Status:
COMPLETED
Efficacy of Vinh Wellness Collagen on Skin Health
Lead Sponsor:
Vinh Hoan Corporation
Collaborating Sponsors:
KGK Science Inc.
Conditions:
Skin Manifestations
Skin Abnormalities
Eligibility:
FEMALE
45-60 years
Phase:
NA
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...
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 nu...
Eligibility Criteria
Inclusion
- 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)
- 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:
- 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
Exclusion
- 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
- Use of medical marijuana
- Participation in clinical research trial within 30 days prior to randomization
- Allergy or sensitivity to study ingredients or who do not consume fish products (i.e. vegetarians)
- Participants who were on a low protein diet
- Cognitively impaired and/or unable to give informed consent
- 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.)
Key Trial Info
Start Date :
November 25 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 16 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04449159
Start Date
November 25 2016
End Date
May 16 2018
Last Update
July 22 2020
Active Locations (1)
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1
KGK Science Inc
London, Ontario, Canada, N6A 5R8