NCT02762032

Natreon Healthy Skin Study - PrimaVie Supplement

The Ability of an Oral Supplement to Improve Skin Microperfusion, Hydration, Elasticity, and Barrier Function

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Ohio State University · Academic / Other
• Sex: Female
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	PrimaVie Herbal Supplement 125	125 mg to take BID for 14 weeks in Arm 1
DIETARY_SUPPLEMENT	PrimaVie Herbal Supplement 250	250 mg to take BID for 14 weeks in Arm 2
DRUG	Placebo	Placebo supplement to take BID for 14 weeks in Arm 3

Timeline

• Start date: 2016-02-01
• Primary completion: 2018-12-01
• Completion: 2019-12-01
• First posted: 2016-05-04
• Last updated: 2017-07-24

Locations

3 sites across 1 country: United States