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

Not Applicable

Completed

• Conditions: Skin Aging
• Interventions: Other: Placebo Cream; Other: Mitopure (Urolithin A) Cream

• Registration Number: NCT06619457
• Lead Sponsor: Amazentis SA

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-25
• Study First Submitted: 2024-09-25
• Study First Submitted QC: 2024-09-27
• Status Verified: 2024-10
• Study First Posted: 2024-10-01
• Primary Completion: 2024-12-12
• Study Completion: 2024-12-12
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Cream	Placebo Cream	-
Active Moisturizing Cream	Mitopure (Urolithin A) Cream	-

Primary Outcome Measures

Name	Time	Method
Anti-wrinkle efficacy	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	12-weeks	DNA methylation patterns analysis (epigenetics) by skin tape stripping (D-Squames)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

SGS proderm GmbH; 🇩🇪 Schenefeld, Hamburg, Germany