NCT02191852已完成1 期
A Pharmacokinetic Study on the Antioxidant Activity of Seresis® in the Skin: an Open, Uncontrolled, Non-randomized Intra-individual Pilot Trial in Healthy, Young Female Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 主要终点
- Total antioxidant capacity in skin biopsies
研究概览
简要总结
Study to evaluate the total antioxidant capacity of Seresis® (with Thiobarbituric acid reactive substances (TBARS) assays)) in the skin; as well as in buccal mucosa cells (BMCs) and in plasma, compared to baseline values; furthermore to detect the quantitative enrichment of individual antioxidant compounds contained in the product and to investigate whether or not some of them accumulate in target tissues such as skin, BMCs and plasma
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female volunteers between 18 and 30 years
- •With skin type II or skin type III
- •BMI < 25
- •Non-smokers
- •Volunteers who have given their written informed consent according to Good Clinical Practice (GCP) and local regulations
排除标准
- •Any serious disorder that may interfere with her participation to the trial and evaluation of the safety of the test drug (e.g. liver and/or renal disease, hypervitaminosis A, psychic disorder, etc.), and/or treatment with chronic medication
- •Pre-treatment (less than 2 weeks prior to inclusion in this trial) and/or concomitant treatment with any drug that may influence the trial symptomatology and may interfere with evaluation of the safety of the test drug (e.g. vitamins and minerals supplementation)
- •Relevant allergy or known hypersensitivity to the investigational drug or its excipients
- •High performance sports
- •Alcohol and drug abuse according to Diagnostic and Statistics Manual, Version IV (DSM-IV)
- •Female volunteers in child-bearing age not using adequate means of birth control (contraceptive pills, Intrauterine devices (IUDs), sterilisation)
- •Pregnancy and/or lactation
- •Known abnormal values of the lab tests (if detected after enrolment, subjects will continue the treatment provided there are no medical objections)
- •Abnormal values of low density lipoproteins (LDL) and triglycerides (TGL) levels in blood
- •Participation in another clinical trial within the last 4 weeks and concurrent participation in another clinical trial
- •Specific dietary requirements that do not allow the volunteers to meet the dietary guidelines set out for this study
研究组 & 干预措施
Seresis®
Experimental
2 capsules per day for a period of 16 consecutive weeks
干预措施: Seresis® (Drug)
结局指标
主要结局
Total antioxidant capacity in skin biopsies
时间窗: Day 0, Day 112
次要结局
- Total antioxidant capacity in skin biopsies(Day 0, Day 56)
- Total antioxidant capacity in buccal mucosa cells (BMCs)(Day 0, 14, 28, 42, 56, 84, 112)
- Total antioxidant capacity in plasma(Day 0, 14, 28, 42, 56, 84, 112)
- Plasma levels of vitamin C and E and carotenoids(Day 0, 14, 28, 42, 56, 84, 112)
- Levels of vitamin E and carotenoids in skin biopsies(Day 0, 56, 112)
- Levels of vitamin E and carotenoids in BMCs(Day 0, 14, 28, 42, 56, 84, 112)
- Number of subjects with adverse events(up to 119 days)
- Assessment of tolerability by investigator on a 4-point scale(Day 112)
- Assessment of tolerability by volunteers on a 4-point scale(Day 112)
- Number of patients with abnormal changes in laboratory parameters(up to 112 days)
研究者
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