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

NCT02603029 | Completed

• 1 other identifier: Belinal 01-2015
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Wrinkles; Ageing; Photoprotection; Skin Care; Skin Cream

Keywords

skin rejuvenation; anti-ageing effects; minimal erythema dose; dermis structure; physiological skin condition; wrinkling

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Reduction of the area of the periorbital facial wrinkles

  6 and 12 weeks of Belinal cream use

• Reduction of the volume of the periorbital facial wrinkles

  6 and 12 weeks of Belinal cream use

• Reduction of trans-epidermal water loss

  6 and 12 weeks of Belinal cream use

• Improved skin hydration

  6 and 12 weeks of Belinal cream use

• Improved skin elasticity

  6 and 12 weeks of Belinal cream use

Study Arms (2)

Placebo cream

PLACEBO COMPARATOR

Cream with 0% Silver fir wood extract (Belinal)

Other: Placebo cream

Belinal cream

ACTIVE COMPARATOR

Cream with 2% Silver fir wood extract (Belinal)

Other: Belinal cream

Interventions

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.

Placebo cream

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.

Belinal cream

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signs of skin aging (mimic wrinkles/ fine lines/ poor skin tone/ photoaged skin),
• Phototype II and III.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VIST - Faculty of Applied Sciences: lead
• Abies Labs d.o.o.: collaborator

Study Officials

• Janko Zmitek, PhD

  VIST - Faculty of Applied Sciences

  STUDY CHAIR

• Katja Zmitek, PhD

  VIST - Faculty of Applied Sciences

  STUDY DIRECTOR

• Nataša Tavčar, BSc

  VIST - Faculty of Applied Sciences

  PRINCIPAL INVESTIGATOR

• Tina Pogačnik, BSc

  VIST - Faculty of Applied Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2015
• First Posted: November 11, 2015
• Study Start: March 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: March 8, 2016

Record last verified: 2015-11