Skin AgingFB_BfWNCT06727292
Biometrical Evaluation of the Efficacy of a Food Supplement Versus Placebo
A study testing Food supplement in people with Skin Aging and Hair Condition, run by Finzelberg GmbH & Co. KG at 1 site in Poland.
Trial summary
The purpose of this clinical trial is to evaluate whether nutritional supplementation over a 2-month period improves skin physiological parameters. This is a national, single-center, double-blind, randomized pilot study. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Aging, Hair Condition, Skin Condition
- What is being tested?
- Food supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 sitePoland
- Study dates
- 14 Oct 2024to 30 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Phototype: I to IV;
- Subjects with normal to dry skin;
- Subjects with healthy skin on the study area;
- Non-smokers;
- Has normal nutritional habits (not vegetarian/vegan);
- Is not pregnant or lactating;
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- Has a BMI of 18 - 33 kg/m2;
- Is willing to refrain from taking dietary supplements (at best not at all, in any case not during the last month before study start);
- Willing not to use any oral products or any nutritional supplementation aiming at improving skin status during the course of the study;
- No history of malabsorption diseases, liver diseases, or diseases of the lipid metabolism;
- Uses no medication, which may interact with the study product
Who cannot join
- For women: pregnant or nursing woman or woman planning to get pregnant during the study;
- Cutaneous pathology on the study zone (eczema, etc.);
- Subject with make-up on the day of the visit at the laboratory;
- Use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the efficacy of the study product:
- change in anti-wrinkle, smoothing and/or firming topical products within previous week on the studied zones,
- non-invasive procedures within previous month on the studied zones,
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- intake of food supplement acting on skin within the three previous months,
- invasive procedures:
- deep chemical peeling within previous 3 months on the studied zones,
- mesotherapy, dermapen, laser within previous 6 months on the studied zones,
- botox and/or hyaluronic acid injections within previous 12 months on the studied zones;
- Intake of vitamin substances and diets comprising a change of normal eating habits;
- Known allergy to one or several investigational product´s ingredients;
- Participation in a nutritional study within the last 30 days;
- Surgical or internal diseases e.g. a metabolic or endocrine disease that may affect the outcome of the study (e.g. diabetes, liver diseases, kidney disorders) or having a history of medical or surgical events that may significantly affect the study outcome including any cardiovascular disease, skin disease, hypertension (>140/90 mm Hg in three repeated measurements).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Eurofins Dermscan Poland
Gdansk, GDANSK, 288
Maja Kreyzmon, Project manager, 0058 7320290, Maja.Jaskolska@cpt.eurofinseu.com
Maja KREZYMON
About this study
The purpose of this clinical trial is to evaluate whether nutritional supplementation over a 2-month period improves skin physiological parameters. This is a national, single-center, double-blind, randomized pilot study.
The study will be conducted using a supplement and a placebo, the safety of which has been assured by the sponsor.
Participants will:
- Take a food supplement or a placebo once daily for 2 months
- Visit the study center at beginning, after 28 days and after 56 days of supplementation.
- Keep a diary of their skin status and tolerability
The secondary objective is to evaluate product characteristics and performance during normal use in healthy subjects.
- Conditions
- Skin Aging, Hair Condition, Skin Condition
- Being tested
- Food supplement, Placebo
- Keywords
- improvements of skin physiological parameters
- Medical subject headings
- Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food supplementDietary supplement
Instant drink in a powder form presented in a sachet to be disolved in a glass of water (200 ml).
PlaceboDietary supplement
Instant drink in powder form in a sachet to be disolved in a glass of water (200ml)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The placebo has similar characteristics as the verum instant drink. Receives: Dietary Supplement: Placebo |
| Food supplement | Experimental | Powder for an instant drink preparation with orange flavor /taste Receives: Dietary Supplement: Food supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Physiological Parameters
Changes in skin hydration: Measurement of skin hydration by means of a Corneometer CM825.
Measured: Skin physiological parameters will be assessed at Day 0, Day 28, Day 56
Skin Physiological Parameters
Assessment of skin barrier integrity measuring transepidermal water loss using the Tewameter® TM 300.
Measured: Skin physiological parameters will be assessed at Day 0, Day 28, Day 56
Skin Physiological Parameters
Change in skin elasticity using Cutometer MPA580
Measured: Skin physiological parameters will be assessed at Day 0, Day 28, Day 56
Skin Physiological Parameters
Changes in skin density using ultrasound measurements with a frequency of 20 MHz (Derma Scan C, Vers. 3) with 2-D-configuration (Cortex Technology, Denmark).
Measured: Skin physiological parameters will be assessed at Day 0, Day 28, Day 56
Secondary outcomes (3)
Subject satisfaction
A subjective evaluation questionnaire on the study product's effects on the skin will be completed by subjects (each item is scored individually on a 5 point Likert scale ranging from 'Totally agree' to 'Totally disagree')
Measured: It will be assessed at Day 28, Day 56
Adverse events
Collection of adverse events throughout the study
Measured: Adverse events will be assessed during the whole study from Day 0 to Day 56
Subject self-assessment quality of the skin and hair.
