Evaluation of the Anti-aging Efficacy of a Novel Skin Health Product

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

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.

Study Overview

• Status: Completed
• Conditions: Skin Aging
• Intervention / Treatment: Other: Topical Placebo Cream; Other: Topical Cream with 0.5% Active; Other: Topical Cream with 1% Active

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Schenefeld, Germany
    • proDERM GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

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
• 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)
• Active skin disease at the test area
• Regular use of tanning beds
• Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, etc. at the test area that could influence the investigation
• Any topical medication at the test area within the last 3 days prior to the start 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
• Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. antiallergics) within the last 7 days prior to the start of the study
• Systemic therapy with anti-phlogistic agents or analgetics (e.g. diclophenac), except for minor pain relief medicine like paracetamol within the last 3 days prior to the start of the study
• Therapy with antibiotics within the last 2 weeks prior to the start of the study
• Regular medication with anti-coagulating drugs like Aspirin®, Macumar®, etc. (e.g. for thrombosis prophylaxis) within up to 15 days prior to the taking of the biopsies
• Past cosmetic surgery procedure in the test area (e.g. laser, facelift)
• History of complications at wound healing (e.g. keloids, hypertrophic scars or contracture scar)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 2	Other: Topical Placebo Cream; cosmetic cream to be applied topically on face and forearms twice/daily using split/face design; Other: Topical Cream with 1% Active; cosmetic cream to be applied topically on face and forearms twice/daily using split/face design
Experimental: Group 1	Other: Topical Placebo Cream; cosmetic cream to be applied topically on face and forearms twice/daily using split/face design; Other: Topical Cream with 0.5% Active; cosmetic cream to be applied topically on face and forearms twice/daily using split/face design

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in skin mitochondrial health and biological age (assessed on skin biopsies) after 8 weeks	8 weeks
Change from baseline in skin barrier function (assessed on transepidermal waterloss by Tewameter [g/(m²h)]) after 8-weeks	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in skin barrier function (assessed on transepidermal waterloss by Tewameter [g/(m²h)]) after 2-weeks	2-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 elasticity by Cutometer 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
Change from baseline for wrinkles and fine lines (assessed on Colorface Image analysis) after 2 and 8 weeks	8 weeks
Subjective Evaluation of product traits assessed via questionnaire after 2 and 8 weeks	2 and 8 weeks

Collaborators and Investigators

• Sponsor: Amazentis SA
• Collaborators: proDERM GmbH

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Actual): May 10, 2022
• Study Completion (Actual): May 16, 2022

Study Registration Dates

• First Submitted: March 19, 2022
• First Submitted That Met QC Criteria: March 19, 2022
• First Posted (Actual): March 29, 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

• Keywords: Mitochondria, Aging
• Other Study ID Numbers: 22.01.AMZ; 22.0052-23 (Other Identifier: proderm GmbH)

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