Clinical trial NCT04449159: Efficacy of Vinh Wellness Collagen on Skin Health
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Manifestations
Skin Abnormalities
Lead sponsor: Vinh Hoan Corporation
Sponsor class: INDUSTRY
Collaborators: name: KGK Science Inc.
First posted: 2020-06-26
Enrollment: 50
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Skin appearance is known to be influenced by endogenous and environmental factors, including nutrition, hormones, as well as exposure to chemicals, smoking, or ultraviolet radiation. The ability of nutritional supplements to enhance skin characteristics has received increasing attention as the population continues aging. A recent study assessed the correlation between nutrient consumption and skin-aging appearance, including skin wrinkles, dryness, and atrophy, and determined that higher intake of linoleic acid and vitamin C, as well as lower intake of fats and carbohydrates are linked with improved skin appearance. Moreover, clinical trials examining the effects of nutritional supplementation with proteins, vitamins, fatty acids, and trace minerals, have suggested that dietary compounds can modulate skin health and function.

As skin gets older it shows a decrease in epidermal thickness, with a flattening of the dermal-epidermal junction. The dermis is the skin layer directly below the epidermis and has decreases in thickness by about 1% per year throughout the adult lifespan. Structural components of the dermis include collagen, elastic fibers, and extrafibrillar matrix. The cosmetic industry has focused its research on supporting these connective tissue components, as they have been established to repair skin damage (i.e. wounds) and enhance the strength and radiance of the skin.

Collagen is the most abundant protein in mammals and is currently being utilized by a diverse number of industries including nutrition, cosmetic, and biomedical fields. Gelatin, which is used extensively in the food sector, is a hydrolyzed analog of collagen and is an excellent source of protein. A subsequent enzymatic degradation of gelatin results in the generation of collagen hydrolysate (CH), which contains peptides of an average molecular weight of 3-6 kDa. Human bioavailability studies have demonstrated that hydrolyzed collagen peptides are present in the blood within 2 h following oral ingestion of gelatin derived from chicken or fish and are present up to 24 h later.

A double-blind, placebo-controlled trial on 69 women treated with a daily CH treatment or placebo for 8 weeks reported that skin elasticity was significantly improved. Skin moisture and skin evaporation were also enhanced but did not reach statistical significance relative to the placebo group. In addition, other studies have examined the effect of daily ingestion of CH (10 g) or placebo on skin hydration in healthy Japanese women over 2 months and found that there was a gradual improvement in skin water absorption capacity. The objective of this randomized, triple-blind, placebo-controlled study is to evaluate the efficacy of Vinh Wellness Collagen, a CH derived from pangasius skin, on skin elasticity, wrinkles, and hydration over 12 weeks of use.

Eligibility criteria: 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.)

Primary outcomes:
measure: Cheek skin elasticity
timeFrame: 12 weeks from baseline
Secondary outcomes:
measure: Underarm skin elasticity
timeFrame: 12 weeks from baseline
measure: Cheek Skin hydration
timeFrame: 12 weeks from baseline
measure: Nasolabial wrinkles
timeFrame: 12 weeks from baseliine
measure: Skin quality using visual analogue scale (VAS) scores
timeFrame: 12 weeks from baseliine
measure: Net Skin elasticity
timeFrame: Baseline, week 6 and week 12.
measure: Biological elasticity
timeFrame: Baseline, week 6 and week 12.
measure: Viscoelastic recovery (overall elasticity)
timeFrame: 12 weeks from baseliine
measure: Systolic and diastolic blood pressure
timeFrame: Baseline, week 6 and week 12.
measure: Heart rate
timeFrame: Baseline, week 6 and week 12.
measure: Body weight
timeFrame: Baseline, week 6 and week 12.
measure: Body mass index (BMI)
timeFrame: Baseline, week 6 and week 12.
measure: Complete blood count (CBC)
timeFrame: Baseline, week 6 and week 12.
measure: Aspartate transaminase (AST)
timeFrame: Baseline, week 6 and week 12.
measure: Alanine transaminase (ALT)
timeFrame: Baseline, week 6 and week 12.
measure: Bilirubin
timeFrame: Baseline, week 6 and week 12.
measure: Sodium ion
timeFrame: Baseline, week 6 and week 12.
measure: Potassium ion
timeFrame: Baseline, week 6 and week 12.
measure: Chloride ion
timeFrame: Baseline, week 6 and week 12.
measure: Creatinine
timeFrame: Baseline, week 6 and week 12.
measure: eGFR
timeFrame: Baseline, week 6 and week 12.
Other outcomes:
Locations:
city: London
country: Canada
facility: KGK Science Inc
state: Ontario
Study officials:
affiliation: KGK Science Inc.
name: Tetyana Pelipyagina, MD
role: PRINCIPAL_INVESTIGATOR
References: