Clinical trial Recruiting at 4 sites Interventional Ages 18 to 65

Evaluating sodium hyaluronate for improving facial skin dryness and dullness

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

Run by IBSA Farmaceutici Italia Srl · NCT06914583 · Data updated 2026-11-12

This study is testing if injections of sodium hyaluronate can help improve dryness and dullness in people's facial skin.

Quick facts

Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment500 (estimated)
SponsorIBSA Farmaceutici Italia Srl
Industry-sponsored
Drugs / interventionschemotherapy
Locations6 sites (Beijing and 5 other locations)
StatusRecruiting
StartedFebruary 19, 2025
Main results expectedNovember 2025
Study endsFebruary 2026
Registry record updatedApril 6, 2025
Trial IDNCT06914583 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 to 65 with skin classified as Fitzpatrick type II-IV, seeking temporary improvement in facial skin conditions.

Probably not a fit

Patients with known allergies to hyaluronic acid or those seeking permanent solutions may not benefit from this treatment.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical investigation aims to assess the safety and efficacy of sodium hyaluronate 32 mg/ml through intradermal injections to improve facial skin dryness and dullness. Participants will be randomly assigned to either a treatment group receiving the injections or a control group with no treatment. The study will evaluate improvements in skin condition at multiple time points, providing a comprehensive analysis of the treatment's effectiveness. The study is conducted across multiple centers to ensure diverse participant representation.

Why it matters

Potential benefit: If successful, this treatment could significantly enhance the appearance and hydration of facial skin for patients suffering from dryness and dullness.

How similar studies have gone: Previous studies have shown positive outcomes with similar injectable treatments for skin conditions, indicating potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Age ≥18 years old and ≤65 years old (based on the time of signing the ICF), gender is not restricted;
2. Skin Fitzpatrick is classified as type II-IV;
3. 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;
4. Subjects who have agreed not to use any other medical cosmetic treatments related to the study during the study period;
5. 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.

Exclusion Criteria:

1. Known allergy to hyaluronic acid or any component of this product;
2. Known history of severe allergies;
3. Known history of severe autoimmune disease;
4. Subjects with episode of herpes cutis;
5. Subjects with cicatricial diathesis;
6. Facial area has unknown injection substances;
7. 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;
8. 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;
9. 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;
10. Have received sodium hyaluronate compound solution injection (mesotherapy, etc) at facial area within 3 months prior to enrolment,
11. Facial area has active or progressive skin infection (including viral, bacterial, fungal);
12. Facial area has skin granuloma;
13. Facial area has active or progressive skin diseases or with isomorphic reactions such as acute eczema, flat warts, lichen planus, psoriasis vulgaris, etc.;
14. Facial area has malignant tumors or skin tumors of unknown nature;
15. Subjects who work outdoors for a long time or need to be exposed to sunlight after surgery;
16. Patients with excessive expectations for treatment effects;
17. Subjects with coagulation dysfunction or other systemic diseases;
18. Subjects undergoing chemotherapy/radiotherapy;
19. Subjects with mental illness or emotional instability;
20. Subjects who had received any thrombolytic agents, anticoagulants or antiplatelet drugs within 2 weeks before enrolment;
21. Subjects who are pregnant or planned to become pregnant during the investigation period, or breastfeeding;
22. Subject who participated in other clinical investigation within 1 month prior to enrolment in this investigation, or currently participating in other clinical investigation;
23. The investigator considers that the subject is not suitable to participate in this clinical investigation.

Where it's running

  • Peking Union Medical College Hospital (PUMCH)
    Beijing, China
    Recruiting
  • Peking University First Hospital
    Beijing, China
    Recruiting
  • The First Principle Hospital of Changde City
    Changde, China
    Recruiting
  • West China Hospital of Stomatology Sichuan Hospital
    Chengdu, China
    Recruiting
  • Tongji Hospital of Tongji University
    Shanghai, China
    Not yet recruiting
  • The Second Affiliated Hospital Of Xi'an Jiaotong University
    Xi'an, China
    Not yet recruiting

Study contacts

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.