Skin Aging
Conditions
Keywords
Mitochondria, Aging
Brief summary
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.
Interventions
cosmetic cream to be applied topically on face and forearms twice/daily using split/face design
cosmetic cream to be applied topically on face and forearms twice/daily using split/face design
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)
Intervention model description
Split face/arm design
Eligibility
Sex/Gender
FEMALE
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 * 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)
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| 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 barrier function (assessed on transepidermal waterloss by Tewameter [g/(m²h)]) after 2-weeks | 2-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 |
| 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 in skin hydration (assessed on skin capacitance by Corneometer [a.u.]) after 2 and 8 weeks | 8 weeks |
Countries
Germany
Outcome results
None listed