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Facial DrynessNCT06914583

Safety and Efficacy Evaluation of Sodium Hyaluronate 32mg/ml in Improving Facial Skin Dryness and Dullness

A study testing Sodium Hyaluronate in people with Facial Dryness and Facial Dullness, run by IBSA Farmaceutici Italia Srl at 6 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The aim of the study is to evaluate the safety and efficacy of sodium hyaluronate 32 mg/ml in improving facial skin dryness and dullness. Subjects are randomized to the treatment group or to the control group. Only subjects in the treatment group are treated by intradermal injection. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Facial Dryness, Facial Dullness
What is being tested?
Sodium Hyaluronate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
6 sitesChina
Study dates
19 Feb 2025to Feb 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years old and ≤65 years old (based on the time of signing the ICF), gender is not restricted;
  • Skin Fitzpatrick is classified as type II-IV;
  • Subjects who are seeking temporary improvement of their dry facial skin and dull complexion. The investigator has assessed the subjects are suitable for receiving injectable treatment to improve these conditions;
  • Subjects who have agreed not to use any other medical cosmetic treatments related to the study during the study period;
  • Subjects who voluntarily sign a written informed consent form, and able to comprehend the full nature and the purpose of the investigation, including possible risks and side effects, and subjects able to cooperate with the investigator and to comply with the requirements of the entire investigation (including ability to attend all the planned investigation visits according to the time limits), based on investigator's judgement.

Who cannot join

  • Known allergy to hyaluronic acid or any component of this product;
  • Known history of severe allergies;
  • Known history of severe autoimmune disease;
  • Subjects with episode of herpes cutis;
  • Subjects with cicatricial diathesis;
  • Facial area has unknown injection substances;
Show all 23Show fewer
  • Have received any permanent or semi-permanent fillers at the facial area (e.g., calcium hydroxyapatite, poly-L-lactic acid, polymethyl methacrylate, silicones, expanded polytetrafluoroethylene (ePTFE), polycaprolactone, etc.), autologous fat, face lift (including thread lifts), etc., or plan to receive any of the above treatments during the investigation;
  • Have received temporary dermal filler treatment (e.g., cross-linked hyaluronic acid, collagen) at the facial area within the 12 months prior to enrolment, or plan to receive any of the above treatments during the investigation;
  • Have received botulinum toxin injection, mesotherapy, or facial cosmetic procedures (e.g., facial liposuction, cosmetic surgery, face slimming, photo modulation therapy, intense pulsed light, radiofrequency, non-cross-linked hyaluronic acid injection (except for mesotherapy), dermabrasion, laser or chemical peels or other ablation procedures, etc.) at facial area within 6 months prior to enrolment, or plan to receive any of the above treatments during the investigation;
  • Have received sodium hyaluronate compound solution injection (mesotherapy, etc) at facial area within 3 months prior to enrolment,
  • Facial area has active or progressive skin infection (including viral, bacterial, fungal);
  • Facial area has skin granuloma;
  • Facial area has active or progressive skin diseases or with isomorphic reactions such as acute eczema, flat warts, lichen planus, psoriasis vulgaris, etc.;
  • Facial area has malignant tumors or skin tumors of unknown nature;
  • Subjects who work outdoors for a long time or need to be exposed to sunlight after surgery;
  • Patients with excessive expectations for treatment effects;
  • Subjects with coagulation dysfunction or other systemic diseases;
  • Subjects undergoing chemotherapy/radiotherapy;
  • Subjects with mental illness or emotional instability;
  • Subjects who had received any thrombolytic agents, anticoagulants or antiplatelet drugs within 2 weeks before enrolment;
  • Subjects who are pregnant or planned to become pregnant during the investigation period, or breastfeeding;
  • Subject who participated in other clinical investigation within 1 month prior to enrolment in this investigation, or currently participating in other clinical investigation;
  • The investigator considers that the subject is not suitable to participate in this clinical investigation.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yan Wu, Professor contact

13910978643

3437477565@qq.com

6 sites in 1 country

China6 sites, 6 recruiting

  • Peking Union Medical College Hospital (PUMCH)

    Beijing

    Recruiting

  • Peking University First Hospital

    Beijing

    Yan Wu, Professor, 13910978643, 3437477565@qq.com

    Recruiting

  • The First Principle Hospital of Changde City

    Changde

    Recruiting

  • West China Hospital of Stomatology Sichuan Hospital

    Chengdu

    Recruiting

  • Tongji Hospital of Tongji University

    Shanghai

    Not yet recruiting

  • The Second Affiliated Hospital Of Xi'an Jiaotong University

    Xi'an

    Not yet recruiting

Other trials in China

About this study

Official title: A Prospective, Multi-center, Randomized, No-treatment Controlled, Evaluator-blinded, Superiority Clinical Trial to Evaluate the Safety and Effectiveness of Sodium Hyaluronate 32 mg/ml for Improvement of Facial Skin Dryness and Dullness

The aim of the study is to evaluate the safety and efficacy of sodium hyaluronate 32 mg/ml in improving facial skin dryness and dullness. Subjects are randomized to the treatment group or to the control group. Only subjects in the treatment group are treated by intradermal injection.

Read the detailed description

This is a prospective multi-center clinical investigation. Enrolled subjects are randomized to the treatment group or to the no-treatment control group. The treatment group will receive intradermal injections of sodium hyaluronate 32 mg/ml. The improvement of facial skin dryness and dullness will be evaluated at multiple timepoints.

