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

Not Applicable

Recruiting

• Conditions: Facial Dryness; Facial Dullness

• Registration Number: NCT06914583
• Lead Sponsor: IBSA Farmaceutici Italia Srl

Brief 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.

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 Timeline

• Study Start: 2025-02-19
• Status Verified: 2025-03
• Study First Submitted: 2025-03-17
• Study First Submitted QC: 2025-03-31
• Last Update Submitted: 2025-03-31
• Study First Posted: 2025-04-06
• Last Update Posted: 2025-04-06
• Primary Completion: 2025-11
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
GAIS (Global Aesthetic Improvement Scale) - Blinded evaluator	12 week	Treatment effective rate (third-party blinded investigator assessment)

Secondary Outcome Measures

Name	Time	Method
Subject treatment satisfaction assessment scale	4week, 8week, 10week, 12week, 16week, 20week	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.
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)	0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week	Systolic blood pressure and diastolic blood pressure will be measured
Temperature (°C)	0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week
Respiration rate	0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week	Times/min
Heart rate	0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week	Beats/min
Incidence rate of adverse events (AEs)	0week, 1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week, 12week, 16week, 20week, 32week	Incidence rate (%) and number of adverse events (AEs)
Incidence rate of serious adverse events (SAEs)	0week, 1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week, 12week, 16week, 20week, 32week	Incidence rate (%) and number of serious adverse events (SAEs)
Incidence rate of adverse device effects (ADE)	0week, 1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week, 12week, 16week, 20week, 32week	Incidence rate (%) and number of adverse device effects (ADE)
Incidence rate of serious adverse device effects (SADE)	0week, 1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week, 12week, 16week, 20week, 32week	Incidence rate (%) and number of serious adverse device effects (SADE)
Incidence rate of injection site reactions	1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week	Incidence rate (%) and number of injection site reactions
Incidence rate of device deficiencies	0week, 4week, 8week	Incidence rate (%) and number of of device deficiencies
GAIS-Blinded evaluator	4week, 8week, 10week, 16week, 20week	Treatment effective rate (third-party blinded investigator assessment)
GAIS-Investigator	4week, 8week, 10week, 12week, 16week, 20week	Treatment effective rate (treating investigator assessment)
GAIS-Subject	4week, 8week, 10week, 12week, 16week, 20week	Treatment effective rate (subject assessment)
Improvement of skin moisture	4week, 8week, 10week, 12week, 16week, 20week	Corneometer assessment
Skin dryness improvement assessment - Investigator	4week, 8week, 10week, 12week, 16week, 20week	Dryness improvement assessment will be performed by the treating investigator. The following scoring will be applied: -1: worse, 0= no change, 1=improvement.
Skin dryness improvement assessment - Subject	4week, 8week, 10week, 12week, 16week, 20week	Dryness improvement assessment will be performed by the subect. The following scoring will be applied: -1: worse, 0= no change, 1=improvement.
Skin dullness improvement assessment - Investigator	4week, 8week, 10week, 12week, 16week, 20week	Skin dullness improvement assessment will be performed by the treating investigator. The following scoring will be applied: -1: worse, 0= no change, 1=improvement.
Skin dulless improvement - Subject	4week, 8week, 10week, 12week, 16week, 20week	Skin dullness improvement assessment will be performed by the subject. The following scoring will be applied: -1: worse, 0= no change, 1=improvement.

Trial Locations

Locations (6)

West China Hospital of Stomatology Sichuan Hospital; 🇨🇳 Chengdu, China

Peking Union Medical College Hospital (PUMCH); 🇨🇳 Beijing, China

Peking University First Hospital; 🇨🇳 Beijing, China

The First Principle Hospital of Changde City; 🇨🇳 Changde, China

Tongji Hospital of Tongji University; 🇨🇳 Shanghai, China

The Second Affiliated Hospital Of Xi'an Jiaotong University; 🇨🇳 Xi'an, China