Placebo Controlled Study of Influence of Cream With the Silver Fir (Abies Alba) Wood Extract on the Skin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 主要终点
- Improvement of the dermis structure
研究概览
简要总结
Objective of the study is to determine the influence of the cream with Silver fir wood (Abies alba) extract (Belinal) on the skin parameters and functions in comparison to the placebo cream. 10 healthy female subjects will use the test cream on one half and placebo cream on the other half of the face and of the gluteal part twice a day for 12 weeks. Various face skin parameters will be evaluated before the cream use (the baseline), after 6 and after 12 weeks of the cream use. To evaluate the photoprotective potential of Belinal the minimal erythema dose (MED) will be determined before (the baseline) and after 12 weeks of the cream use at the gluteal area.
详细描述
Objective of the study is to determine the influence of the cream with Silver fir wood (Abies alba) extract (Belinal; 2% cream) on the skin parameters and functions in comparison to the placebo cream. 10 healthy female subjects will use the test cream on one half and placebo cream on the other half of the face and of the gluteal area (split-face and split-gluteal area ) twice a day for 12 weeks. Face skin parameters will be evaluated before the cream use (the baseline), after 6 and after 12 weeks of the cream use. The photoprotective potential of Belinal will be evaluated with a determination of the minimal erythema dose (MED) at the gluteal area before (the baseline) and after 12 weeks of the cream use. Comparison will be done as the mean of the individual ratios. The differences between the before-after condition will be analyzed with the statistical test of analysis of variance. In case of failure to find homogeneity in the variances the nonparametric ANOVA, the Willcoxon test, will be used. The results will be expressed as mean ± standard error for each group with a significance level of 0.05 for all the statistical tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Signs of skin aging (mimic wrinkles/ fine lines/ poor skin tone/ photoaged skin),
- •Phototype II and III.
排除标准
- •Allergy to ingredients of tested products
- •Diagnosed diabetes
- •Thyroid disease
- •Inflammatory dermatoses
- •Regular use of dietary supplements 6 months or less before start of the study,
- •Invasive rejuvenation treatments (botox injections, hyaluronic acid fillers, needle rollers, needle mesotherapy, etc.) 6 months or less prior to start of the study,
- •Non-invasive rejuvenation treatments (radiofrequency, electrotherapy, ultrasound therapy, no-needle mesotherapy, etc.) 3 months or less prior to start of the study,
- •Regular, at least 14 day use of anti-aging cosmetic products containing peptides/ polyphenols/ stem cells extracts/ vitamins in high concentration/ AHAs/ BHAs/ vitamin A or its derivatives) three months or less prior to start of the study,
- •Gluteal hyperpigmentation,
- •Expected sunbathing (also in solariums) within the study period.
研究组 & 干预措施
Placebo cream
Cream with 0% Silver fir wood extract (Belinal)
干预措施: Placebo cream (Other)
Belinal cream
Cream with 2% Silver fir wood extract (Belinal)
干预措施: Belinal cream (Other)
结局指标
主要结局
Improvement of the dermis structure
时间窗: up to 12 weeks of Belinal cream use
Ultrasound (US) images of the dermis will be taken and intensity of the dermis determined. Higher intensity of the dermis US images indicates improvement of the collagen and elastin network.
Improvement of photoprotective function of the skin
时间窗: up to 12 weeks of the supplementation
Minimal erythema dose (MED) of the skin will be determined. Skin on the gluteal part of the body will be exposed to 10 different doses of UVB light and 24 hours after exposure MED will be determined. Higher MED indicates better photoprotective function of the skin.
次要结局
- An increase of the dermis thickness(6 and 12 weeks of Belinal cream use)
- Reduction of the area of the periorbital facial wrinkles(6 and 12 weeks of Belinal cream use)
- Reduction of the volume of the periorbital facial wrinkles(6 and 12 weeks of Belinal cream use)
- Reduction of trans-epidermal water loss(6 and 12 weeks of Belinal cream use)
- Improved skin hydration(6 and 12 weeks of Belinal cream use)
- Improved skin elasticity(6 and 12 weeks of Belinal cream use)