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The results showed that subjects tolerated the Sodium Hyaluronate Gel for Injection (FACILLE®) well, with no systemic AEs, SAEs, and unanticipated AEs and associated with high satisfaction and self-evaluated effectiveness. Nearly half of the subjects maintained correction for 12 months and were satisfied with the product 3 years after the first injection.
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse events reported 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. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects self-evaluating satisfaction | Patients rate their treatment satisfaction based on highly satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied. | 2 weeks, 1, 3, 6, 12, 18, 24, 30 and 36 months post-injection |
| Subjects self-evaluating effectiveness |
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Inclusion Criteria:
Exclusion Criteria:
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The Institution of Medical Cosmetology
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Patients rate their effectiveness based on effective and ineffective. |
| 2 weeks, 1, 3, 6, 12, 18, 24, 30 and 36 months post-injection |