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NCT Number: NCT06727292

Biometrical Evaluation of the Efficacy of a Food Supplement Versus Placebo

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.

Recruiting

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Key information

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Eurofins Dermscan Poland

Gdansk, GDANSK, 288, Poland

Location status: Recruiting

Location contact

Maja KREZYMON

CONTACT

Maja Kreyzmon, Project manager

CONTACT

[email protected]

0058 7320290

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Food supplement

Dietary Supplement

Instant drink in a powder form presented in a sachet to be disolved in a glass of water (200 ml).

Placebo

Dietary Supplement

Instant drink in powder form in a sachet to be disolved in a glass of water (200ml)

Primary outcomes

  1. Skin Physiological Parameters

    Time frame: Skin physiological parameters will be assessed at Day 0, Day 28, Day 56

    Changes in skin hydration: Measurement of skin hydration by means of a Corneometer CM825.

  2. Skin Physiological Parameters

    Time frame: Skin physiological parameters will be assessed at Day 0, Day 28, Day 56

    Assessment of skin barrier integrity measuring transepidermal water loss using the Tewameter® TM 300.

  3. Skin Physiological Parameters

    Time frame: Skin physiological parameters will be assessed at Day 0, Day 28, Day 56

    Change in skin elasticity using Cutometer MPA580

  4. Skin Physiological Parameters

    Time frame: Skin physiological parameters will be assessed at Day 0, Day 28, Day 56

    Changes in skin density using ultrasound measurements with a frequency of 20 MHz (Derma Scan C, Vers. 3) with 2-D-configuration (Cortex Technology, Denmark).

Secondary outcomes

  1. Subject satisfaction

    Time frame: It will be assessed at Day 28, Day 56

    A subjective evaluation questionnaire on the study product's effects on the skin will be completed by subjects (each item is scored individually on a 5 point Likert scale ranging from 'Totally agree' to 'Totally disagree')

  2. Adverse events

    Time frame: Adverse events will be assessed during the whole study from Day 0 to Day 56

    Collection of adverse events throughout the study

  3. Subject self-assessment quality of the skin and hair.

    Time frame: It will be assessed at Day 28, Day 56

    The quality of the volunteers' skin and hair will be subjectively assessed by a self-assessment questionnaire. This questionnaire will assess the volunteers' perception of improvement in their skin in general and in wrinkles, spots, redness, elasticity, hydration, appearance. In the case of hair, the questionnaire will assess if it is stronger than before. There will be 5 levels in the questionnaire to assess how true the statements are: No Information (0), No improvement (1), Somewhat (2), Clearly Yes (3) and Yes, Very clearly (4).

Study contacts

Contact information is provided by the study sponsor or research team.

Cynthia G Suarez, PhD

CONTACT

[email protected]

004916098144462

Sponsors and collaborators

Lead sponsor

Finzelberg GmbH & Co. KG

Industry

Collaborators

  • Eurofins
  • Eurofins Dermscan Pharmascan

Registry information

Acronym: FB_BfW

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 10, 2024
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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