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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
2% HA
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan
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.
Time frame: 6 months
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).
Time frame: 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'.
Time frame: 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.
Time frame: 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'.
Time frame: 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'.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline