Biometrical Evaluation of the Efficacy of a Food Supplement Versus Placebo
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-65
SponsorFinzelberg GmbH & Co. KG
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Phototype: I to IV;
Subjects with normal to dry skin;
Subjects with healthy skin on the study area;
Non-smokers;
Disqualifiers
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;
change in anti-wrinkle, smoothing and/or firming topical products within previous week on the studied zones,
Trial design
Design model
Parallel
Treatments tested in this trial
Food supplement
Dietary supplementInstant drink in a powder form presented in a sachet to be disolved in a glass of water (200 ml).
Placebo
Dietary supplementInstant drink in powder form in a sachet to be disolved in a glass of water (200ml)
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: Food supplementExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Skin Physiological Parameters
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 562
Skin Physiological Parameters
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 563
Skin Physiological Parameters
Change in skin elasticity using Cutometer MPA580
Time frame
Skin physiological parameters will be assessed at Day 0, Day 28, Day 564
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).
Time frame
Skin physiological parameters will be assessed at Day 0, Day 28, Day 56Secondary outcomes
1
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')
Time frame
It will be assessed at Day 28, Day 562
Adverse events
Collection of adverse events throughout the study
Time frame
Adverse events will be assessed during the whole study from Day 0 to Day 563
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).
Time frame
It will be assessed at Day 28, Day 56Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov