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NCT Number: NCT02603029

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

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.

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Key information

Conditions

Wrinkles Ageing PHOTOPROTECTION Skin Care Skin Cream

Age range

45 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Improvement of photoprotective function of the skin

    Time frame: up to 12 weeks of the supplementation

    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.

  2. Improvement of the dermis structure

    Time frame: up to 12 weeks of Belinal cream use

    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.

Secondary outcomes

  1. Reduction of the area of the periorbital facial wrinkles

    Time frame: 6 and 12 weeks of Belinal cream use

    Area of selected periorbital wrinkles will be quantitatively assessed using CSI programme.

  2. Reduction of the volume of the periorbital facial wrinkles

    Time frame: 6 and 12 weeks of Belinal cream use

    Volume of selected periorbital wrinkles will be quantitatively assessed using CSI programme.

  3. Reduction of trans-epidermal water loss

    Time frame: 6 and 12 weeks of Belinal cream use

    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.

  4. Improved skin hydration

    Time frame: 6 and 12 weeks of Belinal cream use

    Skin hydration will be measured on the face.

  5. Improved skin elasticity

    Time frame: 6 and 12 weeks of Belinal cream use

    Skin elasticity will be measured on the face.

  6. An increase of the dermis thickness

    Time frame: 6 and 12 weeks of Belinal cream use

    Dermis thickness will be measured with ultrasound imaging of the skin.

Sponsors and collaborators

Lead sponsor

VIST - Faculty of Applied Sciences

Other

Collaborators

  • Abies Labs d.o.o.

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Nov 11, 2015
Registry last updated
Mar 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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