Biometrical Evaluation of the Efficacy of a Food Supplement Versus Placebo

Обзор

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.

Вмешательства

• Пищевая добавка Food supplement
  Instant drink in a powder form presented in a sachet to be disolved in a glass of water (200 ml).
• Пищевая добавка Placebo
  Instant drink in powder form in a sachet to be disolved in a glass of water (200ml)

Первичные конечные точки

• Skin Physiological Parameters [Срок оценки: Skin physiological parameters will be assessed at Day 0, Day 28, Day 56]
• Skin Physiological Parameters [Срок оценки: Skin physiological parameters will be assessed at Day 0, Day 28, Day 56]
• Skin Physiological Parameters [Срок оценки: Skin physiological parameters will be assessed at Day 0, Day 28, Day 56]
• Skin Physiological Parameters [Срок оценки: Skin physiological parameters will be assessed at Day 0, Day 28, Day 56]

Вторичные конечные точки (3)

• Subject satisfaction [Срок оценки: It will be assessed at Day 28, Day 56]
• Adverse events [Срок оценки: Adverse events will be assessed during the whole study from Day 0 to Day 56]
• Subject self-assessment quality of the skin and hair. [Срок оценки: It will be assessed at Day 28, Day 56]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Фундаментальное исследование

Центры проведения

Польша · 1 центр

• Eurofins Dermscan Poland — Gdansk

Идентификаторы

NCT: NCT06727292 · STUX824AA0245

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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