Efficacy of Vinh Wellness Collagen on Skin Health

NCT04449159 | Completed DMC

• 1 other identifier: 16ASHV
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Manifestations; Skin Abnormalities

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• Underarm skin elasticity

  12 weeks from baseline

• Cheek Skin hydration

  12 weeks from baseline

• Nasolabial wrinkles

  12 weeks from baseliine

• Skin quality using visual analogue scale (VAS) scores

  12 weeks from baseliine

• Net Skin elasticity

  Baseline, week 6 and week 12.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Vinh Wellness Collagen

EXPERIMENTAL

Dietary Supplement: Vinh Wellness Collagen

Interventions

Vinh Wellness Collagen DIETARY_SUPPLEMENT

Vinh Wellness Collagen is hydrolyzed collagen

Vinh Wellness Collagen

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Females aged 45 to 60 years
• BMI between 20.0-29.9 kg/m2 (±1 kg/m2)
• 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)
• 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:
• 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)
• Double-barrier method
• Intrauterine devices
• Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
• Vasectomy of partner (shown successful as per appropriate follow-up)
• Healthy as determined by laboratory results, medical history, and physical exam
• No known medical or psychological condition that in the investigator's opinion would interfere with study participation
• Has given voluntary, written, informed consent to participate in the study
• Displayed visible signs of natural and photoaging in the face, as assessed through skin condition questionnaire at screening
• Agreed to avoid prolonged exposure to UV radiation for the duration of the study

You may not qualify if:

• Women who were pregnant, breastfeeding, or planning to become pregnant during the trial
• Acute or chronic skin disease (i.e. atopic dermatitis, eczema, rosacea, psoriasis) or dermatological disorders (scars, sunburns, moles) near the test sites
• Topical medications used near the test area within 6 weeks prior to baseline
• 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
• Application of topical alpha hydroxyl acids near the test site within 28 days of baseline
• Use of, or planning to use, systemic corticosteroids within 28 days of baseline or during the study
• Use of natural health supplements for improving the skin (specifically high concentrations of vitamin A, to be assessed on an individual basis)
• 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)
• Botulinum toxin A (Botox) injection treatment near the test sites within 2 years of baseline or plan to receive this treatment during the study
• Filler injection (collagen, hyaluronic acid, etc.) near the test sites within 2 years of baseline or plan to receive this treatment during the study
• Tattoos on or near the test area
• Unstable medical conditions
• Consumption of more than 2 alcoholic drinks /day
• Alcohol or drug abuse within 6 months of baseline
• Tobacco use within 1 year of baseline

Sponsors & Collaborators

• Vinh Hoan Corporation: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc

London, Ontario, N6A 5R8, Canada

Location

MeSH Terms

Conditions

Skin Manifestations; Skin Abnormalities

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Tetyana Pelipyagina, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 26, 2020
• Study Start: November 25, 2016
• Primary Completion: May 16, 2018
• Study Completion: May 16, 2018
• Last Updated: July 22, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)