Evaluating the Efficacy of a Dietary Supplement on Parameters of Skin Aging: a 12-Week, Randomized, Double-Blind, Placebo-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Crow's Feet Wrinkles
研究概览
简要总结
As the body ages, the skin experiences natural changes in structure and composition. These changes may manifest visibly as increased skin dryness, wrinkling, and a loss of firmness/elasticity. In this double-blind, randomized, placebo-controlled trial, the investigators will recruit healthy men and women with mild to moderate signs of skin aging and randomly assign them to either receive a HyaCera™ or placebo for 12 weeks. The investigators will perform a series of objective and subjective measurements to assess changes in skin condition. The investigators hypothesize that consumption of HyaCera™ leads to improvements in the general condition of the skin including skin hydration, crow's feet wrinkling, and other skin aging parameters.
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
- Double (Participant, Investigator)
盲法说明
Neither the participants nor the investigators will know the group assignment. Supplements will be prepared by the sponsor and marked with unidentifiable ID numbers before being sent to study site.
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female volunteers, 25 - 70 years old with mild to moderate fine lines and wrinkles
- •All ethnicities and skin types
- •Willing to maintain current skincare regimen on face, arms, and legs and withhold all facial and body treatments throughout the course of the study
排除标准
- •Self-reported pregnant or breastfeeding or planning to become pregnant during the course of the study
- •Any conditions on the face, arms and legs that would interfere with evaluations
- •Under treatment for any known health issues/medical conditions including chronic health conditions and skin diseases/conditions
结局指标
主要结局
Crow's Feet Wrinkles
时间窗: at week 0, Week 4, Week 8, and Week 12
Degree of crow's feet wrinkling will be measured via Visioscan®
Skin Smoothness
时间窗: at week 0, Week 4, Week 8, and Week 12
Skin smoothness will be measured via Visioscan®
Skin Hydration
时间窗: at week 0, Week 4, Week 8, and Week 12
Skin surface hydration will be measured via Corneometer® 825
次要结局
- Skin Elasticity(at week 0, Week 4, Week 8, and Week 12)
- Skin Scaliness(at week 0, Week 4, Week 8, and Week 12)
- Skin Barrier Function(at week 0, Week 4, Week 8, and Week 12)