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

Amazentis

Status

Completed

Conditions

Skin Aging

Treatments

Other: Placebo Cream

Other: Mitopure (Urolithin A) Cream

Study type

Interventional

Funder types

Industry

Identifiers

NCT06619457

24.0199-23

Details and patient eligibility

About

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

Enrollment

36 patients

Sex

All

Ages

50 to 75 years old

Volunteers

Accepts Healthy Volunteers

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