weight values for the Vihn Wellness Collagen group will be compared with those of the placebo group using statistical analysis to determine significant difference between the two groups. In addition, within group comparison will be made to determine time-dependent change between baseline versus week 6, baseline versus week 12 as well as week 6 versus week 12. | Baseline, week 6 and week 12. | |
Secondary | Body mass index (BMI) | Average BMI values for the Vihn Wellness Collagen group will be compared with those of the placebo group using statistical analysis to determine significant difference between the two groups. In addition, within group comparison will be made to determine time-dependent change between baseline versus week 6, baseline versus week 12 as well as week 6 versus week 12. | Baseline, week 6 and week 12. | |
Secondary | Complete blood count (CBC) | Average CBC values for the Vihn Wellness Collagen group will be compared with those of the placebo group using statistical analysis to determine significant difference between the two groups. In addition, within group comparison will be made to determine time-dependent change between baseline and week 6, baseline and week 12 as well as week 6 and week 12. | Baseline, week 6 and week 12. | |
Secondary | Aspartate transaminase (AST) | Average AST values for the Vihn Wellness Collagen group will be compared with those of the placebo group using statistical analysis to determine significant difference between the two groups. In addition, within group comparison will be made to determine time-dependent change between baseline versus week 6, baseline versus week 12 as well as week 6 versus week 12. | Baseline, week 6 and week 12. | |
Secondary | Alanine transaminase (ALT) | Average ALT values for the Vihn Wellness Collagen group will be compared with those of the placebo group using statistical analysis to determine significant difference between the two groups. In addition, within group comparison will be made to determine time-dependent change between baseline versus week 6, baseline versus week 12 as well as week 6 versus week 12. | Baseline, week 6 and week 12. | |
Secondary | Bilirubin | Average bilirubin values for the Vihn Wellness Collagen group will be compared with those of the placebo group using statistical analysis to determine significant difference between the two groups. In addition, within group comparison will be made to determine time-dependent change between baseline versus week 6, baseline versus week 12 as well as week 6 versus week 12. | Baseline, week 6 and week 12. | |
Secondary | Sodium ion | Average sodium ion values for the Vihn Wellness Collagen group will be compared with those of the placebo group using statistical analysis to determine significant difference between the two groups. In addition, within group comparison will be made to determine time-dependent change between baseline versus week 6, baseline versus week 12 as well as week 6 versus week 12. | Baseline, week 6 and week 12. | |
Secondary | Potassium ion | Average potassium ion values for the Vihn Wellness Collagen group will be compared with those of the placebo group using statistical analysis to determine significant difference between the two groups. In addition, within group comparison will be made to determine time-dependent change between baseline versus week 6, baseline versus week 12 as well as week 6 versus week 12. | Baseline, week 6 and week 12. | |
Secondary | Chloride ion | Average chloride ion values for the Vihn Wellness Collagen group will be compared with those of the placebo group using statistical analysis to determine significant difference between the two groups. In addition, within group comparison will be made to determine time-dependent change between baseline versus week 6, baseline versus week 12 as well as week 6 versus week 12. | Baseline, week 6 and week 12. | |
Secondary | Creatinine | Average creatinine values for the Vihn Wellness Collagen group will be compared with those of the placebo group using statistical analysis to determine significant difference between the two groups. In addition, within group comparison will be made to determine time-dependent change between baseline versus week 6, baseline versus week 12 as well as week 6 versus week 12. | Baseline, week 6 and week 12. | |
Secondary | eGFR | Average eGFR values for the Vihn Wellness Collagen group will be compared with those of the placebo group using statistical analysis to determine significant difference between the two groups. In addition, within group comparison will be made to determine time-dependent change between baseline versus week 6, baseline versus week 12 as well as week 6 versus week 12. | Baseline, week 6 and week 12. |
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