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CompletedNCT06619457SkinBioAgeUpdated Apr 3, 2025

Evaluation of the Anti-aging Efficacy of One Face Care Cosmetic Product

An interventional study of Mitopure (Urolithin A) Cream and Placebo Cream in Skin Aging, sponsored by Amazentis SA. Completed at 1 site in Germany. Open to participants aged 50 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-03.

Sponsored by Amazentis SA · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
50 Years to 75 Years
Sex
All
01

Study 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

02

Conditions studied

  • Skin Aging

Keywords

  • Mitochondria
  • Urolithin A
  • Mitopure
  • Aging
03

In context

Lead sponsor

Amazentis SA is the lead sponsor of 32 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Placebo Cream

    Other: Placebo Cream

  • Experimental
    Active Moisturizing Cream

    Other: Mitopure (Urolithin A) Cream

Interventions

  • OtherMitopure (Urolithin A) Cream

    cosmetic cream to be applied topically on face and forearms twice/daily using split/face design

  • OtherPlacebo Cream

    cosmetic cream to be applied topically on face and forearms twice/daily using split/face design

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 12 weeks

  2. Skin Biological age

    DNA methylation patterns analysis (epigenetics) by skin tape stripping (D-Squames)

    Time frame: 12-weeks

Secondary outcomes

  1. Skin hydration

    Change from baseline in skin hydration (assessed on skin capacitance by Corneometer \[a.u.\])

    Time frame: 12 weeks

  2. Transepidermal Water Loss (TEWL)

    Change from baseline in skin barrier function (assessed as transepidermal waterloss by Tewameter \[g/(m²h)\])

    Time frame: 12 weeks

  3. Mitochondrial morphology in skin

    mitochondrial morphology in skin will be assessed via transmission electron microscopy (TEM) on 3mm punch-biopsies

    Time frame: 12 weeks

  4. Photodocumentation of skin health

    ColorFace image analysis of face via facial photography

    Time frame: 12 weeks

  5. Subjective questionnaire

    Subjective evaluation of product traits assessed via questionnaire

    Time frame: 12 weeks

07

Study locations

1 site
  • SGS proderm GmbH
    Schenefeld, Hamburg 22869, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06619457
Lead sponsor
Amazentis SA
Collaborators
proDERM GmbH
Responsible party
Sponsor
First posted
Oct 1, 2024
Start date
Sep 25, 2024
Primary completion
Dec 12, 2024
Completion
Dec 12, 2024
Last update
Apr 3, 2025

Study contacts

Katrin Unbereit, PhD
principal investigator · SGS proderm GmbH

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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