Being tested
Sodium Hyaluronate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sodium HyaluronateDevice

    Sodium Hyaluronate 32 mg/ml

Study groups in NCT06914583
Study groupRoleWhat they receive
Treatment groupExperimentalThe treatment group will receive intradermal injections of sodium hyaluronate
Receives: Device: Sodium Hyaluronate
Control groupNo interventionThe control group will not receive any treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. GAIS (Global Aesthetic Improvement Scale) - Blinded evaluator

    Treatment effective rate (third-party blinded investigator assessment)

    Measured: 12 week

Secondary outcomes (39)

  1. GAIS-Blinded evaluator

    Treatment effective rate (third-party blinded investigator assessment)

    Measured: 4week, 8week, 10week, 16week, 20week

  2. GAIS-Investigator

    Treatment effective rate (treating investigator assessment)

    Measured: 4week, 8week, 10week, 12week, 16week, 20week

  3. GAIS-Subject

    Treatment effective rate (subject assessment)

    Measured: 4week, 8week, 10week, 12week, 16week, 20week

  4. Improvement of skin moisture

    Corneometer assessment

    Measured: 4week, 8week, 10week, 12week, 16week, 20week

  5. Skin dryness improvement assessment - Investigator

    Dryness improvement assessment will be performed by the treating investigator. The following scoring will be applied: -1: worse, 0= no change, 1=improvement.

    Measured: 4week, 8week, 10week, 12week, 16week, 20week

  6. Skin dryness improvement assessment - Subject

    Dryness improvement assessment will be performed by the subect. The following scoring will be applied: -1: worse, 0= no change, 1=improvement.

    Measured: 4week, 8week, 10week, 12week, 16week, 20week

  7. Skin dullness improvement assessment - Investigator

    Skin dullness improvement assessment will be performed by the treating investigator. The following scoring will be applied: -1: worse, 0= no change, 1=improvement.

    Measured: 4week, 8week, 10week, 12week, 16week, 20week

  8. Skin dulless improvement - Subject

    Skin dullness improvement assessment will be performed by the subject. The following scoring will be applied: -1: worse, 0= no change, 1=improvement.

    Measured: 4week, 8week, 10week, 12week, 16week, 20week

  9. Subject treatment satisfaction assessment scale

    For the question "How do you feel satisfied with the treatment effect of the investigational product?", the answer criteria are from 1 to 5, where 1= very dissatisfied and 5= very much satisfied.

    Measured: 4week, 8week, 10week, 12week, 16week, 20week

  10. Red blood cell (RBC)

    Measured: 0week, 12week, 32 week

  11. White blood cell (WBC)

    Measured: 0week, 12week, 32 week

  12. Platelet count (PLT)

    Measured: 0week, 12week, 32 week

  13. Hemoglobin (HGB)

    Measured: 0week, 12week, 32 week

  14. Serum alanine aminotransferase (ALT)

    Measured: 0week, 12week, 32 week

  15. Serum aspartate aminotransferase (AST)

    Measured: 0week, 12week, 32 week

  16. Serum urea nitrogen/urea (BUN/Urea)

    Measured: 0week, 12week, 32 week

  17. Serum creatinin (Cr)

    Measured: 0week, 12week, 32 week

  18. Blood glucose (GLU)

    Measured: 0week, 12week, 32 week

  19. Urine pH

    Measured: 0week, 12week, 32 week

  20. Urine glucose

    Measured: 0week, 12week, 32 week

  21. Urine protein

    Measured: 0week, 12week, 32 week

  22. Urine specific gravity

    Measured: 0week, 12week, 32 week

  23. Urine red blood cell count

    Measured: 0week, 12week, 32 week

  24. Urine white blood cell count

    Measured: 0week, 12week, 32 week

  25. Urine nitrite

    Measured: 0week, 12week, 32 week

  26. Prothrombin time (PT)

    Measured: 0week

  27. Activated partial thromboplastin time (APTT)

    Measured: 0week

  28. Thrombin time (TT)

    Measured: 0week

  29. Fibrinogen (FIB)

    Measured: 0week

  30. Blood pressure (mmHg)

    Systolic blood pressure and diastolic blood pressure will be measured

    Measured: 0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week

  31. Temperature (°C)

    Measured: 0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week

  32. Respiration rate

    Times/min

    Measured: 0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week

  33. Heart rate

    Beats/min

    Measured: 0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week

  34. Incidence rate of adverse events (AEs)

    Incidence rate (%) and number of adverse events (AEs)

    Measured: 0week, 1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week, 12week, 16week, 20week, 32week

  35. Incidence rate of serious adverse events (SAEs)

    Incidence rate (%) and number of serious adverse events (SAEs)

    Measured: 0week, 1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week, 12week, 16week, 20week, 32week

  36. Incidence rate of adverse device effects (ADE)

    Incidence rate (%) and number of adverse device effects (ADE)

    Measured: 0week, 1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week, 12week, 16week, 20week, 32week

  37. Incidence rate of serious adverse device effects (SADE)

    Incidence rate (%) and number of serious adverse device effects (SADE)

    Measured: 0week, 1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week, 12week, 16week, 20week, 32week

  38. Incidence rate of injection site reactions

    Incidence rate (%) and number of injection site reactions

    Measured: 1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week

  39. Incidence rate of device deficiencies

    Incidence rate (%) and number of of device deficiencies

    Measured: 0week, 4week, 8week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2025
  2. Study start19 Feb 2025
  3. Primary completionNov 2025 (estimated)
  4. Study completionFeb 2026 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06914583
Sponsor's protocol ID
23CHN-Pro-IT01
Status last verified
Mar 2025
First submitted
17 Mar 2025
Last updated
6 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Sodium Hyaluronate in people with Facial Dryness and Facial Dullness, run by IBSA Farmaceutici Italia Srl at 6 sites in China.

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 5 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. 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. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yan Wu, Professor (13910978643, 3437477565@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

GAIS (Global Aesthetic Improvement Scale) - Blinded evaluator (time frame: 12 week). 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 NCT06914583.

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 6 Apr 2025.

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