Skin ConditionsNCT07065110
The Effect of Peroral Sodium Hyaluronate on the Skin
A study testing Blood draw for the laboratory assessment, Skin test panel and HA gel in people with Skin Conditions, run by Contipro Pharma a.s. at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Conditions
- What is being tested?
- Blood draw for the laboratory assessment, Skin test panel and HA gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteCzechia
- Study dates
- 17 Jun 2024to 13 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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
- Being tested
- Blood draw for the laboratory assessment, Skin test panel, HA gel, Xanthan gum
- Keywords
- skin, hydration
- Medical subject headings
- Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood draw for the laboratory assessmentDiagnostic test
Blood draw for testing of metabolics.
Skin test panelDietary supplement
Also called Skin condition testing
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.
Xanthan gumDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Blood draw for the laboratory assessment; Dietary Supplement: Skin test panel; Dietary Supplement: Xanthan gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0, 1, 2 , 3 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 0, 1, 2, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start17 Jun 2024
- Primary completion13 Dec 2024
- Study completion13 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Contipro Pharma a.s.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065110
- Sponsor's protocol ID
- AICE24_II
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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;16(1):2941. doi: 10.1038/s41598-025-32758-5.
PubMed 41422283
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07065110
- Acronym / sponsor ID
- AICE24_II
- Conditions
- Skin Conditions
- Keywords
- skin, hydration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Contipro Pharma a.s.University, hospital or other
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- 13 Dec 2024 (actual)
- Study completion
- 13 Dec 2024 (actual)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HA gel group | Experimental | Diagnostic Test: Blood draw for the laboratory assessment, Dietary Supplement: Skin test panel, Dietary Supplement: HA gelParticipants 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. |
| Xanthan gum group | Placebo comparator | Diagnostic Test: Blood draw for the laboratory assessment, Dietary Supplement: Skin test panel, Dietary Supplement: Xanthan gumParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood draw for the laboratory assessmentBlood draw for testing of metabolics. | Diagnostic test | HA gel group, Xanthan gum group |
| Skin test panelAlso: Skin condition testingTesting of improving the skin hydration and other skin-related parameters. | Dietary supplement | HA gel group, Xanthan gum group |
| HA gelParticipants 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 | HA gel group |
| Xanthan gumParticipants 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. | Dietary supplement | Xanthan gum group |
Primary outcome
Change in skin hydration
Time frame: 0, 1, 2 , 3 months
* 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.
3 secondary outcomes
Change in TEWL
Time frame: 0, 1, 2, 3 months
Change in skin elasticity
Time frame: 0, 1, 2, 3 months
Change in wrinkle depth
Time frame: 0, 1, 2, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Derived from this study: PubMed 41422283Doleckova 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;16(1):2941. doi: 10.1038/s41598-025-32758-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood draw for the laboratory assessment, Skin test panel and HA gel in people with Skin Conditions, run by Contipro Pharma a.s. at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in skin hydration (time frame: 0, 1, 2 , 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07065110, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.