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Completed

NCT Number: NCT06619457

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

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

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Key information

Conditions

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SGS proderm GmbH

Schenefeld, Free and Hanseatic City of Hamburg, 22869, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mitopure (Urolithin A) Cream

Other

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

Placebo Cream

Other

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

Primary outcomes

  1. 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).

  2. Skin Biological age

    Time frame: 12-weeks

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

Secondary outcomes

  1. Skin hydration

    Time frame: 12 weeks

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

  2. Transepidermal Water Loss (TEWL)

    Time frame: 12 weeks

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

  3. Mitochondrial morphology in skin

    Time frame: 12 weeks

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

  4. Photodocumentation of skin health

    Time frame: 12 weeks

    ColorFace image analysis of face via facial photography

  5. Subjective questionnaire

    Time frame: 12 weeks

    Subjective evaluation of product traits assessed via questionnaire

Sponsors and collaborators

Lead sponsor

Amazentis SA

Industry

Collaborators

  • proDERM GmbH

Registry information

Acronym: SkinBioAge

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 1, 2024
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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