NCT06914583
Recruiting
Not Applicable
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
IBSA Farmaceutici Italia Srl6 sites in 1 country500 target enrollmentStarted: February 19, 2025Last updated:
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- IBSA Farmaceutici Italia Srl
- Enrollment
- 500
- Locations
- 6
- Primary Endpoint
- GAIS (Global Aesthetic Improvement Scale) - Blinded evaluator
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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;
- •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,
Outcomes
Primary Outcomes
GAIS (Global Aesthetic Improvement Scale) - Blinded evaluator
Time Frame: 12 week
Treatment effective rate (third-party blinded investigator assessment)
Secondary Outcomes
- Serum alanine aminotransferase (ALT)(0week, 12week, 32 week)
- Subject treatment satisfaction assessment scale(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 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)
- Thrombin time (TT)(0week)
- 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)
- Fibrinogen (FIB)(0week)
- Temperature (°C)(0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week)
- Blood pressure (mmHg)(0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week)
- Respiration rate(0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week)
- Heart rate(0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week)
- Incidence rate of adverse events (AEs)(0week, 1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week, 12week, 16week, 20week, 32week)
- Incidence rate 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)(0week, 1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week, 12week, 16week, 20week, 32week)
- Incidence rate 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(1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week)
- Incidence rate of device deficiencies(0week, 4week, 8week)
- GAIS-Blinded evaluator(4week, 8week, 10week, 16week, 20week)
- GAIS-Investigator(4week, 8week, 10week, 12week, 16week, 20week)
- GAIS-Subject(4week, 8week, 10week, 12week, 16week, 20week)
- Improvement of skin moisture(4week, 8week, 10week, 12week, 16week, 20week)
- Skin dryness improvement assessment - Investigator(4week, 8week, 10week, 12week, 16week, 20week)
- Skin dryness improvement assessment - Subject(4week, 8week, 10week, 12week, 16week, 20week)
- Skin dullness improvement assessment - Investigator(4week, 8week, 10week, 12week, 16week, 20week)
- Skin dulless improvement - Subject(4week, 8week, 10week, 12week, 16week, 20week)
Investigators
Study Sites (6)
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