💬In plain words
What the trial is, and whether it could suit you
The purpose of this clinical trial is to evaluate whether nutritional supplementation over a 2-month period improves skin physiological parameters. This is a national, single-center, double-blind, randomized pilot study.
The study will be conducted using a supplement and a placebo, the safety of which has been assured by the sponsor.
Participants will:
* Take a food supplement or a placebo once daily for 2 months
* Visit the study center at beginning, after 28 days and after 56 days of supplementation.
* Keep a diary of their skin status and tolerability
The secondary objective is to evaluate product characteristics and performance during normal use in healthy subjects.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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).
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