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

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.

Study Overview

• Status: Recruiting
• Conditions: Facial Dryness; Facial Dullness
• Intervention / Treatment: Device: Sodium Hyaluronate

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.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yan Wu, Professor; Phone Number: 13910978643; Email: 3437477565@qq.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University First Hospital
    • Contact: Yan Wu, Professor; Phone Number: 13910978643; Email: 3437477565@qq.com
  • Beijing, China
    • Recruiting
    • Peking Union Medical College Hospital (PUMCH)
  • Changde, China
    • Recruiting
    • The First Principle Hospital of Changde City
  • Chengdu, China
    • Recruiting
    • West China Hospital of Stomatology Sichuan Hospital
  • Shanghai, China
    • Not yet recruiting
    • Tongji Hospital of Tongji University
  • Xi'an, China
    • Not yet recruiting
    • The Second Affiliated Hospital of Xi'an Jiaotong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; The treatment group will receive intradermal injections of sodium hyaluronate	Device: Sodium Hyaluronate; Sodium Hyaluronate 32 mg/ml
No Intervention: Control group; The control group will not receive any treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GAIS (Global Aesthetic Improvement Scale) - Blinded evaluator	Treatment effective rate (third-party blinded investigator assessment)	12 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GAIS-Blinded evaluator	Treatment effective rate (third-party blinded investigator assessment)	4week, 8week, 10week, 16week, 20week
GAIS-Investigator	Treatment effective rate (treating investigator assessment)	4week, 8week, 10week, 12week, 16week, 20week
GAIS-Subject	Treatment effective rate (subject assessment)	4week, 8week, 10week, 12week, 16week, 20week
Improvement of skin moisture	Corneometer assessment	4week, 8week, 10week, 12week, 16week, 20week
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.	4week, 8week, 10week, 12week, 16week, 20week
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.	4week, 8week, 10week, 12week, 16week, 20week
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.	4week, 8week, 10week, 12week, 16week, 20week
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.	4week, 8week, 10week, 12week, 16week, 20week
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.	4week, 8week, 10week, 12week, 16week, 20week
Red blood cell (RBC)		0week, 12week, 32 week
White blood cell (WBC)		0week, 12week, 32 week
Platelet count (PLT)		0week, 12week, 32 week
Hemoglobin (HGB)		0week, 12week, 32 week
Serum alanine aminotransferase (ALT)		0week, 12week, 32 week
Serum aspartate aminotransferase (AST)		0week, 12week, 32 week
Serum urea nitrogen/urea (BUN/Urea)		0week, 12week, 32 week
Serum creatinin (Cr)		0week, 12week, 32 week
Blood glucose (GLU)		0week, 12week, 32 week
Urine pH		0week, 12week, 32 week
Urine glucose		0week, 12week, 32 week
Urine protein		0week, 12week, 32 week
Urine specific gravity		0week, 12week, 32 week
Urine red blood cell count		0week, 12week, 32 week
Urine white blood cell count		0week, 12week, 32 week
Urine nitrite		0week, 12week, 32 week
Prothrombin time (PT)		0week
Activated partial thromboplastin time (APTT)		0week
Thrombin time (TT)		0week
Fibrinogen (FIB)		0week
Blood pressure (mmHg)	Systolic blood pressure and diastolic blood pressure will be measured	0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week
Temperature (°C)		0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week
Respiration rate	Times/min	0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week
Heart rate	Beats/min	0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week
Incidence rate of adverse events (AEs)	Incidence rate (%) and number of adverse events (AEs)	0week, 1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week, 12week, 16week, 20week, 32week
Incidence rate of serious adverse events (SAEs)	Incidence rate (%) and number of serious adverse events (SAEs)	0week, 1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week, 12week, 16week, 20week, 32week
Incidence rate of adverse device effects (ADE)	Incidence rate (%) and number of adverse device effects (ADE)	0week, 1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week, 12week, 16week, 20week, 32week
Incidence rate of serious adverse device effects (SADE)	Incidence rate (%) and number of serious adverse device effects (SADE)	0week, 1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week, 12week, 16week, 20week, 32week
Incidence rate of injection site reactions	Incidence rate (%) and number of injection site reactions	1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week
Incidence rate of device deficiencies	Incidence rate (%) and number of of device deficiencies	0week, 4week, 8week

Collaborators and Investigators

• Sponsor: IBSA Farmaceutici Italia Srl

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2025
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: March 17, 2025
• First Submitted That Met QC Criteria: March 31, 2025
• First Posted (Actual): April 6, 2025

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Facies; Immunologic Factors; Physiological Effects of Drugs; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: 23CHN-Pro-IT01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No