NCT06727292招募中不适用
Biometrical Evaluation of the Efficacy of a Food Supplement Versus Placebo
Finzelberg GmbH & Co. KG2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年10月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Skin Physiological Parameters
研究概览
简要总结
The purpose of this clinical trial is to evaluate whether nutritional supplementation over a 2-month period improves skin physiological parameters. This is a national, single-center, double-blind, randomized pilot study.
The study will be conducted using a supplement and a placebo, the safety of which has been assured by the sponsor.
Participants will:
- Take a food supplement or a placebo once daily for 2 months
- Visit the study center at beginning, after 28 days and after 56 days of supplementation.
- Keep a diary of their skin status and tolerability
The secondary objective is to evaluate product characteristics and performance during normal use in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
the product is also masked
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Phototype: I to IV;
- •Subjects with normal to dry skin;
- •Subjects with healthy skin on the study area;
- •Non-smokers;
- •Has normal nutritional habits (not vegetarian/vegan);
- •Is not pregnant or lactating;
- •Has a BMI of 18 - 33 kg/m2;
- •Is willing to refrain from taking dietary supplements (at best not at all, in any case not during the last month before study start);
- •Willing not to use any oral products or any nutritional supplementation aiming at improving skin status during the course of the study;
- •No history of malabsorption diseases, liver diseases, or diseases of the lipid metabolism;
- •Uses no medication, which may interact with the study product
排除标准
- •For women: pregnant or nursing woman or woman planning to get pregnant during the study;
- •Cutaneous pathology on the study zone (eczema, etc.);
- •Subject with make-up on the day of the visit at the laboratory;
- •Use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the efficacy of the study product:
- •change in anti-wrinkle, smoothing and/or firming topical products within previous week on the studied zones,
- •non-invasive procedures within previous month on the studied zones,
- •intake of food supplement acting on skin within the three previous months,
- •invasive procedures:
- •deep chemical peeling within previous 3 months on the studied zones,
- •mesotherapy, dermapen, laser within previous 6 months on the studied zones,
- •botox and/or hyaluronic acid injections within previous 12 months on the studied zones;
- •Intake of vitamin substances and diets comprising a change of normal eating habits;
- •Known allergy to one or several investigational product´s ingredients;
- •Participation in a nutritional study within the last 30 days;
- •Surgical or internal diseases e.g. a metabolic or endocrine disease that may affect the outcome of the study (e.g. diabetes, liver diseases, kidney disorders) or having a history of medical or surgical events that may significantly affect the study outcome including any cardiovascular disease, skin disease, hypertension (>140/90 mm Hg in three repeated measurements).
结局指标
主要结局
Skin Physiological Parameters
时间窗: Skin physiological parameters will be assessed at Day 0, Day 28, Day 56
Changes in skin hydration: Measurement of skin hydration by means of a Corneometer CM825.
次要结局
- Subject satisfaction(It will be assessed at Day 28, Day 56)
- Adverse events(Adverse events will be assessed during the whole study from Day 0 to Day 56)
- Subject self-assessment quality of the skin and hair.(It will be assessed at Day 28, Day 56)
研究者
研究点 (2)
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