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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
SINGLE
Enrollment
10
Subjects will use placebo cream twice per day for 12 weeks on one half of the face and of the gluteal area.
Subjects will use Belinal cream twice per day for 12 weeks on the other half of the face and of the gluteal area.
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.
Time frame: 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.
Time frame: up to 12 weeks of Belinal cream use
Reduction of the area of the periorbital facial wrinkles
Area of selected periorbital wrinkles will be quantitatively assessed using CSI programme.
Time frame: 6 and 12 weeks of Belinal cream use
Reduction of the volume of the periorbital facial wrinkles
Volume of selected periorbital wrinkles will be quantitatively assessed using CSI programme.
Time frame: 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.
Time frame: 6 and 12 weeks of Belinal cream use
Improved skin hydration
Skin hydration will be measured on the face.
Time frame: 6 and 12 weeks of Belinal cream use
Improved skin elasticity
Skin elasticity will be measured on the face.
Time frame: 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.
Time frame: 6 and 12 weeks of Belinal cream use
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