The Effect of Peroral Sodium Hyaluronate on the Skin

Contipro

Status: Completed

Conditions: Skin Conditions

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07065110

AICE24_II

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups, including a placebo group

HA gel group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Skin test panel

Diagnostic Test: Blood draw for the laboratory assessment

Dietary Supplement: HA gel

Xanthan gum group

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Skin test panel

Diagnostic Test: Blood draw for the laboratory assessment

Dietary Supplement: Xanthan gum