Clinical trial NCT06619457: Evaluation of the Anti-aging Efficacy of One Face Care Cosmetic Product
Official title: Evaluation of the Anti-aging Efficacy of One Face Care Cosmetic Product
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Aging
Keywords: Mitochondria
Urolithin A
Mitopure
Aging
Lead sponsor: Amazentis SA
Sponsor class: INDUSTRY
Collaborators: name: proDERM GmbH
First posted: 2024-10-01
Enrollment: 36
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the anti-wrinkle efficacy and effect on skin epigenetic and on mitochondrial morphology of a facial cosmetic product compared to a placebo


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 approximately 10% male (at least 4 male subjects)
* From 50 to 75 years of age
* Healthy skin in the test areas
* Visible wrinkles in the face (grade 3 to 6 according to SGS proderm scale)

For biopsy subpanel:

-Vaccination of tetanus within the last 10 years

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
* Regular use of tanning beds
* Any topical medication at the test area within the last 3 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
* Therapy with antibiotics within the last 2 weeks 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

For biopsy subpanel:

* 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
* History of complications at wound healing (e.g. keloids, hypertrophic scars or contracture scar)
* Known intolerance to local anaesthetics
* Known Sensitivity to any dressing systems

Primary outcomes:
measure: Anti-wrinkle efficacy
timeFrame: 12 weeks
measure: Skin Biological age
timeFrame: 12-weeks
Secondary outcomes:
measure: Skin hydration
timeFrame: 12 weeks
measure: Transepidermal Water Loss (TEWL)
timeFrame: 12 weeks
measure: Mitochondrial morphology in skin
timeFrame: 12 weeks
measure: Photodocumentation of skin health
timeFrame: 12 weeks
measure: Subjective questionnaire
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Schenefeld
country: Germany
facility: SGS proderm GmbH
state: Hamburg
Study officials:
affiliation: SGS proderm GmbH
name: Katrin Unbereit, PhD
role: PRINCIPAL_INVESTIGATOR
References: