The Effect of Peroral Sodium Hyaluronate on the Skin

Contipro Pharma a.s.150 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

150

Conditions

Skin Conditions

Interventions

Blood draw for the laboratory assessmentDIAGNOSTIC_TEST

Blood draw for testing of metabolics.

Skin test panelDIETARY_SUPPLEMENT

Testing of improving the skin hydration and other skin-related parameters.

HA gelDIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Contipro a.s.

Ústí nad Orlicí, Czechia

Outcomes

Primary Outcomes

Change in skin hydration

* 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.

Time frame: 0, 1, 2 , 3 months

Secondary Outcomes

Change in TEWL

* 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.

Time frame: 0, 1, 2, 3 months

Change in skin elasticity

* 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.

Time frame: 0, 1, 2, 3 months

Change in wrinkle depth

* 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.

Data from ClinicalTrials.gov

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