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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HA + Lidocaine | Experimental |
| |
| Negative | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2% HA | Device | 2% HA |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shin Kong Wu Ho-Su Memorial Hospital | Taipei | Taiwan |
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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 |