NCT07065110

The Effect of Peroral Sodium Hyaluronate on the Skin

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Contipro Pharma a.s. · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Skin Conditions

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Blood draw for the laboratory assessment	Blood draw for testing of metabolics.
DIETARY_SUPPLEMENT	Skin test panel	Testing of improving the skin hydration and other skin-related parameters.
DIETARY_SUPPLEMENT	HA 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_SUPPLEMENT	Xanthan 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.

Timeline

• Start date: 2024-06-17
• Primary completion: 2024-12-13
• Completion: 2024-12-13
• First posted: 2025-07-15
• Last updated: 2025-07-15

Locations

1 site across 1 country: Czechia