Natreon Healthy Skin Study - PrimaVie Supplement
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 30 - 65 |
| Updated: | 6/10/2017 |
| Start Date: | February 2016 |
| End Date: | December 2019 |
| Contact: | Elizabeth A Murphy, BS |
| Email: | elizabeth.murphy@osumc.edu |
| Phone: | 9377283980 |
The Ability of an Oral Supplement to Improve Skin Microperfusion, Hydration, Elasticity, and Barrier Function
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.
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.
Subjects will be assessed based on they type of Fitzpatrick skin type they have, will be
return for a total of 6 study visits over 14 weeks where the following research activities
will take place through the course of the study: medical/dietary history, medications will
be recorded, supplement randomization based on one of the three arms will occur at study
visit 1, and distribution of the study product will occur at all study visits, supplement
tolerabiltity assessment, investigator and subject appearance assessment, photography of the
face (left, right and front) will be taken, non-invasive assessments including
Trans-epidermal Water Loss, hydration, elasticity, laser speckle perfusion, a skin biopsy of
left inner upper arm (only at study visits 2 and 6), adverse event review, and supplement
count/compliance review.
return for a total of 6 study visits over 14 weeks where the following research activities
will take place through the course of the study: medical/dietary history, medications will
be recorded, supplement randomization based on one of the three arms will occur at study
visit 1, and distribution of the study product will occur at all study visits, supplement
tolerabiltity assessment, investigator and subject appearance assessment, photography of the
face (left, right and front) will be taken, non-invasive assessments including
Trans-epidermal Water Loss, hydration, elasticity, laser speckle perfusion, a skin biopsy of
left inner upper arm (only at study visits 2 and 6), adverse event review, and supplement
count/compliance review.
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
We found this trial at
3
sites
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2050 Kenny Road
Columbus, Ohio 43210
Columbus, Ohio 43210
Principal Investigator: Gayle M Gordillo, M.D.
Phone: 614-685-3173
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