Biometrical Evaluation of the Efficacy of a Food Supplement Versus Placebo

NCT06727292 | Recruiting DMC

• 1 other identifier: STUX824AA0245
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Aging; Hair Condition; Skin Condition

Keywords

improvements of skin physiological parameters

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Subject satisfaction

  It will be assessed at Day 28, Day 56

• Adverse events

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

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

  It will be assessed at Day 28, Day 56

Study Arms (2)

Placebo

PLACEBO COMPARATOR

The placebo has similar characteristics as the verum instant drink.

Dietary Supplement: Placebo

Food supplement

EXPERIMENTAL

Powder for an instant drink preparation with orange flavor /taste

Dietary Supplement: Food supplement

Interventions

Food supplement DIETARY_SUPPLEMENT

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

Food supplement

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 45 Years - 65 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Finzelberg GmbH & Co. KG: lead
• Eurofins: collaborator
• Eurofins Dermscan Pharmascan: collaborator

Study Sites (1)

Eurofins Dermscan Poland

Gdansk, GDANSK, 288, Poland

RECRUITING

MeSH Terms

Conditions

Skin Diseases

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Cynthia G Suarez, PhD

CONTACT

004916098144462; cynthia.suarez-rizzo@finzelberg.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: the product is also masked
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: single-center, ,double-blind, randomized pilot study

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 10, 2024
• Study Start: October 14, 2024
• Primary Completion: April 1, 2025
• Study Completion: May 30, 2025
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)