Actively Recruiting
Biometrical Evaluation of the Efficacy of a Food Supplement Versus Placebo
Led by Finzelberg GmbH & Co. KG · Updated on 2024-12-10
66
Participants Needed
1
Research Sites
32 weeks
Total Duration
On this page
Sponsors
F
Finzelberg GmbH & Co. KG
Lead Sponsor
E
Eurofins
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Biometrical Evaluation of the Efficacy of a Food Supplement Versus Placebo
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 45 to 65 years
- Phototype I to IV
- Normal to dry skin
- Healthy skin on the study area
- Non-smoker
- Normal nutritional habits (not vegetarian or vegan)
- Not pregnant or lactating
- BMI between 18 and 33 kg/m2
- Willing to refrain from dietary supplements before and during the study
- No history of malabsorption, liver, or lipid metabolism diseases
- No medication that may interact with the study product
You will not qualify if you...
- Pregnant, nursing, or planning pregnancy during the study
- Skin conditions like eczema on the study area
- Wearing make-up on study visit days
- Recent use of treatments affecting skin assessment (anti-wrinkle products, non-invasive or invasive procedures) within specified timeframes
- Intake of vitamin substances or diets changing normal eating habits
- Known allergy to study product ingredients
- Participation in a nutritional study within 30 days
- Surgical or internal diseases affecting study outcomes, including diabetes, liver or kidney disorders, cardiovascular disease, skin disease, or hypertension (>140/90 mm Hg in three measurements)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Eurofins Dermscan Poland
Gdansk, GDANSK, Poland, 288
Actively Recruiting
Research Team
C
Cynthia G Suarez, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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