This study will demonstrate the ability of the oral supplement, PrimaVie® to improve skin microperfusion, hydration, elasticity and barrier function. 45 females will be enrolled in 1 of 3 arms where they will receive either 125 mg PrimaVie, 250 mg PrimaVie or placebo (control) to take twice daily for 14 weeks.
Who can participate
Age range
30 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects willing to discontinue any dietary or nutritional supplements, other than a general multivitamin, starting two weeks before onset of study and also during the study.
* Subjects must be willing to maintain their present diet with no major changes throughout the study.
* Subjects must be willing to take the dietary supplements as required by the study protocol twice daily.
* Female subjects must be between the ages of 30 to 65 years of age
* Subjects must provide written informed consent and are willing to comply with all study procedures.
Exclusion Criteria:
* Any dermatological disorder that may interfere with the accurate evaluation of the subject's skin.
* Subjects who are pregnant, breast feeding, or planning a pregnancy.
* Clinically significant unstable medical disorders.
* History of, diabetes, heart or kidney disease
* History of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study.
* Any skin disease in the area of the upper inner arm where the biopsies will be obtained.
* Currently taking the following medications:
* Steroids
* Beta-blockers
* Immunosuppressant's
* Hydochlorothiazide,
* Statins
* Aspirin
* ACE Inhibitors
* Muscle relaxants
* Stimulants
* Prisoners
* Males
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Improvement in Non-invasive Skin Assessment of Skin Microperfusion
Timeframe: 14 weeks after oral supplementation
2
Improvement in Non-invasive Skin Assessment of Hydration
Timeframe: 14 weeks after oral supplementation
3
Improvement in Non-invasive Skin Assessment of Elasticity
Timeframe: 14 weeks after oral supplementation
4
Improvement in Non-invasive Skin Assessment of Barrier Function