The Effect of Peroral Sodium Hyaluronate on the Skin

NCT ID: NCT07065110

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-17
• Study Completion Date: 2024-12-13

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.

Conditions

Skin Conditions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

HA gel group

Participants obtained altogether 3 flasks with 500 mL of SH60, SH120 solution. They took 15 mL of the SH60 or SH120 supplements (experimental groups) once daily in the morning before breakfast for 3 months.

Group Type: EXPERIMENTAL

Blood draw for the laboratory assessment

Intervention Type: DIAGNOSTIC_TEST

Blood draw for testing of metabolics.

Skin test panel

Intervention Type: DIETARY_SUPPLEMENT

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

HA gel

Intervention Type: DIETARY_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.

Xanthan gum group

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.

Group Type: PLACEBO_COMPARATOR

Blood draw for the laboratory assessment

Intervention Type: DIAGNOSTIC_TEST

Blood draw for testing of metabolics.

Skin test panel

Intervention Type: DIETARY_SUPPLEMENT

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

Xanthan gum

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

Blood draw for the laboratory assessment

Blood draw for testing of metabolics.

Intervention Type: DIAGNOSTIC_TEST

Skin test panel

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Skin condition testing

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Contipro Pharma a.s.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Contipro a.s.

Ústí nad Orlicí, , Czechia

Countries

Czechia

Other Identifiers

AICE24_II

Identifier Type: -

Identifier Source: org_study_id