Skin Aging
Conditions
Keywords
Mitochondria, Urolithin A, Mitopure, Aging
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
Interventions
OTHERMitopure (Urolithin A) Cream
cosmetic cream to be applied topically on face and forearms twice/daily using split/face design
OTHERPlacebo Cream
cosmetic cream to be applied topically on face and forearms twice/daily using split/face design
Sponsors
proDERM GmbH
Amazentis SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-wrinkle efficacy | 12 weeks | Anti-wrinkle efficacy will be assessed in the periorbital regions wrinkles using AEVA. Parameters measured: Rz and Ra, representing mainly the rough structure (Rz) or the finer skin structure (Ra). |
| Skin Biological age | 12-weeks | DNA methylation patterns analysis (epigenetics) by skin tape stripping (D-Squames) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mitochondrial morphology in skin | 12 weeks | mitochondrial morphology in skin will be assessed via transmission electron microscopy (TEM) on 3mm punch-biopsies |
| Skin hydration | 12 weeks | Change from baseline in skin hydration (assessed on skin capacitance by Corneometer \[a.u.\]) |
| Subjective questionnaire | 12 weeks | Subjective evaluation of product traits assessed via questionnaire |
| Photodocumentation of skin health | 12 weeks | ColorFace image analysis of face via facial photography |
| Transepidermal Water Loss (TEWL) | 12 weeks | Change from baseline in skin barrier function (assessed as transepidermal waterloss by Tewameter \[g/(m²h)\]) |
Countries
Germany
Outcome results
None listed