Eurofins Dermscan Poland
Gdansk, GDANSK, 288, Poland
Location status: Recruiting
NCT Number: NCT06727292
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.
Interested in participating?
Request Info45 year–65 year
Female
Interventional
Not applicable
Gdansk, GDANSK, 288, Poland
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Instant drink in a powder form presented in a sachet to be disolved in a glass of water (200 ml).
Instant drink in powder form in a sachet to be disolved in a glass of water (200ml)
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.
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.
Time frame: Skin physiological parameters will be assessed at Day 0, Day 28, Day 56
Change in skin elasticity using Cutometer MPA580
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).
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')
Time frame: Adverse events will be assessed during the whole study from Day 0 to Day 56
Collection of adverse events throughout the study
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).
Contact information is provided by the study sponsor or research team.
Finzelberg GmbH & Co. KG
Industry
Acronym: FB_BfW
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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