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| Name | Class |
|---|---|
| Abies Labs d.o.o. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo cream | Placebo Comparator | Cream with 0% Silver fir wood extract (Belinal) |
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| Belinal cream | Active Comparator | Cream with 2% Silver fir wood extract (Belinal) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo cream | Other | Subjects will use placebo cream twice per day for 12 weeks on one half of the face and of the gluteal area. |
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| Measure | Description | Time Frame |
|---|---|---|
| Improvement of photoprotective function of the skin | 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. | up to 12 weeks of the supplementation |
| Improvement of the dermis structure | 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. | up to 12 weeks of Belinal cream use |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of the area of the periorbital facial wrinkles | Area of selected periorbital wrinkles will be quantitatively assessed using CSI programme. | 6 and 12 weeks of Belinal cream use |
| Reduction of the volume of the periorbital facial wrinkles |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janko Zmitek, PhD | VIST - Faculty of Applied Sciences | Study Chair |
| Katja Zmitek, PhD | VIST - Faculty of Applied Sciences | Study Director |
| Nataša Tavčar, BSc | VIST - Faculty of Applied Sciences | Principal Investigator |
| Tina Pogačnik, BSc | VIST - Faculty of Applied Sciences | Principal Investigator |
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| Belinal cream | Other | Subjects will use Belinal cream twice per day for 12 weeks on the other half of the face and of the gluteal area. |
|
Volume of selected periorbital wrinkles will be quantitatively assessed using CSI programme.
| 6 and 12 weeks of Belinal cream use |
| Reduction of trans-epidermal water loss | Trans-epidermal water loss (TEWL) will be measured on the face using open-chamber probe. Lower TEWL indicates better skin barrier function and improved skin condition. | 6 and 12 weeks of Belinal cream use |
| Improved skin hydration | Skin hydration will be measured on the face. | 6 and 12 weeks of Belinal cream use |
| Improved skin elasticity | Skin elasticity will be measured on the face. | 6 and 12 weeks of Belinal cream use |
| An increase of the dermis thickness | Dermis thickness will be measured with ultrasound imaging of the skin. | 6 and 12 weeks of Belinal cream use |