Biometrical Evaluation of the Efficacy of a Food Supplement Versus Placebo

Launched by FINZELBERG GMBH & CO. KG · Dec 6, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at whether a specific food supplement can improve the health and appearance of skin over a period of two months. The study is being done at a single center and involves participants taking either the food supplement or a placebo (a non-active version) once a day. During the trial, participants will visit the study center three times to check on their skin's progress and will keep a diary to note any changes or side effects they experience.

To participate, individuals should be healthy women aged 16 to 40, with normal to dry skin and not currently pregnant or breastfeeding. They should also not be using any dietary supplements or medications that could affect the study results. If you join the study, you will be asked to refrain from using any other skin treatments during the trial period. This study aims to find out how well the supplement works in improving skin conditions, so if you're interested in helping advance our understanding of skin health, this could be a great opportunity!

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Phototype: I to IV;
• • Subjects with normal to dry skin;
• • Subjects with healthy skin on the study area;
• • Non-smokers;
• • Has normal nutritional habits (not vegetarian/vegan);
• • Is not pregnant or lactating;
• • Has a BMI of 18 - 33 kg/m2;
• • Is willing to refrain from taking dietary supplements (at best not at all, in any case not during the last month before study start);
• • Willing not to use any oral products or any nutritional supplementation aiming at improving skin status during the course of the study;
• • No history of malabsorption diseases, liver diseases, or diseases of the lipid metabolism;
• • Uses no medication, which may interact with the study product
• Exclusion Criteria:
• • For women: pregnant or nursing woman or woman planning to get pregnant during the study;
• • Cutaneous pathology on the study zone (eczema, etc.);
• • Subject with make-up on the day of the visit at the laboratory;
• * Use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the efficacy of the study product:
• • change in anti-wrinkle, smoothing and/or firming topical products within previous week on the studied zones,
• • non-invasive procedures within previous month on the studied zones,
• • intake of food supplement acting on skin within the three previous months,
• * invasive procedures:
• • deep chemical peeling within previous 3 months on the studied zones,
• • mesotherapy, dermapen, laser within previous 6 months on the studied zones,
• • botox and/or hyaluronic acid injections within previous 12 months on the studied zones;
• • Intake of vitamin substances and diets comprising a change of normal eating habits;
• • Known allergy to one or several investigational product´s ingredients;
• • Participation in a nutritional study within the last 30 days;
• • Surgical or internal diseases e.g. a metabolic or endocrine disease that may affect the outcome of the study (e.g. diabetes, liver diseases, kidney disorders) or having a history of medical or surgical events that may significantly affect the study outcome including any cardiovascular disease, skin disease, hypertension (\>140/90 mm Hg in three repeated measurements).