Evaluation of the Anti-aging Efficacy of Four Cosmetic Products

Amazentis SA1 site in 1 country144 target enrollmentJuly 13, 2022

ConditionsAnti-Aging Skin Aging

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Anti-Aging
Sponsor: Amazentis SA
Enrollment: 144
Locations: 1
Primary Endpoint: Anti-wrinkle efficacy will be assessed in the periorbital regions wrinkles using DermaTOP. Parameters measured: Rz and Ra, representing mainly the rough structure (Rz) or the finer skin structure (Ra).
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to assess the anti-wrinkle and anti-aging efficacy of four different cosmetic products compared to an untreated control (split-face study design)

Registry

clinicaltrials.gov

Start Date

July 13, 2022

End Date

October 17, 2022

Last Updated

3 years ago

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 male
•From 40 to 65 years of age
•BMI \< 30 kg/m2
•Healthy skin in the test areas
•Uniform skin color and no erythema or dark pigmentation in the test area
•Visible wrinkle in the face (grade 3 to 6 according to proderm scale) see Appendix 2
•Ethnicity: at least one Black, Asian and Hispanic subject per study 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
•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
•Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, freckles, etc. at the test area that could influence the investigation

Outcomes

Primary Outcomes

Anti-wrinkle efficacy will be assessed in the periorbital regions wrinkles using DermaTOP. Parameters measured: Rz and Ra, representing mainly the rough structure (Rz) or the finer skin structure (Ra).

Time Frame: 8-weeks

Secondary Outcomes

Change from baseline in skin elasticity by Cutometer after 2, 4 and 8 weeks(8-weeks)
Change from baseline in ceramides by Raman Spectroscopy [a.u.] on a subgroup of n=12 subjects per test product group after 2, 4 and 8 weeks(8-weeks)
Change in Image grading (Photodocumentation via USR-Clip) for skin radiance (3 trained graders will rank each pair of images in a blinded fashion) after 2, 4 and 8 weeks(8-weeks)
Change from baseline in skin firmness by Cutometer [mm] after 2, 4 and 8 weeks(8-weeks)
Change in wrinkle scores (Photodocumentation via USR-Clip) for anti-wrinkle efficacy (3 trained graders will rank each pair of images at the area of the crow feet's in a blinded manner)(8-weeks)
Change from baseline in skin hydration (assessed on skin capacitance by Corneometer [a.u.]) after 2, 4 and 8 weeks(8-weeks)
Change from baseline in skin barrier function (assessed on transepidermal waterloss by Tewameter [g/(m²h)]) after 2, 4, 8-weeks(8-weeks)
Subjective Evaluation of product traits assessed via questionnaire after 2, 4 and 8 weeks(8-weeks)