Safety and Efficacy Evaluation of Sodium Hyaluronate 32mg/ml in Improving Facial Skin Dryness and Dullness
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 Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Yan Wu, Professor
- Phone Number: 13910978643
- Email: 3437477565@qq.com
Study Locations
-
-
-
Beijing, China
- Recruiting
- Peking University First Hospital
-
Contact:
- Yan Wu, Professor
- Phone Number: 13910978643
- Email: 3437477565@qq.com
-
Beijing, China
- Recruiting
- Peking Union Medical College Hospital (PUMCH)
-
Changde, China
- Recruiting
- The First Principle Hospital of Changde City
-
Chengdu, China
- Recruiting
- West China Hospital of Stomatology Sichuan Hospital
-
Shanghai, China
- Not yet recruiting
- Tongji Hospital of Tongji University
-
Xi'an, China
- Not yet recruiting
- The Second Affiliated Hospital of Xi'an Jiaotong University
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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,
- Facial area has active or progressive skin infection (including viral, bacterial, fungal);
- Facial area has skin granuloma;
- Facial area has active or progressive skin diseases or with isomorphic reactions such as acute eczema, flat warts, lichen planus, psoriasis vulgaris, etc.;
- Facial area has malignant tumors or skin tumors of unknown nature;
- Subjects who work outdoors for a long time or need to be exposed to sunlight after surgery;
- Patients with excessive expectations for treatment effects;
- Subjects with coagulation dysfunction or other systemic diseases;
- Subjects undergoing chemotherapy/radiotherapy;
- Subjects with mental illness or emotional instability;
- Subjects who had received any thrombolytic agents, anticoagulants or antiplatelet drugs within 2 weeks before enrolment;
- Subjects who are pregnant or planned to become pregnant during the investigation period, or breastfeeding;
- Subject who participated in other clinical investigation within 1 month prior to enrolment in this investigation, or currently participating in other clinical investigation;
- The investigator considers that the subject is not suitable to participate in this clinical investigation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Treatment group
The treatment group will receive intradermal injections of sodium hyaluronate
|
Sodium Hyaluronate 32 mg/ml
|
|
No Intervention: Control group
The control group will not receive any treatment
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
GAIS (Global Aesthetic Improvement Scale) - Blinded evaluator
Time Frame: 12 week
|
Treatment effective rate (third-party blinded investigator assessment)
|
12 week
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
GAIS-Blinded evaluator
Time Frame: 4week, 8week, 10week, 16week, 20week
|
Treatment effective rate (third-party blinded investigator assessment)
|
4week, 8week, 10week, 16week, 20week
|
|
GAIS-Investigator
Time Frame: 4week, 8week, 10week, 12week, 16week, 20week
|
Treatment effective rate (treating investigator assessment)
|
4week, 8week, 10week, 12week, 16week, 20week
|
|
GAIS-Subject
Time Frame: 4week, 8week, 10week, 12week, 16week, 20week
|
Treatment effective rate (subject assessment)
|
4week, 8week, 10week, 12week, 16week, 20week
|
|
Improvement of skin moisture
Time Frame: 4week, 8week, 10week, 12week, 16week, 20week
|
Corneometer assessment
|
4week, 8week, 10week, 12week, 16week, 20week
|
|
Skin dryness improvement assessment - Investigator
Time Frame: 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.
|
4week, 8week, 10week, 12week, 16week, 20week
|
|
Skin dryness improvement assessment - Subject
Time Frame: 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.
|
4week, 8week, 10week, 12week, 16week, 20week
|
|
Skin dullness improvement assessment - Investigator
Time Frame: 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.
|
4week, 8week, 10week, 12week, 16week, 20week
|
|
Skin dulless improvement - Subject
Time Frame: 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.
|
4week, 8week, 10week, 12week, 16week, 20week
|
|
Subject treatment satisfaction assessment scale
Time Frame: 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.
|
4week, 8week, 10week, 12week, 16week, 20week
|
|
Red blood cell (RBC)
Time Frame: 0week, 12week, 32 week
|
0week, 12week, 32 week
|
|
|
White blood cell (WBC)
Time Frame: 0week, 12week, 32 week
|
0week, 12week, 32 week
|
|
|
Platelet count (PLT)
Time Frame: 0week, 12week, 32 week
|
0week, 12week, 32 week
|
|
|
Hemoglobin (HGB)
Time Frame: 0week, 12week, 32 week
|
0week, 12week, 32 week
|
|
|
Serum alanine aminotransferase (ALT)
Time Frame: 0week, 12week, 32 week
|
0week, 12week, 32 week
|
|
|
Serum aspartate aminotransferase (AST)
Time Frame: 0week, 12week, 32 week
|
0week, 12week, 32 week
|
|
|
Serum urea nitrogen/urea (BUN/Urea)
Time Frame: 0week, 12week, 32 week
|
0week, 12week, 32 week
|
|
|
Serum creatinin (Cr)
Time Frame: 0week, 12week, 32 week
|
0week, 12week, 32 week
|
|
|
Blood glucose (GLU)
Time Frame: 0week, 12week, 32 week
|
0week, 12week, 32 week
|
|
|
Urine pH
Time Frame: 0week, 12week, 32 week
|
0week, 12week, 32 week
|
|
|
Urine glucose
Time Frame: 0week, 12week, 32 week
|
0week, 12week, 32 week
|
|
|
Urine protein
Time Frame: 0week, 12week, 32 week
|
0week, 12week, 32 week
|
|
|
Urine specific gravity
Time Frame: 0week, 12week, 32 week
|
0week, 12week, 32 week
|
|
|
Urine red blood cell count
Time Frame: 0week, 12week, 32 week
|
0week, 12week, 32 week
|
|
|
Urine white blood cell count
Time Frame: 0week, 12week, 32 week
|
0week, 12week, 32 week
|
|
|
Urine nitrite
Time Frame: 0week, 12week, 32 week
|
0week, 12week, 32 week
|
|
|
Prothrombin time (PT)
Time Frame: 0week
|
0week
|
|
|
Activated partial thromboplastin time (APTT)
Time Frame: 0week
|
0week
|
|
|
Thrombin time (TT)
Time Frame: 0week
|
0week
|
|
|
Fibrinogen (FIB)
Time Frame: 0week
|
0week
|
|
|
Blood pressure (mmHg)
Time Frame: 0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week
|
Systolic blood pressure and diastolic blood pressure will be measured
|
0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week
|
|
Temperature (°C)
Time Frame: 0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week
|
0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week
|
|
|
Respiration rate
Time Frame: 0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week
|
Times/min
|
0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week
|
|
Heart rate
Time Frame: 0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week
|
Beats/min
|
0week, 4week, 8week, 10week, 12week, 16week, 20week, 32week
|
|
Incidence rate of adverse events (AEs)
Time Frame: 0week, 1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week, 12week, 16week, 20week, 32week
|
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)
Time Frame: 0week, 1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week, 12week, 16week, 20week, 32week
|
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)
Time Frame: 0week, 1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week, 12week, 16week, 20week, 32week
|
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)
Time Frame: 0week, 1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week, 12week, 16week, 20week, 32week
|
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
Time Frame: 1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week
|
Incidence rate (%) and number of injection site reactions
|
1week, 2week, 4week, 5week, 6week, 8week, 9week, 10week
|
|
Incidence rate of device deficiencies
Time Frame: 0week, 4week, 8week
|
Incidence rate (%) and number of of device deficiencies
|
0week, 4week, 8week
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 23CHN-Pro-IT01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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