Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eurofins | INDUSTRY |
| Eurofins Dermscan Pharmascan | INDUSTRY |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | The placebo has similar characteristics as the verum instant drink. |
|
| Food supplement | Experimental | Powder for an instant drink preparation with orange flavor /taste |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Food supplement | Dietary Supplement | Instant drink in a powder form presented in a sachet to be disolved in a glass of water (200 ml). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Skin Physiological Parameters | Changes in skin hydration: Measurement of skin hydration by means of a Corneometer CM825. | 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. | Skin physiological parameters will be assessed at Day 0, Day 28, Day 56 |
| Skin Physiological Parameters | Change in skin elasticity using Cutometer MPA580 | 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). | Skin physiological parameters will be assessed at Day 0, Day 28, Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| 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') | It will be assessed at Day 28, Day 56 |
| Adverse events |
Not provided
Inclusion Criteria:
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:
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).
Female
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cynthia G Suarez, PhD | Contact | 004916098144462 | cynthia.suarez-rizzo@finzelberg.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurofins Dermscan Poland | Recruiting | Gdansk | GDANSK | 288 | Poland |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
Not provided
Not provided
single-center, ,double-blind, randomized pilot study
Not provided
Not provided
the product is also masked
| Placebo | Dietary Supplement | Instant drink in powder form in a sachet to be disolved in a glass of water (200ml) |
|
Collection of adverse events throughout the study |
| 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). | It will be assessed at Day 28, Day 56 |