Only healthy subjects
Conditions
Interventions
Group 1: 30 subjects will be included in the verum group of the study. The allocation of the study products will be done by randomisation. All participants will undergo the "Düsseldorf Pollution Patch
Sponsors
IUF - Leibniz-Institut für umweltmed. Forschung GmbH
Eligibility
Sex/Gender
All
Age
30 Years to 65 Years
Inclusion criteria
Inclusion criteria: - Females capable of becoming pregnant must use a highly effective contraception and must show a negative urine pregnancy test at V1; - Healthy with no clinically significant abnormality identified by medical history and clinical examination; - No knowm skin diseases (e.g. psoriasis, eczema); - Must agree not to use cosmetic products from the beginning of the study at the screening visit and throughout the study in the tested areas at the back; - Fitzpatrick skin types III – IV (for subjects participating in the biopsy sub study)
Exclusion criteria
Exclusion criteria: - vegan/ vegetarian - Pregnant or lactating women; - Known allergy or intolerance to any component of the test preparations; subjects are asked at screening to show an ‘Allergy Pass’ if available; - Use of sunbeds during the last three months or planned vacations for sunbathing during the study; - Known hepatic disease; - Known skin cancer; - Permanent use of prescription medicines (with the exception of contraceptives); - Any use of oral nutritional anti-oxidant and/or vitamin supplementation three months before and during the study other than the test products; - Scars, cuts, wounds, intensely tanned skin or dermal abnormalities in the designated test areas; - Belonging to a high-risk group for HIV, hepatitis or other infectious diseases; - Participation in a clinical research trial within 30 days prior to randomization • For participants in the biopsies: - Known allergies/ intolerances to plasters, suture material, local anaesthetics or other substances/ materials used in the course of biopsies; - Known blood coagulation disorders or use of anticoagulants/antiplatelet agents; - Known photosensitivity or use of photosensitising drugs/ food supplements, e.g. St. John's wort, tetracycline;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Protection against diesel exhaust particle (DEP)-induced skin pigmentation after supplementation with a food supplement (Hamaforton) (assessed by DPPT); - Changes in gene regulation associated with skin ageing (MMP-1, TIMP, COL1A1) after UVA1 irradiation assessed by RT-PCR; - Changes in concentrations of Hamamelis virginia metabolites in serum samples after supplementation; - Assessment of potential effects of serum samples containing Hamamelis virginia metabolites on human senescent skin fibroblastes assessed by FACS analysis and ELISA (analysis of the ‘senescence-associated secretory phenotype’); - Safety of the investigational product as determined by collection of AE reports. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Changes in skin physiological parameters under supplementation: Skin hydration, elasticity (cutometer), antioxidant level, skin barrier function (TEWL); - Changes under supplementation in skin topography (wrinkles, skin texture, volume, skin colour; assessed by Antera 3D); | — |
Countries
Germany
Contacts
Public ContactNatalie Aue
IUF - Leibniz-Institut für umweltmed. Forschung GmbH
Outcome results
None listed