NCT06254209招募中不适用
Randomized and Double-blind Study to Evaluate the Physiological Effects on the Skin of 3 Food Supplements Versus Placebo in 40-60 Years Old Female Subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Nexira
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Firmness of the skin
研究概览
简要总结
The objective is to evaluate the effects on the skin of 3 foods supplements compared to placebo after daily intake for 3 months in female subjects presenting healthy skin.
Skin parameters measured are: the firmness of the skin and other biomechanical skin properties (elasticity, tonicity, density), cellulitis visibility, radiance complexion, skin condition (microrelief, skin barrier function and moisturizing)
详细描述
Study design: Monocentric, randomized, double blind, placebo controlled, 3 groups in parallel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Phototype II to IV (Fitzpatrick)
- •Visual skin radiance score (face) ≤ 7 (0 to 9 points numeric scale)
- •Tactile skin firmness score (cheek) ≤ 7 (0 to 9 points numeric scale)
- •Visual cellulite score (thigh) ≥ 3 (0 to 9 points numeric scale)
排除标准
- •Chronic pathology or systemic disorder
- •Subjects presenting imperfections on the test sites
- •Pregnant or who are planning to become pregnant
- •Medication or condition that may interfere with tested outcomes
结局指标
主要结局
Firmness of the skin
时间窗: Day 0 (inclusion) and Day 84 (last visit)
Cutometry measurements using Cutometer (cheekbone)
次要结局
- Score of fine lines visibility on face, assessed by panelist (trained technician)(Day 0 (inclusion) and Day 84 (last visit))
- Score of skin radiance of face, assessed by panelist (trained technician)(Day 0 (inclusion) and Day 84 (last visit))
- Score of skin firmness (tactile pinch of right cheek), assessed by panelist (trained technician)(Day 0 (inclusion) and Day 84 (last visit))
- Skin elasticity and tonicity(Day 0 (inclusion) and Day 84 (last visit))
- Score of nourishing aspect (hydration and quality aspect) of face, assessed by panelist (trained technician)(Day 0 (inclusion) and Day 84 (last visit))
- Skin density(Day 0 (inclusion) and Day 84 (last visit))
- Score of cellulite visibility (right thigh), assessed by panelist (trained technician)(Day 0 (inclusion) and Day 84 (last visit))
- Skin color texture - Haralick parameter (contrast & entropy - no unit)(Day 0 (inclusion) and Day 84 (last visit))
- Score of skin softness (tactile perception of right cheek), assessed by panelist (trained technician)(Day 0 (inclusion) and Day 84 (last visit))
- Dimpled skin - surface (mm2) of humps and dimples(Day 0 (inclusion) and Day 84 (last visit))
- Skin specular reflectance (spectral reflectance - no unit)(Day 0 (inclusion) and Day 84 (last visit))
- Dimpled skin - volume (mm3) of humps and dimples(Day 0 (inclusion) and Day 84 (last visit))
- Skin luminosity - CIELAB (L*a*b)(Day 0 (inclusion) and Day 84 (last visit))
- Skin barrier function (g/h/m²)(Day 0 (inclusion) and Day 84 (last visit))
- Self perceived questionnaire (4 scales)(Day 0 (inclusion), Day 42 (intermediate) and Day 84 (last visit))
- Skin roughness (mean height - µm)(Day 0 (inclusion) and Day 84 (last visit))
- Skin moisture (%)(Day 0 (inclusion) and Day 84 (last visit))
研究者
研究点 (2)
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