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

NCT ID: NCT06619457

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-25
• Study Completion Date: 2024-12-12

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

Conditions

Skin Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo Cream

Group Type: EXPERIMENTAL

Placebo Cream

Intervention Type: OTHER

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

Active Moisturizing Cream

Group Type: EXPERIMENTAL

Mitopure (Urolithin A) Cream

Intervention Type: OTHER

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

Interventions

Mitopure (Urolithin A) Cream

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

Intervention Type: OTHER

Placebo Cream

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

proDERM GmbH

INDUSTRY

Sponsor Role: collaborator

Amazentis SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katrin Unbereit, PhD

Role: PRINCIPAL_INVESTIGATOR

SGS proderm GmbH

Locations

SGS proderm GmbH

Schenefeld, City state of Hamburg, Germany

Countries

Germany

Other Identifiers

24.0199-23

Identifier Type: -

Identifier Source: org_study_id