The Effect of Peroral Sodium Hyaluronate on the Skin

NCT07065110 | Completed

• 1 other identifier: AICE24_II
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Conditions

Keywords

skin; hydration

Outcome Measures

Primary Outcomes (1)

• 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.

  0, 1, 2 , 3 months

Secondary Outcomes (3)

• Change in TEWL

  0, 1, 2, 3 months

• Change in skin elasticity

  0, 1, 2, 3 months

• Change in wrinkle depth

  0, 1, 2, 3 months

Study Arms (2)

HA gel group

EXPERIMENTAL

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.

Diagnostic Test: Blood draw for the laboratory assessment; Dietary Supplement: Skin test panel; Dietary Supplement: HA gel

Xanthan gum group

PLACEBO COMPARATOR

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.

Diagnostic Test: Blood draw for the laboratory assessment; Dietary Supplement: Skin test panel; Dietary Supplement: Xanthan gum

Interventions

Blood draw for the laboratory assessment DIAGNOSTIC_TEST

Blood draw for testing of metabolics.

HA gel group; Xanthan gum group

Skin test panel DIETARY_SUPPLEMENT

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

Also known as: Skin condition testing

HA gel group; Xanthan gum group

HA gel 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.

HA gel group

Xanthan gum 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.

Xanthan gum group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Contipro Pharma a.s.: lead

Study Sites (1)

Contipro a.s.

Ústí nad Orlicí, Czechia

Location

Related Publications (1)

• Doleckova I, Kusnierik P, Berka V, Simek M, Matejkova I, Prokopec F, Ovesna P. Oral sodium hyaluronate improves skin hydration, barrier function and signs of aging: a randomized, double-blind, placebo-controlled trial in 150 healthy adults. Sci Rep. 2025 Dec 20. doi: 10.1038/s41598-025-32758-5. Online ahead of print.

  PMID: 41422283 DERIVED

MeSH Terms

Conditions

Skin Diseases

Interventions

Blood Specimen Collection; xanthan gum

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: July 15, 2025
• Study Start: June 17, 2024
• Primary Completion: December 13, 2024
• Study Completion: December 13, 2024
• Last Updated: July 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)