Biometrical Evaluation of the Efficacy of a Food Supplement Versus Placebo

Finzelberg GmbH & Co. KG1 site in 1 country66 target enrollmentOctober 14, 2024

ConditionsSkin Aging Hair Condition Skin Condition

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Skin Aging
Sponsor: Finzelberg GmbH & Co. KG
Enrollment: 66
Locations: 1
Primary Endpoint: Skin Physiological Parameters
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 14, 2024

End Date

May 30, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Finzelberg GmbH & Co. KG

Responsible Party

Sponsor

Eligibility Criteria

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;

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,

Outcomes

Primary Outcomes

Skin Physiological Parameters

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).

Secondary Outcomes

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)