Biometrical Evaluation of the Efficacy of a Food Supplement Versus Placebo

Not Applicable

Recruiting

• Conditions: Skin Aging; Hair Condition; Skin Condition

• Registration Number: NCT06727292
• Lead Sponsor: Finzelberg GmbH & Co. KG

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-14
• Study First Submitted: 2024-11-26
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-06
• Last Update Submitted: 2024-12-06
• Study First Posted: 2024-12-10
• Last Update Posted: 2024-12-10
• Primary Completion: 2025-04-01
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Skin Physiological Parameters	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 Outcome Measures

Name	Time	Method
Subject satisfaction	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')
Adverse events	Adverse events will be assessed during the whole study from Day 0 to Day 56	Collection of adverse events throughout the study
Subject self-assessment quality of the skin and hair.	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).

Trial Locations

Locations (1)

Eurofins Dermscan Poland; 🇵🇱 Gdansk, Poland