The Ability of an Oral Supplement to Improve Skin Microperfusion, Hydration, Elasticity, and Barrier Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 6
- 主要终点
- Improvement in non-invasive skin assessment of elasticity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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:
- •Beta-blockers
- •Immunosuppressant's
- •Hydochlorothiazide,
- •ACE Inhibitors
- •Muscle relaxants
- •Stimulants
- •Prisoners
研究组 & 干预措施
Arm 1
15 subjects will be randomized to receive PrimaVie Herbal Supplement 125 mg to take twice daily for 14 weeks.
干预措施: PrimaVie Herbal Supplement 125 (Dietary Supplement)
Arm 3
15 subjects will be randomized to receive placebo (control supplement) to take twice daily for 14 weeks.
干预措施: Placebo (Drug)
Arm 2
15 subjects will be randomized to receive PrimaVie Herbal Supplement 250 mg to take twice daily for 14 weeks.
干预措施: PrimaVie Herbal Supplement 250 (Dietary Supplement)
结局指标
主要结局
Improvement in non-invasive skin assessment of elasticity
时间窗: 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 and ms units)
Improvement in non-invasive skin assessment of barrier function
时间窗: 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 using the DermaLab Combo Series (g/m2/h)
Improvement in non-invasive skin assessment of skin microperfusion
时间窗: 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)
Improvement in non-invasive skin assessment of hydration
时间窗: 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)
次要结局
- Gene Chip Analysis(14 weeks)
研究者
Gayle Gordillo
Professor
University of Pittsburgh