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Biometrical Evaluation of the Efficacy of a Food Supplement Versus Placebo

Biometrical Evaluation of the Efficacy of a Food Supplement Versus Placebo

Recruiting
45-65 years
Female
Phase N/A

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Overview

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

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;
  • Uses no medication, which may interact with the study product

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,
      • botox and/or hyaluronic acid injections within previous 12 months on the studied zones;
  • Intake of vitamin substances and diets comprising a change of normal eating habits;
  • Known allergy to one or several investigational product´s ingredients;
  • Participation in a nutritional study within the last 30 days;
  • Surgical or internal diseases e.g. a metabolic or endocrine disease that may affect the outcome of the study (e.g. diabetes, liver diseases, kidney disorders) or having a history of medical or surgical events that may significantly affect the study outcome including any cardiovascular disease, skin disease, hypertension (>140/90 mm Hg in three repeated measurements).

Study details
    Skin Aging
    Hair Condition
    Skin Condition

NCT06727292

Finzelberg GmbH & Co. KG

14 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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