Influence of of Cream With the Silver Fir Wood Extract (Belinal) on Skin

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Placebo Controlled Study of Influence of Cream With the Silver Fir (Abies Alba) Wood Extract on the Skin

Conditions
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Wrinkles, Ageing, Photoprotection, Skin Care, Skin Cream

Intervention / Treatment
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* Other: Placebo cream
* Other: Belinal cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signs of skin aging (mimic wrinkles/ fine lines/ poor skin tone/ photoaged skin), Phototype II and III. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo cream<br>Cream with 0% Silver fir wood extract (Belinal) | Other: Placebo cream<br>* Subjects will use placebo cream twice per day for 12 weeks on one half of the face and of the gluteal area.<br>|
| Active Comparator: Belinal cream<br>Cream with 2% Silver fir wood extract (Belinal) | Other: Belinal cream<br>* Subjects will use Belinal cream twice per day for 12 weeks on the other half of the face and of the gluteal area.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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skin rejuvenation, anti-ageing effects, minimal erythema dose, dermis structure, physiological skin condition, wrinkling