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

Evaluation of the Anti-aging Efficacy of Four Cosmetic Products

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)

Study Overview

• Status: Completed
• Conditions: Skin Aging; Anti-Aging
• Intervention / Treatment: Other: Day Cream cosmetic product compared to untreated side; Other: Night cream cosmetic product compared to untreated side; Other: Eye cream cosmetic product compared to untreated side; Other: Serum cosmetic product compared to untreated side

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Schenefeld, Germany
    • proDERM GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 2	Other: Night cream cosmetic product compared to untreated side; Applied once daily in the evening
Experimental: Group 1	Other: Day Cream cosmetic product compared to untreated side; Applied once daily in the morning
Experimental: Group 3	Other: Eye cream cosmetic product compared to untreated side; Applied twice daily in the morning and in the evening around the eye area
Experimental: Group 4	Other: Serum cosmetic product compared to untreated side; Applied twice daily in the morning and in the evening

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Change from baseline in skin firmness by Cutometer [mm] after 2, 4 and 8 weeks	8-weeks
Change from baseline in skin elasticity by Cutometer after 2, 4 and 8 weeks	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
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 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
Subjective Evaluation of product traits assessed via questionnaire after 2, 4 and 8 weeks	8-weeks

Collaborators and Investigators

• Sponsor: Amazentis SA
• Collaborators: proDERM GmbH

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2022
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): October 17, 2022

Study Registration Dates

• First Submitted: July 18, 2022
• First Submitted That Met QC Criteria: July 22, 2022
• First Posted (Actual): July 26, 2022

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 5, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 22.0229-39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No