Skin AgingSkinBioAgeNCT06619457
Evaluation of the Anti-aging Efficacy of One Face Care Cosmetic Product
A study testing Mitopure (Urolithin A) Cream in people with Skin Aging, run by Amazentis SA at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the anti-wrinkle efficacy and effect on skin epigenetic and on mitochondrial morphology of a facial cosmetic product compared to a placebo Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Aging
- What is being tested?
- Mitopure (Urolithin A) Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- 25 Sep 2024to 12 Dec 2024
- 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 50 to 75 years
- All sexes
- 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 and approximately 10% male (at least 4 male subjects)
- From 50 to 75 years of age
- Healthy skin in the test areas
- Visible wrinkles in the face (grade 3 to 6 according to SGS proderm scale)
- 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 24Show fewer
- Documented allergies to face/eye care products
- 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
The purpose of this study is to evaluate the anti-wrinkle efficacy and effect on skin epigenetic and on mitochondrial morphology of a facial cosmetic product compared to a placebo
- Conditions
- Skin Aging
- Being tested
- Mitopure (Urolithin A) Cream, Placebo Cream
- Keywords
- Mitochondria, Urolithin A, Mitopure, Aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitopure (Urolithin A) CreamOther
cosmetic cream to be applied topically on face and forearms twice/daily using split/face design
Placebo CreamOther
cosmetic cream to be applied topically on face and forearms twice/daily using split/face design
| Study group | Role | What they receive |
|---|---|---|
| Placebo Cream | Experimental | Not described Receives: Other: Placebo Cream |
| Active Moisturizing Cream | Experimental | Not described Receives: Other: Mitopure (Urolithin A) Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-wrinkle efficacy
Anti-wrinkle efficacy will be assessed in the periorbital regions wrinkles using AEVA. Parameters measured: Rz and Ra, representing mainly the rough structure (Rz) or the finer skin structure (Ra).
Measured: 12 weeks
Skin Biological age
DNA methylation patterns analysis (epigenetics) by skin tape stripping (D-Squames)
Measured: 12-weeks
Secondary outcomes (5)
Skin hydration
Change from baseline in skin hydration (assessed on skin capacitance by Corneometer [a.u.])
Measured: 12 weeks
Transepidermal Water Loss (TEWL)
Change from baseline in skin barrier function (assessed as transepidermal waterloss by Tewameter [g/(m²h)])
Measured: 12 weeks
Mitochondrial morphology in skin
mitochondrial morphology in skin will be assessed via transmission electron microscopy (TEM) on 3mm punch-biopsies
Measured: 12 weeks
Photodocumentation of skin health
ColorFace image analysis of face via facial photography
Measured: 12 weeks
Subjective questionnaire
Subjective evaluation of product traits assessed via questionnaire
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 posted1 Oct 2024
- Study start25 Sep 2024
- Primary completion12 Dec 2024
- Study completion12 Dec 2024
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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amazentis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- proDERM GmbH
- Responsible party
- Sponsor
- Investigators
- Katrin Unbereit, PhD, Principal investigator, SGS Proderm GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06619457
- Sponsor's protocol ID
- 24.0199-23
- Acronym
- SkinBioAge
- Status last verified
- Oct 2024
- First submitted
- 25 Sep 2024
- Last updated
- 3 Apr 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 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Anti-aging Efficacy of One Face Care Cosmetic Product
- ClinicalTrials.gov ID
- NCT06619457
- Acronym / sponsor ID
- SkinBioAge / 24.0199-23
- Conditions
- Skin Aging
- Keywords
- Mitochondria, Urolithin A, Mitopure, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Amazentis SAIndustry (pharma, biotech, devices)
- Collaborators
- proDERM GmbH
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 12 Dec 2024 (actual)
- First posted
- 1 Oct 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 study is to evaluate the anti-wrinkle efficacy and effect on skin epigenetic and on mitochondrial morphology of a facial cosmetic product compared to a placebo
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
| Arm | Type | Receives |
|---|---|---|
| Placebo Cream | Experimental | Other: Placebo Cream |
| Active Moisturizing Cream | Experimental | Other: Mitopure (Urolithin A) Cream |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- 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 and approximately 10% male (at least 4 male subjects)
- From 50 to 75 years of age
- Healthy skin in the test areas
Key exclusion criteria (24 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 |
|---|---|---|
| Mitopure (Urolithin A) Creamcosmetic cream to be applied topically on face and forearms twice/daily using split/face design | Other | Active Moisturizing Cream |
| Placebo Creamcosmetic cream to be applied topically on face and forearms twice/daily using split/face design | Other | Placebo Cream |
Primary outcome
Anti-wrinkle efficacy
Time frame: 12 weeks
Anti-wrinkle efficacy will be assessed in the periorbital regions wrinkles using AEVA. Parameters measured: Rz and Ra, representing mainly the rough structure (Rz) or the finer skin structure (Ra).
Skin Biological age
Time frame: 12-weeks
DNA methylation patterns analysis (epigenetics) by skin tape stripping (D-Squames)
5 secondary outcomes
Skin hydration
Time frame: 12 weeks
Transepidermal Water Loss (TEWL)
Time frame: 12 weeks
Mitochondrial morphology in skin
Time frame: 12 weeks
Photodocumentation of skin health
Time frame: 12 weeks
Subjective questionnaire
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 3 Apr 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, PhD 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 Mitopure (Urolithin A) Cream in people with Skin Aging, 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 24 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 3 Apr 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. 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). 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 3 Apr 2025.