Evaluation of the Anti-aging Efficacy of Four Skin Health Products

Not Applicable

Completed

• Conditions: Anti-Aging; Skin Aging
• Interventions: Other: Night cream cosmetic product compared to untreated side; Other: Day Cream cosmetic product compared to untreated side; Other: Eye cream cosmetic product compared to untreated side; Other: Serum cosmetic product compared to untreated side

• Registration Number: NCT05473832
• Lead Sponsor: Amazentis SA

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-13
• Study First Submitted: 2022-07-18
• Study First Submitted QC: 2022-07-22
• Study First Posted: 2022-07-26
• Primary Completion: 2022-09-30
• Study Completion: 2022-10-17
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-05
• Last Update Posted: 2023-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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
• Epilepsy
• Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, freckles, etc. at the test area that could influence the investigation
• Sun-tanned skin (important for the subgroup of subjects planned for Raman measurements)
• Regular use of tanning beds
• Any topical medication at the test area within the last 7 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
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Night cream cosmetic product compared to untreated side	-
Group 1	Day Cream cosmetic product compared to untreated side	-
Group 3	Eye cream cosmetic product compared to untreated side	-
Group 4	Serum cosmetic product compared to untreated side	-

Primary Outcome Measures

Name	Time	Method
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).	8-weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

proderm GmbH; 🇩🇪 Schenefeld, Germany