Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-24 @ 2:52 PM
NCT ID:
NCT04449159
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.)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
45 Years
Maximum Age:
60 Years
Study:
NCT04449159
Study Brief:
Protocol Section:
NCT04449159