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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
500
Sodium Hyaluronate 32 mg/ml
Peking Union Medical College Hospital (PUMCH)
Beijing, China
RECRUITINGPeking University First Hospital
Beijing, China
RECRUITINGThe First Principle Hospital of Changde City
Changde, China
GAIS (Global Aesthetic Improvement Scale) - Blinded evaluator
Treatment effective rate (third-party blinded investigator assessment)
Time frame: 12 week
GAIS-Blinded evaluator
Treatment effective rate (third-party blinded investigator assessment)
Time frame: 4week, 8week, 10week, 16week, 20week
GAIS-Investigator
Treatment effective rate (treating investigator assessment)
Time frame: 4week, 8week, 10week, 12week, 16week, 20week
GAIS-Subject
Treatment effective rate (subject assessment)
Time frame: 4week, 8week, 10week, 12week, 16week, 20week
Improvement of skin moisture
Corneometer assessment
Time frame: 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.
Time frame: 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.
Time frame: 4week, 8week, 10week, 12week, 16week, 20week
Skin dullness improvement assessment - Investigator
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West China Hospital of Stomatology Sichuan Hospital
Chengdu, China
RECRUITINGTongji Hospital of Tongji University
Shanghai, China
NOT_YET_RECRUITINGThe Second Affiliated Hospital Of Xi'an Jiaotong University
Xi'an, China
NOT_YET_RECRUITINGSkin dullness improvement assessment will be performed by the treating investigator. The following scoring will be applied: -1: worse, 0= no change, 1=improvement.
Time frame: 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.
Time frame: 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.
Time frame: 4week, 8week, 10week, 12week, 16week, 20week
Red blood cell (RBC)
Time frame: 0week, 12week, 32 week
White blood cell (WBC)
Time frame: 0week, 12week, 32 week
Platelet count (PLT)
Time frame: 0week, 12week, 32 week
Hemoglobin (HGB)
Time frame: 0week, 12week, 32 week
Serum alanine aminotransferase (ALT)
Time frame: 0week, 12week, 32 week
Serum aspartate aminotransferase (AST)
Time frame: 0week, 12week, 32 week
Serum urea nitrogen/urea (BUN/Urea)
Time frame: 0week, 12week, 32 week
Serum creatinin (Cr)
Time frame: 0week, 12week, 32 week
Blood glucose (GLU)
Time frame: 0week, 12week, 32 week
Urine pH
Time frame: 0week, 12week, 32 week
Urine glucose
Time frame: 0week, 12week, 32 week
Urine protein
Time frame: 0week, 12week, 32 week
Urine specific gravity
Time frame: 0week, 12week, 32 week
Urine red blood cell count
Time frame: 0week, 12week, 32 week
Urine white blood cell count
Time frame: 0week, 12week, 32 week
Urine nitrite
Time frame: 0week, 12week, 32 week
Prothrombin time (PT)
Time frame: 0week
Activated partial thromboplastin time (APTT)
Time frame: 0week
Thrombin time (TT)
Time frame: 0week
Fibrinogen (FIB)
Time frame: 0week
Blood pressure (mmHg)
Systolic blood pressure and diastolic blood pressure will be measured
Time frame: 0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week
Temperature (°C)
Time frame: 0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week
Respiration rate
Times/min
Time frame: 0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week
Heart rate
Beats/min
Time frame: 0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week
Incidence rate of adverse events (AEs)
Incidence rate (%) and number of adverse events (AEs)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week
Incidence rate of device deficiencies
Incidence rate (%) and number of of device deficiencies
Time frame: 0week, 4week, 8week