Monocentre, randomized, double-blind, placebo-controlled, parallel-group in vivo study to evaluate the effects of the food supplement Hamaforton™ (Hamamelis virginiana L. Extract)
- Conditions
- Only healthy subjects
- Registration Number
- DRKS00032925
- Lead Sponsor
- IUF - Leibniz-Institut für umweltmed. Forschung GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
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)
- 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;
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Protection against diesel exhaust particle (DEP)-induced skin pigmentation after supplementation with a food supplement (Hamaforton) (assessed by DPPT);<br>- Changes in gene regulation associated with skin ageing (MMP-1, TIMP, COL1A1) after UVA1 irradiation assessed by RT-PCR; <br>- Changes in concentrations of Hamamelis virginia metabolites in serum samples after supplementation;<br>- 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’);<br><br>- Safety of the investigational product as determined by collection of AE reports.
- Secondary Outcome Measures
Name Time Method - Changes in skin physiological parameters under supplementation: Skin hydration, elasticity (cutometer), antioxidant level, skin barrier function (TEWL);<br>- Changes under supplementation in skin topography (wrinkles, skin texture, volume, skin colour; assessed by Antera 3D);