The quality of the volunteers' skin and hair will be subjectively assessed by a self-assessment questionnaire. This questionnaire will assess the volunteers' perception of improvement in their skin in general and in wrinkles, spots, redness, elasticity, hydration, appearance. In the case of hair, the questionnaire will assess if it is stronger than before. There will be 5 levels in the questionnaire to assess how true the statements are: No Information (0), No improvement (1), Somewhat (2), Clearly Yes (3) and Yes, Very clearly (4).
Measured: It will be assessed at Day 28, Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start14 Oct 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single-center, ,double-blind, randomized pilot study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Finzelberg GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eurofins, Eurofins Dermscan Pharmascan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727292
- Sponsor's protocol ID
- STUX824AA0245
- Acronym
- FB_BfW
- Status last verified
- Dec 2024
- First submitted
- 26 Nov 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To comply with European regulations and national provisions, subjects are informed that not sharing of IPD is planned in order to protect their personal data. If data is to be shared, participants must be informed individually, and their consent obtained.
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biometrical Evaluation of the Efficacy of a Food Supplement Versus Placebo
- ClinicalTrials.gov ID
- NCT06727292
- Acronym / sponsor ID
- FB_BfW / STUX824AA0245
- Conditions
- Skin Aging, Hair Condition, Skin Condition
- Keywords
- improvements of skin physiological parameters
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Finzelberg GmbH & Co. KGIndustry (pharma, biotech, devices)
- Collaborators
- Eurofins, Eurofins Dermscan Pharmascan
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 10 Dec 2024 (actual)
- 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.
The purpose of this clinical trial is to evaluate whether nutritional supplementation over a 2-month period improves skin physiological parameters. This is a national, single-center, double-blind, randomized pilot study.
The study will be conducted using a supplement and a placebo, the safety of which has been assured by the sponsor.
Participants will:
- Take a food supplement or a placebo once daily for 2 months
- Visit the study center at beginning, after 28 days and after 56 days of supplementation.
- Keep a diary of their skin status and tolerability
The secondary objective is to evaluate product characteristics and performance during normal use in healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- single-center, ,double-blind, randomized pilot study
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe placebo has similar characteristics as the verum instant drink. |
| Food supplement | Experimental | Dietary Supplement: Food supplementPowder for an instant drink preparation with orange flavor /taste |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Phototype: I to IV;
- Subjects with normal to dry skin;
- Subjects with healthy skin on the study area;
- Non-smokers;
- Has normal nutritional habits (not vegetarian/vegan);
Key exclusion criteria (15 listed)
- For women: pregnant or nursing woman or woman planning to get pregnant during the study;
- Cutaneous pathology on the study zone (eczema, etc.);
- Subject with make-up on the day of the visit at the laboratory;
- Use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the efficacy of the study product:
- Intake of vitamin substances and diets comprising a change of normal eating habits;
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 |
|---|---|---|
| Food supplementInstant drink in a powder form presented in a sachet to be disolved in a glass of water (200 ml). | Dietary supplement | Food supplement |
| PlaceboInstant drink in powder form in a sachet to be disolved in a glass of water (200ml) | Dietary supplement | Placebo |
Primary outcome
Skin Physiological Parameters
Time frame: Skin physiological parameters will be assessed at Day 0, Day 28, Day 56
Changes in skin hydration: Measurement of skin hydration by means of a Corneometer CM825.
Skin Physiological Parameters
Time frame: Skin physiological parameters will be assessed at Day 0, Day 28, Day 56
Assessment of skin barrier integrity measuring transepidermal water loss using the Tewameter® TM 300.
Skin Physiological Parameters
Time frame: Skin physiological parameters will be assessed at Day 0, Day 28, Day 56
Change in skin elasticity using Cutometer MPA580
Skin Physiological Parameters
Time frame: Skin physiological parameters will be assessed at Day 0, Day 28, Day 56
Changes in skin density using ultrasound measurements with a frequency of 20 MHz (Derma Scan C, Vers. 3) with 2-D-configuration (Cortex Technology, Denmark).
3 secondary outcomes
Subject satisfaction
Time frame: It will be assessed at Day 28, Day 56
Adverse events
Time frame: Adverse events will be assessed during the whole study from Day 0 to Day 56
Subject self-assessment quality of the skin and hair.
Time frame: It will be assessed at Day 28, Day 56
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: No. To comply with European regulations and national provisions, subjects are informed that not sharing of IPD is planned in order to protect their personal data. If data is to be shared, participants must be informed individually, and their consent obtained.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food supplement in people with Skin Aging and Hair Condition, run by Finzelberg GmbH & Co. KG at 1 site in Poland.
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 11 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cynthia G Suarez, PhD (004916098144462, cynthia.suarez-rizzo@finzelberg.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin Physiological Parameters (time frame: Skin physiological parameters will be assessed at Day 0, Day 28, Day 56). The study lists 4 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 10 Dec 2024.