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

VIST - Faculty of Applied Sciences

Status: Completed

Conditions: Wrinkles; Ageing; Skin Cream; Photoprotection; Skin Care

Treatments: Other: Belinal cream; Other: Placebo cream

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02603029

Belinal 01-2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: Female

Ages: 45 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

10 participants in 2 patient groups, including a placebo group

Placebo cream

Placebo Comparator group

Description:

Cream with 0% Silver fir wood extract (Belinal)

Treatment:

Other: Placebo cream

Belinal cream

Active Comparator group

Description:

Cream with 2% Silver fir wood extract (Belinal)

Treatment:

Other: Belinal cream