An interventional study of Food supplement and Placebo in Skin Aging, Hair Condition and Skin Condition, sponsored by Finzelberg GmbH & Co. KG. Recruiting at 1 site in Poland. Open to female participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-10.
Sponsored by Finzelberg GmbH & Co. KG · Not applicable, Interventional, and Basic science
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:
The secondary objective is to evaluate product characteristics and performance during normal use in healthy subjects.
538 studies on the registry are indexed under Skin Diseases; 92 are open to participants now.
This study's planned enrollment of 66 is close to the median of 60 across 372 interventional studies indexed under Skin Diseases.
Browse Skin Diseases studies →This is the only study on the registry with Finzelberg GmbH & Co. KG as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the efficacy of the study product:
invasive procedures:
The placebo has similar characteristics as the verum instant drink.
Dietary Supplement: Placebo
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).
Instant drink in powder form in a sachet to be disolved in a glass of water (200ml)
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 56
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 56
Skin Physiological Parameters
Change in skin elasticity using Cutometer MPA580
Time frame: 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).
Time frame: Skin physiological parameters will be assessed at Day 0, Day 28, Day 56
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 56
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 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).
Time frame: It will be assessed at Day 28, Day 56
Plan to share: No — 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.
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