Evaluation of the Anti-aging Efficacy of a Novel Cosmetic Product

Amazentis SA1 site in 1 country48 target enrollmentMarch 15, 2022

ConditionsSkin Aging

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Skin Aging
Sponsor: Amazentis SA
Enrollment: 48
Locations: 1
Primary Endpoint: Change from baseline in skin mitochondrial health and biological age (assessed on skin biopsies) after 8 weeks
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this study is to investigate the effect of cosmetic products with two different concentrations of the active on skin aging and in acting on the mitochondrial health of skin in comparison to a placebo product.

Registry

clinicaltrials.gov

Start Date

March 15, 2022

End Date

May 16, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

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
•From 50 to 75 years of age
•Visible wrinkle in the face (grade 3 to 6 according to proderm scale) see Appendix 2
•Healthy skin in the test areas
•Vaccination of tetanus within the last 10 years (for biopsy sub group)

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
•Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years
•Diabetes mellitus (type 1 and 2)
•One of the following illnesses with reduced physical capability/fitness: asthma (symptom-free allergic asthma is not an exclusion criterion), hypertension, cardiovascular diseases
•Documented allergies to cosmetic products and/or ingredients, skin care and/or skin cleansing products
•Intolerability against adhesive dressing (e.g. acrylate)

Outcomes

Primary Outcomes

Change from baseline in skin mitochondrial health and biological age (assessed on skin biopsies) after 8 weeks

Time Frame: 8 weeks

Change from baseline in skin barrier function (assessed on transepidermal waterloss by Tewameter [g/(m²h)]) after 8-weeks

Time Frame: 8 weeks

Secondary Outcomes

Change from baseline in skin elasticity by Cutometer after 2 and 8 weeks(8 weeks)
Change from baseline for wrinkles and fine lines (assessed on Colorface Image analysis) after 2 and 8 weeks(8 weeks)
Change from baseline in skin barrier function (assessed on transepidermal waterloss by Tewameter [g/(m²h)]) after 2-weeks(2-weeks)
Subjective Evaluation of product traits assessed via questionnaire after 2 and 8 weeks(2 and 8 weeks)
Change from baseline in skin hydration (assessed on skin capacitance by Corneometer [a.u.]) after 2 and 8 weeks(8 weeks)
Change from baseline in pigmentation (assessed on skin color by Spectrophotometer) after 2 and 8 weeks(8 weeks)
Change from baseline in skin firmness by Cutometer [mm] after 2 and 8 weeks(8 weeks)
Change from baseline in skin layer thickness and undulation index of DEJ (assessed on Line field confocal Optical Coherence Tomography Image analysis) after 8 weeks for both groups or after 2 and 8 weeks(8 weeks)