WrinklesNCT02603029
Influence of of Cream With the Silver Fir Wood Extract (Belinal) on Skin
A study testing Belinal cream in people with Wrinkles and Ageing, run by VIST - Faculty of Applied Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Wrinkles, Ageing, Photoprotection
- What is being tested?
- Belinal cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signs of skin aging (mimic wrinkles/ fine lines/ poor skin tone/ photoaged skin),
- Phototype II and III.
Who cannot join
- 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,
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- 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.
About this study
Official title: Placebo Controlled Study of Influence of Cream With the Silver Fir (Abies Alba) Wood Extract on the 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.
Read the 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.
- Conditions
- Wrinkles, Ageing, Photoprotection, Skin Care, Skin Cream
- Being tested
- Placebo cream, Belinal cream
- Keywords
- skin rejuvenation, anti-ageing effects, minimal erythema dose, dermis structure, physiological skin condition, wrinkling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo creamOther
Subjects will use placebo cream twice per day for 12 weeks on one half of the face and of the gluteal area.
Belinal creamOther
Subjects will use Belinal cream twice per day for 12 weeks on the other half of the face and of the gluteal area.
| Study group | Role | What they receive |
|---|---|---|
| Placebo cream | Placebo comparator | Cream with 0% Silver fir wood extract (Belinal) Receives: Other: Placebo cream |
| Belinal cream | Active comparator | Cream with 2% Silver fir wood extract (Belinal) Receives: Other: Belinal cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 12 weeks of Belinal cream use
Secondary outcomes (6)
Reduction of the area of the periorbital facial wrinkles
Area of selected periorbital wrinkles will be quantitatively assessed using CSI programme.
Measured: 6 and 12 weeks of Belinal cream use
Reduction of the volume of the periorbital facial wrinkles
Volume of selected periorbital wrinkles will be quantitatively assessed using CSI programme.
Measured: 6 and 12 weeks of Belinal cream use
Reduction of trans-epidermal water loss
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.
Measured: 6 and 12 weeks of Belinal cream use
Improved skin hydration
Skin hydration will be measured on the face.
Measured: 6 and 12 weeks of Belinal cream use
Improved skin elasticity
Skin elasticity will be measured on the face.
Measured: 6 and 12 weeks of Belinal cream use
An increase of the dermis thickness
Dermis thickness will be measured with ultrasound imaging of the skin.
Measured: 6 and 12 weeks of Belinal cream use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinklesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIST - Faculty of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Abies Labs d.o.o.
- Responsible party
- Sponsor
- Investigators
- Janko Zmitek, PhD, Study chair, VIST - Faculty of Applied SciencesKatja Zmitek, PhD, Study director, VIST - Faculty of Applied SciencesNataša Tavčar, BSc, Principal investigator, VIST - Faculty of Applied SciencesTina Pogačnik, BSc, Principal investigator, VIST - Faculty of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02603029
- Sponsor's protocol ID
- Belinal 01-2015
- Status last verified
- Nov 2015
- First submitted
- 10 Nov 2015
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo Controlled Study of Influence of Cream With the Silver Fir (Abies Alba) Wood Extract on the Skin
- ClinicalTrials.gov ID
- NCT02603029
- Acronym / sponsor ID
- Belinal 01-2015
- Conditions
- Wrinkles, Ageing, Photoprotection, Skin Care, Skin Cream
- Keywords
- skin rejuvenation, anti-ageing effects, minimal erythema dose, dermis structure, physiological skin condition, wrinkling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- VIST - Faculty of Applied SciencesUniversity, hospital or other
- Collaborators
- Abies Labs d.o.o.
- Study start
- Mar 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 11 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo cream | Placebo comparator | Other: Placebo creamCream with 0% Silver fir wood extract (Belinal) |
| Belinal cream | Active comparator | Other: Belinal creamCream with 2% Silver fir wood extract (Belinal) |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Signs of skin aging (mimic wrinkles/ fine lines/ poor skin tone/ photoaged skin),
- Phototype II and III.
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo creamSubjects will use placebo cream twice per day for 12 weeks on one half of the face and of the gluteal area. | Other | Placebo cream |
| Belinal creamSubjects will use Belinal cream twice per day for 12 weeks on the other half of the face and of the gluteal area. | Other | Belinal cream |
Primary outcome
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.
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.
6 secondary outcomes
Reduction of the area of the periorbital facial wrinkles
Time frame: 6 and 12 weeks of Belinal cream use
Reduction of the volume of the periorbital facial wrinkles
Time frame: 6 and 12 weeks of Belinal cream use
Reduction of trans-epidermal water loss
Time frame: 6 and 12 weeks of Belinal cream use
Improved skin hydration
Time frame: 6 and 12 weeks of Belinal cream use
Improved skin elasticity
Time frame: 6 and 12 weeks of Belinal cream use
An increase of the dermis thickness
Time frame: 6 and 12 weeks of Belinal cream use
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janko Zmitek, PhD study chair
VIST - Faculty of Applied Sciences
Katja Zmitek, PhD study director
VIST - Faculty of Applied Sciences
Nataša Tavčar, BSc principal investigator
VIST - Faculty of Applied Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Belinal cream in people with Wrinkles and Ageing, run by VIST - Faculty of Applied Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of photoprotective function of the skin (time frame: up to 12 weeks of the supplementation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2016.