Natreon Healthy Skin Study - PrimaVie Supplement

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02762032

Enrollment

Registered

2016-05-04

Start date

2016-02-20

Completion date

2019-12-20

Last updated

2026-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Skin Biopsy, PrimaVie, Herbal Supplement

Brief 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.

Interventions

DIETARY_SUPPLEMENTPrimaVie Herbal Supplement 125

125 mg to take BID for 14 weeks in Arm 1

DIETARY_SUPPLEMENTPrimaVie Herbal Supplement 250

250 mg to take BID for 14 weeks in Arm 2

DRUGPlacebo

Placebo supplement to take BID for 14 weeks in Arm 3

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Improvement in Non-invasive Skin Assessment of Skin Microperfusion	14 weeks after oral supplementation	To see the improvement in noninvasive skin assessment of objective measurements such as skin microperfusion (laser speckle contrast imaging) (scale Pu). An increase in PU means improved perfusion of the skin.
Improvement in Non-invasive Skin Assessment of Hydration	14 weeks after oral supplementation	To see the improvement in noninvasive skin assessment of objective measurements such as skin hydration using the DermaLab Combo Series (unit of micro-Siemens uS), which are arbitrary. An increase in uS means improved skin hydration and improved skin barrier function.
Improvement in Non-invasive Skin Assessment of Elasticity	14 weeks after oral supplementation	To see the improvement in noninvasive skin assessment of objective measurements such as skin elasticity using the DermaLab Combo Series (mega Pascal mPa). An increase in mPA means worsening of skin elasticity.
Improvement in Non-invasive Skin Assessment of Barrier Function	14 weeks after oral supplementation	To see the improvement in noninvasive skin assessment of objective measurements such as barrier function using Trans-Epidermal Water Loss (TEWL) using the DermaLab Combo Series (g/m2/h). An increase in these units indicates a worsening of TEWL, and reduction of the barrier function of the skin.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORGayle M Gordillo, M.D.

Indiana University

Participant flow

Recruitment details

Study protocols and materials were approved by the Western Institutional Review Board. Written informed consent was collected from all subjects before participation. Female subjects aged between 30 and 65 were included in the study. Supplement randomization was done at study visit 1 and distribution of the supplements were done at each study visit.

Pre-assignment details

Subjects using medications for cardiovascular disease-related disorders (hydrochlororthiazide, aspirin, steroids, ACE inhibitors, beta-blockers and statins) were excluded from the study. Pregnant females and individuals being treatment for being immunocompromised were also not included.

Baseline characteristics

Characteristic	—
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	45 Participants
Age, Continuous	42.15 years STANDARD_DEVIATION 8.09
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	2 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	37 Participants
Region of Enrollment United States	15 participants
Sex: Female, Male Female	15 Participants
Sex: Female, Male Male	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 15	0 / 15	0 / 15
other Total, other adverse events	0 / 15	0 / 15	0 / 15
serious Total, serious adverse events	0 / 15	0 / 15	0 / 15

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 26, 2026