A 56-Day Single-Arm Exploratory Study of NatureU® Mind Care BeautyU Caps on Crow's-Feet Wrinkle Count, Skin Hydration, and Related Skin-Aging Parameters in Adult Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Change From Baseline in Crow's-Feet Wrinkle Count at Day 56
研究概览
简要总结
This was a 56-day, single-center, open-label, single-arm exploratory study evaluating within-participant changes in skin-aging parameters after daily oral intake of NatureU® Mind Care BeautyU Caps in adult women. Participants took one capsule daily for 56 days. The primary outcome was change from baseline in crow's-feet wrinkle count at Day 56 assessed by PRIMOS CR imaging. The secondary outcome was change from baseline in stratum corneum hydration at Day 56 assessed by Corneometer CM 825. Additional exploratory outcomes included other wrinkle topography parameters, skin elasticity, radiance, pigmentation, pore-related parameters, dermal thickness and density, and participant-reported skin appearance outcomes.
详细描述
The study was designed as an exploratory, signal-generating human evaluation of an oral nutricosmetic supplement. Adult female participants received NatureU® Mind Care BeautyU Caps once daily for 56 days and underwent skin assessments at baseline, Day 28, and Day 56. Instrumental assessments included PRIMOS CR imaging for wrinkle-related parameters and Corneometer CM 825 measurement for stratum corneum hydration. Additional skin-aging parameters were assessed using validated or commonly used skin analysis instruments according to the study protocol. The study was single-arm and open-label, with no placebo or parallel control group. Analyses were based on participants who completed the study assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 36 Years 至 56 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adult woman aged 36 to 56 years, inclusive.
- •Healthy participant as judged by the investigator.
- •Cheek skin hydration below 60 C.U.
- •Visible crow's-feet wrinkles.
- •Facial laxity or reduced facial radiance.
- •At least one visible facial spot meeting the prespecified size and ITA value criteria.
- •Willing to take the study product once daily for 56 consecutive days.
- •Willing to complete scheduled skin assessments at baseline, Day 28, and Day
- •Willing to maintain regular lifestyle habits during the study period.
- •Willing to avoid confounding skincare products, cosmetic procedures, medications, and health products during the study period.
- •Provided written informed consent before any study-related procedure.
排除标准
- •Skin condition that could interfere with study assessments.
- •Highly allergic constitution.
- •Known allergy or intolerance to any ingredient of the study product.
- •Pregnant or lactating.
- •Planned pregnancy during the study period.
- •Severe systemic illness.
- •Serious psychiatric disorder.
- •Serious endocrine disorder.
- •Recent participation in another clinical study.
- •Recent use of products or procedures that could influence skin outcomes.
- •Use of other oral or topical products that could interfere with skin-aging assessments during the study period.
- •Recent cosmetic dermatology procedures or treatments that could affect the target assessment areas.
- •Inability to comply with study procedures.
- •Any condition judged by the investigator to make participation inappropriate.
研究组 & 干预措施
NatureU® Mind Care BeautyU Caps
Participants received NatureU® Mind Care BeautyU Caps, one capsule orally once daily for 56 days.
干预措施: NatureU® Mind Care BeautyU Caps (Dietary Supplement)
结局指标
主要结局
Change From Baseline in Crow's-Feet Wrinkle Count at Day 56
时间窗: Baseline and Day 56
Crow's-feet wrinkle count was assessed using PRIMOS CR imaging. The primary endpoint was the within-participant change from baseline to Day 56.
次要结局
- Change From Baseline in Stratum Corneum Hydration at Day 56(Baseline and Day 56)