The Evaluation of the Safety and Effectiveness of a Novel Gel-type Sodium Hyaluronate for the Correction of Aging Mid-face

Study Overview
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Brief Summary
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This study is to evaluate the safety and effectiveness for the correction of aging mid-face of treatment group compared with the negative control group.

Official Title
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The Evaluation of the Safety and Effectiveness of a Novel Gel-Type Sodium Hyaluronate for the Correction of Aging Mid-Face

Conditions
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Dermal Filler, Hyaluronic Acid, Lidocaine, Aging Mid-Face

Intervention / Treatment
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* Device: 2% HA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 30 to 60 years of male or female MidFace Volume Deficit Scale (MFVDS) of midface graded 2 to 5 by evaluator. Exclusion Criteria: Injection site with infection or other skin diseases present which may affect the evaluation With medical history of chromatosis, discoloration, keloid formation, hypertrophic scarring at midface With permanent implants or planning to receive permanent implants during the study period at the injection sites Hyaluronate facial dermal implant injection or other impermanent dermal fillers injection at injection sites within the past 6 months With under-eye facial Botox or fat injection within the past 6 months or planning to receive under-eye facial Botox or fat injection during the study period With Major surgery 3 months before the start of the trial With under-eye facial chemical or lasers peeling, non-invasive skin tightening, thermocool within the past 3 months or planning to receive these aesthetic procedures during the study period With systemic immunosuppressive therapy or systemic corticosteroids within the past 2 months or planning to receive these therapies during the study period (subjects who have received inhaled/intranasal corticosteroids could be considered to include.) With clinical meaningful coagulation disorders, underdoing anticoagulant treatment or within the past 10 days, or taking blood circulation promotion and blood stasis movement medications With epilepsy or porphyria With congenital or idiopathic methemoglobinemia or glucose-6-phosphate dehydrogenase deficiency With analgesic dependence, analgesics within the past 2 weeks or planning to receive analgesics during the study period With history of hypersensitivity or allergy to lidocaine, amide anesthetics, hyaluronic acid or any component of the device; Gram-positive bacterial or Streptococcus proteins; other severe hypersensitivity history unsuitable for participating in the study Planning to undergo any surgery which may cause significant body weight change (such as bariatric surgery) or take any medication which may cause significant body weight change Pregnant, planning pregnancy or in breastfeeding females Participated in clinical study of other device or drug and have not terminated within the past 30 days -Other circumstances which judged to be unsuitable for participating in the study by the investigator

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HA + Lidocaine<br> | Device: 2% HA<br>* 2% HA<br>|
| No Intervention: Negative<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate of a ≥ 1 Grade improvement on the assessment of MidFace Volume Deficit Scale (MFVDS). | The response rate is a ≥ 1 Grade improvement on the assessment of MidFace Volume Deficit Scale (MFVDS) as assessed by the evaluator. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Face fullness value evaluated by the digital image scoring system after injection and post 1, 3, 6, 12, 18, 24 months. | The digital image scoring system analyzes the volume change (ml). | Baseline, 1, 3, 6, 12, 18 and 24 months post-injection | 
| On-site MFVDS value evaluated by blinded-evaluator after injection and 1, 3, 6, 12, 18, 24 months. | Evaluators assess the midface volume deficit scale on site with 5 graded scale, 0 to 5 was represented 'Fullness' to 'Severe concavity'. | Baseline, 1, 3, 6, 12, 18 and 24 months post-injection | 
| A Response rate of On-site MFVDS value evaluated by blinded-evaluator after injection and 1, 3, 6, 12, 18, 24 months. | The response rate is a ≥ 1 Grade improvement on the assessment of MidFace Volume Deficit Scale (MFVDS) as assessed by the evaluator. | Baseline, 1, 3, 6, 12, 18 and 24 months post-injection | 
| GAIS evaluated photographically by blinded-evaluator after injection and 1, 3, 6, 12, 18, 24 months. | Evaluators and subjects assess the improvement of correction with 5 graded scale,1 to 5 was represented 'exceptional improvement' to 'worsened'. | Baseline, 1, 3, 6, 12, 18 and 24 months post-injection | 
| VAS pain evaluated immediately and 15, 30, 45 and 60 minutes after injection. | The VAS scale uses a 100 mm line labelled at '0' with 'no pain' and '100' with 'worst pain'. | Immediate,15, 30, 45 and 60 minutes post-injection | 
| Adverse events reported from the baseline and during the study period | The safety assessment was based on reports of adverse events, defined as any unwanted events whether it was thought to be related to the study drugs or not, were recorded during each follow up and at any time the patient reported an event to the investigator during the study period. | Baseline, 1, 3, 6, 12, 18 and 24 months post-injection | 
| Serious adverse events reported from the baseline and during the study period | The safety assessment was based on reports of adverse events, defined as any unwanted events whether it was thought to be related to the study drugs or not, were recorded during each follow up and at any time the patient reported an event to the investigator during the study period. | Baseline, 1, 3, 6, 12, 18 and 24 months post-injection | 
| Device failure reported from the baseline and during the study period | The safety assessment was based on reports of adverse events, defined as any unwanted events whether it was thought to be related to the study drugs or not, were recorded during each follow up and at any time the patient reported an event to the investigator during the study period. | Baseline |