Clinical trial NCT02603029: Influence of of Cream With the Silver Fir Wood Extract (Belinal) on Skin
Official title: Placebo Controlled Study of Influence of Cream With the Silver Fir (Abies Alba) Wood Extract on the Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrinkles
Ageing
Photoprotection
Skin Care
Skin Cream
Keywords: skin rejuvenation
anti-ageing effects
minimal erythema dose
dermis structure
physiological skin condition
wrinkling
Lead sponsor: VIST - Faculty of Applied Sciences
Sponsor class: OTHER
Collaborators: name: Abies Labs d.o.o.
First posted: 2015-11-11
Enrollment: 10
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Improvement of photoprotective function of the skin
timeFrame: up to 12 weeks of the supplementation
measure: Improvement of the dermis structure
timeFrame: up to 12 weeks of Belinal cream use
Secondary outcomes:
measure: Reduction of the area of the periorbital facial wrinkles
timeFrame: 6 and 12 weeks of Belinal cream use
measure: Reduction of the volume of the periorbital facial wrinkles
timeFrame: 6 and 12 weeks of Belinal cream use
measure: Reduction of trans-epidermal water loss
timeFrame: 6 and 12 weeks of Belinal cream use
measure: Improved skin hydration
timeFrame: 6 and 12 weeks of Belinal cream use
measure: Improved skin elasticity
timeFrame: 6 and 12 weeks of Belinal cream use
measure: An increase of the dermis thickness
timeFrame: 6 and 12 weeks of Belinal cream use
Other outcomes:
Locations:
Study officials:
affiliation: VIST - Faculty of Applied Sciences
name: Janko Zmitek, PhD
role: STUDY_CHAIR
affiliation: VIST - Faculty of Applied Sciences
name: Katja Zmitek, PhD
role: STUDY_DIRECTOR
affiliation: VIST - Faculty of Applied Sciences
name: Nataša Tavčar, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: VIST - Faculty of Applied Sciences
name: Tina Pogačnik, BSc
role: PRINCIPAL_INVESTIGATOR
References: