AgingIn&OutNCT06932770
Anti-aging Efficacy of Food Supplement and Cosmetic Routine
A study testing Food Supplement active and Skin care product active in people with Aging and Wrinkle, run by Amazentis SA at 1 site in Germany.
Trial summary
The aim of this study is to investigate the impact of a topical and an oral product alone and in combination compared to placebo on skin aging Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- What is being tested?
- Food Supplement active and Skin care product active
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- 23 Apr 2025to 17 Jul 2025
- 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 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written Informed Consent to participate in the study
- Willingness to actively participate in the study and to come to the scheduled visits
- Female
- From 40 to 70 years of age, in order to include sufficient subjects for the study, if necessary, the age may be gradually increased to 70 years or decreased to 40 years
- Healthy skin in the test areas
- Visible wrinkles in the face (grade 3 to 6 according to proderm wrinkle score)
- For biopsy subpanel:
- Vaccination of tetanus within the last 10 years
Who cannot join
- Female subjects: Pregnancy or lactation
- Drug addicts, alcoholics
- AIDS, HIV-positive or infectious hepatitis
- Conditions which exclude a participation or might influence the test reaction/evaluation
- Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area
- Active skin disease at the test area
Show all 25Show fewer
- Documented allergies to face/eye care products and food supplements or their ingredients
- Intake of dietary supplements within the last 3 months before the start of the study
- Diabetes mellitus
- Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years
- One of the following illnesses with reduced physical capability/fitness: asthma (symptom-free allergic asthma is not an exclusion criterion), hypertension (if not adjusted with medication), cardiovascular diseases
- Epilepsy
- Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, freckles, etc. at the test area that could influence the investigation
- Regular use of tanning beds
- Any topical medication at the test area within the last 3 days prior to the start of the study
- Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. antiallergics) and/or within the last 7 days prior to the start of the study
- Therapy with antibiotics within the last 2 weeks prior to the start of the study
- Past cosmetic surgery procedure in the test area (e.g. laser, facelift)
- Cosmetic surgery procedure in the test area, e.g. IPL (Intensed Pulsed Light), botox, chemical peel, dermabrasion within the last 2 years prior to the start of the study and/or throughout the entire course of the study
- Medical treatment for wrinkle reduction (e.g. peeling with vitamin A or fruit acids) on the face within the last 2 weeks prior to the start of the study
- For biopsy subpanel:
- Regular medication with anti-coagulating drugs like Aspirin®, Macumar®, etc. (e.g. for thrombosis prophylaxis) within up to 15 days prior to the taking of the biopsies
- History of complications at wound healing (e.g. keloids, hypertrophic scars or contracture scar)
- Known intolerance to local anaesthetics
- Known Sensitivity to any dressing systems
Trial locations and contacts
1 site in 1 country.
Germany1 site
SGS proderm GmbH
Schenefeld, Free and Hanseatic City of Hamburg, 22869
About this study
Official title: Anti-aging Efficacy Study With Food Supplement and Cosmetic Routine vs Placebo
The aim of this study is to investigate the impact of a topical and an oral product alone and in combination compared to placebo on skin aging
- Being tested
- Food Supplement active, Food supplement placebo, Skin care product active, Skin care product placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food Supplement activeDietary supplement
The food supplement active (2 soft gels) will be consumed once per day with a large glass of water.
Food supplement placeboDietary supplement
The food supplement placebo (2 soft gels) will be consumed once per day with a large glass of water.
Skin care product activeOther
The cosmetic skin care product active will be applied twice daily to half of the face and to one volar forearm.
Skin care product placeboOther
The cosmetic skin care product placebo will be applied twice daily to half of the face and to one volar forearm.
| Study group | Role | What they receive |
|---|---|---|
| Food supplement and cosmetic routine | Experimental | The "food supplement and cosmetic routine" arm will consume the food supplement active and apply the skin care product active. Receives: Dietary Supplement: Food Supplement active; Other: Skin care product active |
| Food supplement | Experimental | The "food supplement" arm will consume the food supplement active and apply the skin care product placebo. Receives: Dietary Supplement: Food Supplement active; Other: Skin care product placebo |
| Cosmetic routine | Experimental | The "cosmetic routine" arm will consume the food supplement placebo and apply the skin care product active. Receives: Dietary Supplement: Food supplement placebo; Other: Skin care product active |
| Placebo | Placebo comparator | The "placebo" arm will consume the food supplement placebo and apply the skin care product placebo. Receives: Dietary Supplement: Food supplement placebo; Other: Skin care product placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-wrinkle efficacy
Change from baseline in anti-wrinkles efficacy (assessed on three-dimensional structure of the wrinkles in the periorbital regions) after 6 and 12 weeks. Anti-wrinkle efficacy will be assessed using DermaTOP. Parameters measured: Rz and Ra, representing mainly the rough structure (Rz) or the finer skin structure (Ra).
Measured: 12 weeks
Secondary outcomes (7)
Skin barrier function
Change from baseline in skin barrier function (assessed onTransepidermal water loss (TEWL) by Tewameter [g/(m²h)]) after 6 and 12 weeks
Measured: 12 weeks
Skin hydration
Change from baseline in skin hydration (assessed on skin capacitance by Corneometer) after 6 and 12 weeks
Measured: 12 weeks
Skin firmness
Change from baseline in skin firmness (assessed by R0 (Uf) by Cutometer [mm]) after 6 and 12 weeks
Measured: 12 weeks
Skin elasticity
Change from baseline in skin elasticity (assessed by R7 (Ur/Uf) by Cutometer) after 6 and 12 weeks
Measured: 12 weeks
Wrinkles and fine lines
Change from baseline for wrinkles and fine lines (assessed on VISIA-CR Image analysis) after 6 and 12 weeks
Measured: 12 weeks
Skin aging hallmarks
Change from baseline in skin hallmarks of aging (assessed on 3mm punch skin biopsies) after 12 weeks in a subpanel of participants
Measured: 12 weeks
Product traits
Subjective evaluation of product traits assessed via questionnaire after 6 and 12 weeks.
Product traits will be assessed by the subjects with a list of closed questions with the following predefined identical options to tick:
- 2 = Fully disagree;
- 1 = Rather disagree;
- = Rather agree;
- = Fully agree
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start23 Apr 2025
- Primary completion17 Jul 2025
- Study completion17 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Split-face design. Subjects will be divided equally in 2 treatment groups (food supplement active or food supplement placebo). Group 1 will receive treatments A and B (food supplement active with cosmetic active on one volar forearm and one side of face and cosmetic placebo on the other volar forearm and side of face) and group 2 C and D (food supplement placebo with cosmetic active on one volar forearm and one side of face and cosmetic placebo on the other volar forearm and side of face). Treatments will be randomly and balanced assigned to left and right test area in each group.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amazentis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SGS Proderm GmbH
- Responsible party
- Sponsor
- Investigators
- Katrin Unbereit, Principal investigator, SGS Proderm GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932770
- Sponsor's protocol ID
- 25.0036-23
- Acronym
- In&Out
- Status last verified
- Jul 2025
- First submitted
- 10 Apr 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-aging Efficacy Study With Food Supplement and Cosmetic Routine vs Placebo
- ClinicalTrials.gov ID
- NCT06932770
- Acronym / sponsor ID
- In&Out / 25.0036-23
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Amazentis SAIndustry (pharma, biotech, devices)
- Collaborators
- SGS Proderm GmbH
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- 17 Jul 2025 (actual)
- Study completion
- 17 Jul 2025 (actual)
- First posted
- 17 Apr 2025 (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 aim of this study is to investigate the impact of a topical and an oral product alone and in combination compared to placebo on skin aging
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Split-face design. Subjects will be divided equally in 2 treatment groups (food supplement active or food supplement placebo). Group 1 will receive treatments A and B (food supplement active with cosmetic active on one volar forearm and one side of face and cosmetic placebo on the other volar forearm and side of face) and group 2 C and D (food supplement placebo with cosmetic active on one volar forearm and one side of face and cosmetic placebo on the other volar forearm and side of face). Treatments will be randomly and balanced assigned to left and right test area in each group.
| Arm | Type | Receives |
|---|---|---|
| Food supplement and cosmetic routine | Experimental | Dietary Supplement: Food Supplement active, Other: Skin care product activeThe "food supplement and cosmetic routine" arm will consume the food supplement active and apply the skin care product active. |
| Food supplement | Experimental | Dietary Supplement: Food Supplement active, Other: Skin care product placeboThe "food supplement" arm will consume the food supplement active and apply the skin care product placebo. |
| Cosmetic routine | Experimental | Dietary Supplement: Food supplement placebo, Other: Skin care product activeThe "cosmetic routine" arm will consume the food supplement placebo and apply the skin care product active. |
| Placebo | Placebo comparator | Dietary Supplement: Food supplement placebo, Other: Skin care product placeboThe "placebo" arm will consume the food supplement placebo and apply the skin care product placebo. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written Informed Consent to participate in the study
- Willingness to actively participate in the study and to come to the scheduled visits
- Female
- From 40 to 70 years of age, in order to include sufficient subjects for the study, if necessary, the age may be gradually increased to 70 years or decreased to 40 years
- Healthy skin in the test areas
Key exclusion criteria (25 listed)
- Female subjects: Pregnancy or lactation
- Drug addicts, alcoholics
- AIDS, HIV-positive or infectious hepatitis
- Conditions which exclude a participation or might influence the test reaction/evaluation
- Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area
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 Supplement activeThe food supplement active (2 soft gels) will be consumed once per day with a large glass of water. | Dietary supplement | Food supplement, Food supplement and cosmetic routine |
| Food supplement placeboThe food supplement placebo (2 soft gels) will be consumed once per day with a large glass of water. | Dietary supplement | Cosmetic routine, Placebo |
| Skin care product activeThe cosmetic skin care product active will be applied twice daily to half of the face and to one volar forearm. | Other | Cosmetic routine, Food supplement and cosmetic routine |
| Skin care product placeboThe cosmetic skin care product placebo will be applied twice daily to half of the face and to one volar forearm. | Other | Food supplement, Placebo |
Primary outcome
Anti-wrinkle efficacy
Time frame: 12 weeks
Change from baseline in anti-wrinkles efficacy (assessed on three-dimensional structure of the wrinkles in the periorbital regions) after 6 and 12 weeks. Anti-wrinkle efficacy will be assessed using DermaTOP. Parameters measured: Rz and Ra, representing mainly the rough structure (Rz) or the finer skin structure (Ra).
7 secondary outcomes
Skin barrier function
Time frame: 12 weeks
Skin hydration
Time frame: 12 weeks
Skin firmness
Time frame: 12 weeks
Skin elasticity
Time frame: 12 weeks
Wrinkles and fine lines
Time frame: 12 weeks
Skin aging hallmarks
Time frame: 12 weeks
Product traits
Time frame: 12 weeks
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 25 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Katrin Unbereit principal investigator
SGS Proderm GmbH
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 active and Skin care product active in people with Aging and Wrinkle, run by Amazentis SA at 1 site in Germany.
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 8 inclusion and 25 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 25 Jul 2025. 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 Germany. 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?
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?
Anti-wrinkle efficacy (time frame: 12 weeks). 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 25 Jul 2025.