Clinical trial NCT06727292: Biometrical Evaluation of the Efficacy of a Food Supplement Versus Placebo
Official title: Biometrical Evaluation of the Efficacy of a Food Supplement Versus Placebo
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Skin Aging
Hair Condition
Skin Condition
Keywords: improvements of skin physiological parameters
Lead sponsor: Finzelberg GmbH & Co. KG
Sponsor class: INDUSTRY
Collaborators: name: Eurofins
name: Eurofins Dermscan Pharmascan
First posted: 2024-12-10
Enrollment: 66
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-center, ,double-blind, randomized pilot study
Primary purpose: BASIC_SCIENCE

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.


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;
* 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).

Primary outcomes:
measure: Skin Physiological Parameters
timeFrame: Skin physiological parameters will be assessed at Day 0, Day 28, Day 56
measure: Skin Physiological Parameters
timeFrame: Skin physiological parameters will be assessed at Day 0, Day 28, Day 56
measure: Skin Physiological Parameters
timeFrame: Skin physiological parameters will be assessed at Day 0, Day 28, Day 56
measure: Skin Physiological Parameters
timeFrame: Skin physiological parameters will be assessed at Day 0, Day 28, Day 56
Secondary outcomes:
measure: Subject satisfaction
timeFrame: It will be assessed at Day 28, Day 56
measure: Adverse events
timeFrame: Adverse events will be assessed during the whole study from Day 0 to Day 56
measure: Subject self-assessment quality of the skin and hair.
timeFrame: It will be assessed at Day 28, Day 56
Other outcomes:
Locations:
city: Gdansk
country: Poland
facility: Eurofins Dermscan Poland
Study officials:
References: