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

April 2, 2025 updated by: Amazentis SA
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hamburg
      • Schenefeld, Hamburg, Germany, 22869
        • SGS proderm GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Placebo Cream
Other: Placebo Cream
cosmetic cream to be applied topically on face and forearms twice/daily using split/face design
Experimental: Active Moisturizing Cream
Other: Mitopure (Urolithin A) Cream
cosmetic cream to be applied topically on face and forearms twice/daily using split/face design

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 weeks
Skin Biological age
Time Frame: 12-weeks
DNA methylation patterns analysis (epigenetics) by skin tape stripping (D-Squames)
12-weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin hydration
Time Frame: 12 weeks
Change from baseline in skin hydration (assessed on skin capacitance by Corneometer [a.u.])
12 weeks
Transepidermal Water Loss (TEWL)
Time Frame: 12 weeks
Change from baseline in skin barrier function (assessed as transepidermal waterloss by Tewameter [g/(m²h)])
12 weeks
Mitochondrial morphology in skin
Time Frame: 12 weeks
mitochondrial morphology in skin will be assessed via transmission electron microscopy (TEM) on 3mm punch-biopsies
12 weeks
Photodocumentation of skin health
Time Frame: 12 weeks
ColorFace image analysis of face via facial photography
12 weeks
Subjective questionnaire
Time Frame: 12 weeks
Subjective evaluation of product traits assessed via questionnaire
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amazentis SA

Collaborators

proDERM GmbH

Investigators

  • Principal Investigator: Katrin Unbereit, PhD, SGS proderm GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2024

Primary Completion (Actual)

December 12, 2024

Study Completion (Actual)

December 12, 2024

Study Registration Dates

First Submitted

September 25, 2024

First Submitted That Met QC Criteria

September 27, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2025

Last Update Submitted That Met QC Criteria

April 2, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 24.0199-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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