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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | The treatment group will receive intradermal injections of sodium hyaluronate |
|
| Control group | No Intervention | The control group will not receive any treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Hyaluronate | Device | Sodium Hyaluronate 32 mg/ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| GAIS (Global Aesthetic Improvement Scale) - Blinded evaluator | Treatment effective rate (third-party blinded investigator assessment) | 12 week |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Wu, Professor | Contact | 13910978643 | 3437477565@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital (PUMCH) | Recruiting | Beijing | China | |||
| Peking University First Hospital |
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| 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 |
| Recruiting |
| Beijing |
| China |
|
| The First Principle Hospital of Changde City | Recruiting | Changde | China |
| West China Hospital of Stomatology Sichuan Hospital | Recruiting | Chengdu | China |
| Tongji Hospital of Tongji University | Not yet recruiting | Shanghai | China |
| The Second Affiliated Hospital Of Xi'an Jiaotong University | Not yet recruiting | Xi'an | China |