Status and phase
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About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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:
Prisoners
Males
Primary purpose
Allocation
Interventional model
Masking
45 participants in 3 patient groups, including a placebo group
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Central trial contact
Gayle M Gordillo, M.D.; Elizabeth A Murphy, BS
Data sourced from clinicaltrials.gov
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