Biometrical Evaluation of the Efficacy of a Food Supplement Versus Placebo (FB_BfW)

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.

Study Overview

• Status: Recruiting
• Conditions: Skin Condition; Skin Aging; Hair Condition
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Food supplement

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cynthia G Suarez, PhD; Phone Number: 004916098144462; Email: cynthia.suarez-rizzo@finzelberg.com

Study Locations

• Poland
  • Gdansk, Poland, 288
    • Recruiting
    • Eurofins Dermscan Poland
    • Contact: Maja Kreyzmon, Project manager; Phone Number: 0058 7320290; Email: Maja.Jaskolska@cpt.eurofinseu.com
    • Contact: Maja KREZYMON

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; The placebo has similar characteristics as the verum instant drink.	Dietary supplement: Placebo; Instant drink in powder form in a sachet to be disolved in a glass of water (200ml)
Experimental: Food supplement; Powder for an instant drink preparation with orange flavor /taste	Dietary supplement: Food supplement; Instant drink in a powder form presented in a sachet to be disolved in a glass of water (200 ml).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin Physiological Parameters	Changes in skin hydration: Measurement of skin hydration by means of a Corneometer CM825.	Skin physiological parameters will be assessed at Day 0, Day 28, Day 56
Skin Physiological Parameters	Assessment of skin barrier integrity measuring transepidermal water loss using the Tewameter® TM 300.	Skin physiological parameters will be assessed at Day 0, Day 28, Day 56
Skin Physiological Parameters	Change in skin elasticity using Cutometer MPA580	Skin physiological parameters will be assessed at Day 0, Day 28, Day 56
Skin Physiological Parameters	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).	Skin physiological parameters will be assessed at Day 0, Day 28, Day 56

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject satisfaction	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')	It will be assessed at Day 28, Day 56
Adverse events	Collection of adverse events throughout the study	Adverse events will be assessed during the whole study from Day 0 to Day 56
Subject self-assessment quality of the skin and hair.	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).	It will be assessed at Day 28, Day 56

Collaborators and Investigators

• Sponsor: Finzelberg GmbH & Co. KG
• Collaborators: Eurofins; Eurofins Dermscan Pharmascan

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): May 30, 2025

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: December 6, 2024
• First Posted (Estimated): December 10, 2024

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: improvements of skin physiological parameters
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Skin Diseases
• Other Study ID Numbers: STUX824AA0245

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: To comply with European regulations and national provisions, subjects are informed that not sharing of IPD is planned in order to protect their personal data. If data is to be shared, participants must be informed individually, and their consent obtained.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No