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

Amazentis SA1 site in 1 country36 target enrollmentSeptember 25, 2024

ConditionsSkin Aging

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Skin Aging
Sponsor: Amazentis SA
Enrollment: 36
Locations: 1
Primary Endpoint: Skin Biological age
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

September 25, 2024

End Date

December 12, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Amazentis SA

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Skin Biological age

Time Frame: 12-weeks

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

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).