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

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ClinicalTrials.gov Identifier: NCT02603029
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : March 8, 2016
Sponsor:
Collaborator:
Abies Labs d.o.o.
Information provided by (Responsible Party):
Higher School of Applied Sciences (VIST)

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.

Condition or disease Intervention/treatment Phase
Wrinkles Ageing Photoprotection Skin Care Skin Cream Other: Placebo cream Other: Belinal cream Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Placebo Controlled Study of Influence of Cream With the Silver Fir (Abies Alba) Wood Extract on the Skin
Study Start Date : March 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Arm Intervention/treatment
Placebo Comparator: Placebo cream
Cream with 0% Silver fir wood extract (Belinal)
Other: Placebo cream
Subjects will use placebo cream twice per day for 12 weeks on one half of the face and of the gluteal area.

Active Comparator: Belinal cream
Cream with 2% Silver fir wood extract (Belinal)
Other: Belinal cream
Subjects will use Belinal cream twice per day for 12 weeks on the other half of the face and of the gluteal area.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02603029


Sponsors and Collaborators
Higher School of Applied Sciences (VIST)
Abies Labs d.o.o.
Investigators
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Study Chair: Janko Zmitek, PhD Higher School of Applied Sciences (VIST)
Study Director: Katja Zmitek, PhD Higher School of Applied Sciences (VIST)
Principal Investigator: Nataša Tavčar, BSc Higher School of Applied Sciences (VIST)
Principal Investigator: Tina Pogačnik, BSc Higher School of Applied Sciences (VIST)

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Responsible Party: Higher School of Applied Sciences (VIST)
ClinicalTrials.gov Identifier: NCT02603029     History of Changes
Other Study ID Numbers: Belinal 01-2015
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: March 8, 2016
Last Verified: November 2015

Keywords provided by Higher School of Applied Sciences (VIST):
skin rejuvenation
anti-ageing effects
minimal erythema dose
dermis structure
physiological skin condition
wrinkling