A 12-Week, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Benefits of FloraGLO™ Lutein on Skin Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Objective Skin Hydration
研究概览
简要总结
Therefore, the present study is designed to contribute to the body of literature by investigating the effect of 12-weeks of lutein supplementation on multiple parameters of skin health and appearance in healthy women.
详细描述
This is a randomized, double-blind, placebo-controlled, parallel twelve-week study of the performance of an oral test product to evaluate the effects of twelve weeks of lutein supplementation on skin health and appearance in healthy women. A seven-day washout period will precede the evaluation period. The subjects in each cohort will use consume one softgel of their assigned test product (treatment or placebo) daily in the morning with breakfast for 12 weeks. Changes in skin condition and appearance as well as blood chemistry will be assessed using results from expert visual grading, instrumental assessments, skin and blood assays and subjective questionnaire responses. Subjects will be recruited during the winter season to account for seasonal variations of skin parameters.
Evaluation points will occur pre-application (Baseline; Week 0) and after 42 and 84 days of use (D42, D84; Week 6, Week 12). Data will be collected on the following outcomes:
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Skin Hydration 2. Skin texture/smoothness 2. Reduction of facial fine lines and wrinkles 3. Skin elasticity and firmness 4. Sagging skin, dry skin, skin tone, appearance from expert clinical grading and subjective questionnaire responses.
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Skin hydration 7. Skin collagen 8. Skin lipid content. 9. Skin Carotenoids
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Envelopes that contain information regarding the coding of treatment and placebo will be provided to Sponsor, Site, and PI and kept in a secure location. Envelopes will be readily available for the investigator or site to open in the event that it becomes necessary to know which product a participant is taking for the sake of the participant health care. The sponsor must be notified of any unblinding by the site within 24 hours.
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
- •Females in good health, and between the ages of 30 and 65 years old
- •Fitzpatrick Skin Type I-V
- •Mild to moderate loss of skin elasticity, wrinkles (global) and rough skin texture
- •Able to read, understand and sign an informed consent form
- •Willing and able to follow all study directions, attend study visits as scheduled and willing to accept the restrictions of the study
- •Willing and able to maintain regular diet, exercise, hydration, and sleep patterns throughout the study
排除标准
- •Participating in any other clinical study
- •Acute or chronic disease or medical condition
- •Unreliable or unlikely to be available for the duration of the study
- •Routine use of tanning bed(s)
- •History of abnormal response to sunshine
- •Current usage of medications with contraindication of enhancing sun exposure, or medications for skin conditions.
- •History of allergic reactions, skin sensitization and/or known allergies to cosmetic ingredients, toiletries, sunscreens, etc.
- •Immunocompromised subjects
- •Subject has a history of unconventional sleep patterns
- •Started Hormone Replacement Therapy within the last three months
- •Using oral contraception for less than three months
- •Known to be pregnant, lactating or planning to become pregnant within six months
- •Unable to communicate or cooperate with the Principal Investigator due to language problems, poor mental development, or impaired cerebral function
结局指标
主要结局
Objective Skin Hydration
时间窗: ANOVA including weeks 6 and 12
Corneometer Value
Subjective Skin Hydration
时间窗: ANOVA including weeks 6 and 12
Subjective Questionnaire Visual Analog Scale
次要结局
- Objective Skin Texture(ANOVA including weeks 6 and 12)
- Objective Facial Lines and Wrinkles(ANOVA including weeks 6 and 12)
- Skin Collagen SIAsScope(ANOVA including weeks 6 and 12)
- Skin Carotenoids(ANOVA including weeks 6 and 12)
- Subjective Facial Lines and Wrinkles(ANOVA including weeks 6 and 12)
- Skin Collagen Ultrasound(ANOVA including weeks 6 and 12)
- Subjective Skin Texture(ANOVA including weeks 6 and 12)
- Objective Skin elasticity(ANOVA including weeks 6 and 12)
- Skin Lipids(ANOVA including weeks 6 and 12)
- Objective Sagging skin, dry skin, skin tone, and overall appearance(ANOVA including weeks 6 and 12)
- Subjective Skin elasticity(ANOVA including weeks 6 and 12)
- Subjective Sagging skin, dry skin, skin tone, and overall appearance(ANOVA including weeks 6 and 12)