NCT06032598已完成不适用
Clinical-instrumental Evaluation of the Efficacy of Two Dietary Supplements Claiming Anti-aging Properties and Skin Complexion Improvement. A Double-blind, Randomized, Placebo-controlled Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Seppic
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Skin profilometry
研究概览
简要总结
The study is aimed to assess the efficacy of two dietary supplements composed of berry extracts in reducing skin aging signs and improving skin complexion.
详细描述
A double blind, parallel groups, placebo-controlled study is carried out on 90 healthy female subjects aged between 35 and 65 (±2) years old with phototypes from I to III, uneven skin tone, visible Crow's feet wrinkles and mild-moderate skin slackness at cheek level.
The study foresees 84 days of products intake. Evaluations of the parameters under study are performed at baseline, after 28, 56 and 84 days of products consumption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female subjects,
- •Caucasian ethnicity,
- •Age between 35 and 65 (limits of ±2 years old could be included)
- •Phototypes from I to III
- •Subject with uneven skin tone (grade 1-3 - internal clinical scale)
- •Subject with visible Crow's feet wrinkles (≥2 according to Skin Aging Atlas - Caucasian and Asian Type - Bazin Roland)
- •Subject with mild-moderate skin slackness at cheek level (grade 1-3 - internal clinical scale).
- •Willingness to not assume during the study period products other than the test product
- •Subjects registered with National Health Service (NHS)
- •Subjects certifying the truthfulness of the personal data disclosed to the investigator
- •Subjects able to understand the language used in the investigation centre and the information given by the investigator
- •Subjects able to respect the instructions given by the investigator as well as able to respect the study constraints and specific requirements
- •The pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) should be stable for at least one month without any changes expected or planned during the study
- •Commitment not to change the daily routine or the lifestyle
- •Subjects who have not been recently involved in any other similar study (at least one month of wash-out)
- •Subject under effective contraception (oral/not oral) therapy
- •Subjects who accept not to expose in intensive way to UV rays during the whole study duration.
- •Subject aware of the study procedures and having signed an informed consent form and privacy information form.
排除标准
- •Subject does not meet the inclusion criteria,
- •Subjects with acute or chronic diseases able to interfere with the outcome of the study or that are considered dangerous for the subject or incompatible with the study requirements
- •Subjects participating or planning to participate in other clinical trials
- •Subjects deprived of freedom by administrative or legal decision or under guardianship
- •Subjects not able to be contacted in case of emergency
- •Subjects admitted to a health or social facility
- •Subjects planning a hospitalisation during the study
- •Subjects who participated in a similar study without respecting an adequate washout period
- •Subjects having an acute, chronic or progressive illness liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
- •Subjects under pharmacological treatments that are considered incompatible with the study requirement by the investigator
- •Subjects having a skin disease or condition liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
- •Subject with known or suspected sensitization to one or more test formulation ingredients
- •Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential)
- •Consumption of food supplement(s) and/or use of topical skincare products with whitening activity currently or within the past 4 weeks before the study
- •Subjects accustomed to use tanning beds
- •Subjects taking medication with photosensitizing potential, drugs and/or dietary supplements able to induce skin coloring, corticoids, currently or during the month before the study.
结局指标
主要结局
Skin profilometry
时间窗: 84 days
Primos 3D
次要结局
- Skin homogeneity improvment from baseline(84 days)
- Self-assessment of product efficacy(84 days)
- Skin firmness(84 days)
- Skin color(84 days)
- Skin elasticity(84 days)
- Crow's feet(84 days)
- Skin antioxidant potential(84 days)
研究者
研究点 (2)
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