Skin Conditions
Conditions
Keywords
skin, hydration
Brief summary
A single-center, double-blind, randomized, parallel-group, placebo-controlled study to evaluate the superiority of peroral sodium hyaluronate to placebo in improving the skin hydration and other skin-related parameters.
Detailed description
Study type: * Single-center, randomized, placebo-controlled, double-blind, parallel-group study. * Participants will be stratified based on their sex (males/females) and age (young 18-39 years and old 40-60 years, max difference in median age between males and females 2 years), and randomly assigned to receive either the SH dietary supplements (lower concentration, daily dose 60 mg (SH60); and higher concentration, daily dose 120 mg (SH120)) or placebo in a 1:1:1 ratio. * The study will follow a superiority framework, aiming to demonstrate that the SH60 and SH120 dietary supplements are superior to placebo in improving facial skin hydration. * This study is a parallel-group trial: The three groups of participants (SH60/SH120/placebo group) will receive the treatments and will be assessed for their outcomes at the same time points.
Interventions
DIAGNOSTIC_TESTBlood draw for the laboratory assessment
Blood draw for testing of metabolics.
DIETARY_SUPPLEMENTSkin test panel
Testing of improving the skin hydration and other skin-related parameters.
DIETARY_SUPPLEMENTHA gel
Participants obtained altogether 3 flasks with 500ml of SH60, SH 120 solution. They tooj 15 ml of the SH60 or SH120 aupplements (experimental group) once daily in the morning before breakfast for 3 months.
DIETARY_SUPPLEMENTXanthan gum
Participants obtained altogether 3 flasks of placebo solution. They took 15 mL of placebo solution (control group) once daily in the morning before breakfast for 3 months.
Sponsors
Contipro Pharma a.s.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult subjects * Skin type: Caucasian, Fitzpatrick I-III * Sex: male and female * Age: 18 - 60 years. * No acute or chronic skin diseases affecting the face or volar forearm. * No acute or chronic gastrointestinal diseases. * Willing to keep their standard facial skincare routine and avoid any new products or procedures affecting facial or volar forearm skin during the study period. * Willing to avoid excessive UV exposure (tanning beds, excessive sunbathing) during the study period. * Willing to avoid longer stays in significantly different climates (will be assessed on a case-by-case basis) * Willing to avoid taking other dietary supplements containing SH
Exclusion criteria
* Subjects with known allergies to any ingredients in the dietary supplement. * Pregnant or lactating individuals. * Significant facial skin conditions or disorders. * Acute or chronic disease affecting the skin or gastrointestinal system. * Subjects currently using topical or oral medications affecting the gastrointestinal system or the skin. * Subjects who are taking or has taken diet pills or supplements containing SH within the past 3 months. * Subjects who are taking or has taken oral antibiotics in the last 3 months. * Subjects with diabetes mellitus * Subjects with increased bleeding tendency, poor superficial veins in the antecubital fossa, and those with a fear of blood draws that makes blood draw impossible
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in skin hydration | 0, 1, 2 , 3 months | * Measurement site: forehead, volar forearm * Measurement time points: 0, 1, 2, 3 months * Measurement site: cheek * Measurement time points: 0, 1, 2 months * Measurement device: Corneometer CM 825 * Parameter unit: AU (arbitrary unit) * Number of measurements at each time point: at least 5 * Outcome measure: Change from baseline * Method of analysis: * Mean, standard deviation and confidence intervals will be calculated. * Normality of the data distribution will be assessed. * Comparison between HA group and placebo group will be assessed using independent sample T-test or Mann-Whitney U test as a nonparametric alternative. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in TEWL | 0, 1, 2, 3 months | * Measurement site: forehead, cheek * Measurement time points: 0 (baseline), 1, 2, 3 months * Measurement device: Tewameter TM 300 * Parameter unit: AU (arbitrary unit) * Number of measurements at each time point: at least 10 * Outcome measure: Change from baseline * Method of analysis: * Mean, standard deviation and confidence intervals will be calculated. * Normality of the data distribution will be assessed. * Comparison between HA group and placebo group will be assessed using independent sample T-test or Mann-Whitney U test as a nonparametric alternative. |
| Change in skin elasticity | 0, 1, 2, 3 months | * Measurement site: forehead, cheek * Measurement time points: 0, 1, 2, 3 months * Measurement device: Cutometer MPA 580 * Parameter unit: AU (arbitrary unit) * Number of measurements at each time point: at least 1 * Outcome measure: Change from baseline * Method of analysis: * Mean, standard deviation and confidence intervals will be calculated. * Normality of the data distribution will be assessed. * Comparison between HA group and placebo group will be assessed using independent sample T-test or Mann-Whitney U test as a nonparametric alternative. |
| Change in wrinkle depth | 0, 1, 2, 3 months | * Measurement site: crow´s feet area * Measurement time points: 0, 1, 2, 3 months * Measurement device: Primos Lite * Parameter unit: mm * Number of measurements at each time point: at least 3 * Outcome measure: Change from baseline * Method of analysis: * Mean, standard deviation and confidence intervals will be calculated. * Normality of the data distribution will be assessed. * Comparison between HA group and placebo group will be assessed using independent sample T-test or Mann-Whitney U test as a nonparametric alternative. |
Countries
Czechia
Outcome results
None listed