Monocentre, randomized, double-blind, placebo-controlled, parallel-group in vivo study to evaluate the effects of the food supplement Hamaforton™ (Hamamelis virginiana L. Extract)

IUF - Leibniz-Institut für umweltmed. Forschung GmbH0 个研究点目标入组 60 人开始时间: 2023年10月31日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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;

发起方

IUF - Leibniz-Institut für umweltmed. Forschung GmbH