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

Last updated: April 2, 2025
Sponsor: Amazentis SA
Overall Status: Completed

Phase

N/A

Condition

Skin Aging

Treatment

Mitopure Cream

Mitopure (Urolithin A) Cream

Placebo Cream

Clinical Study ID

NCT06619457
24.0199-23
  • Ages 50-75
  • All Genders
  • Accepts Healthy Volunteers

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

Eligibility Criteria

Inclusion

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

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 testreaction/evaluation

  • Participation or being in the waiting period after participation in cosmetic and/orpharmaceutical 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/orhormonal 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 notadjusted 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 ofthe study

  • Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/orantihistamines (e.g. antiallergics) and/or within the last 7 days prior to the startof 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 thestudy 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 orcontracture scar)

  • Known intolerance to local anaesthetics

  • Known Sensitivity to any dressing systems

Study Design

Total Participants: 36
Treatment Group(s): 3
Primary Treatment: Mitopure Cream
Phase:
Study Start date:
September 25, 2024
Estimated Completion Date:
December 12, 2024

Connect with a study center

  • SGS proderm GmbH

    Schenefeld, Hamburg 22869
    Germany

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.