Clinical trial NCT06914583: Safety and Efficacy Evaluation of Sodium Hyaluronate 32mg/ml in 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Facial Dryness
Facial Dullness
Lead sponsor: IBSA Farmaceutici Italia Srl
Sponsor class: INDUSTRY
First posted: 2025-04-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: GAIS (Global Aesthetic Improvement Scale) - Blinded evaluator
timeFrame: 12 week
Secondary outcomes:
measure: GAIS-Blinded evaluator
timeFrame: 4week, 8week, 10week, 16week, 20week
measure: GAIS-Investigator
timeFrame: 4week, 8week, 10week, 12week, 16week, 20week
measure: GAIS-Subject
timeFrame: 4week, 8week, 10week, 12week, 16week, 20week
measure: Improvement of skin moisture
timeFrame: 4week, 8week, 10week, 12week, 16week, 20week
measure: Skin dryness improvement assessment - Investigator
timeFrame: 4week, 8week, 10week, 12week, 16week, 20week
measure: Skin dryness improvement assessment - Subject
timeFrame: 4week, 8week, 10week, 12week, 16week, 20week
measure: Skin dullness improvement assessment - Investigator
timeFrame: 4week, 8week, 10week, 12week, 16week, 20week
measure: Skin dulless improvement - Subject
timeFrame: 4week, 8week, 10week, 12week, 16week, 20week
measure: Subject treatment satisfaction assessment scale
timeFrame: 4week, 8week, 10week, 12week, 16week, 20week
measure: Red blood cell (RBC)
timeFrame: 0week, 12week, 32 week
measure: White blood cell (WBC)
timeFrame: 0week, 12week, 32 week
measure: Platelet count (PLT)
timeFrame: 0week, 12week, 32 week
measure: Hemoglobin (HGB)
timeFrame: 0week, 12week, 32 week
measure: Serum alanine aminotransferase (ALT)
timeFrame: 0week, 12week, 32 week
measure: Serum aspartate aminotransferase (AST)
timeFrame: 0week, 12week, 32 week
measure: Serum urea nitrogen/urea (BUN/Urea)
timeFrame: 0week, 12week, 32 week
measure: Serum creatinin (Cr)
timeFrame: 0week, 12week, 32 week
measure: Blood glucose (GLU)
timeFrame: 0week, 12week, 32 week
measure: Urine pH
timeFrame: 0week, 12week, 32 week
measure: Urine glucose
timeFrame: 0week, 12week, 32 week
measure: Urine protein
timeFrame: 0week, 12week, 32 week
measure: Urine specific gravity
timeFrame: 0week, 12week, 32 week
measure: Urine red blood cell count
timeFrame: 0week, 12week, 32 week
measure: Urine white blood cell count
timeFrame: 0week, 12week, 32 week
measure: Urine nitrite
timeFrame: 0week, 12week, 32 week
measure: Prothrombin time (PT)
timeFrame: 0week
measure: Activated partial thromboplastin time (APTT)
timeFrame: 0week
measure: Thrombin time (TT)
timeFrame: 0week
measure: Fibrinogen (FIB)
timeFrame: 0week
measure: Blood pressure (mmHg)
timeFrame: 0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week
measure: Temperature (°C)
timeFrame: 0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week
measure: Respiration rate
timeFrame: 0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week
measure: Heart rate
timeFrame: 0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week
measure: Incidence rate of adverse events (AEs)
timeFrame: 0week, 1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week, 12week, 16week, 20week, 32week
measure: Incidence rate of serious adverse events (SAEs)
timeFrame: 0week, 1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week, 12week, 16week, 20week, 32week
measure: Incidence rate of adverse device effects (ADE)
timeFrame: 0week, 1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week, 12week, 16week, 20week, 32week
measure: Incidence rate of serious adverse device effects (SADE)
timeFrame: 0week, 1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week, 12week, 16week, 20week, 32week
measure: Incidence rate of injection site reactions
timeFrame: 1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week
measure: Incidence rate of device deficiencies
timeFrame: 0week, 4week, 8week
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital (PUMCH)
city: Beijing
country: China
facility: Peking University First Hospital
city: Changde
country: China
facility: The First Principle Hospital of Changde City
city: Chengdu
country: China
facility: West China Hospital of Stomatology Sichuan Hospital
city: Shanghai
country: China
facility: Tongji Hospital of Tongji University
city: Xi'an
country: China
facility: The Second Affiliated Hospital Of Xi'an Jiaotong University
Study officials:
References: